Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Torrent Pharmaceuticals Limited
TELMISARTAN
TELMISARTAN 20 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
TELMISARTAN- TELMISARTAN TABLET TORRENT 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, 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 সম্পূর্ণ নথি পড়ুন