Oxybutynin Chloride Extended Release 15 mg/1
Oxybutynin Chloride · TABLET, EXTENDED RELEASE · Rising Pharma Holdings, Inc.
Oxybutynin Chloride Extended Release is a tablet, extended release containing oxybutynin chloride at 15 mg/1, taken oral. Manufactured by Rising Pharma Holdings, Inc..
Key Facts
- Brand Name
- Oxybutynin Chloride Extended Release
- Generic Name
- Oxybutynin Chloride
- NDC Code (Product)
64980-211- Manufacturer
- Rising Pharma Holdings, Inc.
- Strength
- 15 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206121
- Marketing Start
- 09/27/2016
Recall History
Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications
Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
AVKARE Inc.
Failed Dissolution Specifications
Lannett Company Inc.
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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)
Dosage & 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 recommen…
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-administ…
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 Prefe…
Frequently Asked Questions
What is Oxybutynin Chloride Extended Release used for?
Oxybutynin Chloride Extended Release contains Oxybutynin Chloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Oxybutynin Chloride Extended Release a controlled substance?
Oxybutynin Chloride Extended Release is not classified as a controlled substance by the DEA.
What is the generic name for Oxybutynin Chloride Extended Release?
The generic name for Oxybutynin Chloride Extended Release is Oxybutynin Chloride. There are 10 other brand versions of Oxybutynin Chloride.
What is the NDC code for Oxybutynin Chloride Extended Release 15 mg/1?
The NDC (National Drug Code) for Oxybutynin Chloride Extended Release 15 mg/1 is 64980-211, listed by Rising Pharma Holdings, Inc..
Other Oxybutynin Chloride Extended Release Dosages
Other Oxybutynin Brands
See all →- oxybutynin chloride10 mg/172789-049
- Oxybutynin Chloride10 mg/172888-031
- oxybutynin chloride15 mg/116729-319
- Oxybutynin Chloride5 mg/143353-978
- OXYBUTYNIN CHLORIDE5 mg/150090-6638
- Oxybutynin Chloride5 mg/5mL54838-510
- oxybutynin chloride5 mg/162135-507
- Oxybutynin Chloride5 mg/170518-2640
- Oxybutynin Chloride5 mg/171335-0519
- Oxybutynin Chloride5 mg/171610-277
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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