ENABLEX- darifenacin tablet, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Allergan, Inc.

DCI (Dénomination commune internationale):

DARIFENACIN HYDROBROMIDE

Composition:

DARIFENACIN 7.5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Enablex (darifenacin) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Enablex 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 effect

Descriptif du produit:

Enablex® , 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........................................................................ NDC  0430-0170-15 Bottle of 90........................................................................ NDC  0430-0170-23 Enablex® , 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........................................................................ NDC  0430-0171-15 Bottle of 90........................................................................ NDC  0430-0171-23 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.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

ENABLEX- DARIFENACIN TABLET, EXTENDED RELEASE
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENABLEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ENABLEX.
ENABLEX (DARIFENACIN) EXTENDED-RELEASE TABLETS
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Enablex 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 Enablex 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 Enablex 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)
Enablex is not recommended for use in patients with severe hepatic
impairment (Child-Pugh C) (2, 8.6)
Enablex 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
Enablex 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
Enablex should be administered with caution to patients with
clinically significant bladder outflow obstruction because of
the risk of urinary retention (5.1)
Enablex should be administered with caution to patients with
gastrointestinal obstructive disorders because of the risk
of gastric retention (5.2)
Enablex 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
Enablex. Advise patients not to drive or operate
heavy machinery un