Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
A-S Medication Solutions
VALSARTAN
VALSARTAN 160 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
Product: 50090-1412 NDC: 50090-1412-0 90 TABLET, FILM COATED in a BOTTLE NDC: 50090-1412-1 30 TABLET, FILM COATED in a BOTTLE Product: 50090-1420 NDC: 50090-1420-0 90 TABLET, FILM COATED in a BOTTLE Product: 50090-1422 NDC: 50090-1422-0 90 TABLET, FILM COATED in a BOTTLE
Abbreviated New Drug Application
VALSARTAN AND HYDROCHLOROTHIAZIDE - VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED A-S MEDICATION SOLUTIONS ---------- 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 depl Lue koko asiakirja