TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent 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 variet

Product summary:

Telmisartan tablets, USP are available as white or off-white to yellowish uncoated tablets containing telmisartan 20 mg, 40 mg or 80 mg. Tablets are provided as follows: Telmisartan tablets, USP 20 mg are white or off-white to yellowish round uncoated tablets, debossed with '156' on one side and '20' on other side. Bottles of 30                           NDC 13668-156-30 Bottles of 100                         NDC 13668-156-01 30 Unit dose Tablets                NDC 13668-156-72 100 Unit dose Tablets              NDC 13668-156-74 Telmisartan tablets, USP 40 mg are white or off-white to yellowish oblong biconvex uncoated tablets, debossed with '1157' on one side and '40' on other side. Bottles of 30                           NDC 13668-157-30 Bottles of 100                         NDC 13668-157-01 30 Unit dose Tablets                NDC 13668-157-72 100 Unit dose Tablets              NDC 13668-157-74 Telmisartan tablets, USP 80 mg are white or off-white to yellowish oval biconvex uncoated tablets, debossed with '1158' on one side and '80' on other side. Bottles of 30                           NDC 13668-158-30 Bottles of 100                         NDC 13668-158-01 30 Unit dose Tablets                NDC 13668-158-72 100 Unit dose Tablets              NDC 13668-158-74 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 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
TORRENT PHARMACEUTICALS LIMITED
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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, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNINGS._
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 tablets, USP 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)
DOSAGE AND ADMINISTRATION
May be administered with or without food (2.1)
INDICATION
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
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)
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)
Avoid concomitant use of an ACE inhibitor and angiotensin receptor
blocker (5.6)
ADVERSE REACTIONS
Hypertension: The most common adverse events (≥1%) reported in
hypertension trials are back pain,
sinusitis, and diarrhea (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact TORRENT PHARMA Inc. at
1-800-912-9561 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTION