DIOVAN HCT- valsartan and hydrochlorothiazide tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

VALSARTAN

Sammensetning:

VALSARTAN 80 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Diovan HCT (valsartan and hydrochlorothiazide, USP) is 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 Diovan HCT. 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 Program’s Joint National Comm

Produkt oppsummering:

Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. Strengths are available as follows. 80/12.5  mg Tablet  - Light orange, ovaloid with slightly convex faces debossed CG on one side and HGH on the other side. 160/12.5  mg Tablet  - Dark red, ovaloid with slightly convex faces debossed CG on one side and HHH on the other side. 160/25 mg  Tablet  - Brown orange, ovaloid with slightly convex faces debossed NVR on one side and HXH on the other side. 320/12.5  mg Tablet  - Pink, ovaloid with beveled edge, debossed NVR on one side and HIL on the other side. 320/25 mg  Tablet  - Yellow, ovaloid with beveled edge, debossed NVR on one side and CTI on the other side. Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Autorisasjon status:

New Drug Application

Preparatomtale

DIOVAN HCT - VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIOVAN HCT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR_ _DIOVAN HCT.
DIOVANHCT (VALSARTAN AND HYDROCHLOROTHIAZIDE USP) TABLETS
INITIAL U.S. APPROVAL: 1998
WARNING: AVOID USE IN PREGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE DIOVAN HCT AS SOON AS
POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. (5.1)
RECENT MAJOR CHANGES
Indications and Usage: Benefits of lowering blood pressure (1) 12/2011
Warnings and Precautions: Acute Angle-Closure Glaucoma (5.9) 2/2011
INDICATIONS AND USAGE
Diovan HCT is the combination tablet of valsartan (Diovan), an
angiotensin II receptor blocker (ARB) and
hydrochlorothiazide (HCTZ), a diuretic. Diovan HCT is indicated for
the treatment of hypertension, to lower blood
pre ssure :
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
GENERAL CONSIDERATIONS:
Maximum effects within 2 to 4 weeks after dose change (2.1)
Renal impairment: Not recommended for patients with severe renal
impairment (creatinine clearance
≤30 mL/min) (2.1, 5.8)
Diovan HCT may be administered with or without food.
HYPE RTE NSIO N
ADD-ON THERAPY OR INITIAL THERAPY: Initiate with 160/12.5 mg. Titrate
upwards as needed to a maximum dose of
320/25 mg. One tablet daily (2.2, 2.4)
REPLACEMENT THERAPY: 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 an