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:

A-S Medication Solutions

INN (Nome Internazionale):

VALSARTAN

Composizione:

VALSARTAN 160 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

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