The following additional adverse drug 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.
Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Cardiac Disorders: arrhythmia, tachycardia, QT interval prolongation; Vascular Disorders: flushing; 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; rare 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.
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.
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.
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.
Dosing information for pediatric patients aged 6 years and older is approved for Alza Corporation’s oxybutynin chloride extended release tablets. However, due to Alza Corporation’s marketing exclusivity rights, this drug product is not labeled for pediatric use.
Oxybutynin chloride extended-release tablets, 5 mg – Each light purple, film-coated, round convex tablets, debossed with “G 341” on one side and plain on the other side
Bottles of 100 NDC 0093-5206-01
Oxybutynin chloride extended-release tablets, 10 mg – Each light pink, film-coated, round convex tablets, debossed with “G 342” on one side and plain on the other side
Bottles of 100 NDC 0093-5207-01
Oxybutynin chloride extended-release tablets, 15 mg – Each off-white, film-coated, round convex tablets, debossed with “G 343” on one side and plain on the other side
Bottles of 100 NDC 0093-5208-01
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.
Dispense in a tightly-closed, light-resistant container (USP).
IMPAX Laboratories, Inc.
Hayward, CA 94544 USA
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Label
| OXYBUTYNIN CHLORIDE |
oxybutynin chloride tablet, extended release
|Labeler — Dispensing Solutions, Inc. (066070785)|
|Registrant — PSS World Medical, Inc. (101822682)|
|Dispensing Solutions, Inc.||066070785||relabel (66336-604), repack (66336-604)|
Revised: 10/2013 Dispensing Solutions, Inc.
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