RVP

Drug Catalog - Product Detail

OXYBUTYNIN CHLORIDE TB 5MG 500

NDC Mfr Size Str Form
50111-0456-02 TEVA PHARMACEUTICALS USA 500 5MG TABLET
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears below: C 22 H 31 NO 3 •HCl M.W. 393.9 C 22 H 31 NO 3 •HCl M.W. 393.9 Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake. Oxybutynin Chloride Tablets USP are for oral administration. Meets USP Dissolution Test 2. Therapeutic Category: Antispasmodic, anticholinergic. Oxybutynin Structural Formula
How Supplied
HOW SUPPLIED Oxybutynin Chloride Tablets USP are available as follows: 5 mg – Very pale blue, round, biconvex, scored tablets. Debossed with PLIVA 456 on one side and scored on the other side . Available in bottles of 100 (NDC 50111-456-01), 500 (NDC 50111-456-02), and 1000 (NDC 50111-456-03) tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Indications & Usage
INDICATIONS AND USAGE Oxybutynin Chloride Tablets USP are 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 and Administration
DOSAGE AND ADMINISTRATION Adults The usual dose is one 5 mg tablet two to three times a day. The maximum recommended dose is one 5 mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly. Pediatric Patients Over 5 Years of Age The usual dose is one 5 mg tablet two times a day. The maximum recommended dose is one 5 mg tablet three times a day.