Page last updated: 2024-11-05

ephedrine

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Description

Ephedrine: A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

(-)-ephedrine : A phenethylamine alkaloid that is 2-phenylethanamine substituted by a methyl group at the amino nitrogen and a methyl and a hydroxy group at position 2 and 1 respectively. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

FloraRankFlora DefinitionFamilyFamily Definition
EphedragenusA plant genus of the family Ephedraceae, order Ephedrales, class Gnetopsida, division Gnetophyta.[MeSH]Ephedraceae[no description available]

Cross-References

ID SourceID
PubMed CID9294
CHEMBL ID211456
CHEBI ID15407
SCHEMBL ID4785
MeSH IDM0007539

Synonyms (113)

Synonym
emerphed (ephedrine sulfate injection)
gtpl556
(1r,2s)-2-methylamino-1-phenylpropan-1-ol
nsc-170951
l-erythro-2-(methylamino)-1-phenylpropan-1-ol
(1r,2s)-2-(methylamino)-1-phenylpropan-1-ol
CHEBI:15407 ,
ephedrine l-form
2-methylamino-1-phenyl-1-propanol
(l)-ephedrine
nsc 8971
alpha-(1-(methylamino)ethyl)benzenemethanol
alpha-hydroxy-beta-methylaminopropylbenzene
ephedremal
einecs 206-080-5
nsc 170951
1-phenyl-1-hydroxy-2-methylaminopropane
benzenemethanol, alpha-(1-(methylamino)ethyl)-, (-)-
ephedrine [usan:ban]
eciphin
ephedral
benzenemethanol, alpha-((1s)-1-(methylamino)ethyl)-, (alphar)-
1-2-methylamino-1-phenylpropanol
(-)-alpha-(1-methylaminoethyl)benzyl alcohol
ai3-02761
biophedrin
hsdb 3072
alpha-hydroxy-beta-methyl amine propylbenzene
1-alpha-(1-methylaminoethyl)benzyl alcohol
benzenemethanol, alpha-(1-(methylamino)ethyl)-, (r-(r*,s*))-
ephedrine (usp)
D00124
ephedrine (tn)
fedrin
ephedrin
i-sedrin
l(-)-ephedrine
ephedrine, l-(-)-
nsc-8971
norephedrine, n-methyl-
sanedrine
mandrin
lexofedrin
l-2-methylamino-1-phenylpropanol
ephedrol
PDSP2_001327
PDSP2_001330
1-sedrin
(1r,2s)-(-)-2-methylamino-1-phenyl-1-propanol
l-alpha-(1-methylaminoethyl)benzyl alcohol
(1r,2s)-(-)-alpha-(1-methylaminoethyl)benzenemethanol
(1r,2s)-2-(methylamino)-1-phenyl-propan-1-ol
C01575
ephedrine
(-)-ephedrine
(1r,2s)-1-phenyl-1-hydroxy-2-methylaminopropane
l-ephedrine
299-42-3
DB01364
LOPAC0_000501
(1r,2s)-(-)-ephedrine, 98%
NCGC00162174-01
erythro isomer of ephedrine
sal-phedrine
(1r,2s)-2-methylamino-1-phenyl-propan-1-ol
ephedrine erythro isomer
ephedrinum, anhydrous
ephedrine, anhydrous
CHEMBL211456
xenadrine
NCGC00162174-02
A820118
(1r,2s)-2-(methylamino)-1-phenyl-1-propanol
CCG-204592
AKOS016011257
gn83c131xs ,
ec 206-080-5
unii-gn83c131xs
ephedrinum, anhydrous [who-ip latin]
(r-(r*,s*))-.alpha.-(1-(methylamino)ethyl)benzenemethanol [who-ip]
ephedrine [ep monograph]
ephedrine [hsdb]
ephedrine, anhydrous [who-ip]
ephedrine [mi]
ephedrine [mart.]
ephedrine [usp monograph]
ephedrine [who-dd]
ephedrine [vandf]
benzenemethanol, .alpha.-(1-(methylamino)ethyl)-, (r-(r*,s*))-
pseudoephedrine hydrochloride impurity a [ep impurity]
SCHEMBL4785
J-500280
CS-4802
1(-)ephedrine
(1r*,2s*)-2-methylamino-1-phenyl-1-propanol
(1r,2s)-(-)-2-(n-methylamino)-1-phenylpropan-1-ol
(1r,2s)-2-methylamino-1-phenyl-1-propanol
benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, (.alpha.r)-
HY-B1195
AB00375843_06
DTXSID0022985 ,
SR-01000075166-1
sr-01000075166
SBI-0051362.P003
Q219626
(1r, 2s)-(-)-ephedrine
-(1r,2s)-(-)-ephedrine
efedrina
(r-(r*,s*))-alpha-(1-(methylamino)ethyl)benzenemethanol
ephedrine (mart.)
ephedrine (ep monograph)
ephedrine (usp monograph)
dtxcid402985

Research Excerpts

Overview

Ephedrine (EPH) is an alkaloid commonly used to relieve nasal congestion. Ephedrine nasal spray is a fast-onset, short-acting decongestant.

ExcerptReferenceRelevance
"Ephedrine is a commonly used vasopressor, however, we report the case of a patient with unusually severe blood pressure elevation following intravenous ephedrine administration during CEA."( Severe blood pressure elevation following ephedrine administration during carotid endarterectomy under general anesthesia: A CARE-compliant case report.
Kim, H; Kim, JE; Yu, T, 2023
)
1.9
"Ephedrine is a mixed α- and β-agonist vasopressor that is frequently used for the correction of hypotension during general anesthesia. "( Hemodynamic impact of ephedrine on hypotension during general anesthesia: a prospective cohort study on middle-aged and older patients.
Kinoshita, M; Sakai, Y; Tanaka, K; Uemura, Y, 2023
)
2.67
"Ephedrine is a compound isolated from Ephedra and plays a regulatory role in inflammatory response."( Ephedrine alleviates bleomycin-induced pulmonary fibrosis by inhibiting epithelial-mesenchymal transition and restraining NF-κB signaling.
Fu, T; Tian, H; Wang, L, 2023
)
3.07
"Ephedrine is a typical compound found in lots of plant species that is used in several medicines for the treatment of asthma and bronchitis. "( Multi-phase extraction of ephedrine from Pinellia ternata and herbal medicine using molecular imprinted polymer coated ionic liquid-based silica.
Fang, L; Lin, L; Row, KH; Tian, M; Xie, J, 2020
)
2.3
"Ephedrine is a common starting compound for methamphetamine synthesis."( Stereoselective analysis of ephedrine and its stereoisomers as impurities and/or by-products in seized methamphetamine by supercritical fluid chromatography/tandem mass spectrometry.
Iwata, YT; Kanamori, T; Kuwayama, K; Okada, Y; Segawa, H; Tsujikawa, K; Yamamuro, T, 2021
)
1.64
"The ephedrine study is a prospective, randomized, open-label, controlled, dose-escalation trial. "( Determination of the optimal dose of ephedrine in the treatment of arterial hypotension due to general anesthesia in neonates and infants below 6 months old: the ephedrine study protocol for a randomized, open-label, controlled, dose escalation trial.
Boucher, P; Chassard, D; de Queiroz Siqueira, M; Gaillard, S; Gerst, A; Granier, M; Kassai, B; Lambert, A; Martin, P; Merquiol, F; Nony, P; Saunier, C; Storme, T; Subtil, F; Szostek, AS; Zerzaihi, O, 2021
)
1.45
"Ephedrine (EPH) is an alkaloid commonly used to relieve nasal congestion caused by colds, allergic rhinitis, rhinitis, and sinusitis, and to control bronchial asthma. "( [Organ-Specific Accumulation and Toxicokinetics of Ephedrine in Adult Zebrafish (
Deng, YH; Guo, CS; Qiu, ZW; Teng, YG; Xu, J; Yin, XX; Zhang, Y, 2021
)
2.32
"Ephedrine nasal spray is a fast-onset, short-acting decongestant. "( Two-Hour Nasal Responses after a Single Dose of Ephedrine Nasal Spray in Healthy Males.
Arpornchayanon, W; Fooanant, S; Hanprasertpong, N; Manorot, M; Roongapinun, S; Trakarnsilpa, C, 2017
)
2.15
"Ephedrine is a direct/indirect vasoactive drug. "( Ephedrine shows synergistic motor blockade when combined with bupivacaine or lidocaine for spinal anesthesia in a rat model.
Danninger, T; Djalali, AG; Fritsch, G; Gerner, P; Perez-Valdivieso, JR; Wang, JC; Zurakowski, D, 2013
)
3.28
"Ephedrines are an example where the optimal separation of their isomers and related substances is complicated due to both their hydrophilicity and basic nature."( Comparison of reversed-phase and hydrophilic interaction liquid chromatography for the quantification of ephedrines using medium-resolution accurate mass spectrometry.
Cowan, DA; Gray, N; Heaton, J; Musenga, A; Plumb, RS; Smith, NW, 2013
)
1.33
"Ephedrine is an emergency drug available in ampules and syringes need to be prepared in advance according to one of two strategies in our establishment: strategy 1 (S1: 1 ampule per patient) and strategy 2 (S2: 1 ampule per operating room). "( [Economic impact of strategies using ephedrine prefilled syringes].
Crégut-Corbaton, J; Fagnoni, P; Guignard, MH; Malbranche, C, 2013
)
2.11
"Ephedrine is a sympathomimetic substance used by sportsmen as a doping substance because of its stimulating and slimming effects. "( Ventricular arrhythmias induced by long-term use of ephedrine in two competitive athletes.
Andreini, D; Bologna, F; Bolognese, L; Casella, M; Colombo, D; Dello Russo, A; Izzo, G; Pieroni, M; Russo, E; Tondo, C; Zeppilli, P, 2015
)
2.11
"Ephedrine use in sport is a common practice among men. "( 'It is safe to use if you are healthy': A discursive analysis of men's online accounts of ephedrine use.
Gough, B; Grogan, S; Hall, M, 2015
)
2.08
"Ephedrine (Eph) is an alkaloid extracted from the Chinese traditional medicine plant Ephedra Sinica or Ma huang, which has been known for effects on the central nervous system, cardiovascular system, and smooth muscles. "( Ephedrine controls heart rhythms by activating cardiac I(ks) currents.
He, G; Jing, H; Li, H; Luo, L; Sun, J; Wang, C; Wu, Y; Yi, H, 2010
)
3.25
"Ephedrine appears to be an effective treatment for Dok-7 CMS. "( Ephedrine treatment in congenital myasthenic syndrome due to mutations in DOK7.
Beeson, D; Jayawant, S; Lashley, D; Palace, J; Robb, S, 2010
)
3.25
"Oral ephedrine hydrochloride is an effective treatment for carefully selected children with resistant non-neurogenic daytime urinary incontinence."( Ephedrine hydrochloride: novel use in the management of resistant non-neurogenic daytime urinary incontinence in children.
Affleck, S; Boddy, SA; Featherstone, N; Murphy, F; Stanwell, J; Wang, K, 2013
)
2.35
"Ephedrine is a sympathicomimetic agent that stimulates the central nervous and cardiovascular systems and causes bronchodilatation. "( [Ephedrine and ephedra in weight loss products and other preparations].
Stricker, BH; van der Hooft, CS, 2002
)
2.67
"Ephedrine is a long-studied stimulant available both as a prescription and over-the-counter medication, as well as an ingredient in widely marketed herbal preparations, and is also used as a precursor for the illicit synthesis of methamphetamine. "( In vitro characterization of ephedrine-related stereoisomers at biogenic amine transporters and the receptorome reveals selective actions as norepinephrine transporter substrates.
Birkes, J; Compton-Toth, BA; Glennon, RA; Hufeisen, SJ; Partilla, JS; Roth, BL; Rothman, RB; Vu, N; Young, R, 2003
)
2.05
"Ephedrine is a mixed adrenergic agonist, stimulating both alpha- and beta-adrenergic receptors. "( Effect of inhibition of nitric oxide synthase on the vasopressor response to ephedrine.
Dabisch, PA; Kadowitz, PJ; Liles, JT, 2003
)
1.99
"Ephedrine is a central nervous system stimulant that has a pharmacological profile similar to amphetamines. "( Mecamylamine attenuates ephedrine-induced hyperactivity in rats.
Miller, DK; Segert, IL, 2005
)
2.08
"Ephedrine is a potential slimming drug that stimulates thermogenesis in man and laboratory animals. "( Ephedrine, a potential slimming drug, directly stimulates thermogenesis in brown adipocytes via beta-adrenoreceptors.
Bukowiecki, L; Follea, N; Jahjah, L, 1982
)
3.15
"Ephedrine appears to be a safe and effective treatment clozapine-associated UI. "( Clozapine-induced urinary incontinence: incidence and treatment with ephedrine.
Borovicka, MC; Fuller, MA; Jaskiw, GE; Konicki, PE; Kwon, K; Simon, MR, 1996
)
1.97
"(+/-)Ephedrine is a relatively weak partial agonist of human beta1- and beta2-adrenoreceptors, and had no detectable activity at human beta3-adrenoreceptors."( Acute effect of ephedrine on 24-h energy balance.
Candelore, MR; Chen, K; Flattery, S; Gertz, B; Gottesdiener, K; Jordan, J; Larson, PJ; Robertson, D; Shannon, JR; Sun, M, 1999
)
1.1
"l-Ephedrine is an active ingredient in several herbal formulations with a mechanism of action similar to amphetamine and methamphetamine. "( An evaluation of l-ephedrine neurotoxicity with respect to hyperthermia and caudate/putamen microdialysate levels of ephedrine, dopamine, serotonin, and glutamate.
Bowyer, JF; Ferguson, SA; Gough, B; Newport, GD; Slikker, W; Tor-Agbidye, J, 2000
)
1.36
"Ephedrine is a sympathomimetic drug that is currently found in many over-the-counter preparations. "( Reinforcing and discriminative-stimulus effects of ephedrine isomers in rhesus monkeys.
Anderson, KG; Winger, G; Woods, J; Woolverton, WL, 2001
)
2.01
"Ephedrine is a potent bronchodilator that, in appropriate doses, can be administered safely along with therapeutic doses of theophylline without fear of progressive tolerance or toxicity."( Ephedrine therapy in asthmatic children. Clinical tolerance and absence of side effects.
Avner, SE; Tinkelman, DG, 1977
)
2.42

Effects

Ephedrine has significant vasopressor activity in the pulmonary vascular bed of the cat. Hydrochloride oxymetazoline has neither effect on nasal mucosa, nor destroying the physical function of nose. Ephedrine abuse has spread in many parts of the world, severely threatening human health.

ExcerptReferenceRelevance
"Ephedrine has an antimicrobial activity on Staphylococcus aureus and Acinetobacter species which were frequently encountered pathogens as a cause of nosocomial infections."( [The antimicrobial activity of ephedrine and admixture of ephedrine and propofol: an in vitro study].
Alasehir, EA; Selvi, O; Tulgar, S,
)
1.86
"Ephedrine abuse has spread in many parts of the world, severely threatening human health. "( Effects of Chronic Ephedrine Toxicity on Functional Connections, Cell Apoptosis, and CREB-Related Proteins in the Prefrontal Cortex of Rhesus Monkeys.
Duan, S; Guo, R; Huang, J; Lin, Z; Lv, J; Ma, S; Ma, Y; Sun, Z; Xie, L; Xie, Y; Zheng, L, 2020
)
2.33
"Ephedrine (EPH) has been proven to have anti-inflammatory and anti-oxidative stress effects."( Ephedrine alleviates middle cerebral artery occlusion-induced neurological deficits and hippocampal neuronal damage in rats by activating PI3K/AKT signaling pathway.
Huang, L; Jiang, H; Li, Q; Wu, J; Zhao, B, 2021
)
2.79
"Ephedrine has an antimicrobial activity on Staphylococcus aureus and Acinetobacter species which were frequently encountered pathogens as a cause of nosocomial infections."( [The antimicrobial activity of ephedrine and admixture of ephedrine and propofol: an in vitro study].
Alasehir, EA; Selvi, O; Tulgar, S,
)
1.86
"Ephedrine (E) has been reported to be the major bioactive constituent in MH for the treatment of asthma."( GC-MS based metabolomics study of stems and roots of Ephedra sinica.
Fan, H; Huang, W; Lv, M; Sun, J; Wang, M; Xu, F; Zhang, Z, 2015
)
1.14
"Ephedrine has been shown to improve the intubating conditions of rocuronium following its priming with a small dose."( Effects of ephedrine on intubating conditions following priming with atracurium: a randomized clinical trial.
Alagha, AE; Hajimohamadi, F; Rahimi, I; Rashidi, A, 2009
)
1.46
"(-)-Ephedrine has caused concern because of its use as a precursor in the manufacture of street drugs (e.g."( Discriminative stimulus effects of (-)-ephedrine in rats: analysis with catecholamine transporter and receptor ligands.
Cunningham, KA; McMahon, LR, 2003
)
1.07
"Ephedrine has significant vasopressor activity in the pulmonary vascular bed of the cat meditated predominantly by alpha1 adrenergic receptor activation."( Ephedrine in the cat lung vasculature.
Fields, AM; Ibrahim, IN; Kaye, AD; Richards, TA, 2003
)
3.2
"Ephedrine has been used as a stimulant and weight-loss product, guaifenesin as an expectorant and cough suppressant; both are found in combination in many antitussives and expectorants."( Ephedrine- and guaifenesin-induced nephrolithiasis.
Bennett, S; Hoffman, N; Monga, M, 2004
)
2.49
"Ephedrine has ill effects on nasal mucosa; Hydrochloride oxymetazoline has neither effect on nasal mucosa, nor destroying the physical function of nose, it is an ideal nasal decongestant."( [The observation of the ciliotoxicity of nasal mucosa with nasal decongestant].
Cai, Q; Teng, Y; Xu, G; Xu, J; Zhang, X, 2005
)
1.77
"Ephedrine, however, has limited efficacy, is difficult to titrate, causes maternal tachycardia and depresses fetal pH and base excess."( Vasopressors in obstetrics: what should we be using?
Khaw, KS; Ngan Kee, WD, 2006
)
1.06
"Ephedrine has been the vasopressor of choice for long, but has a weak prophylactic efficacy."( [Spinal anaesthesia for caesarean section: fluid loading, vasopressors and hypotension].
Banu, F; Bonnet, MP; De la Dorie, A; Edouard, D; Hanaf, A; Mercier, FJ; Moufouki, M; Roger-Christoph, S,
)
0.85
"(-)-Ephedrine has been shown to increase energy expenditure and cause the loss of body fat in rats and mice. "( Thermogenic and anorectic effects of ephedrine and congeners in mice and rats.
Ainsworth, AT; Arch, JR; Cawthorne, MA, 1982
)
1.1
"Ephedrine has both alpha- and beta-adrenergic activity, and both direct and indirect effects on receptors. "( [Ephedrine psychosis].
Shufman, NE; Vass, A; Witztum, E, 1994
)
2.64
"(-)-Ephedrine has been used in the treatment of patients with myasthenia gravis. "( Ephedrine: effects on neuromuscular transmission.
Engel, AG; Sieb, JP, 1993
)
2.29
"Ephedrine has adrenergic effects on the circulation."( The effects of midazolam and ephedrine on post-exercise autonomic chronotropic control of the heart in normal subjects.
Jalonen, J; Laitinen, LA; Lindqvist, A; Seppälä, T; Strömberg, C, 1996
)
1.31
"Ephedrine has stimulating effects on the CNS which have been shown as increased locomotor activity, for example. "( Pharmacokinetics and locomotor activity increasing effect of ephedrine in mice.
Kivirinta, R; Marvola, M, 1978
)
1.94
"1 Ephedrine plasma levels have been measured in ten asthmatic patients given a singel dose of ephedrine hydrochloride (22 mg) along and in combination with theophylline and a barbiturate. "( The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment.
May, CS; Paterson, JW; Pickup, ME; Ssendagire, R, 1976
)
1.28
"Ephedrine has been proposed to activate fibrinolysis, but we found no increased tPA activity."( Hemostatic effects of ephedrine.
Flordal, PA; Svensson, J, 1992
)
1.32
"Ephedrine has not been reviewed as useful in such situations."( Ephedrine in the initial treatment of haemorrhagic shock.
Eldor, J, 1991
)
2.45

Actions

Ephedrine does not increase the effectiveness of chlorpheniramine against motion sickness, but counteracts sedative and performance effects successfully. Ephedrine can enhance spatial orientation and learning and memory abilities of HIBD rats.

