DARIFENACIN tablet, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Macleods Pharmaceuticals Limited

INN (Algemene Internationale Benaming):

DARIFENACIN HYDROBROMIDE

Samenstelling:

DARIFENACIN 7.5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Darifenacin is 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. 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 ossification in rats at about 59 times) and during pregnan

Product samenvatting:

Darifenacin extended-release tablets, 7.5 mg are white-colored, round, bi-convex, film coated and are debossed with “L48” on one side and plain on the other side. Bottle of 30 .......................................NDC 33342-276-07 Bottle of 90 .......................................NDC 33342-276-10 Carton of 100 tablets (10 x 10 unit-dose)…..NDC 33342-276-12 Darifenacin extended-release tablets, 15 mg are light peach-colored, round, bi-convex, film coated and are debossed with “L49” on one side and plain on the other side. Bottle of 30 ................................NDC 33342-277-07 Bottle of 90 ................................NDC 33342-277-10 Carton of 100 tablets (10 x 10 unit-dose)…NDC 33342-277-12 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DARIFENACIN - DARIFENACIN TABLET, EXTENDED RELEASE
MACLEODS PHARMACEUTICALS LIMITED
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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 tablet 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 t