TELMISARTAN tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)

Sẵn có từ:

West-Ward Pharmaceuticals Corp.

INN (Tên quốc tế):

TELMISARTAN

Thành phần:

TELMISARTAN 20 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety o

Tóm tắt sản phẩm:

Telmisartan is available as white or off-white, uncoated tablets containing telmisartan 20 mg, 40 mg, or 80 mg. Tablets are marked with the Boehringer Ingelheim company symbol on one side, and on the other side, with either 50H, 51H, or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows: Telmisartan tablets 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0054-0542-18). Telmisartan tablets 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0054-0543-18). Telmisartan tablets 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0054-0544-18). Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

TELMISARTAN- TELMISARTAN TABLET
WEST-WARD PHARMACEUTICALS CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TELMISARTAN TABLETS.
TELMISARTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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INDICATIONS AND USAGE
Telmisartan is an angiotensin II receptor blocker (ARB) indicated for:
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DOSAGE AND ADMINISTRATION
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Indication
Starting Dose
Dose Range
Hypertension (2.1)
40 mg once daily
40 to 80 mg once daily
Cardiovascular
Risk Reduction (2.2)
80 mg once daily
80 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg, 80 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AS SOON AS
POSSIBLE (5.1, 8.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS (5.1, 8.1)
Treatment of hypertension, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions.
(1.1)
Cardiovascular (CV) risk reduction in patients unable to take ACE
inhibitors (1.2)
May be administered with or without food (2.1)
When used for cardiovascular risk reduction, monitoring of blood
pressure is recommended, and if appropriate,
adjustment of medications that lower blood pressure may be necessary
(2.2)
Known hypersensitivity (e.g., anaphylaxis or angioedema) to
telmisartan or any other component of this product (4)
Do not co-administer aliskiren with telmisartan tablets in patients
with diabetes (4)
Avoid fetal or neonatal exposure (5.1)
Hypotension: Correct any volume or salt depletion before initiating
therapy. Observe for signs and symptoms of
hypotension (5.2)
Monitor carefully in patients with impaired hepatic (5.4) or renal
function (5.5)