DARIFENACIN HYDROBROMIDE EXTENDED-RELEASE- darifenacin hydrobromide tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DARIFENACIN HYDROBROMIDE (UNII: CR02EYQ8GV) (DARIFENACIN - UNII:APG9819VLM)

Available from:

AvKARE, Inc.

INN (International Name):

DARIFENACIN HYDROBROMIDE

Composition:

DARIFENACIN 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 90…NDC 42291-206-90 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 90…NDC 42291-207-90 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DARIFENACIN HYDROBROMIDE EXTENDED-RELEASE- DARIFENACIN HYDROBROMIDE
TABLET,
EXTENDED RELEASE
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DARIFENACIN HYDROBROMIDE EXTENDED-RELEASE TABLETS
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
1. 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-rele