País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)
Bryant Ranch Prepack
OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE 10 mg
PRESCRIPTION DRUG
New Drug Application
OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OXYBUTYNIN CHLORIDE EXTENDED RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYBUTYNIN CHLORIDE EXTENDED RELEASE TABLETS. OXYBUTYNIN CHLORIDE EXTENDED RELEASE TABLETS (OXYBUTYNIN CHLORIDE) FOR ORAL USE INITIAL U.S. APPROVAL: 1975 INDICATIONS AND USAGE Oxybutynin Chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1) Oxybutynin Chloride Extended Release Tablets are 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 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. (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, 10 mg and 15 mg (3) CONTRAINDICATIONS Urinary retention (4) Gastric Retention (4) Uncontrolled narrow angle glaucoma (4) Known hypersensitivity to oxybutynin chloride or any component of Oxybutynin Chloride Extended Release Tablets (4) WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue Oxybutynin Chloride Extended Release Tablets immediately and initiate appropriate therapy. (5.1) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin. If patient Leia o documento completo