{"id":"oxybutynin","rwe":[{"pmid":"41902910","year":"2026","title":"Efficacy and safety of first-line therapies and first-line-based combination therapies for monosymptomatic nocturnal enuresis in children: a network meta-analysis.","finding":"","journal":"Pediatric nephrology (Berlin, Germany)","studyType":"Clinical Study"},{"pmid":"41886704","year":"2026","title":"Old Dog, New Tricks: Oxybutynin for the Treatment of Androgen Deprivation Therapy-Related Vasomotor Symptoms.","finding":"","journal":"Journal of clinical oncology : official journal of the American Society of Clinical Oncology","studyType":"Clinical Study"},{"pmid":"41871366","year":"2026","title":"Advances in pharmacological treatment and management of hyperhidrosis.","finding":"","journal":"Expert opinion on pharmacotherapy","studyType":"Clinical Study"},{"pmid":"41859431","year":"2026","title":"A 17-year-old boy with hemifacial flushing and anhidrosis.","finding":"","journal":"JAAD case reports","studyType":"Clinical Study"},{"pmid":"41826576","year":"2026","title":"The Influence of Occlusion on Oxybutynin Absorption from Gel-Deposited Excipients Using Ex Vivo Skin and Healthy Human Volunteers.","finding":"","journal":"The AAPS journal","studyType":"Clinical Study"}],"_fda":{"id":"a9056bad-e15c-4be4-a63c-f51362e2f025","set_id":"02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a","openfda":{"unii":["L9F3D9RENQ"],"route":["ORAL"],"rxcui":["863619","863628","863636"],"spl_id":["a9056bad-e15c-4be4-a63c-f51362e2f025"],"brand_name":["Oxybutynin Chloride Extended Release"],"spl_set_id":["02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a"],"package_ndc":["43353-282-30","43353-282-53","43353-282-60","43353-282-80","43353-284-30","43353-284-60","43353-322-16"],"product_ndc":["43353-282","43353-284","43353-322"],"generic_name":["OXYBUTYNIN CHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["OXYBUTYNIN CHLORIDE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"application_number":["ANDA078503"],"original_packager_product_ndc":["42291-633","42291-634","42291-635"]},"version":"2","pregnancy":["8.1 Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies using Oxybutynin chloride extended-release tablets in pregnant women. Oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician. Risk Summary Based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk. Animal Data Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus."],"overdosage":["10 OVERDOSAGE The continuous release of oxybutynin from Oxybutynin chloride extended-release tablets should be considered in the treatment of overdosage. Patients should be monitored for at least 24 hours. Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment."],"description":["11 DESCRIPTION Oxybutynin chloride extended-release tablets are an antispasmodic, muscarinic antagonist. Each Oxybutynin chloride extended-release tablets contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl. Its structural formula is: Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets also contain the following inert ingredients: lactose, mannitol, dextrose, tartaric acid, colloidal silicon dioxide, magnesium stearate, cellulose acetate, polyethylene glycol, titanium dioxide, triacetin, black iron oxide, propylene glycol, hypromellose. Chemical Structure System Components and Performance Oxybutynin chloride extended-release tablets uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Oxybutynin chloride extended-release tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. USP Drug Release Test 3."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Oxybutynin chloride extended-release tablets 5 mg are round, biconvex, white coated tablets imprinted in black ink with \"270\" on one side and \"KU\" on the other side. They are supplied as follows: Bottles of 100 Tablets NDC 42291-633-01 Bottles of 500 Tablets NDC 42291-633-50 Oxybutynin chloride extended-release tablets 10 mg are round, biconvex, white coated tablets imprinted in black ink with \"271\" on one side and \"KU\" on the other side. They are supplied as follows: Bottles of 100 Tablets NDC 42291-634-01 Bottles of 500 Tablets NDC 42291-634-50 Oxybutynin chloride extended-release tablets 15 mg are round, biconvex, white coated tablets imprinted in black ink with \"272\" on one side and \"KU\" on the other side. They are supplied as follows: Bottles of 100 Tablets NDC 42291-635-01 16.1 Storage Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity."],"geriatric_use":["8.5 Geriatric Use The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of Oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age)."],"pediatric_use":["8.4 Pediatric Use The safety and efficacy of Oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6–15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that administration of Oxybutynin chloride extended-release tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%. Urodynamic results were consistent with clinical results. Administration of Oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 60% to 28%. The pharmacokinetics of Oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see Clinical Pharmacology (12.3) ]. Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6."],"effective_time":"20230531","nursing_mothers":["8.3 Nursing Mothers It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxybutynin chloride extended-release tablets are administered to a nursing woman."],"clinical_studies":["14 CLINICAL STUDIES Oxybutynin chloride extended-release tablets were evaluated for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in three controlled efficacy studies. The majority of patients were Caucasian (89.0%) and female (91.9%) with a mean age of 59 years (range, 18 to 98 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge) as evidenced by ≥ 6 urge incontinence episodes per week and ≥ 10 micturitions per day. Study 1 was a fixed-dose escalation design, whereas the other two studies used a dose-adjustment design in which each patient's final dose was adjusted to a balance between improvement of incontinence symptoms and tolerability of side effects. All three studies included patients known to be responsive to oxybutynin or other anticholinergic medications, and these patients were maintained on a final dose for up to 2 weeks. The efficacy results for the three controlled trials are presented