Country: United States
Language: English
Source: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Alembic Pharmaceuticals Inc.
TELMISARTAN
TELMISARTAN 20 mg
ORAL
PRESCRIPTION DRUG
Telmisartan is 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 of pharmacol
Telmisartan Tablets, USP are supplied as below: 20 mg, white to off-white color, round, flat, beveled edge, uncoated tablets debossed with ‘L202’ on one side and plain on other side. NDC 62332-087-30 bottle of 30 units NDC 62332-087-91 bottle of 1000 units NDC 62332-087-10 blister of 100 units as 10 x 10 cards 40 mg, white to off-white color, oval shape, biconvex, uncoated tablets debossed with ‘L203’ on one side and plain on other side. NDC 62332-088-30 bottle of 30 units NDC 62332-088-91 bottle of 1000 units NDC 62332-088-10 blister of 100 units as 10 x 10 cards 80 mg, white to off-white color, oval shape, biconvex, uncoated tablets debossed with ‘L204’ on one side and plain on other side. NDC 62332-089-30 bottle of 30 units NDC 62332-089-91 bottle of 1000 units NDC 62332-089-10 blister of 100 units as 10 x 10 cards Storage Store at 20° to 25°C (68° to 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.
Abbreviated New Drug Application
TELMISARTAN - TELMISARTAN TABLET ALEMBIC PHARMACEUTICALS INC. ---------- 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 WARNINGS._ 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 EVEN DEATH TO THE DEVELOPING FETUS (5.1, 8.1) INDICATIONS AND USAGE Telmisartanis an angiotensin II receptor blocker (ARB) indicated for: (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) (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) 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) Avoid concomitant use of an ACE inhibitor an Read the complete document