ExcerptReferenceRelevance
"Ephedrine could cause significant increase in diastolic blood pressure 2 minutes after IV injection, which could last until at least 9 minutes in the prone position group compared to only for 5 minutes in the supine position group (all P< .05)."( Prone position results in enhanced pressor response to ephedrine compared with supine position during general anesthesia.
Lu, X; Xia, J; Yin, N; Yuan, J, 2016
)
1.4
"Ephedrine does not increase the effectiveness of chlorpheniramine against motion sickness, but counteracts sedative and performance effects successfully."( Chlorpheniramine and ephedrine in combination for motion sickness.
Alvarenga, DL; Buckey, JC; MacKenzie, TA, 2007
)
2.1
"Ephedrine can enhance spatial orientation and learning and memory abilities of HIBD rats in later life. "( [Effect of ephedrine on neuronal plasticity in neonatal rats after hypoxic-ischemic brain injury].
Li, SZ; Xiao, N; Zhang, XP, 2007
)
2.17
"Ephedrine may enhance memory, the abilities of spatial orientation and learning in HIBD rats. "( Effect of ephedrine on neuronal plasticity of hypoxic-ischemic brain damage in neonatal rats.
Chen, S; Li, S; Xiao, N; Zhang, X, 2008
)
2.19
"ephedrine. An increase in heart rate or systolic pressure of > or = 20% from baseline was found in two patients in the ephedrine group and in one patient in the placebo group."( Prophylactic i.m. ephedrine in bupivacaine spinal anaesthesia.
Rettrup, A; Sandin, R; Sternlo, JE, 1995
)
1.35
"Ephedrine may also enhance certain physical and mental functions related to "energy," but the evidence that ginseng has such properties is exceedingly weak."( The effects of ginseng, ephedrine, and caffeine on cognitive performance, mood and energy.
Lieberman, HR, 2001
)
1.34
"An ephedrine-induced increase of the interscapular skin temperature has been interpreted as evidence of the presence of thermogenic BAT."( Thermogenesis in human brown adipose tissue and skeletal muscle induced by sympathomimetic stimulation.
Astrup, A, 1986
)
0.78

Treatment

Ephedrine treatment for hypotension during DIEP flap cases is associated with decreased intraoperative flap complication rates. Ephedrine as add-on treatment for myasthenia gravis resulted in a small but consistent reduction of symptoms.

ExcerptReferenceRelevance
"Ephedrine treatment also suppressed TNF-α and IL-1β production and NOD-like receptor pyrin domain 3 (NLRP3) inflammasome activation in BV2 microglial cells."( Ephedrine ameliorates cerebral ischemia injury via inhibiting NOD-like receptor pyrin domain 3 inflammasome activation through the Akt/GSK3β/NRF2 pathway.
Huang, L; Li, Q; Wu, J; Zhao, B, 2021
)
2.79
"Ephedrine treatment significantly alleviated the cerebral ischemia/reperfusion injury, evidenced by decreased neurological deficit score, infarct volume and water content."( Ephedrine attenuates cerebral ischemia/reperfusion injury in rats through NF-κB signaling pathway.
Li, J; Shi, C, 2021
)
2.79
"Ephedrine treatment for hypotension during DIEP flap cases is associated with decreased intraoperative flap complication rates compared with controls who did not receive vasopressors, whereas phenylephrine has no significant association. "( Selective Intraoperative Vasopressor Use Is Not Associated with Increased Risk of DIEP Flap Complications.
Caterson, SA; Huang, CC; Lu, JT; Ogura, A; Orgill, DP; Szabo Eltorai, A, 2017
)
1.9
"Ephedrine as add-on treatment for myasthenia gravis resulted in a small but consistent reduction of symptoms and weakness in patients with moderate disease severity."( Ephedrine treatment for autoimmune myasthenia gravis.
Cornel, MC; Hekster, YA; Kuijpers, MR; Lipka, AF; Schimmel, KJ; van Zwet, EW; Verschuuren, JJ; Vrinten, C; Weinreich, SS, 2017
)
2.62
"Ephedrine as a treatment for asthma reached its zenith in the late 1950s, since when there has been a gradual and inevitable decline in its therapeutic use."( The history of Ephedra (ma-huang).
Lee, MR, 2011
)
1.09
"Ephedrine is used in treatment of hypotension during anesthesia. "( Ephedrine accelerates psychomotor recovery from anesthesia in macaque monkeys.
Hess, L; Kurzová, A; Málek, J; Slíva, J; Stein, K; Votava, M, 2012
)
3.26
"In ephedrine-caffeine-treated animals terminated after the second dosing, foci of myocardial degeneration and necrosis were already infiltrated by mixed inflammatory cells."( Acute hemorrhagic myocardial necrosis and sudden death of rats exposed to a combination of ephedrine and caffeine.
Collins, BJ; Dunnick, JK; Foley, JF; Hanlon, P; Howden, R; Murphy, E; Nyska, A; Petranka, J, 2005
)
1.06
"Some ephedrine-treated NZM391 mice also were preadministered the beta-AR antagonist propranolol to investigate beta-AR involvement."( The dietary supplement ephedrine induces beta-adrenergic mediated exacerbation of systemic lupus erythematosus in NZM391 mice.
Cao, L; Huber, VC; Hudson, CA; Kasten-Jolly, J; Lawrence, DA; Mondal, TK, 2005
)
1.09
"Ephedrine treatment was very effective, with 15/16 patients showing improvement within 24 hours after reaching maximum ephedrine dosage."( Clozapine-induced urinary incontinence: incidence and treatment with ephedrine.
Borovicka, MC; Fuller, MA; Jaskiw, GE; Konicki, PE; Kwon, K; Simon, MR, 1996
)
1.25
"Ephedrine treated group of patient had significant less emetic score than propofol."( Prevention of post-operative nausea and vomiting following laparoscopic surgery--ephedrine vs propofol.
Al-Khayat, HC; Naguib, K; Osman, HA; Zikri, AM, 1998
)
1.25
"The ephedrine treated patients had significantly less nausea, retching and vomiting, and need of antiemetic rescue during the first 3 h postoperatively compared with the placebo patients. "( Intramuscular ephedrine reduces emesis during the first three hours after abdominal hysterectomy.
Hagemann, E; Halvorsen, A; Holgersen, O; Raeder, JC; Tveit, T, 2000
)
1.23
"Ephedrine treatment was administered based on the degree of hypotension observed."( Baseline heart rate may predict hypotension after spinal anesthesia in prehydrated obstetrical patients.
Caton, D; Frölich, MA, 2002
)
1.04
"Ephedrine or PPA pretreatment had no apparent effect on these parameters."( Further metabolic studies of codeine and morphine in mice pretreated with sympathomimetics.
Chan, K; Dambisya, YM; Wong, CL, 1992
)
1
"Treatment with ephedrine or oral salbutamol can result in a slow, steady, and often dramatic improvement over months."( DOK7 congenital myasthenic syndrome.
Palace, J, 2012
)
0.72
"Pretreatment with ephedrine 30 microg/kg did not attenuate pain associated with intravenous injection of propofol, nor did it improve haemodynamic stability during induction."( Pain during injection of propofol: the effect of prior administration of ephedrine.
Agarwal, A; Dhiraaj, S; Gupta, D; Ranjan, R; Raza, M; Singh, PK; Singh, U; Singhal, V, 2004
)
0.88
"Pretreatment by ephedrine improved significantly (p<0.0001) intubating conditions after succinylcholine and rocuronium."( [Effect of ephedrine on the intubation conditions using rocuronium versus succinylcholine].
Atmani, M; Azendour, H; Belyamani, L; Elhassouni, A; Kamili, ND; Zidouh, S, 2008
)
1.07
"Treatment with ephedrine produced a tendency toward an increase of nasal airflow. "( Topical ephedrine administration and nasal chemosensory function in healthy human subjects.
Herneth, A; Hummel, T; Quint, C; Temmel, AF; Toth, J, 1999
)
1.09
"Treatment with ephedrine had no influence on either the UtPI or UmPI, but treatment with methoxamine resulted in brief increases in the UtPI of 0.47 (0.24-0.69) during the first 5 min after its administration; the increases were brief and resolved within 2 min."( Vasopressor therapy for hypotension during epidural anesthesia for cesarean section: effects on maternal and fetal flow velocity ratios.
Fitzpatrick, KT; Iftikhar, M; Moore, J; Thompson, W; Wright, PM, 1992
)
0.62

Toxicity

The objective of the study was to evaluate the adverse reactions of Loratadine plus Pseudoephedrine Sulfate Repetabs Tables. Ephedra Herb extract (EFE) has been developed to eliminate the adverse effects caused by ephedrine alkaloid-induced sympathetic hyperactivation.

ExcerptReferenceRelevance
" No adverse effects (including tachyphylaxis and tremor) were observed for either drug during a three-month period."( Safety and effectiveness of terbutaline in children with chronic asthma.
Gavani, UD; Hyde, JS; Khurana, S; Manaligod, LM, 1979
)
0.26
" A search of the English literature from 1966 to 1984 revealed 12 prospective clinical studies out of 37 articles that specifically addressed the potential adverse pressor effect of SMDs."( Are oral decongestants safe in hypertension? An evaluation of the evidence and a framework for assessing clinical trials.
Deck, CC; Radack, K, 1986
)
0.27
"" Toxic effects may result from overdose, drug interactions, or diseases that increase sensitivity to sympathomimetic agents."( Toxicity of over-the-counter stimulants.
Pentel, P, 1984
)
0.27
" Generally, toxic reactions involve excessive CNS stimulation (e."( Managing acute toxicity from nonprescription stimulants.
Conner, CS; Rumack, BH; Sawyer, DR,
)
0.13
" All treatments were generally well tolerated with no serious or unusual adverse events."( Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis.
Boggs, P; Bronsky, E; Findlay, S; Gawchik, S; Georgitis, J; Mansmann, H; Meltzer, E; Morris, R; Sholler, L; Wolfe, J, 1995
)
0.53
"7% for the two adverse events, respectively) than in the T/Ps group (10."( Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis.
Falliers, CJ; Grant, JA; Huster, WJ; McNutt, B; Podleski, WK; Segal, AT; Woehler, TR, 1993
)
0.55
"During December 1993-September 1995, the Bureau of Food and Drug Safety, Texas Department of Health (TDH), received approximately 500 reports of adverse events in persons who consumed dietary supplement products containing ephedrine and associated alkaloids (pseudoephedrine, norephedrine, and N-methyl ephedrine)."( Adverse events associated with ephedrine-containing products--Texas, December 1993-September 1995.
, 1996
)
0.76
" 5 mg loratadine plus 120 mg pseudoephedrine was safe and effective in relieving the symptoms of allergic rhinitis."( [Evaluation of the efficiency and safety of the loratadine with pseudoephedrine combination drug in treatment of seasonal allergic rhinitis].
Lipiec, A; Rapiejko, P; Zawisza, E, 1998
)
0.81
" Both medications were well tolerated, and no serious adverse events occurred during the study."( Efficacy and safety relative to placebo of an oral formulation of cetirizine and sustained-release pseudoephedrine in the management of nasal congestion.
Berger, UE; Burtin, B; Duby, C; Horak, F; Jäger, S; Marks, B; Stübner, UP; Toth, J, 1998
)
0.51
" No serious adverse events occurred, and both regimens were equally well tolerated."( Efficacy and safety relative to placebo of an oral formulation of cetirizine and sustained-release pseudoephedrine in the management of nasal congestion.
Berger, UE; Burtin, B; Duby, C; Horak, F; Jäger, S; Marks, B; Stübner, UP; Toth, J, 1998
)
0.51
" For this reason, the adverse effects and drug interactions associated with herbal remedies are largely unknown."( Herbal remedies: adverse effects and drug interactions.
Cupp, MJ, 1999
)
0.3
" No serious adverse events were reported in any of the treatment groups."( The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in combination, in seasonal allergic rhinitis.
Compton, D; Mason, J; Ricard, N; Stewart, J; Sussman, GL, 1999
)
0.55
" (3) The relatively high sensitivity of the Neuro-2a cell line to the toxicity of ma-huang extracts suggests that the toxic principles were acting on neuronal cells."( Cytotoxicity assessment of Ma-huang (Ephedra) under different conditions of preparation.
Che, CT; Cheng, BW; Hsieh, DP; Lee, MK, 2000
)
0.31
" Adverse events were negligible and did not differ between the CE and PL groups."( Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents.
Erhardt, E; Jeges, S; Molnár, D; Török, K, 2000
)
0.57
"According to the present pilot study, CE can be a safe and effective compound for the treatment of obesity in adolescents."( Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents.
Erhardt, E; Jeges, S; Molnár, D; Török, K, 2000
)
0.57
" No clinically relevant adverse events were recorded."( Efficacy and safety of an oral formulation of cetirizine and prolonged-release pseudoephedrine versus xylometazoline nasal spray in nasal congestion.
Berger, UE; Burtin, B; Horak, F; Marks, B; Stübner, UP; Toth, J, 2001
)
0.53
"In this 6-month placebo-controlled trial, herbal ephedra/caffeine (90/192 mg/day) promoted body weight and body fat reduction and improved blood lipids without significant adverse events."( Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial.
Blanchard, D; Boozer, CN; Daly, PA; Homel, P; Meredith, T; Nasser, JA; Solomon, JL; Strauss, R, 2002
)
0.31
" Reports of adverse events associated with the use of these non-prescription supplements have raised concerns in the United States regulatory community."( The safety and efficacy of pharmaceutical and herbal caffeine and ephedrine use as a weight loss agent.
Greenway, FL, 2001
)
0.55
"Fexofenadine-pseudoephedrine was safe and effective in treating a broad range of allergy symptoms, with a rapid onset of action at 45 minutes."( Onset of action, efficacy, and safety of fexofenadine 60 mg/pseudoephedrine 120 mg versus placebo in the Atlanta allergen exposure unit.
Berkowitz, RB; Lutz, C; Meeves, S; Moss, M; Weiler, J; Weiler, K; Woodworth, GG, 2002
)
0.88
"The objective of the study was to evaluate the adverse reactions of Loratadine plus Pseudoephedrine Sulfate Repetabs Tables (LTD+PSE Repetabs) (Loratadine 5 mg + Pseudoephedrine 120 mg) twice daily with that of loratadine (5 mg) twice daily and pseudoephedrine (60 mg) quarter daily in the treatment of patients with allergic rhinitis."( A comparative study of the side effects between pseudoephedrine in Loratadine plus Pseudoephedrine Sulfate Repetabs Tables and loratadine + pseudoephedrine tablet in treatment of allergic rhinitis in Thai patients.
Chochaipanichnon, L; Kerekhanjanarong, V; Saengpanich, S; Supiyaphun, P, 2002
)
0.78
" Somnolence, fatigue, and nausea were the most common volunteered adverse events; only somnolence was significantly greater after CPA than after either PA or placebo."( Efficacy and safety of clemastine-pseudoephedrine-acetaminophen versus pseudoephedrine-acetaminophen in the treatment of seasonal allergic rhinitis in a 1-day, placebo-controlled park study.
Casale, TB; del Rio, E; Gold, MS; Meltzer, EO; O'Connor, R; Reitberg, D; Weiler, JM; Weiler, K, 2003
)
0.59
"Treatment with CPA was safe and highly effective in reducing symptoms associated with SAR."( Efficacy and safety of clemastine-pseudoephedrine-acetaminophen versus pseudoephedrine-acetaminophen in the treatment of seasonal allergic rhinitis in a 1-day, placebo-controlled park study.
Casale, TB; del Rio, E; Gold, MS; Meltzer, EO; O'Connor, R; Reitberg, D; Weiler, JM; Weiler, K, 2003
)
0.59
" However, there have been reports of patients experiencing adverse events with related agents."( Safety of selegiline with cold medications.
Jacob, JE; Sage, JI; Wagner, ML, 2003
)
0.32
" If selegiline is used with these medications, watch for adverse events or replace selegiline with another drug."( Safety of selegiline with cold medications.
Jacob, JE; Sage, JI; Wagner, ML, 2003
)
0.32
"We searched 9 databases using the terms ephedra, ephedrine, adverse effect, side effect, efficacy, effective, and toxic."( Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis.
Gagné, J; Hardy, ML; Jungvig, L; Maglione, M; Mojica, WA; Morton, SC; Rhodes, SL; Shekelle, PG; Suttorp, MJ, 2003
)
0.85
"Eligible studies were controlled trials of ephedra or ephedrine used for weight loss or athletic performance and case reports of adverse events associated with such use."( Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis.
Gagné, J; Hardy, ML; Jungvig, L; Maglione, M; Mojica, WA; Morton, SC; Rhodes, SL; Shekelle, PG; Suttorp, MJ, 2003
)
0.84
" Weight loss and athletic performance appear to be only modestly improved, for short durations, in the setting of large numbers of (some serious) adverse event reports."( Safety concerns regarding ephedrine-type alkaloid-containing dietary supplements.
Miller, SC, 2004
)
0.62
"The safe use of ephedra represents the best possible outcome of a convergence of variables, some with troubling potential outcomes."( Safety of ephedra: lessons learned.
Burdock, GA; Carabin, IG; Griffiths, JC; Soni, MG, 2004
)
0.32
" There were 54 patients who reported 61 adverse events."( [A clinical trial to evaluate the efficacy and safety of compound pseudoephedrine hydrochloride sustained release capsule in patients with seasonal allergic rhinitis].
, 2004
)
0.56
" Five adverse events were reported in both treatment groups and these were deemed to be unrelated to treatment."( Efficacy and safety of single and multiple doses of pseudoephedrine in the treatment of nasal congestion associated with common cold.
Angello, JT; Druce, HM; Eccles, R; Jawad, MS; Jawad, SS,
)
0.38
"The results demonstrate that pseudoephedrine is a safe and effective treatment for nasal congestion associated with URTI."( Efficacy and safety of single and multiple doses of pseudoephedrine in the treatment of nasal congestion associated with common cold.
Angello, JT; Druce, HM; Eccles, R; Jawad, MS; Jawad, SS,
)
0.65
" No unusual or unexpected adverse events were reported."( Efficacy and safety of an extended-release formulation of desloratadine and pseudoephedrine vs the individual components in the treatment of seasonal allergic rhinitis.
Grubbe, R; Lutsky, B; Pleskow, W; Weiss, S, 2005
)
0.55
" The most frequently reported adverse events were insomnia, headache, and dry mouth."( Efficacy and safety of desloratadine/pseudoephedrine tablet, 2.5/120 mg two times a day, versus individual components in the treatment of patients with seasonal allergic rhinitis.
Chervinsky, P; Danzig, M; Nayak, A; Rooklin, A,
)
0.39
"Three toxic substances have been made into a mixture administered intravenously, similar to methcathinone."( Neurotoxicity following chronic intravenous use of "Russian cocktail".
Delipoyraz, I; Filiz, G; Gecim, NO; Tireli, H; Varlibas, F; Yuksel, G, 2009
)
0.35
" The adverse drug reactions and compliance were assessed as well."( [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].
Lu, Q, 2010
)
0.57
" Animals were sacrificed on GD 21, and fetuses were examined for the presence of various developmental toxic endpoints."( Developmental toxicity of Citrus aurantium in rats.
Hansen, DK; Juliar, BE; Pellicore, LS; White, GE, 2011
)
0.37
"At doses up to 100 mg synephrine/kg body weight, there were no adverse effects on embryolethality, fetal weight, or incidences of gross, visceral, or skeletal abnormalities."( Developmental toxicity of Citrus aurantium in rats.
Hansen, DK; Juliar, BE; Pellicore, LS; White, GE, 2011
)
0.37
"It is generally accepted that the primary pharmacological activities and adverse effects of Ephedra Herb are caused by ephedrine alkaloids."( Ephedrine alkaloids-free Ephedra Herb extract: a safer alternative to ephedra with comparable analgesic, anticancer, and anti-influenza activities.
Amakura, Y; Goda, Y; Hakamatsuka, T; Hanawa, T; Hyuga, M; Hyuga, S; Kamakura, H; Maruyama, T; Odaguchi, H; Oshima, N; Yamashita, T; Yoshimura, M, 2016
)
2.09
"Ephedrine alkaloids-free Ephedra Herb extract (EFE) has been developed to eliminate the adverse effects caused by ephedrine alkaloid-induced sympathetic hyperactivation."( Ephedrine Alkaloids-Free Ephedra Herb Extract, EFE, Has No Adverse Effects Such as Excitation, Insomnia, and Arrhythmias.
Amakura, Y; Goda, Y; Hakamatsuka, T; Hanawa, T; Hyuga, M; Hyuga, S; Kobayashi, Y; Maruyama, T; Odaguchi, H; Oshima, N; Takahashi, J; Takemoto, H; Uchiyama, N; Yamashita, T, 2018
)
3.37
" Despite its high effectiveness, Ephedra Herb exert several adverse effects, including palpitation, excitation, insomnia, and dysuria."( [The Adverse Effects of Ephedra Herb and the Safety of Ephedrine Alkaloids-free Ephedra Herb Extract (EFE)].
Amakura, Y; Goda, Y; Hakamatsuka, T; Hanawa, T; Huang, X; Hyuga, M; Hyuga, S; Kobayashi, Y; Nakamori, S; Odaguchi, H; Oshima, N; Sekine, M; Shimada, N; Takemoto, H; Uchiyama, N; Yang, J, 2019
)
0.76
" After 8-weeks of exposure to ephedrine, the toxic effects of ephedrine included significant weight loss and induction of behavioral changes in rhesus macaques."( Long-term exposure to ephedrine leads to neurotoxicity and neurobehavioral disorders accompanied by up-regulation of CRF in prefrontal cortex and hippocampus in rhesus macaques.
Duan, S; Guo, R; Huang, J; Lin, Z; Lv, J; Ma, S; Sun, Z; Xie, L; Xie, Y; Zheng, L, 2020
)
1.16
" However, its use is associated with adverse events that involve to a large extent the cardiovascular and the central nervous system."( In search of an ideal drug for safer treatment of obesity: The false promise of pseudoephedrine.
Bernardini, R; Burgaletto, C; Cantarella, G; Cortinovis, M; Di Mauro, R; Frara, S; Giustina, A; Munafò, A; Perico, N; Remuzzi, G, 2021
)
0.84
"Intraoperative hypotension (IOH) is a highly prevalent adverse event associated with the induction and maintenance of general anesthesia."( The Safety and Efficacy of Peripherally Administered Norepinephrine during the Perioperative Period.
Simons, C, 2022
)
0.72

Pharmacokinetics

The objective of the two pharmacokinetic studies reported here was to compare the relative bioavailability of an ibuprofen/pseudoephedrine modified-release capsule with each of the active ingredients given alon. Changes in the pharmacodynamics due to the sauna were consistent with the pharmacokinetics findings.

