RVP

Drug Catalog - Product Detail

OXYBUTYNIN CHLORIDE TB 5MG 100

NDC Mfr Size Str Form
00603-4975-21 PAR PHARMACEUTICALS 100 5MG TABLET
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Each scored oxybutynin chloride tablet contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl. The structural formula appears below: Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. This is an image of the structural formula for Oxybutynin Chloride. Oxybutynin Chloride Tablets also contain: FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Oxybutynin Chloride Tablets are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic.
How Supplied
HOW SUPPLIED Oxybutynin Chloride Tablets USP, 5 mg, are round, light blue, scored tablets debossed "4853" and "V" on one side separated by a horizontal score and plain on the reverse side. The tablets are supplied as follows: Bottles of 100: NDC 0603-4975-21 Bottles of 500: NDC 0603-4975-28 Bottles of 1000: NDC 0603-4975-32
Indications & Usage
INDICATIONS AND USAGE Oxybutynin chloride tablets 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.