Page last updated: 2024-12-08

aluminum hydroxide, magnesium hydroxide, drug combination

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Description

aluminum hydroxide, magnesium hydroxide, simethicone drug combination: antacid contains aluminum hydroxide, magnesium hydroxide and simethicone; mylanta II contains aluminum/magnesium hydroxide mixture [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID6335494
MeSH IDM0061456

Synonyms (41)

Synonym
simeco
mylanta
diovol ex
coalgel 60
regla ph (liquid)
maaloxan
alucol
aluminum hydroxide (al(oh)3), mixt. with magnesium hydroxide (mg(oh)2)
supralox
gelcocaine
neogelco
winton
magnesium hydroxide (mg(oh)2), mixt. with aluminum hydroxide (al(oh)3)
riopone
delcid
aluminum hydroxide, mixt. with magnesium hydroxide
novalucol
maalox 70
digex
maaloxon
maalox tc
dioval
aluminum hydroxide - magnesium hydroxide
mylanta ii
ditopax
dimalan
aluminum hydroxide, magnesium hydroxide, simethicone drug combination
aluminum hydroxide, magnesium hydroxide, drug combination
37317-08-1
maalox-plus
siloxforte
exocid
antasil
siloxogene
aluminum hydroxide (al(oh)3), mixt. with magnesium hydroxide (mg(oh)2) and simethicone
digene
39322-42-4
gelusil mps
antacid mps
merasyn
aluminum hydroxide - magnesium hydroxide mixt.

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"A total of 64 courses of ifosfamide (IFM) treatments for sarcoma patients were evaluated for toxic effects."( [Toxic effects of ifosfamide in the treatment of bone and soft tissue sarcomas].
Ishii, T; Kitoh, M; Satoh, T; Tatezaki, S; Umeda, T, 1993
)
0.29

