mometasone-furoate and Drug-Related-Side-Effects-and-Adverse-Reactions

This report describes a new observation of hyperglycemia in a child with Type 1 diabetes after off-label use of otic ciprofloxacin/dexamethasone drops in the nasal passage and reviews previous reports of adverse endocrine effects from intranasal corticosteroids in pediatric patients.. We describe the clinical case and conducted a literature review of MEDLINE (PubMed) and EMBASE.. A 9-month-old female with a history of Type 1 diabetes who underwent unilateral choanal atresia repair was started on 1 week of ciprofloxacin 0.3%/dexamethasone 0.1% otic drops twice a day for choanal obstruction with granulation tissue. While the patient's airway patency improved, average daily blood glucose increases by 40 to 50 points were noted on the patient's continuous glucose monitor. The hyperglycemia resolved within 2 days after switching to mometasone furoate 0.05% spray. We also review 21 pediatric otolaryngology cases of iatrogenic Cushing's syndrome associated with on- and off-label use of topical steroid suspensions in the airway. Patients ranged from 3 months to 16 years in age and used doses of 50 μg/day to 2 mg/day.. This is the first reported pediatric case of increased blood glucose levels associated with intranasal steroid suspensions, to the best of our knowledge. Counseling families on precise dose administration and potential endocrine disturbances is critical when prescribing these medications for off-label use in infants and small children, particularly among patients with underlying endocrine disorders such as diabetes.

Topics: Administration, Intranasal; Blood Glucose; Child; Ciprofloxacin; Dexamethasone; Diabetes Mellitus, Type 1; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Hyperglycemia; Iatrogenic Disease; Infant; Mometasone Furoate; Off-Label Use; Steroids; Suspensions

In subjects with mild-to-moderate nasal polyposis, treatment with mometasone furoate nasal spray (MFNS) 200 microg once daily (QD) significantly decreases nasal congestion, reduces polyp size, and improves quality of life.. To evaluate the efficacy and safety of MFNS, administered QD in the morning, in subjects with mild-to-moderate nasal polyposis.. This randomized, double-blind, double-dummy, placebo-controlled clinical trial enrolled subjects with mild-to-moderate nasal polyposis at 12 centers in Denmark, Finland, Norway, and Sweden. Inclusion criteria were: age > or = 18 years, a diagnosis of bilateral nasal polyps, and clinically significant nasal congestion. Following a 2-4-week run-in period, subjects were randomized to receive MFNS 200 microg QD or matching placebo for 16 weeks.. A total of 298 subjects were randomized to treatment. Of those subjects included in the intent-to-treat efficacy analysis (n = 291), a statistically greater proportion of the MFNS group than the placebo group had improvements in investigator-assessed nasal congestion score between baseline and end point (the primary outcome) (74.3% vs 46.8%; p < 0.001). Significant benefits of MFNS were also seen for secondary end points, including polyp size, sense of smell, peak nasal inspiratory flow, therapeutic improvement, and quality-of-life measures. MFNS was well tolerated, with no unusual or unexpected adverse events.

Topics: Administration, Intranasal; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Nasal Polyps; Pregnadienediols; Quality of Life; Treatment Outcome

Exogenous glucocorticoids (CGs) possess relevant therapeutic effects but exert diabetogenic actions when in excess. Thus, ligands with potential therapeutic applications and fewer adverse effects are needed. To this, we analyzed whether mometasone furoate (MF), a CG expected to cause fewer side effects, given through systemic routes, could maintain the anti-inflammatory actions without relevant repercussions on metabolism.. The anti-inflammatory effect of MF was evaluated with both peritonitis and colitis models in rodents. Glucose and lipid metabolism were investigated in male and female rats treated daily with MF with different doses and routes of administration for seven days. The involvement of glucocorticoid receptor (GR) on MF actions was assessed in animals pretreated with mifepristone. Also, the potential reversibility of the adverse effects was assessed. Dexamethasone was used as a positive control.. MF treatment resulted in glucose intolerance in male rats treated through intraperitoneal (ip) but not oral gavage route (og). In female rats, none of the routes led to glucose intolerance. MF treatment attenuated insulin sensitivity and increased pancreatic β-cell mass, regardless of the sex and route of administration. MF treatment through og route did not result in dyslipidemia, as observed in rats treated through the ip route (both sexes). The anti-inflammatory and metabolic adverse effects of MF were GR-dependent, and metabolic outcomes altered by MF administration were reversible.. MF maintains anti-inflammatory activity when administered by systemic routes and exerts less impact on metabolism when administered orally in male and female rats, effects that are GR-dependent and reversible. Category: Metabolic Disorders and Endocrinology.

Topics: Administration, Inhalation; Animals; Anti-Inflammatory Agents; Drug-Related Side Effects and Adverse Reactions; Female; Glucocorticoids; Glucose Intolerance; Male; Mometasone Furoate; Pregnadienediols; Rats

Adverse drug reactions (ADRs) present a major burden for patients and the healthcare industry. Various computational methods have been developed to predict ADRs for drug molecules. However, many of these methods require experimental or surveillance data and cannot be used when only structural information is available.. We collected 1,231 small molecule drugs and 600 human proteins and utilized molecular docking to generate binding features among them. We developed machine learning models that use these docking features to make predictions for 1,533 ADRs.. These models obtain an overall area under the receiver operating characteristic curve (AUROC) of 0.843 and an overall area under the precision-recall curve (AUPR) of 0.395, outperforming seven structural fingerprint-based prediction models. Using the method, we predicted skin striae for fluticasone propionate, dermatitis acneiform for mometasone, and decreased libido for irinotecan, as demonstrations. Furthermore, we analyzed the top binding proteins associated with some of the ADRs, which can help to understand and/or generate hypotheses for underlying mechanisms of ADRs.. Machine learning combined with molecular docking can help to predict ADRs for drug molecules and provide possible explanations for the ADR mechanisms.

Topics: Acneiform Eruptions; Algorithms; Binding Sites; Drug-Related Side Effects and Adverse Reactions; Fluticasone; Humans; Irinotecan; Libido; Machine Learning; Molecular Docking Simulation; Mometasone Furoate; Protein Binding; Protein Conformation; ROC Curve; Striae Distensae

Topics: Anti-Allergic Agents; Asthma; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Evidence-Based Medicine; Hippocratic Oath; Humans; Mometasone Furoate; Pregnadienediols