in the following tables and figures. Number of Urge Urinary Incontinence Episodes Per Week Study 1 n Oxybutynin chloride extended-release tablets n Placebo Mean Baseline 34 15.9 16 20.9 Mean (SD) Change from Baseline Covariate adjusted mean with missing observations set to baseline values 34 -15.8 (8.9) 16 -7.6 (8.6) 95% Confidence Interval for Difference (-13.6, -2.8) The difference between Oxybutynin chloride extended-release tabletsand placebo was statistically significant. (Oxybutynin chloride extended-release tablets- Placebo) Study 2 n Oxybutynin chloride extended-release tablets n oxybutynin Mean Baseline 53 27.6 52 23.0 Mean (SD) Change from Baseline Covariate adjusted mean with missing observations set to baseline values 53 -17.6 (11.9) 52 -19.4 (11.9) 95% Confidence Interval for Difference (-2.8, 6.5) (Oxybutynin chloride extended-release tablets- oxybutynin) Study 3 n Oxybutynin chloride extended-release tablets n oxybutynin Mean Baseline 111 18.9 115 19.5 Mean (SD) Change from Baseline Covariate adjusted mean with missing observations set to baseline values 111 -14.5 (8.7) 115 -13.8 (8.6) 95% Confidence Interval for Difference (-3.0, 1.6) The difference between Oxybutynin chloride extended-release tabletsand oxybutynin fulfilled the criteria for comparable efficacy. (Oxybutynin chloride extended-release tablets- oxybutynin) Figure 2 Figure 3 Figure 4"],"pharmacodynamics":["12.2 Pharmacodynamics In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption Following the first dose of Oxybutynin chloride extended-release tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from Oxybutynin chloride extended-release tablets are 156% and 187%, respectively, compared with oxybutynin. The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 2. The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin chloride extended-release tablets 10 mg (n=43) Parameters (units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 1.0 (0.6) 1.8 (1.0) T max (h) 12.7 (5.4) 11.8 (5.3) t 1/2 (h) 13.2 (6.2) 12.4 (6.1) AUC (0–48) (ng∙h/mL) 18.4 (10.3) 34.2 (16.9) AUC inf (ng∙h/mL) 21.3 (12.2) 39.5 (21.2) Figure 1: Mean R-oxybutynin plasma concentrations following a single dose of Oxybutynin chloride extended-release tablets 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment). Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated Oxybutynin chloride extended-release tablets dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters. Oxybutynin chloride extended-release tablets steady state pharmacokinetics were studied in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The children were on Oxybutynin chloride extended-release tablets total daily dose ranging from 5 to 20 mg (0.10 to 0.77 mg/kg). Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg per day of Oxybutynin chloride extended-release tablets, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 3. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg per day. Table 3: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5–15 Following Administration of 5 to 20 mg Oxybutynin chloride extended-release tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin chloride extended-release tablets 5 mg Once Daily R-Oxybutynin S-Oxybutynin R- Desethyloxybutynin S- Desethyloxybutynin C max (ng/mL) 0.7 ± 0.4 1.3 ± 0.8 7.8 ± 3.7 4.2 ± 2.3 T max (h) 5.0 5.0 5.0 5.0 AUC (ng∙h/mL) 12.8 ± 7.0 23.7 ± 14.4 125.1 ± 66.7 73.6 ± 47.7 Figure 2: Mean steady state (± SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Oxybutynin chloride extended-release tablets once daily in children aged 5–15. Plot represents all available data normalized to an equivalent of Oxybutynin chloride extended-release tablets 5 mg once daily. Figure 1 Figure 2 Food Effects The rate and extent of absorption and metabolism of oxybutynin are similar under fed and fasted conditions. Distribution Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of distribution is 193 L after intravenous administration of 5 mg oxybutynin chloride. Both enantiomers of oxybutynin are highly bound (>99%) to plasma proteins. Both enantiomers of N-desethyloxybutynin are also highly bound (>97%) to plasma proteins. The major binding protein is alpha-1 acid glycoprotein. Metabolism Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4 found mostly in the liver and gut wall. Its metabolic products include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active. Following Oxybutynin chloride extended-release tablets administration, plasma concentrations of R- and S-desethyloxybutynin are 73% and 92%, respectively, of concentrations observed with oxybutynin. Excretion Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin. Dose Proportionality Pharmacokinetic parameters of oxybutynin and desethyloxybutynin (C max and AUC) following administration of 5–20 mg of Oxybutynin chloride extended-release tablets are dose proportional. Use in Specific Populations Pediatric The pharmacokinetics of Oxybutynin chloride extended-release tablets were evaluated in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The pharmacokinetics of Oxybutynin chloride extended-release tablets in these pediatric patients were consistent with those reported for adults (see Tables 2 and 3, and Figures 1 and 2 above). Gender There are no significant differences in the pharmacokinetics of oxybutynin in healthy male and female volunteers following administration of Oxybutynin chloride extended-release tablets. Race Available data suggest that there are no significant differences in the pharmacokinetics of oxybutynin based on race in healthy volunteers following administration of Oxybutynin chloride extended-release tablets."],"adverse_reactions":["6 ADVERSE REACTIONS The most common (incidence ≥5%) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of Oxybutynin chloride extended-release tablets (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, Oxybutynin chloride IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by ≥ 1% of subjects are shown in Table 1. Table 1: Adverse Drug Reactions Reported by ≥ 1% of Oxybutynin chloride extended-release tablets-treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of Oxybutynin chloride extended-release tablets System/Organ Class Preferred Term Oxybutynin chloride extended-release tablets 5 to 30 mg/day n = 774 % Oxybutynin chloride IR IR = immediate release 5 