Pharmacokinetics

ExcerptReferenceRelevance
" Due to a short elimination half-life and wide therapeutic index, dosage adjustments are not necessary in patients exhibiting moderate renal dysfunction."( Pharmacokinetics of cefaclor AF: effects of age, antacids and H2-receptor antagonists.
Cerimele, BJ; Coleman, DL; DeSante, KA; Hatcher, BL; Kisicki, J; Satterwhite, JH, 1992
)
0.28
"1 mg/l) and a long elimination half-life (7."( Pharmacokinetics of roxithromycin and influence of H2-blockers and antacids on gastrointestinal absorption.
Boeckh, M; Daeschlein, S; Höffken, G; Koeppe, P; Lode, H, 1992
)
0.28
" The relative pharmacokinetic parameters of total flurbiprofen determined from plasma samples were Cmax, tmax, Kel, t1/2, and AUC infinity."( Pharmacokinetic interaction between flurbiprofen and antacids in healthy volunteers.
Caillé, G; du Souich, P; Pollock, SR; Stalker, DJ; Vézina, M,
)
0.13
" The assay data were used to determine the pharmacokinetic parameters of tenidap in each group."( Pharmacokinetics of tenidap sodium administered with food or antacid in healthy volunteers.
Coates, PE; Mesure, R, 1995
)
0.29
" MPA tmax was slightly delayed and Cmax was lowered about 25%, consistent with delay in gastric emptying in the fed state."( Effects of food and antacid on the pharmacokinetics of single doses of mycophenolate mofetil in rheumatoid arthritis patients.
Bullingham, R; Goldblum, R; Schiff, M; Shah, J, 1996
)
0.29
"The pharmacokinetic disposition and relative bioavailability of sertindole administered as a tablet dosage form under fasting conditions, in the presence of food, in the presence of antacid, and as solution was studied in a four-way crossover in young healthy male volunteers."( Effects of food, antacid, and dosage form on the pharmacokinetics and relative bioavailability of sertindole in healthy volunteers.
Granneman, GR; Linnen, P; Mack, R; Wong, SL, 1997
)
0.3
" Unexpectedly, moderate increases in the Cmax and AUC0-infinity values obtained for capecitabine and 5'-deoxy-5-fluorocytidine were observed when Maalox was given together with capecitabine."( Influence of the antacid Maalox on the pharmacokinetics of capecitabine in cancer patients.
Banken, L; Cassidy, J; Clive, S; Goggin, T; Jodrell, D; Mulligan, T; Reigner, B; Roos, B; Schulz, R; Utoh, M; Weidekamm, E, 1999
)
0.3
" Pharmacokinetic parameters were calculated for oseltamivir and Ro 64-0802."( Lack of pharmacokinetic interaction between the oral anti-influenza neuraminidase inhibitor prodrug oseltamivir and antacids.
Barrett, J; Dorr, A; Oo, C; Snell, P, 2002
)
0.31
"Bioequivalence was achieved for the primary pharmacokinetic parameters Cmax and AUC(0, infinity ) of Ro 64-0802 following administration of oseltamivir with either Maalox suspension or Titralac(R) tablets vs administration of oseltamivir alone."( Lack of pharmacokinetic interaction between the oral anti-influenza neuraminidase inhibitor prodrug oseltamivir and antacids.
Barrett, J; Dorr, A; Oo, C; Snell, P, 2002
)
0.31
" There was no pharmacokinetic interaction between oseltamivir with either antacid, demonstrating that the oral absorption of oseltamivir was not impaired in the presence of antacids containing magnesium, aluminium or calcium."( Lack of pharmacokinetic interaction between the oral anti-influenza neuraminidase inhibitor prodrug oseltamivir and antacids.
Barrett, J; Dorr, A; Oo, C; Snell, P, 2002
)
0.31
" Analysis of variance was performed to determine whether lumiracoxib alone differed from lumiracoxib plus omeprazole or from lumiracoxib plus Al/Mg antacid for overall exposure (area under the concentration-time curve from zero to infinity [AUC( infinity )]) and peak concentration (C(max)), with treatment sequence, subject, period and treatment as factors."( Lack of effect of omeprazole or of an aluminium hydroxide/magnesium hydroxide antacid on the pharmacokinetics of lumiracoxib.
Langholff, W; Milosavljev, S; Rordorf, C; Scott, G; Shenouda, M; Vinluan Reynolds, C, 2004
)
0.32
" In this study, we aimed to develop a novel pharmacokinetic model to describe NQs-metal cation interactions in order to estimate the optimal dosing interval."( Antacid interaction with new quinolones: dose regimen recommendations based on pharmacokinetic modeling of clinical data for ciprofloxacin, gatifloxacin and norfloxacin and metal cations.
Miyata, K; Ohtani, H; Sawada, Y; Tsujimoto, M, 2007
)
0.34
"Plasma concentration-time profiles of NQs after administration without or with metal cations at various dosing intervals were collected from the literature and analyzed with a pharmacokinetic model incorporating the formation ofNQs-metal cations complex."( Antacid interaction with new quinolones: dose regimen recommendations based on pharmacokinetic modeling of clinical data for ciprofloxacin, gatifloxacin and norfloxacin and metal cations.
Miyata, K; Ohtani, H; Sawada, Y; Tsujimoto, M, 2007
)
0.34

Compound-Compound Interactions

ExcerptReferenceRelevance
" These parameters were somewhat higher when ceftibuten was administered with ranitidine, but they were still within the ranges seen in normal healthy volunteers."( Pharmacokinetic drug interaction study: administration of ceftibuten concurrently with the antacid mylanta double- strength liquid or with ranitidine.
Affrime, M; Cutler, D; Lin, CC; Nomeir, A; Radwanski, E, 1998
)
0.3