ExcerptReferenceRelevance
"Our preliminary pharmacodynamic studies on the lower urinary tract of adult female dogs indicate that cholinergic and adrenergic (alpha and beta) neuroreceptors in the urethra appear to coordinate the detrusor and urethral function during micturition."( Cholinergic and adrenergic neuroreceptors in urinary tract of female dogs. Evaluation of function with pharmacodynamics.
Gonick, P; Heber, D; Khanna, OP, 1975
)
0.25
"Dose tolerance and pharmacokinetic studies of pseudoephedrine sustained action capsules were performed in thirty-three adult male subjects who received either 120 mg or 150 mg capsules every twelve hours for seven consecutive days in a double-blind parallel design study."( Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man.
Bressler, R; Dickerson, J; Mayersohn, M; Perrier, D, 1978
)
0.75
" 2 Pharmacokinetic assessment of the data indicated no significant intra-subject changes in kinetic parameters before or after chronic treatment with ephedrine HCl (11 mg three times a day) alone or in combination."( The pharmacokinetics of ephedrine after oral dosage in asthmatics receiving acute and chronic treatment.
May, CS; Paterson, JW; Pickup, ME; Ssendagire, R, 1976
)
0.76
" Plasma drug concentrations for pharmacokinetic calculations were estimated from samples drawn up to 24 hours after drug intake."( Exercise alters the pharmacokinetics of midazolam.
Laitinen, LA; Lindqvist, A; Olkkola, KT; Seppälä, T; Strömberg, C; Vanakoski, J, 1992
)
0.28
"In a combined pharmacokinetic and clinical trial the correlation was investigated between plasma levels of oxilofrine and the haemodynamic effects on eight healthy volunteers after an oral dose of 120 mg oxilofrine."( Clinical pharmacokinetics after a single oral dose of oxilofrine.
Angermann, C; Kauert, G; Lex, H; Spes, C, 1988
)
0.27
" It is possible that each enantiomer can reflect significant enantioselective differences with regard to both pharmacokinetic and pharmacodynamic effects."( Pharmacokinetics of oral decongestants.
Dowse, R; Kanfer, I; Vuma, V,
)
0.13
" Changes in the pharmacodynamics due to the sauna were consistent with the pharmacokinetic findings: midazolam decreased flicker recognition and induced exophoria significantly less during the early sauna period than in the control session, whereas ephedrine made the volunteers subjectively more alert at that time."( Effects of a sauna on the pharmacokinetics and pharmacodynamics of midazolam and ephedrine in healthy young women.
Seppälä, T; Strömberg, C; Vanakoski, J, 1993
)
0.69
"The purpose of this study was to evaluate heart rate and blood pressure responses to a commercially available source of ma-haung, a natural source of the sympathomimetic substance, ephedrine, and to evaluate the pharmacokinetic properties of the product in normotensive, healthy adults."( Pharmacokinetics and cardiovascular effects of ma-huang (Ephedra sinica) in normotensive adults.
Estes, M; Gardner, SF; Gurley, BJ; Marx, MA; Wang, PL; White, LM, 1997
)
0.49
"The pharmacokinetic profiles of single and multiple doses of loratadine, descarboethoxyloratadine (DCL) (the major active metabolite of loratadine), and pseudoephedrine were determined in a randomized, open-label, two-way crossover study in 24 healthy men."( Pharmacokinetics of loratadine and pseudoephedrine following single and multiple doses of once- versus twice-daily combination tablet formulations in healthy adult males.
Affrime, MB; Batra, VK; Christopher, D; Kosoglou, T; Lim, JM; Radwanski, E,
)
0.59
" Pharmacokinetic parameters for botanical ephedrine were similar to those for synthetic ephedrine hydrochloride."( Ephedrine pharmacokinetics after the ingestion of nutritional supplements containing Ephedra sinica (ma huang).
Gardner, SF; Gurley, BJ; Wang, PL; White, LM, 1998
)
2.01
" The authors present data evaluating the pharmacokinetic and pharmacodynamic responses to coadministration of oral linezolid with sympathomimetics (pseudoephedrine and phenylpropanolamine) and a serotonin reuptake inhibitor (dextromethorphan)."( Linezolid: pharmacokinetic and pharmacodynamic evaluation of coadministration with pseudoephedrine HCl, phenylpropanolamine HCl, and dextromethorpan HBr.
Antal, EJ; Batts, DH; Hendershot, PE; Hopkins, NK; Welshman, IR, 2001
)
0.73
"We conducted a population pharmacokinetic analysis of ephedrine, the main effective constituent of the two Kampo prescriptions, Sho-seiryu-to (Xiao-Qing-Long-Tang, Formula divinitatis caeruleae minor) and Kakkon-to (Ge-Gen-Tang, Formula puerariae), which are routinely used in the treatment of allergic rhinitis."( Population pharmacokinetic analysis of ephedrine in Kampo prescriptions: a study in healthy volunteers and clinical use of the pharmacokinetic results.
Cyong, JC; Yafune, A, 2001
)
0.83
" The aim of this open, randomized, three-factorial (three-treatment, three-period, six-sequence) Latin Square clinical study was to investigate if there were any pharmacokinetic interactions between ASA and PSE when given as fixed combination of 500 mg ASA/30 mg PSE."( Pharmacokinetic interaction study of a fixed combination of 500 mg acetylsalicylic acid/30 mg pseudoephedrine versus each of the single active ingredients in healthy male volunteers.
Birkel, M; Hey, B; Loose, I; Lücker, PW; Schaefer, A, 2003
)
0.54
" The supplementary evaluation for the non-normalized original parameters AUC and Cmax also revealed bioequivalence."( Pharmacokinetic interaction study of a fixed combination of 500 mg acetylsalicylic acid/30 mg pseudoephedrine versus each of the single active ingredients in healthy male volunteers.
Birkel, M; Hey, B; Loose, I; Lücker, PW; Schaefer, A, 2003
)
0.54
"The objective of the two pharmacokinetic studies reported here was to compare the relative bioavailability of an ibuprofen/pseudoephedrine modified-release capsule with each of the active ingredients given alone as standard formulations."( Common cold and influenza symptom management: the use of pharmacokinetic considerations to predict the efficacy of a twice-daily treatment for colds and flu.
Little, S; Stillings, M; Sykes, J, 2003
)
0.52
" The objective of the present study was to compare the pharmacodynamic responses of ephedrine and sibutramine using surrogate markers of weight loss potential and potential adverse events."( Comparison of the acute pharmacodynamic responses after single doses of ephedrine or sibutramine in healthy, overweight volunteers.
Balderson, DE; Brouwer, KL; Lancaster, ME; Ng, C; Paulik, MA; Persky, AM; Song, MH, 2004
)
0.78
" Healthy, mildly overweight (BMI = 25) subjects were administered the respective treatment and pharmacokinetic and pharmacodynamic measurements (body surface temperature, resting metabolic rate, blood pressure, heart rate, glucose, glycerol, nonesterified fatty acids, triglycerides) were obtained for 8 hours post dose and for an additional 4 measurements during the sibutramine treatment period."( Comparison of the acute pharmacodynamic responses after single doses of ephedrine or sibutramine in healthy, overweight volunteers.
Balderson, DE; Brouwer, KL; Lancaster, ME; Ng, C; Paulik, MA; Persky, AM; Song, MH, 2004
)
0.56
"The combination of ephedrine and caffeine has been used in herbal products for weight loss and athletic performance-enhancement, but the pharmacokinetic profiles of these compounds have not been well characterized."( Mechanistic pharmacokinetic modelling of ephedrine, norephedrine and caffeine in healthy subjects.
Benowitz, NL; Csajka, C; Haller, CA; Verotta, D, 2005
)
0.92
"The pharmacokinetic model was developed based on the simultaneous modelling using plasma samples gathered from two clinical trials."( Mechanistic pharmacokinetic modelling of ephedrine, norephedrine and caffeine in healthy subjects.
Benowitz, NL; Csajka, C; Haller, CA; Verotta, D, 2005
)
0.59
"To support the pharmacokinetic and bioavailability study of an extended-release loratadine (LOR)/pseudoephedrine sulfate (PES) tablet, a high performance liquid chromatographic-electrospray ionisation-mass spectrometric method (LC-MS) was developed for the simultaneous determination of LOR and PES in human plasma."( Simultaneous determination of loratadine and pseudoephedrine sulfate in human plasma by liquid chromatography-electrospray mass spectrometry for pharmacokinetic studies.
Gu, Y; Huang, M; Li, H; Shao, F; Sun, J; Wang, G; Wang, W; Xie, H; Zhang, J; Zhang, Q; Zhao, S, 2005
)
0.8
"To develop a GC-MS method for the determination of pseudo-ephedrine in human plasma and study the mutative rules of the pharmacokinetic parameters of the pseudo-ephedrine in different compositions."( [Effect on pharmacokinetics of pseudo-ephedrine in human plasma among herbs in Mahuang decoction].
He, F; Luo, JB, 2005
)
0.84
"The other herbs erds of MHD have some certain extent effects to the pharmacokinetic parameters of pseudo-ephedrine in the dominant drug."( [Effect on pharmacokinetics of pseudo-ephedrine in human plasma among herbs in Mahuang decoction].
He, F; Luo, JB, 2005
)
0.81
" The method described herein has been first used to reveal the pharmacokinetic characters in healthy Chinese volunteers treated with oral administration of different dosages of cetirizine dihydrochloride and controlled-released pseudoephedrine hydrochloride compound tablet, and approached the influence of a standard meal on the extent and rate of absorption of the combination tablet."( Development and evaluation of an efficient HPLC/MS/MS method for the simultaneous determination of pseudoephedrine and cetirizine in human plasma: application to phase-I pharmacokinetic study.
Cui, S; Feng, F; Liu, H; Ma, M; Sheng, Y, 2007
)
0.74
" Pharmacokinetic parameters obtained following selegiline transdermal system and pseudoephedrine or phenylpropanolamine were unremarkable."( Evaluation of the potential for pharmacodynamic and pharmacokinetic drug interactions between selegiline transdermal system and two sympathomimetic agents (pseudoephedrine and phenylpropanolamine) in healthy volunteers.
Azzaro, AJ; Blob, LF; Campbell, BJ; Kemper, EM; VanDenBerg, CM; Ziemniak, J, 2007
)
0.76
" To determine the pharmacokinetic behaviour of this sympathomimetic compound in the Sprague-Dawley rats, ephedrine hydrochloride, Herba Ephedrae single-herb and Wu Tou Tang decoctions were administered orally, and ephedrine hydrochloride was also administered by intravenous injection, and blood samples were collected over 24 h."( Pharmacokinetic determination of ephedrine in Herba Ephedrae and Wu Tou Tang decoctions in rats using ultra performance liquid chromatography tandem mass spectrometry.
Chen, W; Liu, Z; Tang, L; Yan, T; Ye, L; Zheng, Z, 2012
)
0.87
"An ultra performance liquid chromatography-mass spectrometric (UPLC-MS) method was developed to investigate the pharmacokinetic properties of ephedrine, methylephedrine, amygdalin, and glycyrrhizic acid after oral gavage of Ma Huang Tang (MHT) in Beagles."( UPLC-MS/MS determination of ephedrine, methylephedrine, amygdalin and glycyrrhizic acid in Beagle plasma and its application to a pharmacokinetic study after oral administration of Ma Huang Tang.
Fu, Q; Ma, S; Wang, J; Yan, T, 2015
)
0.91
" Compared with single-herb extracts, alkaloids in plasma (except methylephedrine, benzoylmesaconine and benzoylhypaconine) showed slower elimination (the mean residence time or half-life was longer), although the maximum plasma concentration and area under the plasma concentration curve values decreased."( Simultaneous quantification and pharmacokinetics of alkaloids in Herba Ephedrae-Radix Aconiti Lateralis extracts.
Huo, H; Li, H; Luo, J; Song, S; Tang, Q; Xing, X,
)
0.36
" The pharmacokinetic data showed that pure ephedrine was absorbed significantly faster than ephedrine of the Ephedra extract or the MXGST herbal preparation."( Determination the active compounds of herbal preparation by UHPLC-MS/MS and its application on the preclinical pharmacokinetics of pure ephedrine, single herbal extract of Ephedra, and a multiple herbal preparation in rats.
Chiang, MH; Lu, CM; Tsai, TH; Wang, JW, 2016
)
0.9
" At present, most pharmacokinetic studies focus on the pharmacokinetic process of alkaloids in normal animals."( Comparative pharmacokinetic studies of Ephedra herba in common cold and nephrotic syndrome rat models.
Cao, Y; Feng, W; Liu, T; Wang, Y; Zhang, B; Zhang, J; Zhang, Z; Zheng, X; Zhou, N, 2023
)
0.91

Compound-Compound Interactions

Ephedrine combined with either bupivacaine or lidocaine acted synergistically to block motor function and has the potential to reduce the amount of local anesthetic needed for spinal block.

ExcerptReferenceRelevance
" The aim of this study was to assess whether TEA combined with general anesthesia has any effect on segmental wall motion (SWM) monitored by transesophageal echocardiography in these patients."( Effect of thoracic epidural anesthesia combined with general anesthesia on segmental wall motion assessed by transesophageal echocardiography.
Bonnet, F; Brun, P; Catoire, P; Delaunay, L; Gormezano, G; Macquin-Mavier, I; Saada, M, 1992
)
0.28
" To evaluate the role of an oral alpha agonist alone and in combination with a nonsteroidal anti-inflammatory drug in the treatment of experimental rhinovirus colds, 58 subjects were randomized to receive pseudoephedrine 60 mg alone, pseudoephedrine 60 mg plus ibuprofen 200 mg, or placebo, four times daily for 4 1/2 days beginning 30 hours after intranasal rhinovirus inoculation under double-blind conditions."( Evaluation of an alpha agonist alone and in combination with a nonsteroidal antiinflammatory agent in the treatment of experimental rhinovirus colds.
Hayden, FG; Riker, DK; Sorrentino, JV; Sperber, SJ, 1989
)
0.46
"3 mg) alone or combined with ephedrine (25 mg) was tested for its effectiveness in the prevention of seasickness during 24 h at sea and of motion sickness in rotating chair tests in a laboratory."( Drug treatment of motion sickness: scopolamine alone and combined with ephedrine in real and simulated situations.
Aho, J; Gothoni, G; Laitinen, LA; Tokola, O; Vapaatalo, H, 1984
)
0.79
"Forty-three children with overt neurological disease and neuropathic vesicourethral dysfunction were entered into a trial comparing clean intermittent catheterisation (CIC) with manual expression combined with drug treatment (non-CIC)."( Neuropathic vesicourethral dysfunction in children. A trial comparing clean intermittent catheterisation with manual expression combined with drug treatment.
Borzyskowski, M; Chantler, C; Haycock, GB; Joyce, MR; Kinder, CH; Mundy, AR; Neville, BG; Park, L, 1982
)
0.26
" Scopolamine alone or in combination with ephedrine proved useful in the prevention of seasickness in young healthy male volunteers."( Scopolamine alone or combined with ephedrine in seasickness: a double-blind, placebo-controlled study.
Gothoni, G; Laitinen, LA; Tokola, O; Vapaatalo, H, 1981
)
0.8
"We investigated the effect of ephedrine on left ventricular function in patients without cardiovascular disease under high thoracic epidural anesthesia combined with general anesthesia."( The effect of ephedrine bolus administration on left ventricular loading and systolic performance during high thoracic epidural anesthesia combined with general anesthesia.
Georgieff, M; Goertz, AW; Hübner, C; Lindner, KH; Rockemann, MG; Seefelder, C; Seeling, W, 1994
)
0.94
" Ginkgo biloba extract, advertised as improving cognitive functioning, has been reported to cause spontaneous bleeding, and it may interact with anticoagulants and antiplatelet agents."( Herbal remedies: adverse effects and drug interactions.
Cupp, MJ, 1999
)
0.3
" However, marked tachycardia associated with the use of ephedrine in combination with propofol occurred in the majority of patients, occasionally reaching high levels in individual patients."( The haemodynamic effects of propofol in combination with ephedrine in elderly patients (ASA groups 3 and 4).
Berridge, J; Freeman, J; Gamlin, F; Vucevic, M; Winslow, L, 1999
)
0.79
" In our search for a reporter gene that lacks these limitations, we have evaluated the feasibility of the human norepinephrine transporter (hNET) as a reporter gene in combination with the reporter probe 11C-m-hydroxyephedrine (mHED) for PET."( The human norepinephrine transporter in combination with 11C-m-hydroxyephedrine as a reporter gene/reporter probe for PET of gene therapy.
Beerens, AM; Buursma, AR; de Vries, EF; Haisma, HJ; Hospers, GA; Rots, MG; Vaalburg, W; van Waarde, A, 2005
)
0.75
"2 mL of different concentrations of the following drugs was injected sub-fascially: bupivacaine, lidocaine, and ephedrine alone and bupivacaine or lidocaine combined with ephedrine (n=8 per group)."( Efficacy of lidocaine or bupivacaine combined with ephedrine in rat sciatic nerve block.
Gerner, P; Greco, WR; Hung, YC; Kau, YC; Wang, GK; Zizza, AM; Zurakowski, D,
)
0.59
"Ephedrine combined with bupivacaine interacted additively for both motor and sensory blockade, and ephedrine combined with lidocaine interacted antagonistically (sub-additive) for sensory blockade and additively for motor blockade."( Efficacy of lidocaine or bupivacaine combined with ephedrine in rat sciatic nerve block.
Gerner, P; Greco, WR; Hung, YC; Kau, YC; Wang, GK; Zizza, AM; Zurakowski, D,
)
1.83
" This study examined the potential for drug-drug interactions during treatment with selegiline transdermal system and pseudoephedrine or phenylpropanolamine."( Evaluation of the potential for pharmacodynamic and pharmacokinetic drug interactions between selegiline transdermal system and two sympathomimetic agents (pseudoephedrine and phenylpropanolamine) in healthy volunteers.
Azzaro, AJ; Blob, LF; Campbell, BJ; Kemper, EM; VanDenBerg, CM; Ziemniak, J, 2007
)
0.74
" Ephedrine in combination with either bupivacaine or lidocaine was then injected into the spinal catheters."( Ephedrine shows synergistic motor blockade when combined with bupivacaine or lidocaine for spinal anesthesia in a rat model.
Danninger, T; Djalali, AG; Fritsch, G; Gerner, P; Perez-Valdivieso, JR; Wang, JC; Zurakowski, D, 2013
)
2.74
"Ephedrine combined with either bupivacaine or lidocaine acted synergistically to block motor function and has the potential to reduce the amount of local anesthetic needed for spinal block."( Ephedrine shows synergistic motor blockade when combined with bupivacaine or lidocaine for spinal anesthesia in a rat model.
Danninger, T; Djalali, AG; Fritsch, G; Gerner, P; Perez-Valdivieso, JR; Wang, JC; Zurakowski, D, 2013
)
3.28

Bioavailability

The effect of a high-fat breakfast on the bioavailability of the components of an extended-release tablet containing 10 mg loratadine in the immediate-release coating and 240 mg pseudoephedrine sulfate in the extended- release core was studied in 24 healthy male volunteers.

