TROSPIUM CHLORIDE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

TROSPIUM CHLORIDE (UNII: 1E6682427E) (TROSPIUM - UNII:T4Y8ORK057)

Sẵn có từ:

CIPLA USA INC.,

INN (Tên quốc tế):

TROSPIUM CHLORIDE

Thành phần:

TROSPIUM CHLORIDE 20 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets are contraindicated in patients with: Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of trospium chloride tablets in pregnant women. Trospium chloride tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during trospium chloride tablets treatment are encouraged to contact their physician. Risk Summary Based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure

Tóm tắt sản phẩm:

Trospium chloride tablets, USP 20 mg (light yellow film coated, round biconvex tablets de-bossed with ‘IG’ on one side and ‘336’ on other) are supplied as follows: Bottles of 30s count (NDC 69097-912-02), Bottles of 60s count (NDC 69097-912-03) and Bottles of 1000s count (NDC 69097-912-15) Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

TROSPIUM CHLORIDE- TROSPIUM CHLORIDE TABLET, FILM COATED
CIPLA USA INC.,
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TROSPIUM CHLORIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TROSPIUM CHLORIDE
TABLETS.
TROSPIUM CHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Trospium chloride tablets are a muscarinic antagonist indicated for
the treatment of overactive bladder (OAB) with
symptoms of urge urinary incontinence, urgency, and urinary frequency.
(1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Trospium chloride tablets are contraindicated in
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (greater than or equal to 1%) with
trospium chloride tablets are dry mouth (20.1%),
constipation (9.6%), and headache (4.2%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at
1-866-604-3268 or FDA at 1-800-FDA-1088 or
www.fda.gov/me dwatch.
DRUG INTERACTIONS
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The recommended dose of trospium chloride tablet is one 20 mg tablet
twice daily. Trospium chloride tablets should
be dosed with water on an empty stomach, at least one hour before a
meal. (2)
For patients with severe renal impairment (creatinine clearance less
than 30 mL/min), the recommended dose is 20
mg once daily at bedtime. (2)
In geriatric patients greater than or equal to 75 years of age, dose
may be titrated down to 20 mg once daily based
upon tolerability. (2)
20 mg tablets. (3)
patients with urinary retention, gastric retention, or uncontrolled
narrow-angle glaucoma, and in patients who are at
risk for these conditions (4)
patients with known hypersensitivity (4)
Trospium chloride tablets should be administered with caution to
patients with clinically significant bladder outflow
obstruction or gastrointestinal obstructive disorders due to risk of
urinary or gastric retention. (5.1, 5.3)
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