Bioavailability

ExcerptReferenceRelevance
"The pharmacokinetics and bioavailability of cefaclor advanced formulation (cefaclor AF) were investigated in two studies, one comparing healthy elderly and younger volunteers and the other assessing the effects of an antacid and H2-receptor antagonist on cefaclor AF bioavailability."( Pharmacokinetics of cefaclor AF: effects of age, antacids and H2-receptor antagonists.
Cerimele, BJ; Coleman, DL; DeSante, KA; Hatcher, BL; Kisicki, J; Satterwhite, JH, 1992
)
0.28
"The pharmacokinetics of roxithromycin (300 mg orally) and the influence of the antacid aluminum magnesium hydroxide and the H2-blocker ranitidine on bioavailability of roxithromycin in ten healthy volunteers were studied."( Pharmacokinetics of roxithromycin and influence of H2-blockers and antacids on gastrointestinal absorption.
Boeckh, M; Daeschlein, S; Höffken, G; Koeppe, P; Lode, H, 1992
)
0.28
" Oral bioavailability parameters (area under the concentration-time curve from 0 to 12 h, area under the concentration-time curve from 0 h to infinity, time to maximum concentration of drug in plasma, and maximum concentration of drug in plasma) were obtained by noncompartmental techniques."( Influence of antacid and ranitidine on the pharmacokinetics of oral cefetamet pivoxil.
Ambros, RJ; Blouin, RA; Kneer, J; Stoeckel, K, 1990
)
0.28
"This four-way crossover open-label study on eight healthy subjects was designed to investigate the effect on bioavailability of orally administered nizatidine given concurrently with an antacid (magnesium hydroxide-aluminium hydroxide mixture)."( Oral bioavailability of nizatidine and ranitidine concurrently administered with antacid.
Desager, JP; Harvengt, C,
)
0.13
" Percentages of relative bioavailability compared with control values were 15."( Effects of aluminum and magnesium antacids and ranitidine on the absorption of ciprofloxacin.
Frost, RW; Goldstein, H; Krol, G; Lener, ME; Lettieri, J; Nix, DE; Schentag, JJ; Watson, WA, 1989
)
0.28
" The bioavailability of cimetidine was not significantly affected by metoclopramide and it was marginally reduced by the antacid."( Effects on cimetidine bioavailability of metoclopramide and antacids given two hours apart.
Barzaghi, N; Crema, F; Mescoli, G; Perucca, E, 1989
)
0.28
" The antacid, pirenzepine, and ranitidine had no influence on the bioavailability of amoxicillin, cephalexin, and amoxicillin-clavulanic acid."( Influence of ranitidine, pirenzepine, and aluminum magnesium hydroxide on the bioavailability of various antibiotics, including amoxicillin, cephalexin, doxycycline, and amoxicillin-clavulanic acid.
Deppermann, KM; Höffken, G; Kalz, C; Koeppe, P; Lode, H; Tschink, G, 1989
)
0.28
"Interaction studies in dogs have indicated that antacids significantly decrease the oral bioavailability of cefixime."( Influence of an antacid containing aluminum and magnesium on the pharmacokinetics of cefixime.
Healy, DP; Racht, EM; Sahai, JV; Sterling, LP, 1989
)
0.28
"The relative bioavailability of enteric-coated sodium fluoride (NaF) tablets (10 mg F-) has been assessed following administration with a standard calcium-rich breakfast or calcium-poor lunch, and 2 h before or simultaneously with antacid administration (2."( Influence of food and antacid administration on fluoride bioavailability from enteric-coated sodium fluoride tablets.
Arnold, P; Biollaz, J; Chapuy, MC; Grandjean, EM; Meunier, PJ; Schelling, JL; Wermeille, M, 1989
)
0.28
"To investigate the effect of antacid on the bioavailability and disposition of ranitidine six healthy volunteers were studied on two occasions one week apart."( High dose of antacid (Mylanta II) reduces bioavailability of ranitidine.
Jones, DB; Louis, WJ; Marino, AT; Mihaly, GW; Smallwood, RA; Webster, LK, 1982
)
0.26
" With an intake of 800 mg of calcium/day, calcium balance was only slightly positive, without consideration of dermal losses or other risk factors that may play a role in calcium bioavailability and calcium retention."( Calcium requirements in humans. Report of original data and a review.
De Bartolo, M; Kramer, L; Lesniak, M; Norris, C; Osis, D; Spencer, H, 1984
)
0.27
"In view of contradictory reports on the bioavailability of cimetidine in the presence of concomitantly administered antacids we studied the areas under the plasma concentration time curves (AUC) of cimetidine, the maximal concentrations (cmax) and the time, at which cmax was reached (tmax) in eight patients (five patients with duodenal ulcer, three patients with gastric ulcer) with and without the administration of an aluminum hydroxide magnesium hydroxide containing antacid (Maaloxan)."( Absence of in vivo and in vitro interactions of an aluminum hydroxide, magnesium hydroxide containing antacid with cimetidine in patients with peptic ulcer.
Allgayer, H; Paumgartner, G; Röllinghoff, W, 1983
)
0.27
" Daily renal glycoside excretion, as a further measure of bioavailability of digitoxin, was also unchanged by the antacid."( [Digitoxin blood picture and renal elimination in long-term therapy with aluminum-magnesium hydroxide gel].
Kuhlmann, J, 1984
)
0.27
"The effect of Mylanta on naproxen bioavailability was studied in 11 healthy volunteers."( Effect of Mylanta on naproxen bioavailability.
Bankhurst, AD; Ding, TL; Mroszczak, E; Weber, SS, 1981
)
0.26
"The present study was designed to determine the effects of an antacid suspension containing magnesium hydroxide and aluminum hydroxide (30 ml of Maalox) on the oral bioavailability of rufloxacin (400 mg)."( Effects of magnesium-aluminum hydroxide antacid on absorption of rufloxacin.
Bargiggia, S; Bianchi Porro, G; Broccali, G; Dal Bo, L; Imbimbo, BP; Lazzaroni, M; Sangaletti, O, 1993
)
0.29
" This open, randomized, crossover study was conducted to examine the effects of aspirin, the antacid Maalox (Rhone-Poulenc Rorer, Cologne, Germany), and cimetidine on the pharmacokinetics and bioavailability of a single oral dose of meloxicam 30 mg in healthy male volunteers."( Interaction of meloxicam with cimetidine, Maalox, or aspirin.
Busch, U; Heinzel, G; Narjes, H; Nehmiz, G, 1996
)
0.29
"To determine the effect of the concurrent administration of Maalox and omeprazole in the bioavailability of trovafloxacin (CP-99,219), an open, placebo-controlled, randomized, four-way crossover study was conducted in 12 healthy male volunteers."( Effect of Maalox and omeprazole on the bioavailability of trovafloxacin.
Dogolo, LC; Friedman, HL; Teng, R; Vincent, J; Willavize, SA, 1997
)
0.3
"The pharmacokinetic disposition and relative bioavailability of sertindole administered as a tablet dosage form under fasting conditions, in the presence of food, in the presence of antacid, and as solution was studied in a four-way crossover in young healthy male volunteers."( Effects of food, antacid, and dosage form on the pharmacokinetics and relative bioavailability of sertindole in healthy volunteers.
Granneman, GR; Linnen, P; Mack, R; Wong, SL, 1997
)
0.3
