Oxybutynin

Brand names: Ditropan, OXYBUTYNIN CHLORIDE, Oxybutynin Chloride, Oxybutynin ChlorideExtended Release, oxybutynin chloride, OXYTROL, oxybutynin, Oxytrol for Women

Warnings

No boxed warning. The label warns of "angioedema of the face, lips, tongue and/or larynx," which "may be life-threatening" if there is upper airway involvement. Contraindications include urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, and known hypersensitivity to the drug or its components.

Contraindications

4 CONTRAINDICATIONS Urinary retention ( 4 ) Gastric Retention ( 4 ) Uncontrolled narrow angle glaucoma ( 4 ) Known hypersensitivity to oxybutynin chloride or any component of oxybutynin chloride extended-release tablets ( 4 ) 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 angioedema.

Overdose

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. 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.

Drug interactions

7 DRUG INTERACTIONS 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 ) 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 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., Cmax and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.

Uses

Indicated "for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria)."

Dosage forms & strengths

Tablet Tablet, Extended Release Tablet, Film Coated, Extended Release PATCH TABLET, FILM COATED, EXTENDED RELEASE POWDER

OXYBUTYNIN CHLORIDE 10 mg OXYBUTYNIN CHLORIDE 15 mg OXYBUTYNIN CHLORIDE 5 mg Oxybutynin Chloride 10 mg Oxybutynin Chloride 5 mg oxybutynin chloride 10 mg oxybutynin chloride 15 mg oxybutynin chloride 5 mg OXYBUTYNIN 3.9 mg/d OXYBUTYNIN CHLORIDE 5 mg/1 OXYBUTYNIN CHLORIDE 10 mg/1 OXYBUTYNIN 1 kg/kg OXYBUTYNIN CHLORIDE 15 mg/1

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. ( 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 ) 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. 2.1 Adults The recommended starting dose of oxybutynin chloride extended-release tablet is 5 mg 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 are 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).

Ingredients

Active:

Active ingredient (in each patch [transdermal system]) Oxybutynin 3.9 mg/day

Inactive:

Inactive ingredients acrylic adhesive, polyester/ethylene-vinyl acetate film, siliconized polyester film, and triacetin

All identified pills

0832 38

WHITE ROUND · Oxybutynin

2 manufacturers