DARIFENACIN tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Actavis Pharma, Inc.

INN (Διεθνής Όνομα):

DARIFENACIN HYDROBROMIDE

Σύνθεση:

DARIFENACIN 7.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Darifenacin is a muscarinic antagonist 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. 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 at this dose. At five times the AUC (3 mg/kg/day), there were no effects on d

Περίληψη προϊόντος:

Darifenacin 7.5 mg are round, shallow, bi-convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse. Bottle of 30....................................................................................................N DC  0591-4375-30 Bottle of 90....................................................................................................N DC   0591-4375-19 Darifenacin 15 mg are round, shallow, bi-convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse. Bottle of 30....................................................................................................N DC  0591-4380-30  Bottle of 90....................................................................................................N DC  0591-4380-19 Storage Store at 25° C (77° F); excursions permitted to 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.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

DARIFENACIN- DARIFENACIN TABLET, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DARIFENACIN SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR DARIFENACIN.
DARIFENACIN EXTENDED-RELEASE TABLETS
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Darifenacin 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 the
potential benefits outweigh the risks (5.3)
Central Nervous System Effects: Somnolence has been reported with
Darifenacin. Advise pat