DARIFENACIN tablet, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Alembic Pharmaceuticals Limited

INN (Tên quốc tế):

DARIFENACIN HYDROBROMIDE

Thành phần:

DARIFENACIN 7.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Darifenacin is muscarinic antagonist 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. 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), th

Tóm tắt sản phẩm:

Darifenacin Extended-Release Tablets 7.5 mg are white colored, round, biconvex film-coated tablets debossed with L408 on one side and plain on other side. Bottle of 30                                                                          NDC 46708-223-30 Bottle of 90                                                                           NDC 46708-223-90 Bottle of 1000                                                      NDC 46708-223-91 80 (10 x 8) Tablets Unit Dose Blister Pack      NDC 46708-223-08 Darifenacin Extended-Release Tablets 15 mg are light Peach colored, round, biconvex film-coated tablets debossed with L409 on one side and plain on other side. Bottle of 30                                                                              NDC 46708-224-30 Bottle of 90                                                                              NDC 46708-224-90 Bottle of 1000                                                       NDC 46708-224-91 80 (10 x 8) Tablets Unit Dose Blister Pack        NDC 46708-224-08 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. 

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DARIFENACIN - DARIFENACIN TABLET, EXTENDED RELEASE
ALEMBIC PHARMACEUTICALS LIMITED
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions: Central Nervous System Effects (5.5) 03/2012
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) (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) (2)
The daily dose of darifenacin extended-release tablets should not
exceed 7.5 mg in the following patients:
(2)
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) (2)
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) (2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets 7.5 mg and 15 mg. (3) (3)
CONTRAINDICATIONS
Darifenacin extended-release tablets are contraindicated in patients
with, or at risk for, the following
conditions (4): (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
g