to 20 mg/day n = 199 % Psychiatric Disorders Insomnia 3.0 5.5 Nervous System Disorders Headache 7.5 8.0 Somnolence 5.6 14.1 Dizziness 5.0 16.6 Dysgeusia 1.6 1.5 Eye Disorders Vision blurred 4.3 9.6 Dry eye 3.1 2.5 Respiratory, Thoracic and Mediastinal Disorders Cough 1.9 3.0 Oropharyngeal pain 1.9 1.5 Dry throat 1.7 2.5 Nasal dryness 1.7 4.5 Gastrointestinal Disorders Dry mouth 34.9 72.4 Constipation 8.7 15.1 Diarrhea 7.9 6.5 Dyspepsia 4.5 6.0 Nausea 4.5 11.6 Abdominal pain 1.6 2.0 Vomiting 1.3 1.5 Flatulence 1.2 2.5 Gastro-esophageal reflux disease 1.0 0.5 Skin and Subcutaneous Tissue Disorders Dry skin 1.8 2.5 Pruritus 1.3 1.5 Renal and Urinary Disorders Dysuria 1.9 2.0 Urinary hesitation 1.9 8.5 Urinary retention 1.2 3.0 General Disorders and Administration Site Conditions Fatigue 2.6 3.0 Investigations Residual urine volume The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased. 2.3 3.5 The discontinuation rate due to adverse reactions was 4.4% with Oxybutynin chloride extended-release tablets compared to 0% with Oxybutynin chloride IR. The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7% ). The following adverse reactions were reported by <1% of Oxybutynin chloride extended-release tablets-treated patients and at a higher incidence than placebo in clinical trials: Metabolism and Nutrition Disorders: anorexia, fluid retention; Vascular disorders: hot flush; Respiratory, thoracic and mediastinal disorders: dysphonia; Gastrointestinal Disorders: dysphagia, frequent bowel movements; General disorders and administration site conditions: chest discomfort, thirst. 6.2 Postmarketing Experience The following additional adverse reactions have been reported from worldwide postmarketing experience with Oxybutynin chloride extended-release tablets. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and Infestations: Urinary tract infection; Psychiatric Disorders: psychotic disorder, agitation, confusional state, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Respiratory, Thoracic and Mediastinal Disorders: nasal congestion; Cardiac Disorders: arrhythmia, tachycardia, palpitations; QT interval prolongation; Vascular Disorders: flushing, hypertension; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence;General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; anaphylactic reactions requiring hospitalization for emergency treatment; Injury, poisoning and procedural complications: fall. Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and suppression of lactation. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com ; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["4 CONTRAINDICATIONS Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angiodema. Urinary retention (4) Gastric Retention (4) Uncontrolled narrow angle glaucoma (4) Known hypersensitivity to Oxybutynin chloride extended-release tablets, oxybutynin or any component of Oxybutynin chloride extended-release tablets (4)"],"drug_interactions":["7 DRUG INTERACTIONS The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index. Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide. Mean oxybutynin chloride plasma concentrations were approximately 2 fold higher when Oxybutynin chloride extended-release tablets were administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered. Co-administration with other anticholinergic drugs may increase the frequency and/or severity of anticholinergic-like effects. (7) Co-administration with strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole) increases the systemic exposure of oxybutynin. (7)"],"mechanism_of_action":["12.1 Mechanism of Action Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects). Antimuscarinic activity resides predominantly in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies."],"storage_and_handling":["16.1 Storage Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects). Antimuscarinic activity resides predominantly in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies. 12.2 Pharmacodynamics In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. 12.3 Pharmacokinetics Absorption Following the first dose of Oxybutynin chloride extended-release tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from Oxybutynin chloride extended-release tablets are 156% and 187%, respectively, compared with oxybutynin. The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 2. The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin chloride extended-release tablets 10 mg (n=43) Parameters (units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 1.0 (0.6) 1.8 (1.0) T max (h) 12.7 (5.4) 11.8 (5.3) t 1/2 (h) 13.2 (6.2) 12.4 (6.1) AUC (0–48) (ng∙h/mL) 18.4 (10.3) 34.2 (16.9) AUC inf (ng∙h/mL) 21.3 (12.2) 39.5 (21.2) Figure 1: Mean R-oxybutynin plasma concentrations following a single dose of Oxybutynin chloride extended-release tablets 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment). Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated Oxybutynin chloride extended-release tablets dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters. Oxybutynin chloride extended-release tablets steady state pharmacokinetics were studied in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The children were on Oxybutynin chloride extended-release tablets total daily dose ranging from 5 to 20 mg (0.10 to 0.77 mg/kg). Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg per day of Oxybutynin chloride extended-release tablets, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 3. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg per day. Table 3: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5–15 Following Administration of 5 to 20 mg Oxybutynin chloride extended-release tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin chloride extended-release tablets 5 mg Once Daily R-Oxybutynin S-Oxybutynin R- Desethyloxybutynin S- Desethyloxybutynin C max (ng/mL) 0.7 ± 0.4 1.3 ± 0.8 7.8 ± 3.7 4.2 ± 2.3 T max (h) 5.0 5.0 5.0 5.0 AUC (ng∙h/mL) 12.8 ± 7.0 23.7 ± 14.4 125.1 ± 66.7 73.6 ± 47.7 Figure 2: Mean steady state (± SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Oxybutynin chloride extended-release tablets once daily in children aged 5–15. Plot represents all available data normalized to an equivalent of Oxybutynin chloride extended-release tablets 5 mg once daily. Figure 1 Figure 2 Food Effects The rate and extent of absorption and metabolism of oxybutynin are similar under fed and fasted conditions. Distribution Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of distribution is 193 L after intravenous administration of 5 mg oxybutynin chloride. Both enantiomers of oxybutynin are highly bound (>99%) to plasma proteins. Both enantiomers of N-desethyloxybutynin are also highly bound (>97%) to plasma proteins. The major binding protein is alpha-1 acid glycoprotein. Metabolism Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4 found mostly in the liver and gut wall. Its metabolic products include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active. Following Oxybutynin chloride extended-release tablets administration, plasma concentrations of R- and S-desethyloxybutynin are 73% and 92%, respectively, of concentrations observed with oxybutynin. Excretion Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin. Dose Proportionality Pharmacokinetic parameters of oxybutynin and desethyloxybutynin (C max and AUC) following administration of 5–20 mg of Oxybutynin chloride extended-release tablets are dose proportional. Use in Specific Populations Pediatric The pharmacokinetics of Oxybutynin chloride extended-release tablets were evaluated in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The pharmacokinetics of Oxybutynin chloride extended-release tablets in these pediatric patients were consistent with those reported for adults (see Tables 2 and 3, and Figures 1 and 2 above). Gender There are no significant differences in the pharmacokinetics of oxybutynin in healthy male and female volunteers following administration of Oxybutynin chloride extended-release tablets. Race Available data suggest that there are no significant differences in the pharmacokinetics of oxybutynin based on race in healthy volunteers following administration of Oxybutynin chloride extended-release tablets."],"indications_and_usage":["1 INDICATIONS AND USAGE Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1) Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). (1)"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue Oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy. ( 5.1 ) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin. If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of Oxybutynin chloride extended-release tablets. ( 5.2 ) Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinesterase inhibitors ( 5.2 ), Parkinson's disease ( 5.2 ), Myasthenia gravis ( 5.3 ), and Decreased gastrointestinal motility in patients with autonomic neuropathy. ( 5.4 ) Urinary Retention: Use with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention ( 5.5 ) Gastrointestinal Adverse Reactions: Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention. Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis. ( 5.6 ) 5.1 Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. 5.2 Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6) ]. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Oxybutynin chloride extended-release tablets affect them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Oxybutynin chloride extended-release tablets should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms. Oxybutynin chloride extended-release tablets should be used with caution in patients with Parkinson's disease due to the risk of aggravation of symptoms. 5.3 Worsening of Symptoms of Myasthenia Gravis Oxybutynin chloride extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of symptom aggravation. 5.4 Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy Oxybutynin chloride extended-release tablets should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility. 5.5 Urinary Retention Oxybutynin chloride extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4) ]. 5.6 Gastrointestinal Adverse Reactions Oxybutynin chloride extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4) ]. Oxybutynin chloride extended-release tablets, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony. Oxybutynin chloride extended-release tablets should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis. As with any other nondeformable material, caution should be used when administering Oxybutynin chloride extended-release tablets to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations."],"clinical_studies_table":["
Number of Urge Urinary Incontinence Episodes Per Week
Study 1nOxybutynin chloride extended-release tabletsnPlacebo
Mean Baseline3415.91620.9
Mean (SD) Change from Baseline Covariate adjusted mean with missing observations set to baseline values34-15.8 (8.9)16-7.6 (8.6)
95% Confidence Interval for Difference(-13.6, -2.8) The difference between Oxybutynin chloride extended-release tabletsand placebo was statistically significant.
(Oxybutynin chloride extended-release tablets- Placebo)
","
Study 2nOxybutynin chloride extended-release tabletsnoxybutynin
Mean Baseline5327.65223.0
Mean (SD) Change from Baseline Covariate adjusted mean with missing observations set to baseline values53-17.6 (11.9)52-19.4 (11.9)
95% Confidence Interval for Difference(-2.8, 6.5)
(Oxybutynin chloride extended-release tablets- oxybutynin)
","
Study 3nOxybutynin chloride extended-release tabletsnoxybutynin
Mean Baseline11118.911519.5
Mean (SD) Change from Baseline Covariate adjusted mean with missing observations set to baseline values111-14.5 (8.7)115-13.8 (8.6)
95% Confidence Interval for Difference(-3.0, 1.6) The difference between Oxybutynin chloride extended-release tabletsand oxybutynin fulfilled the criteria for comparable efficacy.
(Oxybutynin chloride extended-release tablets- oxybutynin)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility A 24-month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum human exposure, based on a human equivalent dose taking into account normalization of body surface area. Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae , and Salmonella typhimurium test systems. Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility."],"pharmacokinetics_table":["
Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin chloride extended-release tablets 10 mg (n=43)
Parameters (units)R-OxybutyninS-Oxybutynin
C max (ng/mL) 1.0 (0.6) 1.8 (1.0)
T max (h) 12.7 (5.4) 11.8 (5.3)
t 1/2 (h) 13.2 (6.2) 12.4 (6.1)
AUC (0–48) (ng∙h/mL) 18.4 (10.3) 34.2 (16.9)
