देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)
Janssen Pharmaceuticals, Inc.
oxybutynin chloride
oxybutynin chloride 5 mg
ORAL
PRESCRIPTION DRUG
DITROPAN XL ® (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. DITROPAN XL ® is also indicated for 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 ® is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. DITROPAN XL ® is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. Risk Summary There are no adequate data on DITROPAN XL ® use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscar
DITROPAN XL ® extended-release tablets are available in two dosage strengths, 5 mg (pale yellow) and 10 mg (pink) and are imprinted on one side with "5 XL" or "10 XL" with black ink. DITROPAN XL ® extended-release tablets are supplied in bottles of 100 tablets. Storage 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. Keep out of reach of children.
New Drug Application
DITROPAN XL- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE JANSSEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DITROPAN XL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DITROPAN XL . DITROPAN XL (OXYBUTYNIN CHLORIDE) EXTENDED RELEASE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1975 INDICATIONS AND USAGE DITROPAN XL (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1) DITROPAN XL is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). ( 1) DOSAGE AND ADMINISTRATION DITROPAN XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. DITROPAN XL may be administered with or without food. ( 2) ADULTS: Start with 5 mg or 10 mg, once daily at approximately the same time every day. Dose should not exceed 30 mg per day. ( 2.1) PEDIATRIC PATIENTS (6 YEARS OF AGE OR OLDER): Start with 5 mg, once daily at approximately the same time every day. Dose should not exceed 20 mg per day. ( 2.2) DOSAGE FORMS AND STRENGTHS Extended release tablets 5 mg and 10 mg ( 3) CONTRAINDICATIONS Urinary retention ( 4) Gastric Retention ( 4) Uncontrolled narrow angle glaucoma ( 4) Known hypersensitivity to DITROPAN XL , oxybutynin or any component of DITROPAN XL ( 4) WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue DITROPAN XL immediately and initiate appropriate therapy. ( 5.1) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin. If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of DITROPAN XL . ( 5.2) Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinest पूरा दस्तावेज़ पढ़ें