Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
DARIFENACIN HYDROBROMIDE (UNII: CR02EYQ8GV) (DARIFENACIN - UNII:APG9819VLM)
Par Pharmaceutical, Inc.
DARIFENACIN HYDROBROMIDE
DARIFENACIN 7.5 mg
ORAL
PRESCRIPTION DRUG
Darifenacin hydrobromide extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin hydrobromide extended-release tablets are 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
Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side. Bottle of 30……NDC 10370-170-11 Bottle of 90…NDC 10370-170-09 Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side. Bottle of 30……NDC 10370-171-11 Bottle of 90…NDC 10370-171-09 Storage Store at 20° to 25°C (68° to 77°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 HYDROBROMIDE EXTENDED-RELEASE- DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE PAR PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DARIFENACIN HYDROBROMIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DARIFENACIN HYDROBROMIDE EXTENDED-RELEASE TABLETS. DARIFENACIN HYDROBROMIDE EXTENDED-RELEASE TABLETS INITIAL U.S. APPROVAL: 2004 RECENT MAJOR CHANGES Warnings and Precautions: Central Nervous System Effects (5.5) 03/2012 INDICATIONS AND USAGE Darifenacin hydrobromide extended-release tablets are 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 Hydrobromide Extended-Release Tablets is 7.5 mg (base) once daily. Based upon individual response, the dose may be increased to 15 mg (base) once daily, as early as two weeks after starting therapy. (2) The daily dose of darifenacin hydrobromide extended-release tablets should not exceed 7.5 mg (base) in the following patie nts : Patients with moderate hepatic impairment (Child-Pugh B) (2, 8.6) Patients taking potent CYP3A4 inhibitors (2, 7.1) Darifenacin hydrobromide extended-release tablets are not recommended for use in patients with severe hepatic impairment (Child-Pugh C). (2, 8.6) Darifenacin hydrobromide 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 Extended-release tablets 7.5 mg and 15 mg (base). (3) CONTRAINDICATIONS Darifenacin hydrobromide extended-release tablets are 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 hydrobromide extended-release tablets should be administered with caution to Đọc toàn bộ tài liệu