ExcerptReferenceRelevance
" The medium bioavailability of Fugoa depot dragees was 95% compared to the standard."( [Biopharmaceutic investigations with D-norpseudoephedrine. 2nd communication: Bioavaliability of a depot preparation (author's transl)].
Frosch, F, 1977
)
0.51
"Theophylline bioavailability following chronic dosing of an elixir and two commercial tablet formulations (I and II) relative to an acute dose of elixir was evaluated in healthy volunteers."( Theophylline bioavailability following chronic dosing of an elixir and two solid dosage forms.
Azarnoff, DL; Fixley, M; Shen, DD, 1978
)
0.26
" Calculations of relative bioavailability suggest that the 120 mg capsule formulation has a 30% greater bioavailability compared to the 150 mg capsule."( Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man.
Bressler, R; Dickerson, J; Mayersohn, M; Perrier, D, 1978
)
0.5
"The bioavailability of theophylline from formulations containing this drug alone and also in combination with phenobarbital and ephedrine has been studied in normal volunteers and asthmatic subjects."( Influence of formulation on bioavailability of theophylline.
Domoradzki, J; Reed, CE; Sims, JA; Welling, PG, 1976
)
0.46
" Bioavailability of pseudoephedrine was 91% for fed relative to fasted treatment; for brompheniramine it was 89%."( Effect of food on bioavailability of pseudoephedrine and brompheniramine administered from a gastrointestinal therapeutic system.
Chao, ST; Coen, P; Knowles, M; Pinson, D; Place, V; Prather, D; Pruitt, B, 1991
)
0.84
" A less biased estimate of absorption rate was obtainable for ER formulations by utilizing IR runs."( Application of NONMEM to routine bioavailability data.
Chang, I; Graves, DA, 1990
)
0.28
"Five methods of absorption rate (Ka) estimation were compared using data from a previously reported bioavailability study: Wagner-Nelson (WN), asymptotic WN (AWN), the Hendeles-Weinberger modification of the WN (HW), nonlinear regression performed on plasma concentration vs time data with fixed elimination rates (NL), and nonlinear regression performed on the cumulative sum of AUCs obtained during WN analysis (AUCNL)."( Pseudoephedrine absorption from controlled release formulations: absorption rate constant estimation methods.
Graves, DA; Rotenberg, KS,
)
0.61
"The influence of a standard meal on the extent and rate of absorption of pseudoephedrine from a liquid controlled release (CR) formulation (Pennkinetic System) was studied in 16 normal male volunteers."( Influence of a standard meal on the absorption of a controlled release pseudoephedrine suspension.
Amsel, LP; Bhargava, AK; Graves, DA; Hinsvark, ON; Meyer, MC; Rotenberg, KS; Straughn, AB; Wecker, MT,
)
0.59
"The influence of a standard meal on the extent and rate of absorption of pseudoephedrine from a controlled-release (CR) capsule formulation (Pennkinetic System) was studied in 16 normal male volunteers."( Influence of a standard meal on the absorption of controlled-release pseudoephedrine capsules.
Amsel, LP; Graves, DA; Hinsvark, ON; Rotenberg, KS; Wecker, MT, 1987
)
0.73
" In addition, the major bioavailability parameters (Cmin, Cmax, tmax, and AUC) for days 6 and 7 of dosing were determined and statistically evaluated."( Steady-state bioavailability of dexbrompheniramine and pseudoephedrine from a repeat-action combination tablet.
Digiore, C; Gural, R; Kim, HK; Lim, J; Lin, CC; Symchowicz, S, 1985
)
0.51
" In the multiple-dose study, involving 18 subjects, the bioavailability of the optimal formulation determined from the single-dose study was compared with a reference pseudoephedrine hydrochloride syrup."( Bioavailability assessment of a new liquid controlled-release pseudoephedrine product.
Amsel, LP; Graves, DA; Hinsvark, ON; Rotenberg, KS; Woodworth, JR,
)
0.56
"The bioavailability of pseudoephedrine and triprolidine from combination and single-ingredient products was evaluated in a randomized, four-way crossover study."( Bioavailability of pseudoephedrine and triprolidine from combination and single-ingredient products.
Arnold, JD; Blum, MR; Findlay, JW; Lai, AA; Liao, SH; Perkins, JG; Williams, BO,
)
0.73
"The objective of this study was to compare in man the bioavailability of d-pseudoephedrine and azatadine from a repeat action tablet formulation and from conventional tablets."( Bioavailability of d-pseudoephedrine and azatadine from a repeat action tablet formulation.
Lim, J; Lin, C; Symchowicz, S, 1982
)
0.79
"The bioavailability of a single dose of d-pseudoephedrine sulfate administered to male volunteers in repeat action tablet form (60 mg d-pseudoephedrine sulfate in the coat and 60 mg d-pseudoephedrine sulfate in the core) was compared with the bioavailability of an equivalent quantity of the drug given as two 60 mg conventional tablets, one given at 0 hour and the second 6 hours later."( Comparative bioavailability of d-pseudoephedrine from a conventional d-pseudoephedrine sulfate tablet and from a repeat action tablet.
Lim, J; Lin, C; Symchowicz, S, 1982
)
0.79
"This investigation compared the bioavailability of chlorpheniramine and pseudoephedrine from a sustained-action capsule and a combination of two reference standard tablets in 24 normal human subjects."( Evaluation of sustained-action chlorpheniramine-pseudoephedrine dosage form in humans.
Amann, AH; Baaske, DM; Carter, JE; Chao, GC; Kamath, BL; Lai, CM; Stoll, RG; Yacobi, A, 1980
)
0.74
" Both PPA and PDE are readily and completely absorbed, whereas PE, with a bioavailability of only approximately 38%, is subject to gut wall metabolism and is thought to be absorbed erratically."( Pharmacokinetics of oral decongestants.
Dowse, R; Kanfer, I; Vuma, V,
)
0.13
" Because the absorption rate of the active ingredients pseudoephedrine and gauifenesin is governed by the dissolution rate, the observed differences suggest that the products tested may differ in biologic performance."( Use of in vitro and in vivo data in the design, development, and quality control of sustained-release decongestant dosage forms.
Brock, MH; Dansereau, RJ; Patel, VS,
)
0.37
" A one-to-one correlation was shown between rate of absorption and in vitro release profiles for the GITS products, indicating that drug release from GITS controls absorption."( In vitro and in vivo evaluation of a once-daily controlled-release pseudoephedrine product.
Dye, D; Gorsline, J; Guinta, D; Hamel, L; Hwang, SS; Louie, J, 1995
)
0.52
" The bioavailability of an experimental controlled release tablet containing pseudoephedrine was compared with a marketed controlled release pseudoephedrine capsule in a three-way crossover study."( Bioavailability of pseudoephedrine from controlled release formulations in the presence of guaifenesin in human volunteers.
Aluri, J; Manning, L; Pade, V; Stavchansky, S, 1995
)
0.82
"The effect of a high-fat breakfast on the bioavailability of the components of an extended-release tablet containing 10 mg loratadine in the immediate-release coating and 240 mg pseudoephedrine sulfate in the extended-release core was studied in 24 healthy male volunteers in a single-dose, two-way crossover study."( Influence of food on the oral bioavailability of loratadine and pseudoephedrine from extended-release tablets in healthy volunteers.
Affrime, MB; Cayen, MN; Kosoglou, T; Lin, CC; Mojaverian, P; Nezamis, J; Nomeir, AA; Rodwanski, E, 1996
)
0.72
" The in-vivo bioavailability and pharmacokinetics of these formulations were evaluated in 20 healthy volunteers under fasted conditions."( In-vivo/in-vitro correlation of four extended release formulations of pseudoephedrine sulfate.
Liebowitz, S; Mojaverian, P; Radwanski, E; Rosen, J; Vadino, WA, 1997
)
0.53
" Values for the absorption rate were considerably lower and time to reach maximum concentration was longer for the capsules, compared with the standard tablet."( Pharmacokinetics and cardiovascular effects of ma-huang (Ephedra sinica) in normotensive adults.
Estes, M; Gardner, SF; Gurley, BJ; Marx, MA; Wang, PL; White, LM, 1997
)
0.3
" The drug concentrations were obtained by convoluting the drug absorption rate quadratic function with the drug disposition model function."( DeMonS--a new deconvolution method for estimating drug absorbed at different time intervals and/or drug disposition model parameters using a monotonic cubic spline.
Gupta, SK; Hwang, SS; Yu, Z, 1997
)
0.3
" Two cross-over, single-dose bioavailability studies were carried out on eight healthy volunteers."( Time-controlled release pseudoephedrine tablets: bioavailability and in vitro/in vivo correlations.
Halsas, M; Jürjenson, H; Marvola, M; Penttinen, T; Veski, P, 2001
)
0.6
" black triangle The bioavailability of cetirizine and pseudoephedrine is similar after administration of cetirizine/pseudoephedrine 5/120 mg bilayer tablets or coadministration of cetirizine 5 mg tablets plus pseudoephedrine sustained-release (SR) 120 mg caplets."( Cetirizine/pseudoephedrine.
Jarvis, B; Wellington, K, 2001
)
0.89
" Lack of interaction was assessed by determination of pharmacokinetic characteristics and relative bioavailability of both substances and salicylic acid (CAS 69-72-7, SA), administered in combination and as equally single dosed drugs."( Pharmacokinetic interaction study of a fixed combination of 500 mg acetylsalicylic acid/30 mg pseudoephedrine versus each of the single active ingredients in healthy male volunteers.
Birkel, M; Hey, B; Loose, I; Lücker, PW; Schaefer, A, 2003
)
0.54
" The purpose of this open, randomized, three-factorial (three-treatment, three-period, six-sequence) Latin Square clinical study was to investigate the relative bioavailability of ASA and PSE as well as the establishment of bioequivalence after single administration of the fixed combination (final formulation for approval) of 500 mg ASA/30 mg PSE*HCl and the preliminary formulation of this combination."( Relative bioavailability and bioequivalence of a newly developed fixed combination sachet of acetylsalicylic acid and pseudoephedrine compared with a preliminary combination.
Birkel, M; Hey, B; Loose, I; Lücker, PW; Schaefer, A, 2003
)
0.53
"The objective of the two pharmacokinetic studies reported here was to compare the relative bioavailability of an ibuprofen/pseudoephedrine modified-release capsule with each of the active ingredients given alone as standard formulations."( Common cold and influenza symptom management: the use of pharmacokinetic considerations to predict the efficacy of a twice-daily treatment for colds and flu.
Little, S; Stillings, M; Sykes, J, 2003
)
0.52
" The relative bioavailability of ephedrine differed between the herbal supplement compared with the pharmaceutical formulation."( Mechanistic pharmacokinetic modelling of ephedrine, norephedrine and caffeine in healthy subjects.
Benowitz, NL; Csajka, C; Haller, CA; Verotta, D, 2005
)
0.88
"To support the pharmacokinetic and bioavailability study of an extended-release loratadine (LOR)/pseudoephedrine sulfate (PES) tablet, a high performance liquid chromatographic-electrospray ionisation-mass spectrometric method (LC-MS) was developed for the simultaneous determination of LOR and PES in human plasma."( Simultaneous determination of loratadine and pseudoephedrine sulfate in human plasma by liquid chromatography-electrospray mass spectrometry for pharmacokinetic studies.
Gu, Y; Huang, M; Li, H; Shao, F; Sun, J; Wang, G; Wang, W; Xie, H; Zhang, J; Zhang, Q; Zhao, S, 2005
)
0.8
"To support the pharmacokinetic and bioavailability study of a once-daily fexofenadine/pseudoephedrine combination, a high-performance liquid chromatography/positive ion electrospray tandem mass spectrometry (HPLC/ESI-MS/MS) method for the simultaneous quantification of fexofenadine and pseudoephedrine was developed and validated with 500 microL human plasma using mosapride as an internal standard (IS)."( Simultaneous quantification of fexofenadine and pseudoephedrine in human plasma by liquid chromatography/tandem mass spectrometry with electrospray ionization: method development, validation and application to a clinical study.
Kandikere, VN; Komarneni, P; Maurya, S; Mudigonda, K; Nirogi, RV; Shukla, M, 2006
)
0.8
" The method described herein has been first used to reveal the pharmacokinetic characters in healthy Chinese volunteers treated with oral administration of different dosages of cetirizine dihydrochloride and controlled-released pseudoephedrine hydrochloride compound tablet, and approached the influence of a standard meal on the extent and rate of absorption of the combination tablet."( Development and evaluation of an efficient HPLC/MS/MS method for the simultaneous determination of pseudoephedrine and cetirizine in human plasma: application to phase-I pharmacokinetic study.
Cui, S; Feng, F; Liu, H; Ma, M; Sheng, Y, 2007
)
0.74
" The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies."( Quantification of pseudoephedrine in human plasma by LC-MS/MS using mosapride as internal standard.
Kandikere, VN; Komarneni, P; Maurya, S; Mudigonda, K; Nirogi, RV; Shukla, M, 2007
)
0.65
" The importance of solvent choice in salt formation, of salt selection in the control of bioavailability and of ternary phase equilibria in salt isolation and the relationship between a number of measured and calculated crystal properties are illustrated and discussed."( Structure, solubility, screening, and synthesis of molecular salts.
Black, SN; Collier, EA; Davey, RJ; Roberts, RJ, 2007
)
0.34
" Ephedrine AUC(0-t) values were significantly lower following the Wu Tou Tang decoction compared to the other oral treatments, suggesting that some components in the decoction may reduce the bioavailability of ephedrine."( Pharmacokinetic determination of ephedrine in Herba Ephedrae and Wu Tou Tang decoctions in rats using ultra performance liquid chromatography tandem mass spectrometry.
Chen, W; Liu, Z; Tang, L; Yan, T; Ye, L; Zheng, Z, 2012
)
1.57
"We aimed to determine whether BAT can be activated in lean and obese humans after acute administration of an orally bioavailable sympathomimetic."( Ephedrine activates brown adipose tissue in lean but not obese humans.
Bertovic, D; Carey, AL; Cherk, MH; Duffy, SJ; Eikelis, N; Formosa, MF; Kalff, V; Kingwell, BA; Lambert, GW; Van Every, B, 2013
)
1.83

Dosage Studied

Pseudoephedrine hydrochloride was evaluated at two dosage levels in six normal healthy males, at rest and during submaximal exercise. Application of the proposed NMR spectroscopic method to commercial dosage forms, including ephedrine sulfate injections, yielded assay results ranging from 97.