AUC inf (ng∙h/mL) 21.3 (12.2) 39.5 (21.2)
","
Table 3: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5–15 Following Administration of 5 to 20 mg Oxybutynin chloride extended-release tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin chloride extended-release tablets 5 mg Once Daily
R-OxybutyninS-OxybutyninR- DesethyloxybutyninS- Desethyloxybutynin
C max (ng/mL) 0.7 ± 0.4 1.3 ± 0.8 7.8 ± 3.7 4.2 ± 2.3
T max (h) 5.0 5.0 5.0 5.0
AUC (ng∙h/mL) 12.8 ± 7.0 23.7 ± 14.4 125.1 ± 66.7 73.6 ± 47.7
"],"adverse_reactions_table":["
Table 1: Adverse Drug Reactions Reported by ≥ 1% of Oxybutynin chloride extended-release tablets-treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of Oxybutynin chloride extended-release tablets
System/Organ Class Preferred Term Oxybutynin chloride extended-release tablets 5 to 30 mg/day n = 774 % Oxybutynin chloride IR IR = immediate release 5 to 20 mg/day n = 199 %
Psychiatric Disorders
Insomnia 3.0 5.5
Nervous System Disorders
Headache 7.5 8.0
Somnolence 5.6 14.1
Dizziness 5.0 16.6
Dysgeusia 1.6 1.5
Eye Disorders
Vision blurred 4.3 9.6
Dry eye 3.1 2.5
Respiratory, Thoracic and Mediastinal Disorders
Cough 1.9 3.0
Oropharyngeal pain 1.9 1.5
Dry throat 1.7 2.5
Nasal dryness 1.7 4.5
Gastrointestinal Disorders
Dry mouth 34.9 72.4
Constipation 8.7 15.1
Diarrhea 7.9 6.5
Dyspepsia 4.5 6.0
Nausea 4.5 11.6
Abdominal pain 1.6 2.0
Vomiting 1.3 1.5
Flatulence 1.2 2.5
Gastro-esophageal reflux disease 1.0 0.5
Skin and Subcutaneous Tissue Disorders
Dry skin 1.8 2.5
Pruritus 1.3 1.5
Renal and Urinary Disorders
Dysuria 1.9 2.0
Urinary hesitation 1.9 8.5
Urinary retention 1.2 3.0
General Disorders and Administration Site Conditions
Fatigue 2.6 3.0
Investigations
Residual urine volume The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased. 2.3 3.5
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Patients should be informed that oxybutynin may produce angioedema that could result in life threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience swelling of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that anticholinergic (antimuscarinic) agents such as Oxybutynin chloride extended-release tablets, may produce clinically significant adverse reactions related to anticholinergic activity such as: Urinary retention and constipation Heat prostration due to decreased sweating. Heat prostration can occur when anticholinergic medicines are administered in the presence of high environmental temperature. Patients should be informed that anticholinergic medicines such as Oxybutynin chloride extended-release tablets may produce drowsiness (somnolence), dizziness or blurred vision. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until Oxybutynin chloride extended-release tablets effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as Oxybutynin chloride extended-release tablets. Patients should be informed that Oxybutynin chloride extended-release tablets should be swallowed whole with the aid of liquids. Patients should not chew, divide, or crush tablets. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet. Oxybutynin chloride extended-release tablets should be taken at approximately the same time each day. For more information call 1-855-361-3993 or visit avkare.com."],"spl_unclassified_section":["Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 10/16 AV Rev. 10/18 (P)","Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 5 mg 10 mg 15 mg 30 43353-282-30 43353-284-30 - 60 43353-282-53 - - 90 43353-282-60 43353-284-60 - 180 43353-282-80 - - 6000 - - 43353-322-16 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20230531JK Aphena Pharma Solutions - TN"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food. Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food. (2) Adults: Start with 5 mg or 10 mg, once daily at approximately the same time every day. Dose should not exceed 30 mg per day. ( 2.1 ) Pediatric patients (6 years of age or older): Start with 5 mg, once daily at approximately the same time every day. Dose should not exceed 20 mg per day. ( 2.2 ) 2.1 Adults The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. 2.2 Pediatric Patients Aged 6 Years of Age and Older The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day)."],"spl_product_data_elements":["Oxybutynin Chloride Extended Release Oxybutynin Chloride ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MANNITOL ANHYDROUS DEXTROSE TARTARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE ACETATE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE FERROSOFERRIC OXIDE PROPYLENE GLYCOL HYPROMELLOSE 2208 (100 MPA.S) TRIACETIN OXYBUTYNIN CHLORIDE OXYBUTYNIN KU;270 Oxybutynin Chloride Extended Release Oxybutynin Chloride ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MANNITOL ANHYDROUS DEXTROSE TARTARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE ACETATE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE FERROSOFERRIC OXIDE PROPYLENE GLYCOL HYPROMELLOSE 2208 (100 MPA.S) TRIACETIN OXYBUTYNIN CHLORIDE OXYBUTYNIN KU;271 Oxybutynin Chloride Extended Release Oxybutynin Chloride SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE ACETATE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE FERROSOFERRIC OXIDE PROPYLENE GLYCOL HYPROMELLOSE 2208 (100 MPA.S) TRIACETIN OXYBUTYNIN CHLORIDE OXYBUTYNIN ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MANNITOL ANHYDROUS DEXTROSE TARTARIC ACID KU;272"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Oxybutynin chloride extended-release tablets are available as 5, 10 and 15 mg tablets for oral use: 5 mg: White, round, biconvex tablet with \"270\" printed on one side and \"KU\" printed on the other side with black ink. 10 mg: White, round, biconvex tablet with \"271\" printed on one side and \"KU\" printed on the other side with black ink. 15 mg: White, round, biconvex tablet with \"272\" printed on one side and \"KU\" printed on the other side with black ink. Extended release tablets 5 mg, 10 mg and 15 mg (3)"],"clinical_pharmacology_table":["
Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin chloride extended-release tablets 10 mg (n=43)
Parameters (units)R-OxybutyninS-Oxybutynin
C max (ng/mL) 1.0 (0.6) 1.8 (1.0)
T max (h) 12.7 (5.4) 11.8 (5.3)
t 1/2 (h) 13.2 (6.2) 12.4 (6.1)
AUC (0–48) (ng∙h/mL) 18.4 (10.3) 34.2 (16.9)
AUC inf (ng∙h/mL) 21.3 (12.2) 39.5 (21.2)
","
