Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Aurobindo Pharma Limited
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 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National Hi
Valsartan and hydrochlorothiazide tablets, USP are available as non-scored tablets containing valsartan and hydrochlorothiazide 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. Strengths are available as follows. Valsartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg are light orange colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '61' on other side. Bottles of 90 NDC 65862-547-90 Bottles of 1,000 NDC 65862-547-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-547-10 Valsartan and Hydrochlorothiazide Tablets USP, 160 mg/12.5 mg are dark red colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '62' on other side. Bottles of 90 NDC 65862-548-90 Bottles of 1,000 NDC 65862-548-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-548-10 Valsartan and Hydrochlorothiazide Tablets USP, 160 mg/25 mg are brown-orange colored, ovaloid, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '63' on other side. Bottles of 90 NDC 65862-549-90 Bottles of 1,000 NDC 65862-549-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-549-10 Valsartan and Hydrochlorothiazide Tablets USP, 320 mg/12.5 mg are pink colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '64' on other side. Bottles of 90 NDC 65862-550-90 Bottles of 500 NDC 65862-550-05 Valsartan and Hydrochlorothiazide Tablets USP, 320 mg/25 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with 'I' on one side and '65' on other side. Bottles of 90 NDC 65862-551-90 Bottles of 500 NDC 65862-551-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture and heat. Dispense in tight container (USP).
Abbreviated New Drug Application
VALSARTAN AND HYDROCHLOROTHIAZIDE - VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED AUROBINDO PHARMA LIMITED ---------- 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 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 is the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic. Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure: 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 . DOSAGE AND ADMINISTRATION Dose once daily. Titrate as needed to a maximum dose of 320 mg/25 mg (2) May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or hydrochlorothiazide) (2) May be substituted for titrated components (2.3) DOSAGE FORMS AND STRENGTHS Tablets (valsartan and hydrochlorothiazide): 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. (3) CONTRAINDICATIONS Anuria; Hypersensitivity to any sulfonamide-derived drugs or any component; Do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes (4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume dep Soma hati kamili