OXYBUTYNIN CHLORIDE (Page 4 of 4)

Postmarketing Experience

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.

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.

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.

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.

Pediatric patients

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.

HOW SUPPLIED

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

Storage

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).

Manufactured By:
IMPAX Laboratories, Inc.
Hayward, CA 94544 USA

Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

Rx only

Rev. 11/2012
675-03

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Label

NDC 66336-0604-XX

NDC 66336-0604-30

OXYBUTYNIN CHLORIDE oxybutynin chloride tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66336-604(NDC:0093-5206) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBUTYNIN CHLORIDE (OXYBUTYNIN) OXYBUTYNIN CHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES LACTOSE MONOHYDRATE METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE TALC TRIETHYL CITRATE FD&C BLUE NO. 2 FD&C RED NO. 40

Product Characteristics Color PURPLE (light purple) Score no score Shape ROUND (film-coated, round, convex) Size 7mm Flavor Imprint Code G341 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66336-604-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076745 05/11/2007

Labeler — Dispensing Solutions, Inc. (066070785)

Registrant — PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Operations
Dispensing Solutions, Inc.		066070785	relabel (66336-604), repack (66336-604)

Revised: 10/2013 Dispensing Solutions, Inc.