Drug Catalog - Product Detail
OXYBUTYNIN CHLORIDE ER TB 10MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-6610-05 | MYLAN | 500 | 10MG | TABLET |
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Description
DESCRIPTION Oxybutynin chloride is an antispasmodic, anticholinergic agent. Each oxybutynin chloride extended-release tablet, USP contains 5 mg or 10 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S- enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenyl-cyclohexylglycolate hydrochloride. The molecular formula of oxybutynin chloride is C 22 H 31 NO 3 • HCl. Its structural formula is: Oxybutynin chloride, USP 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. Oxybutynin chloride extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate (anhydrous), hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium hydroxide, talc, titanium dioxide, triacetin and triethyl citrate. The 5 mg strength also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake; and the 10 mg strength also contains FD&C Yellow No. 6 Aluminum Lake. In addition, the imprinting ink contains black iron oxide, hypromellose and propylene glycol. Meets USP Dissolution Test 2. System Components and Performance Oxybutynin chloride extended-release tablets are formulated to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet surrounded by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases drug at a controlled rate via diffusion and/or erosion. Oxybutynin Structural Formula
How Supplied
HOW SUPPLIED Oxybutynin Chloride Extended-release Tablets, USP are available containing 5 mg or 10 mg of oxybutynin chloride, USP. The 5 mg tablets are light green film-coated, round, unscored tablets with M over O 5 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6605-01 bottles of 100 tablets NDC 0378-6605-05 bottles of 500 tablets The 10 mg tablets are peach film-coated, round, unscored tablets with M over O 10 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6610-01 bottles of 100 tablets NDC 0378-6610-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED MAY 2013 OXBN:R6
Indications & Usage
INDICATIONS AND USAGE Oxybutynin chloride extended-release tablets are once daily controlled-release tablets indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated in the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Dosage and Administration
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 mg 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 Aged 6 Years of Age and Older The recommended starting dose of oxybutynin chloride extended-release tablets is 5 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 20 mg/day).