Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Solco Healthcare LLC
TELMISARTAN
TELMISARTAN 40 mg
ORAL
PRESCRIPTION DRUG
Telmisartan and hydrochlorothiazide 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 classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. 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 Committ
Telmisartan and hydrochlorothiazide tablets, USP are available in three strengths as biconvex two-layered, oblong-shaped, uncoated tablets containing telmisartan, USP and hydrochlorothiazide, USP: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and do not remove tablets from bottle until immediately before administration.
Abbreviated New Drug Application
TELMISARTAN AND HYDROCHLOROTHIAZIDE- TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET SOLCO HEALTHCARE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS. TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE. INITIAL U.S. APPROVAL: 2000 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. • • INDICATIONS AND USAGE • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US, LLC, AT 1-866-257- 2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AND HYDROCHLOROTHIAZIDE 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) Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1) Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1) Usual starting dose is 80 mg/12.5 mg once daily (2.1) Titrate up to 160 mg/25 mg as needed (2.1) Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg (2.2) Hypersensitivity to telmisartan or any compo Przeczytaj cały dokument