ExcerptRelevanceReference
"A specific high-pressure liquid chromatographic method for the determination of chlorpheniramine and pseudoephedrine in urine was developed and applied in a urinary excretion study of normal healthy subjects who received a sustained-release dosage form contianing 8 mgof chlorpheniramine maleate and 120 mg of pseudoephedrine hydrochloride."( Urinary excretion of chlorpheniramine and pseudoephedrine in humans.
Lai, CM; Look, ZM; Stoll, RG; Yacobi, A, 1979
)
0.73
" This controlled, double-blind study evaluates these drugs alone and in a standard dosage combination in blocking asthma induced by the inhalation of pollen allergens among highly selected patients."( Pharmacologic modification of induced asthma.
Falliers, CJ; Katsampes, CF, 1976
)
0.26
"4 microgram/ml after two weeks of continuous dosing with the combination drug."( A comparison of a theophylline-ephedrine combination with terbutaline.
Alcala, JC; Bush, RK; Lee, TP; Smith, AM; Welling, PG, 1978
)
0.54
" Pulmonary function tests (FVC, FEV1, FEF25-75) and serum T levels were determined at 0, 4, 1, 2, 4, and 6 hours on both day one and after day 7 of a every-six-hour drug dosage schedule."( The effectiveness of the short- and long-term use of crystallized theophylline in asthmatic children.
Katz, RM; Rachelefsky, GS; Siegel, S, 1978
)
0.26
" A 2-mg dosage of carbuterol hydrochloride, three times daily, was used in comparison with a 25-mg dosage of ephedrine sulfate, three times daily."( A comparative study of bronchodilator effects of carbuterol and ephedrine.
James, TD; Lyons, HA, 1979
)
0.71
" Variable elimination rates for the drug among individuals require careful individualization of dosage guided by measurement of serum theophylline concentration to maintain safe and effective serum theophylline concentrations."( Theophylline for treatment of asthma.
Weinberger, M, 1978
)
0.26
"Theophylline bioavailability following chronic dosing of an elixir and two commercial tablet formulations (I and II) relative to an acute dose of elixir was evaluated in healthy volunteers."( Theophylline bioavailability following chronic dosing of an elixir and two solid dosage forms.
Azarnoff, DL; Fixley, M; Shen, DD, 1978
)
0.26
"A simple and sensitive high-pressure liquid chromatographic (HPLC) determination of pseudoephedrine and chlorpheniramine in a pharmaceutical dosage form is described."( Simultaneous determination of pseudoephedrine and chlorpheniramine in pharmaceutical dosage forms.
Lai, CM; Look, ZM; Yacobi, A, 1978
)
0.75
" For the inhibition of the hypotensive action of clonidine by protriptyline a parallel shift of the dose-response curve was obtained, indicating the possibility of a competitive antagonism."( Interaction between centrally acting hypotensive drugs and tricyclic antidepressants.
van Zwieten, PA, 1975
)
0.25
" The dose-response curves for the compound 48/80-induced release of endogenous Hi and for the various amines taken up by the cells were compared."( Intracellular distribution of amines taken up by rat mast cells.
Bergendorff, A, 1975
)
0.25
" The application of the guaiacolsulfonate potassium assay method to commercial dosage forms is reported."( Colorimetric determinations of chlorpheniramine maleate, ephedrine hydrochloride, and guaiacolsulfonate potassium in a cough syrup.
Das Gupta, V; de Lara, AJ, 1975
)
0.5
" Using a daily dosage of up to 16 mg/kg bodyweight more than 80% of children showed definite improvement leading to prevention or significant reduction of acute attacks and clearly reduced dyspnoeic states between attacks."( [Long-term out-patient treatment of children with asthma with a theophylline-ephedrine-hydroxyzine combination (author's transl)].
Götz, M, 1975
)
0.48
" Insufficient dosage may explain the lack of haemodynamic effect, while possible reasons for the higher SvO2 and lower VO2 are either reduced whole body VO2 or peripheral shunting."( Amrinone before termination of cardiopulmonary bypass: haemodynamic variables and oxygen utilization in the postbypass period.
Bilodeau, J; DeJesus, JM; O'Connor, JP; Ralley, FE; Ramsay, JG; Robbins, GR; Wynands, JE, 1992
)
0.28
" In a separate group of ten patients whose previous reactions to RCM were life threatening (shock), pretreatment was accompanied by a provocative dosing regimen."( Comparison of three pretreatment protocols to prevent anaphylactoid reactions to radiocontrast media.
Lieberman, PL; Marshall, GD, 1991
)
0.28
" Dose-response measurements with tissues from intact or sympathectomized (6-OHDA) animals indicate that the thermogenic effects of low concentrations of ephedrine and also of caffeine are entirely dependent upon the presence of intact sympathetic nerve endings, and thus depend on presynaptic mechanisms."( Peripheral mechanisms of thermogenesis induced by ephedrine and caffeine in brown adipose tissue.
Dulloo, AG; Girardier, L; Seydoux, J, 1991
)
0.73
" Blood flow velocities were not altered significantly after dosing in either the maternal or fetal circulation."( Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow.
Anderson, JC; Appel, LL; Duckworth, AF; Rayburn, WF; Smith, CV, 1990
)
0.55
"Some probable consequences of the dissolution/migration of a major solid dosage component in or into an applied film coating during or after a film coating operation have been investigated using free films of hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA) incorporating small amounts of either lactose (a diluent) or ephedrine hydrochloride (a drug)."( Thermal characterization of drug/polymer and excipient/polymer interactions in some film coating formulation.
Okhamafe, AO; York, P, 1989
)
0.45
" Such polypharmacy often leads to adverse drug reactions, drug-drug interactions, or dosage error."( Pseudoephedrine accumulation in renal failure.
Comstock, TJ; Sica, DA, 1989
)
0.76
" The effects of these drugs on the basal tension, on dose-response curves for muscle contraction produced by histamine and on cAMP level were investigated in guinea pig trachea, together with their influence on the resting and histamine-evoked mechanical and membrane activities of dog trachea."( The effects of methylxanthines, ethymizol, ephedrine and papaverine on guinea pig and dog trachea.
Bauer, V; Bilcíková, L; Kolena, J, 1987
)
0.54
" In a preceding dose finding study equipotent dosage of the substances used was confirmed."( [Hemodynamic effects following bolus administration of different vasopressive agents for blood pressure stabilization during peridural anesthesia].
Boldt, J; Börner, U; Brähler, A; Hempelmann, G; Müller, H; Stoyanov, M, 1985
)
0.27
"In this multicentre, double-blind, randomized, parallel group study, 315 patients with allergic or vasomotor rhinitis were treated on a twice daily dosing schedule with either a 60 mg terfenadine-120 mg pseudoephedrine hydrochloride combination or 120 mg pseudoephedrine hydrochloride (extended release) for 2 weeks."( A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis.
Ayars, GH; Bernstein, IL; Kemp, JP; Podleski, WK; Prenner, BM; Salzmann, JK; Schoenwetter, WF; Stroh, JE,
)
0.57
" The antagonistic component of a partial agonist is seen as a parallel shift of the agonist curve to the right from a constructed additive dose-response curve, from which a dose ratio (DR) was determined for calculation of graphic estimation of KB or pA2 of partial agonists."( Simple pA2 estimation of partial agonists: comparison with the Kaumann-Blinks method.
Pöch, G; Zimmermann, I, 1988
)
0.27
"Single oral doses of 16, 32 and 64 mg oxilofrine as dragées as well as 16mg as drops were given to 12 healthy male volunteers in an open Latin-square design with one week interval between dosing days."( Dose linearity and relative bioavailability testing of oxilofrine, a sympathicomimetic drug, in healthy volunteers.
Kauert, G; Lorenz, H; Malerczyk, V; Verho, M, 1988
)
0.27
" The mean ephedrine dosage was 18."( [Ephedrine administration for cesarean section under spinal anesthesia].
Funato, T; Haruta, M; Naka, Y; Saeki, N; Shinkai, T, 1987
)
1.59
" This was a 4-week study with a 1-week observation (baseline) period and a 3-week period during which the response to three dosage regimens (2 mg per day, 4 mg per day, and 8 mg per day) of FCB and placebo were compared to baseline observations of rhinitis."( Efficacy and tolerance of fluocortin butyl administered twice daily in adult patients with perennial rhinitis.
Hartley, TF; Lieberman, PL; Meltzer, EO; Noyes, JN; Pearlman, DS; Tinkelman, DG, 1985
)
0.27
" For each patient, total theophylline dosage was calculated and a theophylline blood level was obtained at the time of EEG recording."( Central nervous system effects of antiasthma medication--an EEG study.
Cummins, KR; Euwer, RL; Friedman, A; Shucard, DW; Shucard, JL; Spector, SL, 1985
)
0.27
" Blood samples for subsequent assay were obtained at frequent time intervals throughout each 7-d dosing phase."( Steady-state bioavailability of dexbrompheniramine and pseudoephedrine from a repeat-action combination tablet.
Digiore, C; Gural, R; Kim, HK; Lim, J; Lin, CC; Symchowicz, S, 1985
)
0.51
" Dose-response experiments with five logarithmically increased doses of pentagastrin and one dose of isoprenaline showed unchanged calculated maximum response and an increase in half-maximum acid response."( Effect of isoprenaline on pentagastrin-stimulated gastric acid secretion in dogs with gastric fistula.
Andersen, D; Bech, K; Gottrup, F; Hovendal, CP, 1981
)
0.26
" The dose-response curve with five doses of bethanechol with and without isoprenaline was in accordance with a non-competitive inhibition."( Effect of isoprenaline on bethanechol-stimulated gastric acid secrtion and mucosal blood flow in dogs with gastric fistula.
Bech, K; Hovendal, CP, 1982
)
0.26
" The two events generally paralleled one another when analyzed in terms of dose-response and time-response relationships."( Role of cyclic AMP in adrenergically-induced tracheal muscle relaxation.
Lau, YS; Lum, BK, 1983
)
0.27
" Dose-response experiments with bethanechol and dopamine showed inhibition of a non-competitive type."( Dopaminergic and beta-adrenergic effects on gastric antral motility.
Andersen, D; Bech, K; Gottrup, F; Hovendal, CP, 1984
)
0.27
" Three separate dosage regimens were employed."( Multi-center, double-blind, placebo-controlled trial of fluocortin butyl in perennial rhinitis.
Arbesman, C; Bernstein, IL; Bierman, CW; Bocles, JS; Katz, R; Lieberman, PL; Mattucci, K; Meltzer, EO; Middleton, E; Noyes, J; Pearlman, DS; Pence, HL; Slavin, RG; Spector, SL, 1983
)
0.27
" Observed peak concentration (Cmax), corresponding observed peak time (tmax), area under the plasma drug concentration-time curve from dosing to time infinity (AUC), and the ratio between plasma clearance and extent of bioavailability (CL/F) were determined."( Bioavailability of pseudoephedrine and triprolidine from combination and single-ingredient products.
Arnold, JD; Blum, MR; Findlay, JW; Lai, AA; Liao, SH; Perkins, JG; Williams, BO,
)
0.43
" Separate radioimmunoassays (RIAs), developed for d-ephedrine and l-ephedrine, were used to measure the concentrations of the enantiomers of ephedrine in the blood of two volunteers dosed with racemic ephedrine."( Stereospecific radioimmunoassays for l-ephedrine and d-ephedrine in human plasma.
Cooper, JK; Hubbard, JW; Mackonka, C; Midha, KK, 1983
)
0.79
"Pseudoephedrine hydrochloride was evaluated at two dosage levels in six normal healthy males, at rest and during submaximal exercise."( Selected cardiac and metabolic responses to pseudoephedrine with exercise.
Bright, TP; Fletcher, HP; Sandage, BW,
)
0.87
"To investigate the use of in vitro and in vivo data in the development of a sustained-release, carbomer-based dosage form (Entex LA tablets); and to compare the in vitro dissolution of pseudoephedrine from a sustained-release, hydroxypropylcellulose-based dosage form (Entex PSE tablets) and four branded competitors with different sustained-release matrixes."( Use of in vitro and in vivo data in the design, development, and quality control of sustained-release decongestant dosage forms.
Brock, MH; Dansereau, RJ; Patel, VS,
)
0.32
"Sustained-release, polymer-based dosage forms such as Entex LA and Entex PSE can be complex and pose special challenges in design, development, and reformulation."( Use of in vitro and in vivo data in the design, development, and quality control of sustained-release decongestant dosage forms.
Brock, MH; Dansereau, RJ; Patel, VS,
)
0.13
" Application of the proposed NMR spectroscopic method to commercial dosage forms, including ephedrine sulfate injections and pseudoephedrine hydrochloride tablets, yielded assay results ranging from 97."( Determination of ephedrine, pseudoephedrine, and norephedrine in mixtures (bulk and dosage forms) by proton nuclear magnetic resonance spectroscopy.
Hanna, GM,
)
0.69
"The functionality of a once-daily, osmotic dosage form--gastrointestinal therapeutic system (pseudoephedrine HCl) or GITS (PeHCl)--was studied in vitro and in vivo."( In vitro and in vivo evaluation of a once-daily controlled-release pseudoephedrine product.
Dye, D; Gorsline, J; Guinta, D; Hamel, L; Hwang, SS; Louie, J, 1995
)
0.74
"A 31-yr-old woman with a 14-yr history of poorly controlled IDDM first developed peripheral edema 3 yr after diagnosis of IDDM; the edema worsened whenever insulin dosage was increased."( Effective treatment of insulin-induced edema using ephedrine.
Cotton, SJ; Hopkins, DF; Williams, G, 1993
)
0.54
" The relative bioavailability of the tablet dosage form with respect to the capsule was found to be 100."( Bioavailability of pseudoephedrine from controlled release formulations in the presence of guaifenesin in human volunteers.
Aluri, J; Manning, L; Pade, V; Stavchansky, S, 1995
)
0.59
"5 mg/kg twice a day (phenylpropanolamine) as an initial dosage and to reduce this step by step to the lowest dosage that keeps the dog continent."( [Urinary incontinence in castrated female dogs. 2. Therapy].
Blendinger, C; Blendinger, K; Bostedt, H, 1995
)
0.29
" To study the dose-response effect of varying amounts of crystalloid volume prior to spinal anesthesia, we measured maternal hemodynamic variables and maternal and fetal COP in three groups of healthy parturients receiving spinal anesthesia for elective cesarean delivery."( The effects of varying volumes of crystalloid administration before cesarean delivery on maternal hemodynamics and colloid osmotic pressure.
Bader, AM; Curlin, F; Datta, S; Hauch, MA; Park, GE, 1996
)
0.29
" This report describes three patients in which the recommended dosage for the dietary supplements reportedly was not exceeded, summarizes results from ongoing investigations, and underscores the potential health risks associated with the use of products containing ephedrine."( Adverse events associated with ephedrine-containing products--Texas, December 1993-September 1995.
, 1996
)
0.76
" Before dosing and at intervals up to 7 hours after dosing, serum pseudoephedrine or phenylpropanolamine concentrations were measured, and pulse and blood pressure were recorded."( Pharmacokinetics of the orally administered decongestants pseudoephedrine and phenylpropanolamine in children.
Gu, X; Simons, FE; Simons, KJ; Watson, WT, 1996
)
0.77
" The dosage was gradually decreased from week 12 to discontinuation at week 39."( The effect of ephedrine plus caffeine on smoking cessation and postcessation weight gain.
Iversen, E; Jakobsen, HB; Jørgensen, S; Mikkelsen, KL; Nørregaard, J; Søeberg, B; Sørensen, T; Tønnesen, P, 1996
)
0.65
" DeMonS has been applied to (i) the griseofulvin data for estimating drug absorbed at different time intervals when the drug disposition model parameters were determined separately from intravenous data, (ii) veralipride double-peak phenomenon data to estimate simultaneously the percentage of cumulative veralipride absorbed and the veralipride disposition model parameters without reference intravenous data, (iii) a comparative bioequivalence study of gastrointestinal therapeutic system (GITS) pseudoephedrine HCI (PeHCI) controlled-release oral dosage forms when the drug disposition model parameters were not available, and (iv) estimation of both drug disposition model parameters and the absorption rate of drug from Testoderm (testosterone transdermal system) in the presence of endogenous testosterone production."( DeMonS--a new deconvolution method for estimating drug absorbed at different time intervals and/or drug disposition model parameters using a monotonic cubic spline.
Gupta, SK; Hwang, SS; Yu, Z, 1997
)
0.46
"This study describes the development work on a dosage form, which should release the drug pseudoephedrine HCl over twelve hours."( [Controlled release of pseudoephedrine HCl from pellets].
Vertommen, J, 1997
)
0.81
" The dose-response relationship for cocaine demonstrated a a typical inverted U-shaped function."( Reinforcing effects of caffeine, ephedrine, and their binary combination in rats.
Baird, TJ; Briscoe, RJ; Gauvin, DV; Holloway, FA; Vallett, M; Vanecek, SA, 1998
)
0.58
" Doses of (-)ephedrine and caffeine, which produced < or = 1% drug-appropriate responding when administered alone, were able to enhance each other's stimulus effects when administered in combination such that there was a twofold leftward shift in their respective dose-response curves."( (-)Ephedrine and caffeine mutually potentiate one another's amphetamine-like stimulus effects.
Gabryszuk, M; Glennon, RA; Young, R, 1998
)
1.29
"Cross-linked high amylose starches have been developed as excipients for the formulation of controlled-release solid dosage forms for the oral delivery of drugs."( Cross-linked high amylose starch for controlled release of drugs: recent advances.
Cartilier, L; Chouinard, F; Dumoulin, Y; Lenaerts, V; Marchessault, R; Mateescu, MA; Mebsout, F; Moussa, I; Szabo, P, 1998
)
0.3
"An isocratic, reversed-phase liquid chromatographic (LC) method was developed for simultaneous determination of pseudoephedrine hydrochloride (I) and carbinoxamine maleate (II) in a pharmaceutical dosage form."( Determination of pseudoephedrine hydrochloride and carbinoxamine maleate in combination drug formulation by liquid chromatography.
Mansour, AM,
)
0.65
" Methods examined to reduce toxicity include modification of benzaldehyde dosing regimes, immobilization of biomass or purified enzymes, modification of benzaldehyde solubility and the use of two-phase reaction systems."( Factors affecting the production of L-phenylacetylcarbinol by yeast: a case study.
Anderson, BN; Oliver, AL; Roddick, FA, 1999
)
0.3
"A capillary electrophoresis method was developed to separate and quantitate ephedrine (ED), theophylline (TP) and phenobarbital (PB) in a tablet dosage form."( Determination of ephedrine, theophylline and phenobarbital in a tablet dosage form by capillary electrophoresis.
Haque, A; Stewart, JT; Xu, X, 1999
)
0.87
"3 degrees C) but striatal tissue levels of dopamine 7 days after dosing were reduced only 25% or less by ephedrine compared to the 75% reductions produced by amphetamine."( An evaluation of l-ephedrine neurotoxicity with respect to hyperthermia and caudate/putamen microdialysate levels of ephedrine, dopamine, serotonin, and glutamate.
Bowyer, JF; Ferguson, SA; Gough, B; Newport, GD; Slikker, W; Tor-Agbidye, J, 2000
)
0.85
