Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DARIFENACIN HYDROBROMIDE (UNII: CR02EYQ8GV) (DARIFENACIN - UNII:APG9819VLM)
Torrent Pharmaceuticals Limited
DARIFENACIN HYDROBROMIDE
DARIFENACIN 7.5 mg
ORAL
PRESCRIPTION DRUG
Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. Risk Summary There are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, darifenacin was not teratogenic in rats and rabbits at plasma exposure of free drug (via AUC) up to 59 and 28 times the maximum recommended human dose (MRHD) of 15 mg, respectively. Effect on embryofetal development were observed following administration of darifenacn during pregnancy (dilated ureter and/or kidney pelvis in rabbits at asbout 9 times the MRHD, post-implantation loss in rabbits at about 28 times, and delays in rats at about
Darifenacin extended-release tablets, 7.5 mg are white to off-white colored, round, biconvex, bevel edged, film coated tablets, debossed "202" on one side and plain on other side. Bottle of 30.............................................................................................NDC13668-202-30 Bottle of 90.............................................................................................NDC13668-202-90 Bottle of 500..........................................................................................NDC13668-202-05 Darifenacin extended-release tablets, 15 mg are light peach colored, round, biconvex, bevel edged, film coated tablets, debossed "203" on one side and plain on other side. Bottle of 30........................................................................................... NDC13668-203-30 Bottle of 90........................................................................................... NDC13668-203-90 Bottle of 500..........................................................................................NDC13668-203-05 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep this and all drugs out of the reach of children.
Abbreviated New Drug Application
DARIFENACIN- DARIFENACIN TABLET, EXTENDED RELEASE TORRENT PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DARIFENACIN EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL:2004 INDICATIONS AND USAGE Darifenacin extended-release tablets 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. The daily dose of darifenacin extended-release tablets 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 extended-release tablets is not recommended for use in patients with severe hepatic impairment (Child-Pugh C). (2, 8.6) Darifenacin extended-release tablets 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 Darifenacin extended-release tablets 7.5 mg and 15 mg. (3) CONTRAINDICATIONS Darifenacin extended-release tablets 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 extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.1) Darifenacin extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of ga Lire le document complet