" Bioavailability parameters, maximum plasma concentration and area under the plasma concentration-time curve to infinity of ceftibuten were unaffected by treatment with antacid."( Pharmacokinetic drug interaction study: administration of ceftibuten concurrently with the antacid mylanta double- strength liquid or with ranitidine.
Affrime, M; Cutler, D; Lin, CC; Nomeir, A; Radwanski, E, 1998
)
0.3
"The pharmacokinetics of gatifloxacin (400 mg orally) and the influence of the antacid aluminum magnesium hydroxide (20 ml of Maalox 70) on the bioavailability of gatifloxacin in 24 healthy volunteers were assessed."( Pharmacokinetics of gatifloxacin and interaction with an antacid containing aluminum and magnesium.
Koeppe, P; Lober, S; Lode, H; Mignot, A; Rau, M; Schreiber, G; Ziege, S, 1999
)
0.3
"Two open, randomized, crossover bioavailability studies were carried out to assess the influence of concurrent antacid medication and food on the bioavailability of clopidogrel."( Clopidogrel bioavailability: absence of influence of food or antacids.
Dickinson, JP; McEwen, J; Moreland, TE; Necciari, J; Perles, P; Pritchard, G; Strauch, G, 1999
)
0.3
"This open, randomized, 4-way crossover study investigated the effect of the antacid Maalox on the bioavailability of gemifloxacin, a novel fluoroquinolone antimicrobial."( Effect of Maalox on the bioavailability of oral gemifloxacin in healthy volunteers.
Allen, A; Lewis, A; Porter, A; Vousden, M,
)
0.13
"To determine the effect of concomitant administration of the antacid Maalox 70 or the histamine H2 receptor antagonist ranitidine on the bioavailability of moxifloxacin."( Evaluation of the influence of antacids and H2 antagonists on the absorption of moxifloxacin after oral administration of a 400mg dose to healthy volunteers.
Böttcher, MF; Ochmann, K; Stass, H, 2001
)
0.31
"3 mg/L x h with versus without ranitidine; relative bioavailability 103%, 90% confidence interval (CI) 97."( Evaluation of the influence of antacids and H2 antagonists on the absorption of moxifloxacin after oral administration of a 400mg dose to healthy volunteers.
Böttcher, MF; Ochmann, K; Stass, H, 2001
)
0.31
"The bioavailability of moxifloxacin is not affected by concurrent administration of ranitidine."( Evaluation of the influence of antacids and H2 antagonists on the absorption of moxifloxacin after oral administration of a 400mg dose to healthy volunteers.
Böttcher, MF; Ochmann, K; Stass, H, 2001
)
0.31
" Bioavailability (Cmax and area under the curve) increased approximately in proportion with dose, after single and multiple daily oral doses, over the therapeutic dose range (up to 40-80 mg daily), above which systemic availability of olmesartan increased less than proportionally with increase in dose."( The pharmacokinetic and metabolic profile of olmesartan medoxomil limits the risk of clinically relevant drug interaction.
Kirch, W; Laeis, P; Püchler, K, 2001
)
0.31
" The bioavailability (90% confidence intervals) of Ro 64-0802 following administration of oseltamivir together with Maalox suspension vs administration of oseltamivir alone, was 90% (83."( Lack of pharmacokinetic interaction between the oral anti-influenza neuraminidase inhibitor prodrug oseltamivir and antacids.
Barrett, J; Dorr, A; Oo, C; Snell, P, 2002
)
0.31
" Cell viability through MTT assay suggests drug intercalated LDHs as better drug delivery vehicle for cancer cell line against poor bioavailability of the pure drug."( Layered double hydroxides as effective carrier for anticancer drugs and tailoring of release rate through interlayer anions.
Das, P; Duggal, S; Kumar, M; Maiti, P; Mishra, DP; Rana, D; Senapati, S; Shripathi, T; Thakur, R; Verma, SP, 2016
)
0.43