"The terfenadine-pseudoephedrine dosage form discussed here is the sustained-release core tablet composed of outer (fast-release) and inner (sustained-release) layers."( Development of terfenadine-pseudoephedrine double-layer tablet dissolution-equivalent to core tablet.
Choi, HG; Kim, CK; Yong, C, 2000
)
0.9
"5 mg per dosage unit."( Content versus label claims in ephedra-containing dietary supplements.
Gardner, SF; Gurley, BJ; Hubbard, MA, 2000
)
0.31
" Experimental studies in pregnant rabbits using Primatene in both low and high dosage resulted in limb reduction defects and other malformations in a significant number of the offspring compared with controls."( Association of sympathomimetic drugs with malformations.
Drut, RM; Gilbert-Barness, E, 2000
)
0.31
"A high performance liquid chromatography procedure has been developed for the simultaneous determination of guaifenesin pseudoephedrine-dextromethorphan and guaifenesin-pseudoephedrine in commercially available capsule dosage forms and guaifenesin-codeine in a commercial cough syrup dosage form."( HPLC determination of guaifenesin with selected medications on underivatized silica with an aqueous-organic mobile phase.
Stewart, JT; Wilcox, ML, 2000
)
0.51
" For the quantitative assay for all of the investigated substances in the laboratory mixture or in respective pharmaceutical dosage forms the "zero-crossing" technique was applied."( Second-derivative spectrophotometric assay of pseudoephedrine, ibuprofen and loratadine in pharmaceuticals.
Ivanovic, D; Mandic, G; Markovic, S; Medenica, M, 2000
)
0.56
" Topical phenylpropanolamine (1%) and d-pseudoephedrine (1%) 45 minutes after dosing increased blood pressure +44 and +17 mmHg, respectively, over control animals."( Comparative oral and topical decongestant effects of phenylpropanolamine and d-pseudoephedrine.
Egan, RW; Erickson, CH; Hey, JA; McLeod, RL; Mingo, GG; Pedersen, OF,
)
0.61
" A rapid, selective and stability indicating high performance thin layer chromatographic method was developed and validated for their simultaneous estimation in pharmaceutical dosage forms."( Stability indicating HPTLC method for the simultaneous determination of pseudoephedrine and cetirizine in pharmaceutical formulations.
Makhija, SN; Vavia, PR, 2001
)
0.54
" The method has been applied successfully to commercial tablet dosage form."( Kinetic spectrophotometric methods for the quantitation of triprolidine in bulk and in drug formulations.
Metwally, FH, 2001
)
0.31
" Using the pharmacokinetic results, we also conducted a simulation-based study comparing the pharmacokinetic profiles of ephedrine for the usual dosage regimen, a constant dose D three times a day before meals, and two alternative dosage regimens which are often used when patients' symptoms are not improved in the morning using the usual dosage regimen."( Population pharmacokinetic analysis of ephedrine in Kampo prescriptions: a study in healthy volunteers and clinical use of the pharmacokinetic results.
Cyong, JC; Yafune, A, 2001
)
0.79
" The adverse events accompanying acute dosing are mild and transient."( The safety and efficacy of pharmaceutical and herbal caffeine and ephedrine use as a weight loss agent.
Greenway, FL, 2001
)
0.55
"The aim of the study was to assess the effect of maximal therapeutic dosing of sympathomimetic amines found in over-the-counter (OTC) decongestant preparations on endurance running."( Physiological, subjective and performance effects of pseudoephedrine and phenylpropanolamine during endurance running exercise.
Chester, N; Mottram, DR; Reilly, T, 2003
)
0.56
" The described method was applied for the determination of these combinations in synthetic mixtures and dosage forms."( Spectrophotometric determination of binary mixtures of pseudoephedrine with some histamine H1-receptor antagonists using derivative ratio spectrum method.
El-Sayed, MA; El-Yazbi, FA; Gazy, AA; Mahgoub, H; Youssef, RM, 2003
)
0.56
" Lack of interaction was assessed by determination of pharmacokinetic characteristics and relative bioavailability of both substances and salicylic acid (CAS 69-72-7, SA), administered in combination and as equally single dosed drugs."( Pharmacokinetic interaction study of a fixed combination of 500 mg acetylsalicylic acid/30 mg pseudoephedrine versus each of the single active ingredients in healthy male volunteers.
Birkel, M; Hey, B; Loose, I; Lücker, PW; Schaefer, A, 2003
)
0.54
" No interaction was found for AUCnorm and Cmax, norm between the fixed combination ASA/PSE and the equally single dosed drugs as reference."( Pharmacokinetic interaction study of a fixed combination of 500 mg acetylsalicylic acid/30 mg pseudoephedrine versus each of the single active ingredients in healthy male volunteers.
Birkel, M; Hey, B; Loose, I; Lücker, PW; Schaefer, A, 2003
)
0.54
" Sympathomimetic dosage and type, time interval until stroke onset, and neuroimaging findings are described."( Stroke associated with sympathomimetics contained in over-the-counter cough and cold drugs.
Arauz, A; Barinagarrementeria, F; Cantu, C; López, M; Murillo-Bonilla, LM, 2003
)
0.32
" Seventeen (53%) did not reveal the dosage of ephedra alkaloids that was recommended."( A critical evaluation of Internet marketing of products that contain ephedra.
Ashar, BH; Getz, KJ; Miller, RG; Pichard, CP, 2003
)
0.32
" The two methods have been applied successfully for the determination of [I] in its combination with [II] Clarinase tablets and [I] alone in different pharmaceutical dosage forms."( Simultaneous determination of loratadine and pseudoephedrine sulfate in pharmaceutical formulation by RP-LC and derivative spectrophotometry.
el-Fatatry, HM; Hammad, S; Mabrouk, MM; Wahbi, AA, 2003
)
0.57
"To study the elimination of ephedrines with reference to the International Olympic Committee (IOC) doping control cut-off levels, following multiple dosing of over-the-counter decongestant preparations."( Elimination of ephedrines in urine following multiple dosing: the consequences for athletes, in relation to doping control.
Chester, N; Mottram, DR; Powell, M; Reilly, T, 2004
)
0.97
"We examined the dose-response relationship of intrathecal clonidine at small doses (( Small-dose intrathecal clonidine and isobaric bupivacaine for orthopedic surgery: a dose-response study.
Aeschbach, A; Gurzeler, JA; Kindler, CH; Schneider, MC; Strebel, S, 2004
)
0.32
"For treatment of allergic rhinitis, acrivastine with pseudoephedrine in Semprex-D conventional capsules requires dosing every 6-8 hours."( Evaluation and comparison of five matrix excipients for the controlled release of acrivastine and pseudoephedrine.
Fediuk, DJ; Gu, X; Simons, FE; Simons, KJ, 2004
)
0.78
"In this prospective, randomised, double-blind study, we compared the effects of two dosage regimens."( Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section.
Boyne, I; Brown, A; Hannah, P; Harten, JM; Varveris, D, 2005
)
0.33
" NAR and subjective scores of nasal congestion were measured at baseline and after dosing with study medication, every hour over a four-hour period on day 1 after a single dose, and on day 3 after multiple doses of medication."( Efficacy and safety of single and multiple doses of pseudoephedrine in the treatment of nasal congestion associated with common cold.
Angello, JT; Druce, HM; Eccles, R; Jawad, MS; Jawad, SS,
)
0.38
" Because the sugar coating technologies are troublesome and rarely used nowadays, the aim of this study was to develop alternative oral dosage forms containing L (5 mg) and PES (120 mg)."( Development of modified-release dosage forms containing loratadine and pseudoephedrine sulfate.
Cal, K; Kupiec, K; Sznitowska, M, 2004
)
0.55
"Pharmacokinetic parameters AUC0-infinity1 and Cmax1 following a single-dose (Day 1, dose 1), Cmax7, AUC0-24(7) at steady-state and Cmin7 measured at the end of the dosing interval (Day 9, dose 7) revealed bioequivalence between FEX 180 mg/PSE 240 mg combination tablet and the individual components taken concurrently."( Single-dose and steady-state bioequivalence of fexofenadine and pseudoephedrine combination tablets compared with individual formulations in healthy adults.
Agrawala, P; Haribhakti, R; Howard, DR; Kittner, B, 2005
)
0.56
" In subsequent testing, dose-response curves were determined for the individual drugs, for a wide range of dose combinations of the training drugs, and for two drugs to which the pigeons had not been exposed previously (pseudoephedrine and nicotine)."( Effects of amphetamine-CNS depressant combinations and of other CNS stimulants in four-choice drug discriminations.
Li, M; McMillan, DE; Wessinger, WD, 2005
)
0.51
" Therefore, we undertook a dose-response study of hypobaric tetracaine for THR."( Hypobaric spinal anesthesia with 0.2% tetracaine for total joint hip arthroplasy.
Ahn, HJ; Kim, JA, 2005
)
0.33
" The dosage required for peripheral nerve blockade in humans would cause unacceptable cardiovascular side effects."( Efficacy of lidocaine or bupivacaine combined with ephedrine in rat sciatic nerve block.
Gerner, P; Greco, WR; Hung, YC; Kau, YC; Wang, GK; Zizza, AM; Zurakowski, D,
)
0.38
" Furthermore, the cardiovascular side effects will limit the maximal tolerable dosage of ephedrine."( Efficacy of lidocaine or bupivacaine combined with ephedrine in rat sciatic nerve block.
Gerner, P; Greco, WR; Hung, YC; Kau, YC; Wang, GK; Zizza, AM; Zurakowski, D,
)
0.6
"Continuous spinal anaesthesia with spinal catheters allows incremental dosing of the local anaesthetic and, consequently, less haemodynamic change."( Isobaric bupivacaine via spinal catheter for hip replacement surgery: ED50 and ED95 dose determination.
Aantaa, R; Jalonen, J; Olkkola, KT; Sell, A, 2006
)
0.33
" In this study we assessed the utility of using dose-response properties to distinguish urine samples containing amphetamines from samples containing cross-immunoreactive species."( Differentiation of amphetamine/methamphetamine and other cross-immunoreactive sympathomimetic amines in urine samples by serial dilution testing.
Dietzen, DJ; Koenig, JW; Moyer, TP; Saunders, AN; Turk, J; Woodworth, A, 2006
)
0.33
"Use of the slope of the dose-response relationship in patient urine specimens can enhance the PPV of presumptive positive immunoassay results but does not exclude the presence of low amphetamine concentrations in samples containing high concentrations of cross-reactive species."( Differentiation of amphetamine/methamphetamine and other cross-immunoreactive sympathomimetic amines in urine samples by serial dilution testing.
Dietzen, DJ; Koenig, JW; Moyer, TP; Saunders, AN; Turk, J; Woodworth, A, 2006
)
0.33
" Drug dosage determined the degree of nasal mucosa contraction."( A new in vitro method of decongestant assay of nasal mucosa: a preliminary report.
Chu, YH; Kao, CH; Wang, HW,
)
0.13
"In this study, drug dosage determined the degree of nasal mucosa contraction."( A new in vitro method of decongestant assay of nasal mucosa: a preliminary report.
Chu, YH; Kao, CH; Wang, HW,
)
0.13
" The dosage forms were composed of an immediate release core and a release rate regulating shell, fabricated with an aqueous PEH and an ethanolic triethyl citrate (TEC) binder, respectively."( Development of near zero-order release dosage forms using three-dimensional printing (3-DP) technology.
Kay, JL; Monkhouse, DC; Pryor, TJ; Roach, WJ; Surprenant, HL; Tejwani Motwani, MR; Wang, CC; Yoo, J, 2006
)
0.33
" In addition, small tablet size and once-daily dosing may provide patients with increased convenience and improve adherence."( Once-daily immediate-release fexofenadine and sustained-release pseudoephedrine combination: a new treatment option for allergic rhinitis.
Mansfield, LE, 2006
)
0.57
"The method was proved to be highly sensitive, selective, and suitable for pharmacokinetics investigations of different compound preparations containing low dosage of both ephedrine and chlorpheniramine."( [Simultaneous determination of ephedrine and chlorpheniramine in human plasma by a highly sensitive liquid chromatography-tandem mass spectrometric method].
Chen, XY; Duan, XT; Ren, S; Zhong, DF, 2006
)
0.81
" Food and Drug Administration (FDA)-approved dosing recommendations for clinicians prescribing cough and cold medications do not exist for this age group."( Infant deaths associated with cough and cold medications--two states, 2005.
, 2007
)
0.34
" Patients then dosed up to three times daily for 3 days and recorded nasal congestion and pain intensity scores."( Efficacy of a paracetamol-pseudoephedrine combination for treatment of nasal congestion and pain-related symptoms in upper respiratory tract infection.
Burnett, I; Eccles, R; Jawad, M; Jawad, S; Jones, E; North, M; Ridge, D, 2006
)
0.62
"To compare the cutaneous permeation of Kechuan acupoint patch and power, and evaluate the possibility of dosage form reform of Kechuan recipe."( [Cutaneous permeation comparison of Kechuan acupoint patch and power].
Deng, GM; He, Q; Wang, S; Xu, L; Yang, GN, 2007
)
0.34
"Under the conditions of this study, we have shown that when phenylephrine or ephedrine were used to prevent post-spinal hypotension, the dosing requirement of hyperbaric bupivacaine was similar for intrathecal anaesthesia."( Effect of i.v. phenylephrine or ephedrine on the ED50 of intrathecal bupivacaine with fentanyl for caesarean section.
Barnes, J; Belavadi, P; Columb, MO; Hennebry, MC; Lyons, G; Stocks, GM; Wray, S, 2009
)
0.87
" Determining the long-term response and the most effective dosing regimen will require further research."( Ephedrine treatment in congenital myasthenic syndrome due to mutations in DOK7.
Beeson, D; Jayawant, S; Lashley, D; Palace, J; Robb, S, 2010
)
1.8
" The proposed method provides more relevant screening conditions for solid dosage forms, and is useful in selecting optimal solid form(s), determining potential degradation products, and formulation screening during development."( A novel accelerated oxidative stability screening method for pharmaceutical solids.
George, KLST; Zhang, GGZ; Zhou, D; Zhu, DA, 2011
)
0.37
"Sprague-Dawley rats were dosed daily by gavage with one of several different doses of synephrine from one of two different extracts."( Developmental toxicity of Citrus aurantium in rats.
Hansen, DK; Juliar, BE; Pellicore, LS; White, GE, 2011
)
0.37
" The optimum dosing regimen for phenylephrine administration is also discussed."( A review of the impact of phenylephrine administration on maternal hemodynamics and maternal and neonatal outcomes in women undergoing cesarean delivery under spinal anesthesia.
Habib, AS, 2012
)
0.38
" However, the optimal dosing regimen remains unclear."( Closed-loop double-vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: a preliminary study.
Sia, AT; Sng, BL; Tan, HS, 2012
)
0.38
"Simple, rapid, sensitive, precise and accurate spectrophotometeric methods for the determination of ephedrine hydrochloride (E-HCl) and bromhexine hydrochloride (Br-HCl) in bulk samples, dosage form and in spiked urine samples were investigated."( Extractive determination of ephedrine hydrochloride and bromhexine hydrochloride in pure solutions, pharmaceutical dosage form and urine samples.
Abdel-Ghani, NT; Mostafa, M; Rizk, MS, 2013
)
0.9
" The propofol dosage required for anesthetic maintenance was 29% (with a 95% confidence interval, 18-40) lower in patients given dexmedetomidine (2."( Dexmedetomidine reduces propofol and remifentanil requirements during bispectral index-guided closed-loop anesthesia: a double-blind, placebo-controlled trial.
Augé, M; Bonnet, F; Chazot, T; Dardelle, D; Fischler, M; Laloë, PA; Le Guen, M; Liu, N; Sessler, DI; Tounou, F; Tuil, O, 2014
)
0.4
" Ingestion of these products in the form of tablets, capsules, or other solid dosage forms as weight loss aids, exercise performance enhancers, or energy boosters have once again brought their tolerability and efficacy into question."( Multi-ingredient, caffeine-containing dietary supplements: history, safety, and efficacy.
Gurley, BJ; Steelman, SC; Thomas, SL, 2015
)
0.42
" In the third stage, a dose-response trial is planned to test the effectiveness and safety of EFE on chronic joint pain."( Clinical Research Testing the Usefulness of Ephedrine Alkaloids-free Ephedra Herb Extract.
Odaguchi, H, 2017
)
0.72
" We applied conventional meta-analysis, trial sequential analysis, computing the required information size that would exclude type I and II errors, contour-enhanced funnel plot testing for publication bias, meta-regression to assess the dose-response relationship, and the Grading of Recommendations Assessment, Development, and Evaluation system (GRADE)."( Ephedrine versus phenylephrine as a vasopressor for spinal anaesthesia-induced hypotension in parturients undergoing high-risk caesarean section: meta-analysis, meta-regression and trial sequential analysis.
Heesen, M; Hilber, N; Klimek, M; Ngan Kee, WD; Rijs, K; Rossaint, R; van der Marel, C, 2019
)
1.96
" Meta-regression showed no dose-response relationship."( Ephedrine versus phenylephrine as a vasopressor for spinal anaesthesia-induced hypotension in parturients undergoing high-risk caesarean section: meta-analysis, meta-regression and trial sequential analysis.
Heesen, M; Hilber, N; Klimek, M; Ngan Kee, WD; Rijs, K; Rossaint, R; van der Marel, C, 2019
)
1.96
" The dosage ranged 4 to 15 tablets per day with medication duration of more than 1 year for most patients."( A systematic review of phenytoin intoxication induced by compound phenytoin sodium, ephedrine hydrochloride and theophylline tablets in China.
Chen, L; Han, X; Li, C; Li, Z; Ma, G; Shan, M; Zhang, L, 2018
)
0.71
"The recovery studies in both pharmaceutical dosage forms and urine showed that the proposed method ensured good selectivity, precision and accuracy without any interference from inactive excipients."( Voltammetric Analysis of Ephedrine in Pharmaceutical Dosage Forms and Urine Using poly(Nile Blue A) Modified Glassy Carbon Electrode.
Ağın, F; Kul, D; Öztürk, G, 2021
)
0.92
" The method was successfully applied to the syrup dosage form."( Determination of pholcodine alone or in combination with ephedrine in human plasma using fluorescence spectroscopy.
Belal, F; Elmansi, H; Magdy, G, 2022
)
0.97
" The E and PE contents per daily dosage in Kampo extracts were generally proportional to the compounding amount of Ephedrae Herba."( Comparison of ephedrine and pseudoephedrine contents in 34 Kampo extracts containing Ephedrae Herba used clinically in Japan.
Hakamatsuka, T; Hisaka, S; Homma, M; Kobayashi, R; Masada, S; Nose, M; Tada, M, 2023
)
1.27
"Off-label use of medications in paediatric anaesthesia is common practice, owing to the relative paucity of evidence-based dosing regimens in children."( Ephedrine to treat intraoperative hypotension in infants: what is the target?
de Graaff, JC; Frykholm, P, 2023
)
2.35
"Based on this study, 5-10 mg ephedrine and 13-16 μg norepinephrine prophylactic bolus injection may be the optimum dosage of three drugs prevent spinal-induced hypotension, which has the least impact on maternal and neonatal outcomes."( Prevention of spinal hypotension during cesarean section: A systematic review and Bayesian network meta-analysis based on ephedrine, phenylephrine, and norepinephrine.
Lv, X; Ma, X; Xue, X; Yang, Z; Yu, N; Zhou, Y, 2023
)
1.41
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (7)

