SOLIFENACIN SUCCINATE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U)

Sẵn có từ:

CELLTRION USA, INC.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is contraindicated in patients: - With urinary retention [see Warnings and Precautions (5.2)] , - With gastric retention [see Warnings and Precautions (5.3)] , - With uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5) ], and - Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2)]. Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the p

Tóm tắt sản phẩm:

Solifenacin Succinate Tablets are supplied as round, film-coated tablets, available in bottles and unit-dose blister packages as follows:  Each 5 mg tablet is light yellow and plain on one side and debossed with “10” on other side and is available as follows: Bottle of 30                              NDC 72606-009-01 Bottle of 90                              NDC 72606-009-02 Unit Dose Pack of 100              NDC 72606-009-03 Each 10 mg tablet is light pink and plain on one side and debossed with “09” on other side and is available as follows: Bottle of 30                              NDC 72606-010-01 Bottle of 90                              NDC 72606-010-02 Unit Dose Pack of 100              NDC 72606-010-03 Store at 25ºC (77ºF); excursions permitted between 15ºC to 30ºC (59°F to 86ºF) [See USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCINATE TABLET, FILM COATED
CELLTRION USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOLIFENACIN SUCCINATE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SOLIFENACIN SUCCINATE TABLETS.
SOLIFENACIN SUCCINATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Solifenacin succinate is a muscarinic antagonist indicated for the
treatment of adults with overactive bladder with
symptoms of urge urinary incontinence, urgency, and urinary frequency
(1).
DOSAGE AND ADMINISTRATION
5 mg tablet taken orally once daily, and if well tolerated may be
increased to 10 mg once daily (2.1).
Do not exceed the 5 mg dose of solifenacin succinate in patients with:
Severe renal impairment creatinine clearance < 30 mL/min/1.73 m (2.2,
8.6).
Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate is
not recommended in patients with severe
hepatic impairment (Child-Pugh C). (2.3, 8.7).
Concomitant use of strong CYP3A4 inhibitors (2.4, 7.1).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg. (3).
CONTRAINDICATIONS
Urinary retention. (4, 5.2)
Gastric retention. (4, 5.3)
Uncontrolled narrow-angle glaucoma. (4, 5.5)
Hypersensitivity to this product or any of its components (4, 5.1,
6.2).
WARNINGS AND PRECAUTIONS
Angioedema and Anaphylactic Reactions: Promptly discontinue
solifenacin succinate and provide appropriate
the rapy.(5.1)
Urinary Retention: Solifenacin succinate is not recommended for use in
patients with clinically significant bladder outlet
obstruction (5.2)
Gastrointestinal Disorders: Solifenacin succinate is not recommended
for use in patients with decreased
gastrointestinal motility. (5.3)
Central Nervous System Effects: Somnolence has been reported with
solifenacin succinate. Advise patients not to
drive or operate heavy machinery until they know how solifenacin
succinate affects them. (5.4)
Controlled Narrow-Angle Glaucoma: Use solifenacin succinate with
caution