Dosage Studied

ExcerptRelevanceReference
" Due to a short elimination half-life and wide therapeutic index, dosage adjustments are not necessary in patients exhibiting moderate renal dysfunction."( Pharmacokinetics of cefaclor AF: effects of age, antacids and H2-receptor antagonists.
Cerimele, BJ; Coleman, DL; DeSante, KA; Hatcher, BL; Kisicki, J; Satterwhite, JH, 1992
)
0.28
" Each subject received, in an open-labeled, randomized, three-way crossover design, a single oral dose of 1,000 mg (two tablets) of cefetamet pivoxil 10 min after a standard breakfast during each of the following treatments: treatment A, control period; treatment B, antacid (80 ml of suspension; Maalox 70) administered on the evening before cefetamet pivoxil dosing (-12."( Influence of antacid and ranitidine on the pharmacokinetics of oral cefetamet pivoxil.
Ambros, RJ; Blouin, RA; Kneer, J; Stoeckel, K, 1990
)
0.28
" Increasing the ranitidine dosage to 300 mg/day did not provide additional control."( A randomized clinical trial comparing ranitidine and antacids in critically ill patients.
Anderson, BJ; Grace, M; Johnston, RG; Konopad, E; Noseworthy, TW; Shustack, A, 1987
)
0.27
"5 micrograms/ml were maintained for the entire dosing interval in seven of 10 subjects."( Effect of antacids on predicted steady-state cimetidine concentrations.
Doering, PL; Guild, RT; Lopez, LM; Normann, SA; Russell, WL, 1984
)
0.27
"Over a 15-month period, 75 critically ill patients at risk of acute gastrointestinal bleeding were randomized into two groups: one group (38 patients) received the H2-blocker cimetidine intravenously at an initial dosage of 300 mg every six hours, and the other group (37 patients) received antacid (Mylanta II) through a nasogastric tube at an intial dosage of 30 ml every hour."( Antacid versus cimetidine in preventing acute gastrointestinal bleeding. A randomized trial in 75 critically ill patients.
Bushnell, LS; Long, PC; Priebe, HJ; Silen, W; Skillman, JJ, 1980
)
0.26
" Twice a day dosage is likely to improve patient compliance, costs less, and may reduce dose-related side effects."( Twice-a-day dosage of cimetidine in the short-term treatment of peptic ulcer.
Eaves, R; Korman, MG, 1982
)
0.26
"Aluminium absorption from four doses of the antacid preparation 'Aludrox' when taken alone, with orange juice or with milk was compared by measuring the change in urinary aluminium following Aludrox dosage in 15 normal adults."( Orange juice enhances aluminium absorption from antacid preparation.
Fairweather-Tait, S; Hickson, K; McGaw, B; Reid, M, 1994
)
0.29
" Therefore, there is no need for restriction of valaciclovir dosing in patients receiving antacid medication."( Lack of interaction between valaciclovir, the L-valyl ester of acyclovir, and Maalox antacid.
Bidault, R; de Bony, F; Peck, R; Posner, J, 1996
)
0.29
" These profiles are misleading because the uniformity of dosage units was tested before the dissolution studies."( Determination of norfloxacin by fluorescence in the presence of different antacids: quantification of analytical interferences.
Bernabé, I; Córdoba-Borrego, M; Córdoba-Díaz, D; Córdoba-Díaz, M, 1996
)
0.29
"The pharmacokinetic disposition and relative bioavailability of sertindole administered as a tablet dosage form under fasting conditions, in the presence of food, in the presence of antacid, and as solution was studied in a four-way crossover in young healthy male volunteers."( Effects of food, antacid, and dosage form on the pharmacokinetics and relative bioavailability of sertindole in healthy volunteers.
Granneman, GR; Linnen, P; Mack, R; Wong, SL, 1997
)
0.3
" This study was undertaken to determine an optimal time for dosing antacids in relation to sparfloxacin administration to minimize antacid-induced reduction in sparfloxacin bioavailability."( Effect of Maalox on the oral absorption of sparfloxacin.
Caille, G; Dorr, MB; Johnson, RD; Talbot, GH,
)
0.13
" Blood was sampled for 48 h after dosing to determine pharmacokinetic parameters."( Effect of Maalox on the bioavailability of oral gemifloxacin in healthy volunteers.
Allen, A; Lewis, A; Porter, A; Vousden, M,
)
0.13
" Lumiracoxib can, therefore, be administered concurrently with either of these agents without need for lumiracoxib dosage alteration."( Lack of effect of omeprazole or of an aluminium hydroxide/magnesium hydroxide antacid on the pharmacokinetics of lumiracoxib.
Langholff, W; Milosavljev, S; Rordorf, C; Scott, G; Shenouda, M; Vinluan Reynolds, C, 2004
)
0.32
" Dosing and administration of topical agents in the treatment of primary herpetic gingivostomatitis in preschoolers were problematic."( Management of primary herpetic gingivostomatitis in young children.
Faden, H, 2006
)
0.33