RoleDescription
nasal decongestantA drug used to relieve nasal congestion in the upper respiratory tract.
sympathomimetic agentA drug that mimics the effects of stimulating postganglionic adrenergic sympathetic nerves. Included in this class are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters.
vasoconstrictor agentDrug used to cause constriction of the blood vessels.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
environmental contaminantAny minor or unwanted substance introduced into the environment that can have undesired effects.
plant metaboliteAny eukaryotic metabolite produced during a metabolic reaction in plants, the kingdom that include flowering plants, conifers and other gymnosperms.
bacterial metaboliteAny prokaryotic metabolite produced during a metabolic reaction in bacteria.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
phenylethanolaminesAn ethanolamine compound having a phenyl (substituted or unsubstituted) group on the carbon bearing the hydroxy substituent.
phenethylamine alkaloid
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
ephedrine biosynthesis019

Protein Targets (1)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
67.9K proteinVaccinia virusPotency0.44670.00018.4406100.0000AID720579
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (42)

Assay IDTitleYearJournalArticle
AID1253468Inhibition of recombinant human truncated SHIP1 using PI(3,4,5)P3diC8 at 1 mM after 30 mins by malachite green phosphatase release assay2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Synthesis and initial evaluation of quinoline-based inhibitors of the SH2-containing inositol 5'-phosphatase (SHIP).
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID311367Permeability coefficient in human skin2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
Transdermal penetration behaviour of drugs: CART-clustering, QSPR and selection of model compounds.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID266765Effective permeability coefficient in 70% silicon-30% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID215614Dissociation constant against a series of agonists of membranes of the turkey erythrocyte containing mainly beta-adrenoceptors was determined.1982Journal of medicinal chemistry, Dec, Volume: 25, Issue:12
Correlation between affinity toward adrenergic receptors and approximate electrostatic potentials of phenylethylamine derivatives. 1. Effects of the side chain.
AID1145610Dissociation constant, pKa of the compound at pH 6.81977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Use of distribution coefficients in quantitative structure-activity relationships.
AID1144401Reduction of diastolic blood pressure in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis in presence of alpha-blocker phenoxybenzamine1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID781325pKa (acid-base dissociation constant) as determined by Liao ref: J Chem Info Model 20092014Pharmaceutical research, Apr, Volume: 31, Issue:4
Comparison of the accuracy of experimental and predicted pKa values of basic and acidic compounds.
AID266771Permeability in human skin2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1442374Induction of stimulus generalization in rat trained to discriminate S(+)methamphetamine assessed as appropriate responding level to training drug by two lever method2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
The 2014 Philip S. Portoghese Medicinal Chemistry Lectureship: The "Phenylalkylaminome" with a Focus on Selected Drugs of Abuse.
AID1145606Octanol-aqueous phase partition coefficient, log P of the compound1977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Use of distribution coefficients in quantitative structure-activity relationships.
AID1145613Drug absorption in rat small intestine1977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Use of distribution coefficients in quantitative structure-activity relationships.
AID1144408Induction of beta-adrenergic response in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis in presence of propranolol1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1144397Increase in diastolic blood pressure in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID19262Aqueous solubility2000Bioorganic & medicinal chemistry letters, Jun-05, Volume: 10, Issue:11
Prediction of drug solubility from Monte Carlo simulations.
AID310932Permeability across human Skin2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID266766Dissociation constant, pKa of the compound2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID21086Lipid solubility measured as chloroform-water partition coefficient1985Journal of medicinal chemistry, Jan, Volume: 28, Issue:1
1H-2-Benzopyran-1-one derivatives, microbial products with pharmacological activity. Conversion into orally active derivatives with antiinflammatory and antiulcer activities.
AID1145612Dissociation constant, pKa of the compound at pH 5.31977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Use of distribution coefficients in quantitative structure-activity relationships.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID515780Intrinsic solubility of the compound in water2010Bioorganic & medicinal chemistry, Oct-01, Volume: 18, Issue:19
QSAR-based solubility model for drug-like compounds.
AID1145608Drug absorption in anesthetized rat colon at pH 6.81977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Use of distribution coefficients in quantitative structure-activity relationships.
AID1144382Induction of beta-adrenergic response in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID266764Membrane permeability, CA(t)/CD(0) in 70% silicon-30% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID310931Partition coefficient, log P of the compound2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID1145607Octanol-aqueous phase distribution coefficient, log D of the compound1977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Use of distribution coefficients in quantitative structure-activity relationships.
AID237685Lipophilicity determined as logarithm of the partition coefficient in the alkane/water system2005Journal of medicinal chemistry, May-05, Volume: 48, Issue:9
Calculating virtual log P in the alkane/water system (log P(N)(alk)) and its derived parameters deltalog P(N)(oct-alk) and log D(pH)(alk).
AID781326pKa (acid-base dissociation constant) as determined by Avdeef ref: DOI: 10.1002/047145026X2014Pharmaceutical research, Apr, Volume: 31, Issue:4
Comparison of the accuracy of experimental and predicted pKa values of basic and acidic compounds.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1144403Reduction of pulse pressure in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis in presence of alpha-blocker phenoxybenzamine1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID266763Membrane retention in 70% silicon-30% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1144402Reduction of systolic blood pressure in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis in presence of alpha-blocker phenoxybenzamine1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID1144398Increase in systolic blood pressure in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID310933Permeability across PAMPA membrane after 7 hrs2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1144399Increase in pulse pressure in mongrel dog at 2 mg/kg, iv by electrocardiograph analysis1976Journal of medicinal chemistry, Jan, Volume: 19, Issue:1
A conformational study of beta-phenethanolamine receptor sites. 8. Pharmacological study of 3-isopropylamino-2-phenyl-trans-2-decalols.
AID1253470Inhibition of recombinant human truncated SHIP2 using PI(3,4,5)P3diC8 at 1 mM after 30 mins by malachite green phosphatase release assay2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Synthesis and initial evaluation of quinoline-based inhibitors of the SH2-containing inositol 5'-phosphatase (SHIP).
AID1442375Induction of stimulus generalization in rat trained to discriminate (-)ephedrine assessed as appropriate responding level to training drug by two lever method2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
The 2014 Philip S. Portoghese Medicinal Chemistry Lectureship: The "Phenylalkylaminome" with a Focus on Selected Drugs of Abuse.
AID1346250Human beta2-adrenoceptor (Adrenoceptors)1997The Journal of biological chemistry, Sep-19, Volume: 272, Issue:38
beta2-adrenergic receptor desensitization, internalization, and phosphorylation in response to full and partial agonists.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,544)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902403 (52.88)18.7374
1990's611 (13.45)18.2507
2000's910 (20.03)29.6817
2010's480 (10.56)24.3611
2020's140 (3.08)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials740 (14.95%)5.53%
Reviews242 (4.89%)6.00%
Case Studies419 (8.47%)4.05%
Observational8 (0.16%)0.25%
Other3,540 (71.53%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (143)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg of Dr. Reddy's Laboratories Ltd., India C [NCT03706300]Phase 180 participants (Actual)Interventional2014-12-31Completed
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fasting Conditions. [NCT01131728]Phase 126 participants (Actual)Interventional2004-07-31Completed
A Randomized, Open Label, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fasting Conditions. [NCT01131780]Phase 132 participants (Actual)Interventional2004-10-31Completed
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy [NCT05697328]90 participants (Anticipated)Interventional2023-01-31Recruiting
Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial [NCT03252496]140 participants (Actual)Interventional2017-08-19Completed
Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study [NCT04053478]144 participants (Anticipated)Interventional2019-07-08Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Effect of Ozanimod on Blood Pressure and Heart Rate Response to Pseudoephedrine in Healthy Adult Subjects [NCT03644576]Phase 154 participants (Actual)Interventional2018-07-11Completed
Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study [NCT03620513]Phase 4160 participants (Actual)Interventional2018-09-01Completed
Enhancement of Brown Adipose Tissue Function Via Chronic Pharmacological Treatment [NCT02236962]42 participants (Anticipated)Interventional2012-04-30Recruiting
A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia) [NCT05692869]24 participants (Actual)Interventional2023-01-31Completed
Multicenter Clinical Trial, Phase III, Controlled, Open, Parallel Group, Randomized, Comparing the Fixed Dose Combination of Diphenhydramine + Dropropizine + Pseudoephedrine and the Combined Use of Dropropizine and Fixed Dose Combination of Pseudoephedrin [NCT01177852]Phase 30 participants (Actual)Interventional2011-10-31Withdrawn
Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS. [NCT03767296]Phase 433 participants (Actual)Interventional2017-02-06Completed
Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in the Relief of Allergic Symptoms in Rhinitic Patients With Viral Upper Respiratory Tract Infections and Productive Cough [NCT01085721]Phase 3170 participants (Anticipated)InterventionalNot yet recruiting
Influences of Phenylephrine, Dopamine and Ephedrine on Stroke Volume Variation and Pulse Pressure Variation [NCT02201121]94 participants (Actual)Interventional2014-03-31Completed
An Open-label, Randomised, Three-way Cross-over, Single Dose, Single Centre, Comparative Pharmacokinetic Study Between Ibuprofen and Pseudoephedrine Liquid Capsules (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Test), Ibuprofen and Pseudoephedrine Tablet [NCT03184766]Phase 155 participants (Actual)Interventional2016-08-10Completed
Managing Post Spinal Hypotension During Elective Cesarean Section: Epinephrine Versus Ephedrine, a Randomized Double-blinded Controlled Trial [NCT03704909]Phase 4143 participants (Actual)Interventional2018-09-01Completed
Effectivity of Combined Use of Ephedrine and Norepinephrine on Maternal Hemodynamics in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia [NCT03672071]90 participants (Anticipated)Interventional2018-09-30Recruiting
Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age. A Randomized, Controlled, Open-label, Dose Escalation Study. [NCT02384876]Phase 2120 participants (Actual)Interventional2015-06-30Completed
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in at Least 48 [NCT02963701]Phase 156 participants (Actual)Interventional2016-12-20Completed
The Effects of Position and Predictive Factors on Hypotension in Patients Undergoing Prone Percutaneous Nephrolithotomy [NCT05827705]153 participants (Actual)Observational2021-03-01Completed
A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older [NCT02082054]Phase 2125 participants (Anticipated)Interventional2014-03-31Active, not recruiting
Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the Treatment of Outpatients With Perennial Allergic Rhiniti [NCT02182518]Phase 3101 participants (Actual)Interventional2000-05-31Completed
[NCT02522858]Phase 4120 participants (Actual)Interventional2015-08-31Completed
Study of the Decongestant Effect of SCH 900538 Compared With Placebo and Pseudoephedrine as Active Control in Subjects With Seasonal Allergic Rhinitis (SAR) Exposed to Pollen in an Environmental Exposure Unit [NCT00673062]Phase 2265 participants (Actual)Interventional2008-05-31Completed
Non-interventional Study on the Quality of Life Before and After Intake of Sinolpan® (Forte) in Inflammatory Diseases of the Respiratory Tract - an Anonymous Patient Survey [NCT04703673]350 participants (Actual)Observational2021-01-08Completed
A Randomized, Open Label, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fed Conditions. [NCT01132222]Phase 134 participants (Actual)Interventional2004-09-30Completed
Randomized Clinical Study for Efficacy Assessment Between Cloratadd-D, Loratadine + Pseudoephedrine (Coated Pill), Produced by EMS S/A Laboratories and Allegra-D , Produced by Sanofi-Aventis for Patients With Perennial Allergic Rhinitis. [NCT01228630]Phase 3156 participants (Actual)Interventional2011-08-31Completed
An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of Aventis, in Healthy Subjects Under Fasting Conditions [NCT01133470]Phase 154 participants (Actual)Interventional2007-02-28Completed
Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters [NCT01028014]56 participants (Actual)Interventional2010-04-30Completed
Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial [NCT02194192]168 participants (Actual)Interventional2014-07-31Completed
The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial [NCT01124383]95 participants (Actual)Interventional2008-08-31Completed
A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 1 [NCT03517930]Phase 152 participants (Actual)Interventional2018-04-17Completed
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fasting Conditions [NCT01373138]Phase 134 participants (Actual)Interventional2006-04-30Completed
Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Male and Female [NCT01170637]Phase 147 participants (Actual)Interventional2010-07-31Completed
Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section [NCT03719625]Phase 4200 participants (Anticipated)Interventional2019-01-02Not yet recruiting
Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia [NCT01186549]Phase 1/Phase 2165 participants (Actual)Interventional2010-08-31Completed
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fed Conditions. [NCT01131767]Phase 126 participants (Actual)Interventional2004-07-31Completed
An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of Aventis, in Healthy Subjects Under Fed Conditions [NCT01133483]Phase 138 participants (Actual)Interventional2007-04-30Completed
Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Elective Cesarean Section Under Spinal Anesthesia [NCT04370847]100 participants (Actual)Observational2020-06-01Completed
Phenylephrine Versus Ephedrine to Treat Spinal Anesthesia-Induced Hypotension in Preeclamptic Patients During Cesarean Delivery [NCT00458003]110 participants (Actual)Interventional2006-07-31Completed
An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With [NCT00779805]40 participants (Actual)Interventional2004-06-30Completed
A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra® 60 mg [NCT01306721]Phase 3520 participants (Actual)Interventional2011-02-28Completed
Effect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic Failure [NCT02149901]Early Phase 135 participants (Anticipated)Interventional2014-10-31Terminated(stopped due to funding terminated)
Comparison of Ephedrine Versus Norepinephrine Efficacity to Correct Anesthesia Induction Related Hypotension in Chronic Renal Insufficiency Patients [NCT05497700]Phase 360 participants (Anticipated)Interventional2022-09-15Recruiting
Norepinephrine Versus Ephedrine for Treatment of Hypotension During Spinal Anesthesia for Caesarean Section [NCT03163407]110 participants (Actual)Interventional2016-07-01Completed
Evaluation of Diet and Treatment With a Combination of Ephedrine and Caffeine on Thermogenesis, Cardiac Function and on Uncoupling Proteins Expression in Adipose and Muscle Tissue of Morbid Obese Patients Undergoing Bariatric Surgery. [NCT02048215]Phase 313 participants (Actual)Interventional2000-02-29Completed
Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia [NCT04934852]70 participants (Anticipated)Interventional2021-07-01Recruiting
Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering Following Subarachnoid Block [NCT02441673]Phase 2130 participants (Anticipated)Interventional2018-10-12Not yet recruiting
A Study to Assess the Speed of Relief From Nasal Congestion With a Hypertonic Saline Nasal Spray (Phytosun Decongestant) [NCT02100605]50 participants (Actual)Interventional2014-03-31Completed
Hypobaric Rather Than Isobaric Bupivacaine to Prevent Anesthesia-induced Hypotension in Patients Undergoing Surgical Repair of Hip Fracture Under Continuous Spinal Anesthesia: a Prospective Randomized Controlled Study. [NCT02428257]120 participants (Anticipated)Interventional2015-06-30Not yet recruiting
An Observational Study to Test the Effect of the Vasoactive Drugs Phenylephrine and Ephedrine on the Stroke Volume and Microvascular Blood Flow of Healthy Volunteers [NCT02252627]8 participants (Anticipated)Observational2014-08-31Recruiting
Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(MRI Part): a Randomized Controlled Study [NCT05414877]60 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Study of the Pharmacokinetic Interactions and Relative Bioavailability of Epinastine and Pseudoephedrine in Healthy Volunteers, Comparing Tablets Containing the Fixed Combination of the Two Substances With Tablets Containing Each of the Two Substances Sep [NCT02182531]Phase 125 participants (Actual)Interventional1999-08-31Completed
Cerebral Hemodynamic and Metabolic Responses to Anesthesia and Vasopressors in Adult Surgery: A 2x2 Factorial Design Randomized Controlled Trial With Light-based Neuromonitoring (CHEM-FACT Study) [NCT05941494]Phase 480 participants (Anticipated)Interventional2023-10-03Recruiting
Comparative, Randomized, Single Dose, 2 Way Crossover Bioavailability Study of Ranbaxy and Warner - Lambert (Sudafed ® 12 Hour) 120 mg Pseudoephedrine Hydrochloride Extended - Release Tablets in Healthy Adult Volunteers Under Fasting Conditions. [NCT00779831]36 participants (Actual)Interventional2004-06-30Completed
Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial [NCT00991627]Phase 436 participants (Anticipated)Interventional2009-09-30Completed
Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation [NCT01015794]25 participants (Actual)Interventional2009-12-31Completed
Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients [NCT03984526]Phase 4102 participants (Actual)Interventional2019-06-25Completed
A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain. [NCT00963443]Phase 3833 participants (Actual)Interventional2009-09-30Completed
Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study) [NCT00377403]Phase 4172 participants (Actual)Interventional2006-10-31Completed
Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy Under General Anesthesia(TCD Part): a Randomized Controlled Study [NCT05665881]60 participants (Anticipated)Interventional2022-11-01Recruiting
The Effects of Colloid Pre-Loading on D-Dimer of the Mother and Her Baby During Cesarean Section Under Spinal Anesthesia for Mild Preeclampsia [NCT02622126]Phase 260 participants (Actual)Interventional2016-01-31Completed
A Randomized, Single-Dose, Single-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-Over Study to Compare the Relative Efficacy of JNJ-39220675, Pseudoephedrine and Placebo for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber [NCT00804687]Phase 253 participants (Actual)Interventional2008-11-30Completed
Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia. A Prospective Observational Study Using Transthoracic Echocardiography [NCT05269537]60 participants (Actual)Observational2022-03-12Completed
Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients With Cerebral Tumors [NCT02713087]Phase 448 participants (Actual)Interventional2015-09-30Completed
A Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Intramuscular Ephedrine on the Incidence of Perioperative Nausea and Vomiting During Elective Cesarean Section [NCT00432991]Phase 253 participants (Actual)Interventional2007-02-28Completed
Evaluation of Nasal Congestion Clinical Efficacy for Diphenhydramine 25 mg and Diphenhydramine 50 mg in Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo and Pseudoephedrine Controlled Study [NCT00648973]Phase 41,021 participants (Actual)Interventional2006-11-30Completed
Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy Adult Volunteers Under Fasting [NCT00837915]40 participants (Actual)Interventional2002-06-30Completed
Combined Spinal Epidural Anesthesia in Obese Patients Undergoing Cesarean Surgery: A Randomised Comparison of Lateral Decubitus and Sitting Positions [NCT04612998]100 participants (Actual)Interventional2017-02-01Completed
Multicenter, Phase III, Randomized, Open, Parallel, Comparative to Evaluate the Efficacy and Safety of the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis and Allergic Reactions, in Pediatric Patients [NCT01393548]Phase 3879 participants (Actual)Interventional2014-08-31Completed
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fasting Conditions [NCT00881127]Phase 140 participants (Actual)Interventional2005-07-31Completed
Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study [NCT01006863]Phase 2150 participants (Actual)Interventional2004-03-31Completed
Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study [NCT02542748]66 participants (Actual)Interventional2015-10-05Completed
Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly [NCT03858465]50 participants (Actual)Interventional2019-02-01Completed
Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery [NCT02948920]40 participants (Actual)Interventional2016-09-22Completed
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fed Conditions [NCT00881634]Phase 140 participants (Actual)Interventional2005-06-30Completed
[NCT00541216]Phase 1/Phase 215 participants (Anticipated)Interventional2007-10-31Enrolling by invitation
Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber [NCT00276016]Phase 339 participants (Actual)Interventional2006-01-31Completed
A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion [NCT01062360]Phase 31,016 participants (Actual)Interventional2005-12-23Completed
Evaluation and Treatment of Autonomic Failure. [NCT00223691]Phase 1389 participants (Actual)Interventional2002-03-31Completed
Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium With Ephedrine Pretreatment: A Randomized Controlled Trial [NCT05725031]Phase 390 participants (Anticipated)Interventional2023-02-22Recruiting
Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery [NCT02961842]200 participants (Actual)Interventional2016-11-20Completed
Effects of Addition of Systemic Tramadol or Adjunct Tramadol to Lidocaine Used for Intravenous Regional Anesthesia in Patients Undergoing Hand Surgery [NCT02658721]Phase 360 participants (Actual)Interventional2013-01-31Completed
Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction [NCT05276596]500 participants (Anticipated)Interventional2022-03-03Recruiting
The Effect of Pseudoephedrine on Rhinitis and Sleep [NCT00704496]Phase 334 participants (Actual)Interventional2007-06-30Completed
Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section [NCT03620942]173 participants (Actual)Interventional2018-11-07Active, not recruiting
Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in Healthy Adult Volunteers Under Fed Con [NCT00845546]40 participants (Actual)Interventional2002-06-30Completed
Comparison of Intrathecal Levobupivacaine Combined With Sufentanil, Fentanyl, or Placebo for Elective Caesarean Section: A Prospective, Randomized, Double-blind, Controlled Study [NCT01858090]Phase 393 participants (Actual)Interventional2009-01-31Completed
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section [NCT02277730]Phase 2/Phase 3252 participants (Actual)Interventional2013-05-31Completed
A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial) [NCT05720455]Phase 4203 participants (Anticipated)Interventional2024-07-21Not yet recruiting
Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis. [NCT05993182]Phase 4300 participants (Anticipated)Interventional2023-08-20Recruiting
Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation in Patients With Preeclampsia Under Spinal Anesthesia for Cesarean [NCT02245191]60 participants (Actual)Interventional2014-07-31Active, not recruiting
A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy's Reproducibility of a Combination of Pseudoephedrine and Cetirizine on Symptom Scores and Rhinomanometry in Patients With Allergic Rhinitis Following Pollen Exposure in [NCT00474890]70 participants (Anticipated)Interventional2007-06-30Completed
Randomised, Double-blind, Phase IV Study to Compare the Incidence of ECG Changes During Elective Caesarean Section Under Spinal Anaesthesia When Using Phenylephrine or Ephedrine Infusion to Maintain Baseline Systolic Blood Pressure [NCT01243970]Phase 429 participants (Actual)Interventional2012-04-30Terminated(stopped due to Change in clinical practice since the start of the trial in 2011 (phenylephrine superior))
An Investigation to Evaluate the Technique of MRI as an Assessment of the Effect of Anti-allergy Drug Treatment on Internal Nasal and Sinus Mucosal Anatomy Following Intranasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis. [NCT00517946]21 participants (Actual)Observational2007-03-31Completed
Maternal and Neonatal Outcomes After the Use of Vasopressors to Correct Hypotension During Cesarean Section Under Spinal Anesthesia in Pregnant Women With Severe Preeclampsia: Randomized Clinical Trial [NCT01451060]Phase 30 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to We didn't have enough financial support)
A Study to Investigate Continuous Heart Rate Monitoring Using a Chest-worn Biosensor on the Background of Drug-induced Positive and Negative Heart Rate Changes [NCT04682184]21 participants (Actual)Interventional2021-01-27Completed
A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab and Pseudoephedrine on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold [NCT00378144]Phase 4469 participants (Actual)Interventional2007-01-31Completed
"Evaluation of Histamine, CGRP and VIP as Biological Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers in Response to Sinus Symptoms" [NCT00208065]Phase 450 participants Interventional2004-05-31Completed
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Mucinex D as Adjunct Therapy to Antibiotic Treatment of Acute Respiratory Infection [NCT00441246]Phase 4600 participants (Anticipated)Interventional2007-02-28Completed
[NCT01055756]Phase 30 participants (Actual)Interventional2010-01-31Withdrawn
Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis [NCT00000752]Phase 20 participants (Actual)InterventionalWithdrawn
The Effects of Height and Weight Adjusted Dose of Local Anesthetic Compared to Standard Dose for Spinal Anesthesia in Elective Cesarean Section [NCT02635555]160 participants (Actual)Interventional2016-04-30Completed
Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery. Prospective Randomised Controlled and Single Centre Trial [NCT01794273]Phase 480 participants (Actual)Interventional2012-07-31Completed
Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion [NCT00146926]Phase 3200 participants Interventional2005-09-30Active, not recruiting
The Autonomic Nervous System and Obesity [NCT00179023]Phase 1128 participants (Actual)Interventional2003-04-30Completed
Closed-loop Double-vasopressor Automated System vs Manual Bolus Vasopressor to Treat Hypotension During Spinal Anaesthesia for Caesarean Section [NCT04025918]Phase 2/Phase 3216 participants (Actual)Interventional2011-10-31Completed
Decision Support for Intraoperative Low Blood Pressure [NCT02726620]22,435 participants (Actual)Interventional2017-01-05Completed
Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia [NCT02025426]Phase 413 participants (Actual)Interventional2012-09-30Terminated(stopped due to Significant challenges recruiting a difficult patient population with most surgeries occurring out of hours)
A Comparative Study of Coadministered Doses of Ibuprofen and Pseudoephedrine HCl and Each Drug Alone in the Treatment of Primary Nocturnal Enuresis in Children [NCT00240812]Phase 2318 participants (Actual)InterventionalCompleted
A Randomized, Double Blind, Placebo-controlled, Four Way Cross-over Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms Scores and Rhinomanometry in Patients With Allergic Rhinitis Following P [NCT00334698]51 participants (Anticipated)Interventional2006-07-31Completed
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fed Conditions [NCT01506791]Phase 144 participants (Actual)Interventional2006-04-30Completed
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial [NCT01509209]Phase 3137 participants (Actual)Interventional2011-05-31Completed
The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine [NCT01509521]Phase 424 participants (Anticipated)Interventional2012-02-29Completed
The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man [NCT01710722]45 participants (Actual)Interventional2001-02-28Completed
A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold [NCT01744106]Phase 3565 participants (Actual)Interventional2012-11-30Completed
Prophylactic Ephedrine to Reduce Fetal Bradycardia After Combined Spinal Epidural Labor Analgesia: a Randomized Double Blind Placebo-controlled Study [NCT02062801]Phase 4710 participants (Actual)Interventional2012-01-31Completed
The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy [NCT01451294]40 participants (Anticipated)Interventional2011-11-30Not yet recruiting
Middle Ear Pressure Regulation in Health and Disease -- Gas Supply, Demand and Middle Ear Gas Balance -- Specific Aim 2 [NCT01925729]Phase 184 participants (Actual)Interventional2013-10-01Completed
"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Equipotent Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine vs Placebo." [NCT03864094]Phase 499 participants (Anticipated)Interventional2022-03-15Recruiting
Effect of Target Intraoperative Blood Pressure on the Incidence of Post-operative Cognitive Dysfunction in Patients Aged 75 and Older Undergoing General Anesthesia for Non-cardiac Surgery: an International Multicenter Randomized Controlled Trial [NCT02428062]Phase 2/Phase 31,812 participants (Anticipated)Interventional2014-10-31Suspended(stopped due to Pending Pilot study results evaluation)
Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Prospective, Randomized, Double-blind, Placebo-controlled Trial [NCT05498857]Phase 4202 participants (Anticipated)Interventional2022-07-15Recruiting
Treatment of Low Metabolic Rate and Low Weight Loss Rate Following Bariatric Surgery [NCT01596907]218 participants (Actual)Interventional2012-05-31Completed
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions [NCT03429738]Phase 166 participants (Actual)Interventional2014-04-27Completed
Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia for Cesarian Section [NCT03421860]Phase 4120 participants (Actual)Interventional2017-02-23Completed
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis [NCT00002149]40 participants InterventionalCompleted
Synergistic Induction of UCP-1 by Ephedrine/Caffeine and Pioglitazone: A Rationale for Combination Therapy of Obesity [NCT00377975]Phase 296 participants Interventional2003-01-31Completed
Maternal Microcirculation & SDF Imaging: A Novel Assessment of the Microcirculation During Cesarean Delivery With Spinal Anesthesia and the Impact of Phenylephrine Prophylaxis to Prevent Spinal Anesthesia-induced Hypotension. [NCT02376192]Phase 432 participants (Actual)Interventional2014-01-31Completed
Ephedrine vs. Nor-epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section [NCT02477501]Phase 4120 participants (Actual)Interventional2016-01-31Completed
Increasing Blood Pressure During Gastric ESD May Control the Risk of Postoperative Bleeding: a Prospective Randomized Trial [NCT03070665]296 participants (Anticipated)Interventional2017-04-01Recruiting
Ephedrine Versus Phenylephrine Infusion for Prevention of Spinal Hypotension During Cesarean Section: Effect on Maternal Cardiodynamics and Fetal Circulation: Randomized Double-blind Study [NCT03047109]Phase 2/Phase 360 participants (Actual)Interventional2017-02-07Completed
Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting: a Multicenter, Prospective, Non-interventional Study [NCT02893241]2,013 participants (Actual)Observational2016-04-30Completed
Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy: a Randomized Clinical Trial [NCT02327923]Phase 490 participants (Actual)Interventional2015-01-31Completed
Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial [NCT05127876]Phase 4168 participants (Actual)Interventional2022-01-10Completed
NIRS-Based Cerebral Oximetry Monitoring in Elderly Thoracic Surgical Patients Undergoing Single Lung Ventilation Procedures: A Single Center, Prospective, Randomized Controlled Pilot Study Assessing the Clinical Impact of NIRS-Guided Intervention [NCT01866657]74 participants (Actual)Interventional2013-06-30Terminated(stopped due to Funding)
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients [NCT05873218]Phase 4150 participants (Anticipated)Interventional2023-06-26Recruiting
HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial. [NCT05637606]636 participants (Anticipated)Interventional2023-03-06Recruiting
Treatment of Sympathetic Blockade During Spinal Anesthesia in Cesarian Section Patients With Low-dose, Slow-administered Preemptive Atropine [NCT05892913]Phase 460 participants (Actual)Interventional2023-07-19Completed
An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection [NCT01586962]Phase 356 participants (Actual)Interventional2012-05-31Completed
A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit [NCT03443843]Phase 482 participants (Actual)Interventional2018-02-21Completed
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy [NCT04332211]Phase 4105 participants (Actual)Interventional2021-05-01Active, not recruiting
A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 1 [NCT03517943]Phase 129 participants (Actual)Interventional2018-04-24Completed
Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care [NCT02476981]75 participants (Actual)Interventional2012-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00276016 (2) [back to overview]The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
NCT00276016 (2) [back to overview]The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
NCT00377403 (1) [back to overview]SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3
NCT00432991 (3) [back to overview]Post-Operation Nausea Score
NCT00432991 (3) [back to overview]Pre-Induction Nausea Score
NCT00432991 (3) [back to overview]Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea.
NCT00458003 (2) [back to overview]The Umbilical Artery Blood Base Excess
NCT00458003 (2) [back to overview]The Umbilical Artery pH
NCT00804687 (4) [back to overview]Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)
NCT00804687 (4) [back to overview]Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry
NCT00804687 (4) [back to overview]Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1
NCT00804687 (4) [back to overview]Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
NCT01586962 (3) [back to overview]Safety and Tolerability of the Syrup
NCT01586962 (3) [back to overview]Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup
NCT01586962 (3) [back to overview]Subject Acceptability of the Syrup
NCT02025426 (8) [back to overview]Number of Participants With Intraoperative Vomiting
NCT02025426 (8) [back to overview]Number of Participants With Intraoperative Nausea
NCT02025426 (8) [back to overview]Number of Participants With Intraoperative Hypotension
NCT02025426 (8) [back to overview]Neonatal Umbilical Cord Gases, pH
NCT02025426 (8) [back to overview]Neonatal Umbilical Cord Gases, BE
NCT02025426 (8) [back to overview]Neonatal Umbilical Cord Gases, pCO2
NCT02025426 (8) [back to overview]Cerebral Tissue Oxygen Saturation
NCT02025426 (8) [back to overview]Cardiac Output
NCT02062801 (3) [back to overview]Urgent Cesarean Delivery
NCT02062801 (3) [back to overview]Tetanic (Sustained) Uterine Contraction (TUC)
NCT02062801 (3) [back to overview]Early Profound Fetal Bradycardia
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Epinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Glycopyrrolate
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Norepinephrine
NCT02726620 (43) [back to overview]Average Use of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
NCT02726620 (43) [back to overview]Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
NCT02726620 (43) [back to overview]Estimated Intraoperative Blood Loss
NCT02726620 (43) [back to overview]In-hospital Mortality
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 50 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 55 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg for > 10 Minutes
NCT02726620 (43) [back to overview]Incidence of a MAP < 60 mmHg for > 20 Minutes
NCT02726620 (43) [back to overview]Intraoperative Administration of Intravenous Fluids
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]Postoperative Rise in Creatinine Levels
NCT02726620 (43) [back to overview]Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 50 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 55 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 60 mmHg
NCT02726620 (43) [back to overview]Timing of Cardiovascular Drugs for MAP < 65 mmHg
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephedrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Ephinephrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Norepinephrine
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Phenylephrine
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
NCT02726620 (43) [back to overview]Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
NCT02726620 (43) [back to overview]30-day Mortality
NCT02726620 (43) [back to overview]Usage Frequency of Cardiovascular Drugs: Glycopyrrolate
NCT02963701 (13) [back to overview]Maximum Concentration of Pseudoephedrine in Plasma (Cmax).
NCT02963701 (13) [back to overview]Cmax of S-Ibuprofen
NCT02963701 (13) [back to overview]Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
NCT02963701 (13) [back to overview]Cmax of R-Ibuprofen
NCT02963701 (13) [back to overview]AUC0-tz of S-Ibuprofen
NCT02963701 (13) [back to overview]AUC0-tz of R-Ibuprofen
NCT02963701 (13) [back to overview]AUC0-∞ of S-Ibuprofen
NCT02963701 (13) [back to overview]AUC0-∞ of R-Ibuprofen
NCT02963701 (13) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).
NCT02963701 (13) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)
NCT02963701 (13) [back to overview]Area Under the Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
NCT02963701 (13) [back to overview]Maximum Concentration of Ibuprofen in Plasma (Cmax).
NCT02963701 (13) [back to overview]S/R-ibuprofen Ratio for AUC0-tz

