Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Aphena Pharma Solutions - Tennessee, LLC
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 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 High Blood Pressure Education Progra
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. 80/12.5 mg Tablet - Light orange, oval shaped biconvex film coated tablets debossed with "L16" on side and plain on other side. Bottles of 90 NDC 33342-074-10 Bottles of 1000 NDC 33342-074-44 160/12.5 mg Tablet - Dark red, oval shaped biconvex film coated tablets debossed with "L17" on side and plain on other side. Bottles of 90 NDC 33342-075-10 Bottles of 500 NDC 33342-075-15 160/25 mg Tablet - Brown orange, oval shaped biconvex film coated tablets debossed with "L18" on side and plain on other side. Bottles of 90 NDC 33342-076-10 Bottles of 500 NDC 33342-076-15 320/12.5 mg Tablet - Pink, oval shaped biconvex film coated tablets debossed with "L19" on side and plain on other side. Bottles of 90 NDC 33342-077-10 Bottles of 500 NDC 33342-077-15 320/25 mg Tablet - Yellow, oval shaped biconvex film coated tablets debossed with "L20" on side and plain on other side. Bottles of 90 NDC 33342-078-10 Bottles of 500 NDC 33342-078-15 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 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 APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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 the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), 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 320/25mg (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) 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 depletion Lugege kogu dokumenti