देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Hisun Pharmaceuticals USA, Inc.
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 tablets containing 20 mg, 40 mg, or 80 mg of telmisartan USP. Tablets are marked with the HU on one side, and on the other side, with either 20, 40, or 80 for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows: Telmisartan tablets USP 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-135-51). Telmisartan tablets USP 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-136-51). Telmisartan tablets USP 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-137-51). 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 until immediately before administration.
Abbreviated New Drug Application
TELMISARTAN- TELMISARTAN TABLET HISUN PHARMACEUTICALS USA, 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 WARNING._ • 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 DEATH TO THE DEVELOPING FETUS (5.1, 8.1) INDICATIONS AND USAGE Telmisartan tablets USP are 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) 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 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) 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 HISUN PHARMACEUTICALS USA, INC. AT 1-855-554-4786, OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG IN पूरा दस्तावेज़ पढ़ें