Table 3: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5–15 Following Administration of 5 to 20 mg Oxybutynin chloride extended-release tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin chloride extended-release tablets 5 mg Once Daily
R-OxybutyninS-OxybutyninR- DesethyloxybutyninS- Desethyloxybutynin
C max (ng/mL) 0.7 ± 0.4 1.3 ± 0.8 7.8 ± 3.7 4.2 ± 2.3
T max (h) 5.0 5.0 5.0 5.0
AUC (ng∙h/mL) 12.8 ± 7.0 23.7 ± 14.4 125.1 ± 66.7 73.6 ± 47.7
"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Pediatric Use: Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing or crushing, or in children under the age of 6 years. (8.4) Renal or Hepatic Impairment: There have been no studies conducted in patients with renal or hepatic impairment. ( 8.6 , 8.7 ) 8.1 Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies using Oxybutynin chloride extended-release tablets in pregnant women. Oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician. Risk Summary Based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk. Animal Data Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus. 8.3 Nursing Mothers It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxybutynin chloride extended-release tablets are administered to a nursing woman. 8.4 Pediatric Use The safety and efficacy of Oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6–15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that administration of Oxybutynin chloride extended-release tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%. Urodynamic results were consistent with clinical results. Administration of Oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 60% to 28%. The pharmacokinetics of Oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see Clinical Pharmacology (12.3) ]. Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6. 8.5 Geriatric Use The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of Oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age). 8.6 Renal Impairment There were no studies conducted with Oxybutynin chloride extended-release tablets in patients with renal impairment. 8.7 Hepatic Impairment There were no studies conducted with Oxybutynin chloride extended-release tablets in patients with hepatic impairment."],"spl_unclassified_section_table":["
Count5 mg10 mg15 mg
3043353-282-3043353-284-30-
6043353-282-53--
9043353-282-6043353-284-60-
18043353-282-80--
6000--43353-322-16
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mg NDC 43353-282 - Oxybutynin Chloride ER 5 mg - Rx Only Bottle Label 5 mg","PRINCIPAL DISPLAY PANEL - 10 mg NDC 43353-284 - Oxybutynin Chloride ER 10 mg - Rx Only Bottle Label 10 mg","PRINCIPAL DISPLAY PANEL - 15 mg NDC 43353-322 - Oxybutynin Chloride ER 15 mg - Rx Only Bottle Label 15 mg"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility A 24-month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum human exposure, based on a human equivalent dose taking into account normalization of body surface area. Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae , and Salmonella typhimurium test systems. Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility."]},"tags":[{"label":"Cholinergic Muscarinic Antagonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Muscarinic acetylcholine receptor M3","category":"target"},{"label":"CHRM3","category":"gene"},{"label":"CHRM1","category":"gene"},{"label":"CHRM4","category":"gene"},{"label":"G04BD04","category":"atc"},{"label":"Transdermal","category":"route"},{"label":"Oral","category":"route"},{"label":"Gel","category":"form"},{"label":"Patch","category":"form"},{"label":"Solution","category":"form"},{"label":"Syrup","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Bladder muscle dysfunction - overactive","category":"indication"},{"label":"Hyperhidrosis of palms","category":"indication"},{"label":"Increased Urinary Frequency","category":"indication"},{"label":"Neurogenic bladder","category":"indication"},{"label":"Urge incontinence of urine","category":"indication"},{"label":"Urgent desire to urinate","category":"indication"},{"label":"Hisamitsu Pharmaceutical Co., Inc.","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Antagonists","category":"pharmacology"},{"label":"Muscarinic Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Parasympatholytics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Urological Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":477.515,"date":"","count":828,"signal":"Urinary tract infection","source":"DrugCentral FAERS","actionTaken":"Reported 828 times (LLR=478)"},{"llr":362.148,"date":"","count":302,"signal":"Multiple sclerosis relapse","source":"DrugCentral FAERS","actionTaken":"Reported 302 times (LLR=362)"},{"llr":330.198,"date":"","count":990,"signal":"Fall","source":"DrugCentral FAERS","actionTaken":"Reported 990 times (LLR=330)"},{"llr":257.974,"date":"","count":190,"signal":"Multiple sclerosis","source":"DrugCentral FAERS","actionTaken":"Reported 190 times (LLR=258)"},{"llr":184.49,"date":"","count":291,"signal":"Dry mouth","source":"DrugCentral FAERS","actionTaken":"Reported 291 times (LLR=184)"},{"llr":162.155,"date":"","count":182,"signal":"Urinary incontinence","source":"DrugCentral FAERS","actionTaken":"Reported 182 times (LLR=162)"},{"llr":150.001,"date":"","count":6,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=150)"},{"llr":148.505,"date":"","count":68,"signal":"Anticholinergic syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 68 times (LLR=149)"},{"llr":122.878,"date":"","count":8,"signal":"Systemic lupus erythematosus","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=123)"},{"llr":118.216,"date":"","count":54,"signal":"Vaginal flatulence","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=118)"},{"llr":104.851,"date":"","count":3,"signal":"Hand deformity","source":"DrugCentral FAERS","actionTaken":"Reported 3 times (LLR=105)"},{"llr":103.916,"date":"","count":396,"signal":"Gait disturbance","source":"DrugCentral FAERS","actionTaken":"Reported 396 times (LLR=104)"},{"llr":98.237,"date":"","count":13,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=98)"},{"llr":93.404,"date":"","count":60,"signal":"Female genital tract fistula","source":"DrugCentral FAERS","actionTaken":"Reported 60 times (LLR=93)"},{"llr":91.685,"date":"","count":58,"signal":"Application site erythema","source":"DrugCentral FAERS","actionTaken":"Reported 58 times (LLR=92)"}],"commonSideEffects":[{"effect":"dry mouth","drugRate":"≥20%","severity":"common","_validated":true},{"effect":"nasopharyngitis","drugRate":"reported","severity":"unknown"},{"effect":"upper respiratory tract infection","drugRate":"reported","severity":"unknown"},{"effect":"bronchitis","drugRate":"reported","severity":"unknown"},{"effect":"cystitis","drugRate":"reported","severity":"unknown"},{"effect":"fluid retention","drugRate":"reported","severity":"unknown"},{"effect":"confusional state","drugRate":"reported","severity":"unknown"},{"effect":"dysgeusia","drugRate":"reported","severity":"unknown"},{"effect":"sinus headache","drugRate":"reported","severity":"unknown"},{"effect":"kerato conjunctivitis sicca","drugRate":"reported","severity":"unknown"},{"effect":"eye irritation","drugRate":"reported","severity":"unknown"},{"effect":"palpitations","drugRate":"reported","severity":"unknown"},{"effect":"sinus arrhythmia","drugRate":"reported","severity":"unknown"},{"effect":"flushing","drugRate":"reported","severity":"unknown"},{"effect":"nasal dryness","drugRate":"reported","severity":"unknown"},{"effect":"cough","drugRate":"reported","severity":"unknown"},{"effect":"pharyngolaryngeal pain","drugRate":"reported","severity":"unknown"},{"effect":"dry throat","drugRate":"reported","severity":"unknown"},{"effect":"sinus congestion","drugRate":"reported","severity":"unknown"},{"effect":"hoarseness","drugRate":"reported","severity":"unknown"},{"effect":"asthma","drugRate":"reported","severity":"unknown"},{"effect":"nasal congestion","drugRate":"reported","severity":"unknown"},{"effect":"diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"abdominal pain","drugRate":"reported","severity":"unknown"},{"effect":"loose stools","drugRate":"reported","severity":"unknown"},{"effect":"flatulence","drugRate":"reported","severity":"unknown"},{"effect":"vomiting","drugRate":"reported","severity":"unknown"},{"effect":"dysphagia","drugRate":"reported","severity":"unknown"},{"effect":"aptyalism","drugRate":"reported","severity":"unknown"}],"contraindications":["Angle-closure glaucoma","Atony of colon","Benign prostatic hyperplasia","Bladder outflow obstruction","Chronic heart failure","Conduction disorder of the heart","Disease of liver","Disorder of coronary artery","Drowsy","Gastric retention","Gastroesophageal reflux disease","Gastrointestinal hypomotility","Gastrointestinal obstruction","Hiatal hernia","Hypertensive disorder","Hyperthyroidism","Kidney disease","Myasthenia gravis","Paralytic ileus","Retention of urine","Severe chronic ulcerative colitis","Sinus tachycardia","Toxic megacolon","Ulcerative colitis"],"specialPopulations":{"Pregnancy":"The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established. Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.","Geriatric use":"The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar","Paediatric use":"The safety and efficacy of oxybutynin chloride administration have been demonstrated for pediatric patients 6 years of age and older. The safety and efficacy of oxybutynin chloride tablets were studied in 30 children in 24-week, open-label trial."}},"trials":[],"aliases":[],"company":"Hisamitsu Pharmaceutical Co., Inc.","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0597/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$22","description":"OXYBUTYNIN 5 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=OXYBUTYNIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:44:07.393521+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:44:13.155729+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OXYBUTYNIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:44:13.580633+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:06.274248+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:06.274281+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Muscarinic acetylcholine receptor M2 antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:44:14.661547+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1231/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:44:14.280745+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA078503","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:06.274285+00:00"}},"allNames":"ditropan xl","offLabel":[],"synonyms":["oxybutynin hydrochloride","oxybutynin","oxybutynin chloride","oxytrol","ditropan","kentera","oxybutynin HCl"],"timeline":[{"date":"1975-07-16","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"2003-02-26","type":"positive","source":"FDA Orange Book","milestone":"Oxytrol approved — 3.9MG/24HR"},{"date":"2013-01-25","type":"positive","source":"FDA Orange Book","milestone":"Oxytrol For Women approved — 3.9MG/24HR"},{"date":"2014-03-04","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"},{"date":"2023-03-27","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Hisamitsu Pharmaceutical Co., Inc.)"}],"aiSummary":"Ditropan XL (Oxybutynin) is a cholinergic muscarinic antagonist developed by Hisamitsu Pharmaceutical Co., Inc. and currently owned by Allergan. It targets the muscarinic acetylcholine receptor M3 to treat various bladder and urinary disorders. Originally approved by the FDA in 1975, it is now off-patent and available as a generic medication. Ditropan XL is used to treat conditions such as overactive bladder, hyperhidrosis, and urge incontinence. It has a half-life of 7.2 hours and bioavailability of 6%.","approvals":[{"date":"1975-07-16","orphan":false,"company":"","regulator":"FDA"},{"date":"2023-03-27","orphan":false,"company":"Hisamitsu Pharmaceutical Co., Inc.","regulator":"PMDA"}],"brandName":"Ditropan Xl","ecosystem":[{"indication":"Bladder muscle dysfunction - overactive","otherDrugs":[{"name":"butacaine","slug":"butacaine","company":""},{"name":"darifenacin","slug":"darifenacin","company":"Warner Chilcott Llc"},{"name":"fesoterodine","slug":"fesoterodine","company":"Pfizer"},{"name":"mirabegron","slug":"mirabegron","company":"Apgdi"}],"globalPrevalence":null},{"indication":"Hyperhidrosis of palms","otherDrugs":[],"globalPrevalence":null},{"indication":"Increased Urinary Frequency","otherDrugs":[{"name":"butacaine","slug":"butacaine","company":""},{"name":"darifenacin","slug":"darifenacin","company":"Warner Chilcott Llc"},{"name":"fesoterodine","slug":"fesoterodine","company":"Pfizer"},{"name":"flavoxate","slug":"flavoxate","company":""}],"globalPrevalence":null},{"indication":"Neurogenic