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Drug Catalog - Product Detail

OXYBUTYNIN CHLORIDE SYRUP 5MG/5ML 473ML

NDC Mfr Size Str Form
54838-0510-80 SILARX 473 5MG/5ML SYRUP
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Generic Name
OXYBUTYNIN CHLORIDE
Substance Name
OXYBUTYNIN CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA074520
Description
DESCRIPTION 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 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Each 5 mL, for oral administration, contains 5 mg of oxybutynin chloride. In addition, the following inactive ingredients are present: citric acid, FD&C Green #3, raspberry flavor, glycerin, methylparaben, propylene glycol, sodium citrate, sorbitol solution, sucrose, and water. Therapeutic Category: Antispasmodic, anticholinergic. Structure of Oxybutynin
How Supplied
HOW SUPPLIED OXYBUTYNIN CHLORIDE SYRUP USP (5 mg/5 mL) is supplied in bottles of one pint (473 mL). OXYBUTYNIN CHLORIDE SYRUP USP (5 mg/5 mL) is a light bluish-green liquid with a characteristic raspberry flavor. NDC 54838-510-80 Pharmacist: Dispense in tight, light-resistant container as defined in the USP. Store at controlled room temperature 59°F to 86°F (15°C to 30°C).
Indications & Usage
INDICATIONS AND USAGE Oxybutynin Chloride Syrup is 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 Syrup Adults: The usual dose is one teaspoon (5 mg/5 mL) of syrup two to three times a day. The maximum recommended dose is one teaspoon (5 mg/5 mL) of syrup 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 teaspoon (5 mg/5 mL) of syrup two times a day. The maximum recommended dose is one teaspoon (5 mg/5 mL) of syrup three times a day.