Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Alembic Pharmaceuticals Inc.
VALSARTAN
VALSARTAN 80 mg
ORAL
PRESCRIPTION DRUG
Valsartan 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 hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan 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 Hig
Valsartan and Hydrochlorothiazide Tablets, USP are available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. Strengths are available as follows. 80 mg/12.5 mg Tablet - Light orange, oval-shaped film coated tablets debossed with ‘L235’ on one side and plain on other side. NDC 62332-079-30 bottle of 30 tablets NDC 62332-079-90 bottle of 90 tablets NDC 62332-079-71 bottle of 500 tablets NDC 62332-079-10 carton of 100 (10 x 10) tablets unit dose 160 mg/12.5 mg Tablet - Dark red, oval-shaped film coated tablets debossed with ‘L236’ on one side and plain on other side. NDC 62332-080-30 bottle of 30 tablets NDC 62332-080-90 bottle of 90 tablets NDC 62332-080-71 bottle of 500 tablets NDC 62332-080-10 carton of 100 (10 x 10) tablets unit dose 160 mg/25 mg Tablet - Brown orange, oval-shaped film coated tablets debossed with ‘L237’ on one side and plain on other side. NDC 62332-081-30 bottle of 30 tablets NDC 62332-081-90 bottle of 90 tablets NDC 62332-081-71 bottle of 500 tablets NDC 62332-081-10 carton of 100 (10 x 10) tablets unit dose 320 mg/12.5 mg Tablet - Pink, oval-shaped film coated tablets debossed with ‘L238’ on one side and plain on other side. NDC 62332-082-30 bottle of 30 tablets NDC 62332-082-90 bottle of 90 tablets NDC 62332-082-71 bottle of 500 tablets NDC 62332-082-10 carton of 100 (10 x 10) tablets unit dose 320 mg/25 mg Tablet - Yellow, oval-shaped film coated tablets debossed with ‘L239’ on one side and plain on other side. NDC 62332-083-30 bottle of 30 tablets NDC 62332-083-90 bottle of 90 tablets NDC 62332-083-71 bottle of 500 tablets NDC 62332-083-10 carton of 100 (10 x 10) tablets unit dose Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF). [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
VALSARTAN AND HYDROCHLOROTHIAZIDE - VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ALEMBIC PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN AND HYDROCHLOROTHIAZIDE 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 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE. (5.1) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1) INDICATIONS AND USAGE Valsartan and hydrochlorothiazide tablets are combination of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. (1) Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure: (1) In patients not adequately controlled with monotherapy (1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1) DOSAGE AND ADMINISTRATION Dose once daily. Titrate as needed to a maximum dose of 320/25mg (2) May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ) (2) May be substituted for titrated components (2.3) DOSAGE FORMS AND STRENGTHS Tablets (Valsartan/HCTZ mg): 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 (3) (3) CONTRAINDICATIONS Anuria; Hypersensitivity to sulfonamide-derived drugs or any component: Do not co-administer aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes (4) (4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume-depletion prior to initiation (5.2) Obse Baca dokumen lengkapnya