Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Sandoz Inc
TELMISARTAN
TELMISARTAN 20 mg
ORAL
PRESCRIPTION DRUG
Telmisartan tablets 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 variety o
Telmisartan tablets, USP are available as follows: 20 mg, white to almost white, oval, plain tablet, with imprint ‘SZ’ on one side and ‘222’ on the other side 40 mg, white to almost white, oval, plain tablet, with imprint ‘SZ’ on one side and ‘223’ on the other side 80 mg, white to almost white, oval, plain tablet, with imprint ‘SZ’ on one side and ‘224’ on the other side Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.
Abbreviated New Drug Application
TELMISARTAN- TELMISARTAN TABLET SANDOZ 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._ • • INDICATIONS AND USAGE Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • DOSAGE AND ADMINISTRATION • 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 • • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT 1-800-525-8747 OR FDA AT 1-800-FDA- 1088 OR _WWW.FDA.GOV/MEDWATCH_ DRUG INTERACTIONS • • USE IN SPECIFIC POPULATIONS 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) 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) May be administered with or without food (2.1) 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) 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) _Hypertension:_ The most common adverse events (≥1%) reported in hypertension trials are back Đọc toàn bộ tài liệu