Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Zydus Pharmaceuticals USA Inc.
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 vari
Telmisartan Tablets USP, 20 mg are mottled light brown to mottled brown-colored, round-shaped, flat face beveled edge, uncoated tablets debossed with '471' on one side and plain on the other side and are supplied as follows: NDC 68382-471-06 in bottle of 30 tablets with child-resistant closure NDC 68382-471-16 in bottle of 90 tablets with child-resistant closure NDC 68382-471-01 in bottle of 100 tablets NDC 68382-471-05 in bottle of 500 tablets NDC 68382-471-10 in bottle of 1000 tablets NDC 68382-471-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 40 mg are mottled light brown to mottled brown-colored, oblong-shaped, biconvex, uncoated tablets debossed with '472' on one side and plain on the other side and are supplied as follows: NDC 68382-472-06 in bottle of 30 tablets with child-resistant closure NDC 68382-472-16 in bottle of 90 tablets with child-resistant closure NDC 68382-472-01 in bottle of 100 tablets NDC 68382-472-05 in bottle of 500 tablets NDC 68382-472-10 in bottle of 1000 tablets NDC 68382-472-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 80 mg are mottled light brown to mottled-brown colored, oblong-shaped, biconvex, uncoated tablets debossed with '473' on one side and plain on the other side and are supplied as follows: NDC 68382-473-06 in bottle of 30 tablets with child-resistant closure NDC 68382-473-16 in bottle of 90 tablets with child-resistant closure NDC 68382-473-01 in bottle of 100 tablets NDC 68382-473-05 in bottle of 500 tablets NDC 68382-473-10 in bottle of 1000 tablets NDC 68382-473-78 in cartons of 30 tablets (3 x 10 unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Tablets should not be removed from blisters or bottles until immediately before administration. Dispense in a tightly closed container.
Abbreviated New Drug Application
TELMISARTAN- TELMISARTAN TABLET Zydus Pharmaceuticals USA Inc. ---------- Patient Information Telmisartan (tel″ mi sar′ tan) Tablets, USP Read this Patient Information before you start taking telmisartan tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about telmisartan tablets? Telmisartan can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking telmisartan, tell your doctor right away. What is telmisartan? Telmisartan is a prescription medicine used: • to treat high blood pressure (hypertension) • in certain high risk people aged 55 years and older to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death It is not known if telmisartan is safe and effective in children. Who should not take telmisartan? You should not take telmisartan tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet. For patients with diabetes, if you are taking telmisartan you should not take aliskiren. What should I tell my doctor before taking telmisartan tablets? Before you take telmisartan tablets, tell your doctor if you: • are pregnant or are planning to become pregnant. See "WhatisthemostimportantinformationIshouldknowabouttelmisartantablets?" • are breast-feeding or plan to breast-feed. It is not known if telmisartan passes into your breast milk. You and your doctor should decide if you will take telmisartan tablets or breastfeed. You should not do both. Talk with your doctor about the best way to feed your baby if you take telmisartan tablets. • have liver problems • have kidney problems • have heart problems • have any other medical conditions Tell your doctor about al Прочетете целия документ
TELMISARTAN- TELMISARTAN TABLET ZYDUS 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 RENNIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.1) _, (8.1)_ INDICATIONS AND USAGE Telmisartan tablets, USP are 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) Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors (1.2) DOSAGE AND ADMINISTRATION May be administered with or without food (2.1) 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) HEADER$ 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 coadminister 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 angioten Прочетете целия документ