Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Zydus Pharmaceuticals USA Inc.
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, 40 mg/12.5 mg are biconvex two layered, oblong-shaped, uncoated tablets having plain telmisartan layer as mottled light brown to mottled brown colored and hydrochlorothiazide layer is white to off-white debossed with '513' and may contain brown specks of telmisartan layer and are supplied as follows: NDC 68382-513-06 in bottle of 30 tablets NDC 68382-513-16 in bottle of 90 tablets NDC 68382-513-84 in carton of 30 tablets (3 x 10 unit-dose) Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg are biconvex two layered, oblong-shaped, uncoated tablets having plain telmisartan layer as mottled light brown to mottled brown colored and hydrochlorothiazide layer is white to off-white debossed with '514' and may contain brown specks of telmisartan layer and are supplied as follows: NDC 68382-514-06 in bottle of 30 tablets NDC 68382-514-16 in bottle of 90 tablets NDC 68382-514-84 in carton of 30 tablets (3 x 10 unit-dose) Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg are biconvex two layered, oblong-shaped, uncoated tablets having plain telmisartan layer as mottled light brown to mottled brown colored and hydrochlorothiazide layer is yellow debossed with '515' and may contain brown specks of telmisartan layer and are supplied as follows: NDC 68382-515-06 in bottle of 30 tablets NDC 68382-515-16 in bottle of 90 tablets NDC 68382-515-84 in carton of 30 tablets (3 x 10 unit-dose) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Tablets should not be removed from blisters or bottles until immediately before administration.
Abbreviated New Drug Application
TELMISARTAN AND HYDROCHLOROTHIAZIDE - TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ZYDUS PHARMACEUTICALS USA INC. ---------- 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._ 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) INDICATIONS AND USAGE 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) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg (3) CONTRAINDICATIONS Hypersensitivity to telmisartan or any component (4) Anuria (4) Co-Administration with aliskiren in patients with diabetes (4) WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure (5.1) Correct volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension (5.2) Monitor renal function and potassium in susceptible patients (5.3) Observe for clinical signs of fluid or electrolyte imbalance (5.4) Hypersensitivity Reactio Läs hela dokumentet