VALSARTAN AND HYDROCHLOROTHIAZIDE- valsartan and hydrochlorothiazide tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

AvKARE, Inc.

DCI (Denominação Comum Internacional):

VALSARTAN

Composição:

VALSARTAN 80 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 one 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

Resumo do produto:

Valsartan and hydrochlorothiazide tablets, USP are supplied as: 80 mg/12.5 mg tablet: light orange, oval shaped, film-coated tablets with VH1 on one side and > on the other side. Bottle of 90....................................... NDC 42291-884-90 160 mg/12.5 mg tablet: dark red, oval shaped, film-coated tablets with VH2 on one side and > on the other side. Bottle of 90....................................... NDC 42291-885-90 160 mg/25 mg tablet: brown, oval shaped, film-coated tablets with VH3 on one side and > on the other side. Bottle of 90....................................... NDC 42291-887-90 320 mg/12.5 mg tablet: pink, oval shaped, film-coated tablets with VH4 on one side and > on the other side. Bottle of 90....................................... NDC 42291-886-90 320 mg/25 mg tablet: yellow, oval shaped, film-coated tablets with VH5 on one side and > on the other side. Bottle of 90....................................... NDC 42291-888-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Status de autorização:

Abbreviated New Drug Application

Características técnicas

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
VALSARTAN AND HYDROCLOROTHIAZIDE TABLETS, USP
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, USP
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)
RECENT MAJOR CHANGES
Boxed Warning: Fetal Toxicity 1/2012
Indications and Usage: Benefits of lowering blood pressure ( 1)
12/2011
Contraindications: Dual RAS Blockade ( 4)
10/2012
Warnings and Precautions: Fetal Toxicity ( 5.1) 1/2012
Warnings and Precautions: Potassium Abnormalities ( 5.7) 07/2012
Drug Interactions: Dual Blockade of the Renin-Angiotensin System ( 7)
10/2012
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 mg/25 mg (
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 (