TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Telmisartan tablets, USP are available as follows: 20 mg, white to almost white, oval, plain tablet, with imprint ‘SZ’ on one side and ‘222’ on the other side 40 mg, white to almost white, oval, plain tablet, with imprint ‘SZ’ on one side and ‘223’ on the other side 80 mg, white to almost white, oval, plain tablet, with imprint ‘SZ’ on one side and ‘224’ on the other side Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN- TELMISARTAN TABLET
SANDOZ INC
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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 tablets are an angiotensin II receptor blocker (ARB)
indicated for:
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DOSAGE AND ADMINISTRATION
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INDIC ATIO N
STARTING DOSE
DOSE RANGE
Hypertension (2.1)
40 mg once daily
40 to 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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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR _WWW.FDA.GOV/MEDWATCH_
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN TABLETS 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)
May be administered with or without food (2.1)
Known hypersensitivity (e.g., anaphylaxis or angioedema) to
telmisartan or any other component of this product (4)
Do not co-administer aliskiren with telmisartan 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)
Avoid concomitant use of an ACE inhibitor and angiotensin receptor
blocker (5.6)
_Hypertension:_ The most common adverse events (≥1%) reported in
hypertension trials are back