Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
oxybutynin chloride (UNII: L9F3D9RENQ) (oxybutynin - UNII:K9P6MC7092)
Physicians Total Care, Inc.
oxybutynin chloride
oxybutynin chloride 5 mg
ORAL
PRESCRIPTION DRUG
DITROPAN XL® (oxybutynin chloride) is a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. DITROPAN XL® is 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). DITROPAN XL® (oxybutynin chloride) is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. DITROPAN XL® is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
DITROPAN XL® (oxybutynin chloride) Extended Release Tablets are available in three dosage strengths, 10 mg (pink), and 15 mg (gray) and are imprinted with "10 XL", or "15 XL". DITROPAN XL® Extended Release Tablets are supplied in Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.
New Drug Application
DITROPAN XL- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE PHYSICIANS TOTAL CARE, INC. ---------- DITROPAN XL (OXYBUTYNIN CHLORIDE) EXTENDED RELEASE TABLETS DESCRIPTION DITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 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 phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C H NO •HCl. Its structural formula is: 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. DITROPAN XL also contains the following inert ingredients: cellulose acetate, hypromellose, lactose, magnesium stearate, polyethylene glycol, polyethylene oxide, synthetic iron oxides, titanium dioxide, polysorbate 80, sodium chloride, and butylated hydroxytoluene. SYSTEM COMPONENTS AND PERFORMANCE DITROPAN XL uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the push layer to expand. This expansion pushes the suspended drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn con Preberite celoten dokument