" In this study, we aimed to develop a novel pharmacokinetic model to describe NQs-metal cation interactions in order to estimate the optimal dosing interval."( Antacid interaction with new quinolones: dose regimen recommendations based on pharmacokinetic modeling of clinical data for ciprofloxacin, gatifloxacin and norfloxacin and metal cations.
Miyata, K; Ohtani, H; Sawada, Y; Tsujimoto, M, 2007
)
0.34
"Plasma concentration-time profiles of NQs after administration without or with metal cations at various dosing intervals were collected from the literature and analyzed with a pharmacokinetic model incorporating the formation ofNQs-metal cations complex."( Antacid interaction with new quinolones: dose regimen recommendations based on pharmacokinetic modeling of clinical data for ciprofloxacin, gatifloxacin and norfloxacin and metal cations.
Miyata, K; Ohtani, H; Sawada, Y; Tsujimoto, M, 2007
)
0.34
"The developed model can adequately describe the extent of interaction between NQs and metal cations, and should be clinically useful to design dosage regimens to circumvent the interaction."( Antacid interaction with new quinolones: dose regimen recommendations based on pharmacokinetic modeling of clinical data for ciprofloxacin, gatifloxacin and norfloxacin and metal cations.
Miyata, K; Ohtani, H; Sawada, Y; Tsujimoto, M, 2007
)
0.34
"The primary challenge in finding a treatment for tuberculosis (TB) is patient non-compliance to treatment due to long treatment duration, high dosing frequency, and adverse effects of anti-TB drugs."( Development of a biocompatible nanodelivery system for tuberculosis drugs based on isoniazid-Mg/Al layered double hydroxide.
Arulselvan, P; El Zowalaty, ME; Fakurazi, S; Geilich, BM; Hussein, MZ; Saifullah, B; Webster, TJ, 2014
)
0.4
" Utilizing a 90-day BUD, lidocaine can be packaged separately from other magic mouthwash ingredients in individual dosage units and applied to the oral cavity using the swish-and-spit method."( Beyond-use dating of lidocaine alone and in two "magic mouthwash" preparations.
Brown, SD; Huffman, J; Kirk, LM; Lewis, PO; Luu, Y; Ogle, A, 2017
)
0.46
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (241)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990103 (42.74)18.7374
1990's92 (38.17)18.2507
2000's26 (10.79)29.6817
2010's19 (7.88)24.3611
2020's1 (0.41)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 (%)
Trials100 (39.53%)5.53%
Reviews9 (3.56%)6.00%
Case Studies22 (8.70%)4.05%
Observational0 (0.00%)0.25%
Other122 (48.22%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Effects of Moviprep With Simethicone on Colonic Bubbles [NCT01209806]140 participants (Actual)Interventional2009-11-30Completed
An Open-Label, 3-Period, Fixed-Sequence, Study to Examine the Effect of Aluminum Hydroxide/Magnesium Hydroxide/Simethicone and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects [NCT04368585]Phase 120 participants (Actual)Interventional2020-07-01Completed
Evaluating the Effectiveness of Topical Morphine Compared With a Routine Mouthwash in Managing Cancer Treatment-induced Mucositis in Patients With Head and Neck Cancer in Isfahan [NCT01837446]Phase 2/Phase 330 participants (Actual)Interventional2011-07-31Completed
A Study to Evaluate the Effect of Metal Cation-Containing Antacids on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen [NCT01622673]Phase 127 participants (Actual)Interventional2012-06-30Completed
A Study to Evaluate the Effect of Staggered Dosing of a Magnesium/Aluminum Antacid on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Raltegravir-Containing Regimen [NCT01930045]Phase 118 participants (Actual)Interventional2013-10-01Completed
A Three-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0144471 and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adult Subjects [NCT05109390]Phase 172 participants (Actual)Interventional2018-07-27Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01622673 (8) [back to overview]Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
NCT01622673 (8) [back to overview]Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir
NCT01622673 (8) [back to overview]Number of Participants With Any Clinical or Laboratory Adverse Event (AE)
NCT01930045 (6) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1
NCT01930045 (6) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2
NCT01930045 (6) [back to overview]Maximum Plasma Concentration (C Max) of Raltegravir in Part 1
NCT01930045 (6) [back to overview]Maximum Plasma Concentration (C Max) of Raltegravir in Part 2
NCT01930045 (6) [back to overview]Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1
NCT01930045 (6) [back to overview]Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2

Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir5427.15
TUMS® + Raltegravir2584.78
MINTOX® + Raltegravir3013.88

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Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir5678.90
MINTOX® Before Raltegravir2753.64
MINTOX® After Raltegravir4399.66

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Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM*hr (Least Squares Mean)
Raltegravir17577.15
MINTOX® Before Raltegravir8521.95
MINTOX® After Raltegravir12226.11

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Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM*hr (Least Squares Mean)
Raltegravir16399.76
TUMS® + Raltegravir7294.30
MINTOX® + Raltegravir8358.67

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Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®. (NCT01622673)
Timeframe: 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir132.30
TUMS® + Raltegravir89.75
MINTOX® + Raltegravir49.38

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Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®. (NCT01622673)
Timeframe: 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir125.75
MINTOX® Before Raltegravir54.92
MINTOX® After Raltegravir54.47

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Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir

Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

Interventionhr (Mean)
Raltegravir2.06
TUMS® + Raltegravir2.08
MINTOX® + Raltegravir1.48
MINTOX® Before Raltegravir1.52
MINTOX® After Raltegravir1.78

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Number of Participants With Any Clinical or Laboratory Adverse Event (AE)

"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience." (NCT01622673)
Timeframe: Up to 7 days after the last dose of study drug

Interventionparticipants (Number)
Raltegravir1
TUMS® + Raltegravir2
MINTOX® + Raltegravir2
MINTOX® Before Raltegravir2
MINTOX® After Raltegravir1

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Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

Interventionhr.nM (Geometric Mean)
Raltegravir17055.21
Maalox → 4 Hours → Raltegravir13881.87
Raltegravir → 4 Hours → Maalox11602.02

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Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

Interventionhr.nM (Geometric Mean)
Raltegravir17055.21
Maalox → 6 Hours → Raltegravir14799.48
Raltegravir → 6 Hours → Maalox15104.15

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Maximum Plasma Concentration (C Max) of Raltegravir in Part 1

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir4723.00
Maalox → 4 Hours → Raltegravir3690.96
Raltegravir → 4 Hours → Maalox3324.84

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Maximum Plasma Concentration (C Max) of Raltegravir in Part 2

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir4723.00
Maalox → 6 Hours → Raltegravir4268.72
Raltegravir → 6 Hours → Maalox4256.01

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Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1

Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration. (NCT01930045)
Timeframe: 12 hours after dosing on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir241.35
Maalox → 4 Hours → Raltegravir96.29
Raltegravir → 4 Hours → Maalox92.22

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Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2

Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration. (NCT01930045)
Timeframe: 12 hours after dosing on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir241.35
Maalox → 6 Hours → Raltegravir121.52
Raltegravir → 6 Hours → Maalox122.39

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