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:

Dispensing Solutions, Inc.

INN (Algemene Internationale Benaming):

VALSARTAN

Samenstelling:

VALSARTAN 160 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 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:

Valsartan and Hydrochlorothiazide Tablets, USP are 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.     Bottles of 90............................................................................................... NDC 0781-5948-92     Bottles of 1000………………………………………………………………NDC 0781-5948-10     Bottles of 14,000..............................................................................................NDC 0781-5948-87 160/12.5 mg Tablet - Dark red, ovaloid, with slightly convex faces debossed CG on one side and HHH on the other side.     Bottles of 90......................................................................................... NDC 0781-5949-92     Bottles of 1000………………………………………………………………NDC 0781-5949-10     Bottles of 7,000.......................................................................................NDC 0781-5949-84     Unit Dose (blister pack of 30)............................................................... NDC 0781-5949-64 160/25 mg Tablet - Brown orange, ovaloid, with slightly convex faces debossed NVR on one side and HXH on the other side.     Bottles of 90......................................................................................... NDC 0781-5950-92     Bottles of 1000…………………………………………………………......NDC 0781-5950-10     Bottles of 7,000......................................................................................NDC 0781-5950-84     Unit Dose (blister pack of 30)................................................ ................NDC 0781-5950-64 320/12.5 mg Tablet - Pink, ovaloid, with beveled edge, debossed NVR on one side and HIL on the other side.     Bottles of 90......................................................................................... NDC 0781-5951-92     Bottles of 1000……………………………………………………………..NDC 0781-5951-10     Bottles of 3,500......................................................................................NDC 0781-5951-37     Unit Dose (blister pack of 30)............................................................... NDC 0781-5951-64 320/25 mg Tablet - Yellow, ovaloid, with beveled edge, debossed NVR on one side and CTI on the other side.     Bottles of 90......................................................................................... NDC 0781-5952-92     Bottles of 1000 ……………………………………………………………. NDC 0781-5952-10     Bottles of 3,500......................................................................................NDC 0781-5952-37     Unit Dose (blister pack of 30)............................................................... NDC 0781-5952-64 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
DISPENSING SOLUTIONS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS,
USP.
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 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 01/2012
Indications and Usage: Benefits of lowering blood pressure (1) 12/2011
Contraindications: Dual RAS Blockade in Diabetics (4) 10/2012
Warnings and Precautions: Fetal Toxicity (5.1) 01/2012
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, USP are a combination
tablet of valsartan, an angiotensin II receptor blocker
(ARB) and hydrochlorothiazide, a diuretic. Valsartan and
Hydrochlorothiazide Tablets, USP 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 320/25 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 FORM