DARIFENACIN- 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:

Cipla USA Inc.

INN (International Name):

DARIFENACIN HYDROBROMIDE

Composition:

DARIFENACIN 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 exposures of free drug (via AUC) up to 59 and 28 times the maximum recommended human dose (MRHD) of 15 mg, respectively. Effects on embryofetal development were observed following administration of darifenacin during pregnancy (dilated ureter and/or kidney pelvis in rabbits at about 9 times the MRHD, post-implantation loss in rabbits at about 28 times, and delayed os

Product summary:

Darifenacin extended-release tablet 7.5 mg are white to off white colored circular biconvex film coated tablet debossed with "C" on one side and "431" on the other side. Bottle of 30 ...............................................................................................................NDC 69097-431-02 Bottle of 90 ...............................................................................................................NDC 69097-431-05 Bottle of 1000 ...........................................................................................................NDC 69097-431-15 Darifenacin extended-release tablet 15 mg are light peach colored circular biconvex film coated tablet debossed with "C" on one side and "432" on the other side. Bottle of 30................................................................................................................NDC 69097-432-02 Bottle of 90................................................................................................................NDC 69097-432-05 Bottle of 1000 ...........................................................................................................NDC 69097-432-15 Storage Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° 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 - DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE
CIPLA USA INC.
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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 are 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 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 are 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
Extended-release tablets 7.5 mg and 15 mg. (3)
CONTRAINDICATIONS
Darifenacin 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 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 gastric
retention