VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Proficient Rx LP

INN (International Name):

VALSARTAN

Sammensætning:

VALSARTAN 320 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Valsartan and hydrochlorothiazide tablets, USP are supplied as: 320 mg/25 mg tablet: yellow, oval shaped, film-coated tablets with VH5 on one side and > on the other side. Bottles of 30………………………..NDC 63187-428-30 Bottle of 90....................................... NDC 63187-428-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
PROFICIENT RX LP
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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, USP
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
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:
•
•
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions .
DOSAGE AND ADMINISTRATION
•
•
•
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
•
•
•
•
•
ADVERSE REACTIONS
The most common reasons for discontinuation of therapy with valsartan
and hydrochlorothiazide were headache and
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 CAUS