DIOVAN HCT- valsartan and hydrochlorothiazide tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

PD-Rx Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

VALSARTAN

Samenstelling:

VALSARTAN 160 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 angiotensin II receptor blocker (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 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 Pressure Education

Product samenvatting:

Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 160/12.5 mg. Strengths are available as follows. 160/12.5 mg Tablet - Dark red, ovaloid, with slightly convex faces debossed CG on 1 side and HHH on the other side.       Bottles of 30       NDC 55289-838-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Autorisatie-status:

New Drug Application

Productkenmerken

DIOVAN HCT- VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, 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.
DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE USP) 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 DIOVAN HCT 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
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 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 Diovan HCT in patients with
diabetes. ( 4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume depletion prior to initiation ( 5.2)
Observe for signs of fluid or electrolyte imbalance ( 5.9)
Monitor renal function and potassium in susceptible patients ( 5.3,
5.7)
Exacerbation or activation of systemic lupus erythem