bladder","otherDrugs":[{"name":"butacaine","slug":"butacaine","company":""}],"globalPrevalence":null},{"indication":"Urge incontinence of urine","otherDrugs":[{"name":"butacaine","slug":"butacaine","company":""},{"name":"darifenacin","slug":"darifenacin","company":"Warner Chilcott Llc"},{"name":"fesoterodine","slug":"fesoterodine","company":"Pfizer"},{"name":"solifenacin","slug":"solifenacin","company":"Astellas"}],"globalPrevalence":null},{"indication":"Urgent desire to urinate","otherDrugs":[{"name":"butacaine","slug":"butacaine","company":""},{"name":"darifenacin","slug":"darifenacin","company":"Warner Chilcott Llc"},{"name":"fesoterodine","slug":"fesoterodine","company":"Pfizer"},{"name":"flavoxate","slug":"flavoxate","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Muscarinic acetylcholine receptor M3","novelty":"Follow-on","targets":[{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"},{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"SLC6A3","source":"DrugCentral","target":"Sodium-dependent dopamine transporter","protein":"Sodium-dependent dopamine transporter"},{"gene":"DRD3","source":"DrugCentral","target":"D(3) dopamine receptor","protein":"D(3) dopamine receptor"},{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"CYP2C19","source":"DrugCentral","target":"Cytochrome P450 2C19","protein":"Cytochrome P450 2C19"}],"moaClass":"Cholinergic Muscarinic Antagonists","modality":"Small Molecule","drugClass":"Cholinergic Muscarinic Antagonist","explanation":"The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. Oxybutynin acts as competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In patients with conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction. Oxybutynin is racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in in vitro studies.","oneSentence":"Oxybutynin works by blocking the action of a chemical called acetylcholine on the bladder muscle, reducing spasms and urgency.","technicalDetail":"Oxybutynin is a selective M3 muscarinic receptor antagonist that competes with acetylcholine for binding sites on the M3 receptor, thereby inhibiting the contraction of the detrusor muscle and reducing bladder spasms."},"commercial":{"launchDate":"1975","_launchSource":"DrugCentral (FDA 1975-07-16, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2028","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=OXYBUTYNIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OXYBUTYNIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:10:56.907253","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:44:17.844473+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"flavoxate","drugSlug":"flavoxate","fdaApproval":"1970-01-15","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"tolterodine","drugSlug":"tolterodine","fdaApproval":"1998-03-25","genericCount":15,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"solifenacin","drugSlug":"solifenacin","fdaApproval":"2004-11-19","patentExpiry":"May 18, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"trospium","drugSlug":"trospium","fdaApproval":"2004-05-28","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"darifenacin","drugSlug":"darifenacin","fdaApproval":"2004-12-22","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"fesoterodine","drugSlug":"fesoterodine","fdaApproval":"2008-10-31","patentExpiry":"Jun 7, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"mirabegron","drugSlug":"mirabegron","fdaApproval":"2012-06-28","patentExpiry":"Sep 30, 2036","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"oxybutynin","indications":{"approved":[{"name":"Bladder muscle dysfunction - overactive","source":"DrugCentral","snomedId":236633002,"regulator":"FDA"},{"name":"Hyperhidrosis of palms","source":"DrugCentral","snomedId":303090009,"regulator":"FDA"},{"name":"Increased Urinary Frequency","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":{}},{"name":"Neurogenic bladder","source":"DrugCentral","snomedId":398064005,"regulator":"FDA"},{"name":"Urge incontinence of urine","source":"DrugCentral","snomedId":87557004,"regulator":"FDA"},{"name":"Urgent desire to urinate","source":"DrugCentral","snomedId":75088002,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Allergan","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"flavoxate","brandName":"flavoxate","genericName":"flavoxate","approvalYear":"1970","relationship":"same-class"},{"drugId":"tolterodine","brandName":"tolterodine","genericName":"tolterodine","approvalYear":"1998","relationship":"same-class"},{"drugId":"solifenacin","brandName":"solifenacin","genericName":"solifenacin","approvalYear":"2004","relationship":"same-class"},{"drugId":"trospium","brandName":"trospium","genericName":"trospium","approvalYear":"2004","relationship":"same-class"},{"drugId":"darifenacin","brandName":"darifenacin","genericName":"darifenacin","approvalYear":"2004","relationship":"same-class"},{"drugId":"fesoterodine","brandName":"fesoterodine","genericName":"fesoterodine","approvalYear":"2008","relationship":"same-class"},{"drugId":"mirabegron","brandName":"mirabegron","genericName":"mirabegron","approvalYear":"2012","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06966778","phase":"NA","title":"Oxybutynin ER to Promote 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Syndrome"],"enrollment":22,"completionDate":"2022-12-30"},{"nctId":"NCT07114640","phase":"PHASE3","title":"The Effect of Nighttime Mirabegron, Solifenacin, Tolterodine, or Oxybutynin on Nocturia, Sexual Function, Autonomic Function, and Lower Urinary Tract Blood Flow Perfusion in Women With Overactive Bladder Syndrome: Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Far Eastern Memorial Hospital","startDate":"2025-08-07","conditions":["Urinary Bladder, Overactive"],"enrollment":220,"completionDate":"2028-12-31"},{"nctId":"NCT07081906","phase":"NA","title":"Transdermal Versus Oral Oxybutynin in Pediatric OAB","status":"COMPLETED","sponsor":"Dr. Lutfi Kirdar Kartal Training and Research Hospital","startDate":"2019-02-15","conditions":["Overactive Bladder (OAB)","Drug Delivery Systems","Anticholinergic Side Effects","Children and Adolescents, Boys and Girls"],"enrollment":90,"completionDate":"2020-05-01"},{"nctId":"NCT05100017","phase":"NA","title":"Methocarbamol vs 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