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo

"To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing.~The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results." (NCT00276016)
Timeframe: Baseline to endpoint (6 hour period)

,
InterventionUnits on a scale (Mean)
Baseline scoreChange from Baseline to Endpoint Score
Phenylephrine2.20-0.18
Placebo2.20-0.12

[back to top]

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.

"To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo~The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results." (NCT00276016)
Timeframe: Baseline to endpoint (6 hour period)

,
InterventionUnits on a scale (Mean)
BaselineEndpoint
Placebo2.20-0.12
Pseudoephedrine2.26-0.47

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SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3

The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact). (NCT00377403)
Timeframe: 4 days

InterventionUnits on a scale (Mean)
Intervention Arm1.12
Symptomatic Treatments Only1.14

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Post-Operation Nausea Score

"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU.~The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject." (NCT00432991)
Timeframe: post-operation

Interventionunits on a scale (Mean)
Saline Placebo0.067
IM Ephedrine0.53

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Pre-Induction Nausea Score

Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea (NCT00432991)
Timeframe: immediately pre-induction

Interventionunits on a scale (Mean)
Saline Placebo0.067
IM Ephedrine0

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Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea.

"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin.~The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject." (NCT00432991)
Timeframe: intra-operation

Interventionunits on a scale (Mean)
Saline Placebo0.16
IM Ephedrine0.28

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The Umbilical Artery Blood Base Excess

"The umbilical artery blood base excess immediately after delivery. Base excess and base deficit refer to an excess or deficit, in the amount of base present in the blood.~The value (-2 to +2 normal range) is usually reported as a concentration in units of mEq/L, with positive numbers indicating an excess of base and negative a deficit" (NCT00458003)
Timeframe: Immediately after delivery

InterventionmEq/L (Median)
Phenylephrine-2.8
Ephedrine-3.4

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The Umbilical Artery pH

"The umbilical artery blood pH immediately after delivery. The pH scale ranges from 0 to 14. A normal pH sample from the umbilical artery ranges from pH: 7.18 - 7.38.~The lower the pH the more acidic and the higher the pH the more basic." (NCT00458003)
Timeframe: Immediately after delivery

InterventionpH (Median)
Phenylephrine7.22
Ephedrine7.20

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Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)

The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry). (NCT00804687)
Timeframe: 2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

Interventionunits on a scale * hours (Mean)
Placebo45.720
JNJ-3922067536.536
Pseudoephedrine43.195

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Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry

The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC. (NCT00804687)
Timeframe: 2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Interventionsquare centimeter*hour (cm^2*h) (Mean)
Placebo-0.682
JNJ-39220675-0.504
Pseudoephedrine-0.550

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Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1

The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline. (NCT00804687)
Timeframe: Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

,,
Interventionsquare centimeter (cm^2) (Mean)
BaselineChange at Hour 1Change at Hour 2Change at Hour 3Change at Hour 4Change at Hour 5Change at Hour 6Change at Hour 7Change at Hour 8
JNJ-392206750.294-0.028-0.041-0.055-0.077-0.082-0.091-0.079-0.090
Placebo0.304-0.054-0.048-0.086-0.100-0.104-0.108-0.094-0.111
Pseudoephedrine0.312-0.0350.060-0.053-0.072-0.092-0.081-0.099-0.110

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Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1

The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline. (NCT00804687)
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

,,
Interventionunits on a scale (Mean)
Change at Hour 0.5Change at Hour 1Change at Hour 1.5Change at Hour 2Change at Hour 2.5Change at Hour 3.0Change at Hour 3.5Change at Hour 4Change at Hour 4.5Change at Hour 5Change at Hour 5.5Change at Hour 6Change at Hour 6.5Change at Hour 7Change at Hour 7.5Change at Hour 8
JNJ-392206751.42.23.23.94.14.74.95.45.35.35.45.65.76.16.16.5
Placebo2.73.54.15.05.65.85.66.16.46.56.66.97.07.07.07.4
Pseudoephedrine1.73.44.24.65.05.45.66.05.66.36.46.56.86.96.97.0

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Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG

Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction. (NCT01028014)
Timeframe: 2 weeks

Interventionmicrovolts (Median)
Pseudoephedrine 120mg ER Daily-18
Solifenacin 5mg Daily10
Tamsulosin 0.4mg Daily11
Imipramine 25mg Daily-15
Cyclobenzaprine 10mg Daily12
Lactose Capsules, One Daily36

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Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry

Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual. (NCT01028014)
Timeframe: 2 weeks

Interventionmilliliters per second (Median)
Pseudoephedrine 120mg ER Daily-7.3
Solifenacin 5mg Daily5.0
Tamsulosin 0.4mg Daily-5.6
Imipramine 25mg Daily-6.6
Cyclobenzaprine 10mg Daily10.3
Lactose Capsules, One Daily10.4

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Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.

Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm. (NCT01028014)
Timeframe: 2 weeks

InterventionMilliamps (Median)
Pseudoephedrine 120mg ER Daily0.06
Solifenacin 5mg Daily0.06
Tamsulosin 0.4mg Daily-0.8
Imipramine 25mg Daily-0.12
Cyclobenzaprine 10mg Daily0.0
Lactose Capsules, One Daily0.03

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Safety and Tolerability of the Syrup

Number of participants with adverse events. (NCT01586962)
Timeframe: 1 hour

InterventionParticipants (Number)
Upper Respiratory Infections9

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Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup

Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation (NCT01586962)
Timeframe: 1 minute

Interventionmm (Mean)
Upper Respiratory Infections34.2

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Subject Acceptability of the Syrup

"How do you like the warming sensation you have experienced for this product?~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely" (NCT01586962)
Timeframe: 1 hour

InterventionParticipants (Number)
Upper Respiratory Infections39

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Number of Participants With Intraoperative Vomiting

(NCT02025426)
Timeframe: Intraoperatively from time of spinal placement until end of surgery

InterventionParticipants (Count of Participants)
Phenylephrine2
Ephedrine1

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Number of Participants With Intraoperative Nausea

(NCT02025426)
Timeframe: Intraoperatively from time of spinal placement until end of surgery

InterventionParticipants (Count of Participants)
Phenylephrine5
Ephedrine3

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Number of Participants With Intraoperative Hypotension

(NCT02025426)
Timeframe: Intraoperatively from spinal placement till 10 minutes after delivery

InterventionParticipants (Count of Participants)
Phenylephrine8
Ephedrine4

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Neonatal Umbilical Cord Gases, pH

Used to assess acid-base balance. pH ranges from 0 to 14 and a pH of 7.40 is considered standard (normal) conditions. (NCT02025426)
Timeframe: Within 5 minutes after delivery

Interventionunitless (Mean)
Phenylephrine7.24
Ephedrine7.19

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Neonatal Umbilical Cord Gases, BE

The amount of strong acid (in mmol/L) that needs to be added in vitro to 1 liter of fully oxygenated blood in order to return the sample to standard (normal) conditions (pH 7.40, pCO2 40 mmHg and temperature 37 °C.) (NCT02025426)
Timeframe: Within 5 minutes after delivery

Interventionmmol/L (Mean)
Phenylephrine-4.83
Ephedrine-8.23

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Neonatal Umbilical Cord Gases, pCO2

Partial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord. (NCT02025426)
Timeframe: Within 5 minutes after delivery

InterventionmmHg (Mean)
Phenylephrine56.71
Ephedrine55.93

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Cerebral Tissue Oxygen Saturation

(NCT02025426)
Timeframe: Intraoperative from spinal placement till 10 min after delivery

InterventionmmHg (Mean)
Phenylephrine30.08
Ephedrine19.10

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Cardiac Output

(NCT02025426)
Timeframe: Intraoperative from spinal placement till 10 min after delivery

InterventionmL/minute (Mean)
Phenylephrine8.19

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Urgent Cesarean Delivery

Incidence of urgent cesarean delivery (NCT02062801)
Timeframe: Within 30 minutes of combined spinal epidural (CSE) placement

Interventionparticipants (Number)
Prophylactic Ephedrine1
Normal Saline Control Group2

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Tetanic (Sustained) Uterine Contraction (TUC)

Incidence of Tetanic (sustained) Uterine Contraction (TUC) (NCT02062801)
Timeframe: Within 30 minutes of combined spinal epidural (CSE) placement

Interventionparticipants (Number)
Prophylactic Ephedrine58
Normal Saline Control Group58

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Early Profound Fetal Bradycardia

Incidence of early profound fetal bradycardia (NCT02062801)
Timeframe: Within 30 minutes of combined spinal epidural (CSE) placement

Interventionparticipants (Number)
Prophylactic Ephedrine8
Normal Saline Control Group14

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Average Use of Cardiovascular Drugs: Ephedrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosages would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group20
Hypotension Decision Support15

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Average Use of Cardiovascular Drugs: Epinephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group1.00
Hypotension Decision Support0.70

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Average Use of Cardiovascular Drugs: Glycopyrrolate

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.40
Hypotension Decision Support0.40

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Average Use of Cardiovascular Drugs: Norepinephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.62
Hypotension Decision Support0.70

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Average Use of Cardiovascular Drugs: Phenylephrine

Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmg (Median)
Usual Care Group0.90
Hypotension Decision Support1.30

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group19
Hypotension Decision Support19

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group23
Hypotension Decision Support23

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group57
Hypotension Decision Support52

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group96
Hypotension Decision Support86

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group273
Hypotension Decision Support235

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Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg

Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmmHg*minute (Median)
Usual Care Group485
Hypotension Decision Support417

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Estimated Intraoperative Blood Loss

The estimated blood loss in mL during the surgical procedure (NCT02726620)
Timeframe: During the surgical procedure: an expected average of 2 hours

InterventionmL (Median)
Usual Care Group100
Hypotension Decision Support75

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In-hospital Mortality

Hospital mortality rate during a single hospital admission after the surgery (NCT02726620)
Timeframe: All postoperative days during a single hospital admission, expected median of 5 days

InterventionParticipants (Count of Participants)
Usual Care Group487
Hypotension Decision Support137

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Incidence of a MAP < 50 mmHg

Incidence of a mean arterial pressure (MAP) < 50 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group7781
Hypotension Decision Support2196

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Incidence of a MAP < 50 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1159
Hypotension Decision Support326

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Incidence of a MAP < 50 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group304
Hypotension Decision Support85

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Incidence of a MAP < 55 mmHg

Incidence of a mean arterial pressure (MAP) < 55 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group10991
Hypotension Decision Support3045

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Incidence of a MAP < 55 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group3181
Hypotension Decision Support759

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Incidence of a MAP < 55 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1223
Hypotension Decision Support284

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Incidence of a MAP < 60 mmHg

Incidence of a mean arterial pressure (MAP) < 60 mmHg during anesthesia for 1 minute or more. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group13779
Hypotension Decision Support3798

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Incidence of a MAP < 60 mmHg for > 10 Minutes

Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group6989
Hypotension Decision Support1723

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Incidence of a MAP < 60 mmHg for > 20 Minutes

Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group3632
Hypotension Decision Support792

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Intraoperative Administration of Intravenous Fluids

Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionmL (Median)
Usual Care Group1500.00
Hypotension Decision Support1400.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg

Average concentrations of propofol infusion rates during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group65.00
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg

Average concentrations of propofol infusion rates during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group63.95
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg

Average concentrations of propofol infusion rates during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group61.07
Hypotension Decision Support50.00

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Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg

Average concentrations of propofol infusion rates during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionmcg/kg/min (propofol) (Median)
Usual Care Group60.10
Hypotension Decision Support48.59

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Postoperative Rise in Creatinine Levels

Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported. (NCT02726620)
Timeframe: Within 7 days after surgery

Interventionmg/dL (Median)
Usual Care Group0.00
Hypotension Decision Support0.00

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Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)

The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes). (NCT02726620)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours

Interventionminutes (Median)
Usual Care Group67
Hypotension Decision Support60

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Timing of Cardiovascular Drugs for MAP < 50 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0

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Timing of Cardiovascular Drugs for MAP < 55 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group1
Hypotension Decision Support0.5

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Timing of Cardiovascular Drugs for MAP < 60 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group0.8
Hypotension Decision Support1.5

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Timing of Cardiovascular Drugs for MAP < 65 mmHg

Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

Interventionminutes (Median)
Usual Care Group2
Hypotension Decision Support1.14

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Usage Frequency of Cardiovascular Drugs: Ephedrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group9310
Hypotension Decision Support2718

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Usage Frequency of Cardiovascular Drugs: Ephinephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group1215
Hypotension Decision Support409

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Usage Frequency of Cardiovascular Drugs: Norepinephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group762
Hypotension Decision Support233

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Usage Frequency of Cardiovascular Drugs: Phenylephrine

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group12211
Hypotension Decision Support3685

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg

Average concentrations of inhalational anesthesia during MAP < 50 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.230.654.70
Usual Care Group1.320.654.28

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg

Average concentrations of inhalational anesthesia during MAP < 55 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.674.65
Usual Care Group1.340.684.60

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg

Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.250.672.33
Usual Care Group1.350.684.36

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Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg

Average concentrations of inhalational anesthesia during MAP < 65 mmHg episodes (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

,
InterventionEndTidal% (other) (Median)
Sevoflurane (EndTidal %)Isoflurane (EndTidal %)Desflurane (EndTidal %)
Hypotension Decision Support1.270.682.31
Usual Care Group1.350.684.10

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30-day Mortality

Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days) (NCT02726620)
Timeframe: 30 days after surgery

InterventionParticipants (Count of Participants)
Usual Care Group511
Hypotension Decision Support143

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Usage Frequency of Cardiovascular Drugs: Glycopyrrolate

Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. (NCT02726620)
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours

InterventionParticipants (Count of Participants)
Usual Care Group11093
Hypotension Decision Support1257

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Maximum Concentration of Pseudoephedrine in Plasma (Cmax).

This outcome is maximum measured concentration of the Pseudoephedrine in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionng/mL (Geometric Mean)
Reference Product (R)320.4
Test Product (T)327.4

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Cmax of S-Ibuprofen

This outcome is maximum measured concentration of the S-Ibuprofen in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionng/mL (Geometric Mean)
Reference Product (R)15050
Test Product (T)13020

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Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)143000
Test Product (T)141600

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Cmax of R-Ibuprofen

This outcome is maximum measured concentration of the R-Ibuprofen in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionng/mL (Geometric Mean)
Reference Product (R)18630
Test Product (T)16910

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AUC0-tz of S-Ibuprofen

This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)70290
Test Product (T)71610

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AUC0-tz of R-Ibuprofen

This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)68520
Test Product (T)65760

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AUC0-∞ of S-Ibuprofen

This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)72270
Test Product (T)73460

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AUC0-∞ of R-Ibuprofen

This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)69420
Test Product (T)66740

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Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).

This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)2547
Test Product (T)2540

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Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)

This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point. (NCT02963701)
Timeframe: Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

InterventionHour nano gram per milliliter (h*ng/mL) (Geometric Mean)
Reference Product (R)140500
Test Product (T)139300

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Area Under the Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).

This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 extrapolated to infinity (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

Interventionh*ng/mL (Geometric Mean)
Reference Product (R)2622
Test Product (T)2614

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Maximum Concentration of Ibuprofen in Plasma (Cmax).

This outcome is maximum measured concentration of the Ibuprofen in plasma (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

InterventionNano gram per milliliter (ng/mL) (Geometric Mean)
Reference Product (R)33580
Test Product (T)29940

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S/R-ibuprofen Ratio for AUC0-tz

AUC0-tz S-ibuprofen / AUC0-tz R-ibuprofen (NCT02963701)
Timeframe: Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.

InterventionRatio (Geometric Mean)
Reference Product (R)1.026
Test Product (T)1.089

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