VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Commercializzato da:

NuCare Pharmaceuticals,Inc.

INN (Nome Internazionale):

VALSARTAN

Composizione:

VALSARTAN 320 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Valsartan and hydrochlorothiazide tablets, USP 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, USP. 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 Pr

Dettagli prodotto:

320/25 mg Tablet - Yellow, oval shaped biconvex film coated tablets debossed with L20 on side and plain on other side. NDC 68071-4096-3 Bottles of 30 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).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLETS, USP, SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP.
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP, 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, USP are the combination
tablet of valsartan, an angiotensin II
receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic.
Valsartan and hydrochlorothiazide tablets, USP 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 v