País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DARIFENACIN HYDROBROMIDE (UNII: CR02EYQ8GV) (DARIFENACIN - UNII:APG9819VLM)
Actavis Pharma, Inc.
DARIFENACIN HYDROBROMIDE
DARIFENACIN 7.5 mg
ORAL
PRESCRIPTION DRUG
Darifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin is contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. Pregnancy Category C There are no studies of darifenacin in pregnant women. Darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via AUC) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [MRHD] of 15 mg. At approximately 59 times the MRHD in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the AUC. Dystocia was observed in dams at approximately 17 times the AUC (10 mg/kg/day). Slight developmental delays were observed in pups at this dose. At five times the AUC (3 mg/kg/day), there were no effects on d
Darifenacin 7.5 mg are round, shallow, bi-convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse. Bottle of 30....................................................................................................N DC 0591-4375-30 Bottle of 90....................................................................................................N DC 0591-4375-19 Darifenacin 15 mg are round, shallow, bi-convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse. Bottle of 30....................................................................................................N DC 0591-4380-30 Bottle of 90....................................................................................................N DC 0591-4380-19 Storage Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F) [see USP Controlled Room Temperature]. Protect from light. Keep this and all drugs out of the reach of children.
New Drug Application
DARIFENACIN- DARIFENACIN TABLET, EXTENDED RELEASE ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DARIFENACIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DARIFENACIN. DARIFENACIN EXTENDED-RELEASE TABLETS INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE Darifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency (1) DOSAGE AND ADMINISTRATION The recommended starting dose of Darifenacin extended-release tablets is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy (2) The daily dose of Darifenacin should not exceed 7.5 mg in the following patients: Patients with moderate hepatic impairment (Child-Pugh B) (2, 8.6) Patients taking potent CYP3A4 inhibitors (2, 7.1) Darifenacin is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) (2, 8.6) Darifenacin may be taken with or without food. The tablet should be swallowed whole with water and not chewed, divided or crushed (2) DOSAGE FORMS AND STRENGTHS Extended-release tablets 7.5 mg and 15 mg (3) CONTRAINDICATIONS Darifenacin is contraindicated in patients with, or at risk for, the following conditions (4): urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. WARNINGS AND PRECAUTIONS Darifenacin should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (5.1) Darifenacin should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (5.2) Darifenacin should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks (5.3) Central Nervous System Effects: Somnolence has been reported with Darifenacin. Advise pat Leer el documento completo