TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Telmisartan tablets, USP 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 v

Product summary:

Telmisartan tablets USP, 20 mg are white to off-white, round shaped, uncoated tablet, debossed with "C44" on one side and plain on other side and are supplied as follows: NDC 71209-049-16, in blister pack of 30 tablets (3 x 10 Unit-Dose) NDC 71209-049-18, in child resistant blister pack of 30 tablets (3 x 10 Unit-Dose) NDC 71209-049-01 Bottles of 30 NDC 71209-049-04 Bottles of 90 NDC 71209-049-05 Bottles of 100 NDC 71209-049-10 Bottles of 500 NDC 71209-049-11 Bottles of 1000 Telmisartan tablets USP, 40 mg are white to off-white, oblong, biconvex, uncoated tablet,debossed with "C141" on one side and plain on other side and are supplied as follows: NDC 71209-050-16, in blister pack of 30 tablets (3 x 10 Unit-Dose) NDC 71209-050-18, in child resistant blister pack of 30 tablets (3 x 10 Unit-Dose) NDC 71209-050-01 Bottles of 30 NDC 71209-050-04 Bottles of 90 NDC 71209-050-05 Bottles of 100 NDC 71209-050-10 Bottles of 500 NDC 71209-050-11 Bottles of 1000 Telmisartan tablets USP, 80 mg are white to off-white, oval, biconvex, uncoated tablet, debossed with "C144" on one side and plain on other side and are supplied as follows: NDC  71209-051-16, in blister pack of 30 tablets (3 x 10 Unit-Dose) NDC 71209-051-18, in child resistant blister pack of 30 tablets (3 x 10 Unit-Dose) NDC 71209-051-01 Bottles of 30 NDC 71209-051-04 Bottles of 90 NDC 71209-051-05 Bottles of 100 NDC 71209-051-10 Bottles of 500 NDC 71209-051-11 Bottles of 1000 Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters or bottles until immediately before administration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN - TELMISARTAN TABLET
CADILA PHARMACEUTICALS LIMITED
----------
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._
• 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)
INDICATIONS AND USAGE
Telmisartan is an angiotensin II receptor blocker (ARB) indicated for:
• 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) (1)
• Cardiovascular (CV) risk reduction in patients unable to take ACE
inhibitors (1.2) (1)
DOSAGE AND ADMINISTRATION
• May be administered with or without food (2.1) (2)
• 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)
(2)
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) (3)
CONTRAINDICATIONS
• 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) (4)
WARNINGS AND PRECAUTIONS
• 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)
•