DARIFENACIN tablet, film coated, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Aurobindo Pharma Limited

INN（国際名）:

DARIFENACIN HYDROBROMIDE

構図:

DARIFENACIN 7.5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 extended-release tablets 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 del

製品概要:

Darifenacin Extended-Release Tablets, 7.5 mg are white colored, round convex, film-coated tablets debossed with “Z” on one side and “22” on other side.             Bottles of 30                                                   NDC 65862-861-30             Bottles of 90                                                   NDC 65862-861-90             Bottles of 500                                                 NDC 65862-861-05             Bottles of 1,000                                              NDC 65862-861-99 Darifenacin Extended-Release Tablets, 15 mg are light peach colored, round convex, film-coated tablets debossed with “Z” on one side and “23” on other side.             Bottles of 30                                                   NDC 65862-862-30             Bottles of 90                                                   NDC 65862-862-90             Bottles of 500                                                 NDC 65862-862-05             Bottles of 1,000                                              NDC 65862-862-99 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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

DARIFENACIN - DARIFENACIN TABLET, FILM COATED, EXTENDED RELEASE
AUROBINDO PHARMA 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 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 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