DIOVAN HCT- valsartan and hydrochlorothiazide tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Dispensing Solutions, Inc.

INN:

VALSARTAN

composition:

VALSARTAN 160 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 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 Program’s Joint National Committe

leaflet_short:

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 1 side and HGH on the other side.       Bottles of 90       NDC 0078-0314-34       Bottles of 14,000       NDC 0078-0314-33       Unit Dose (blister pack)       NDC 0078-0314-06       Box of 100 (strips of 10) 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 90       NDC 0078-0315-34       Bottles of 7,000       NDC 0078-0315-17       Unit Dose (blister pack)       NDC 0078-0315-06       Box of 100 (strips of 10)       Unit Dose (blister pack of 30)       NDC 0078-0315-15 160/25 mg Tablet  - Brown orange, ovaloid, with slightly convex faces debossed NVR on 1 side and HXH on the other side.       Bottles of 90       NDC 0078-0383-34       Bottles of 7,000       NDC 0078-0383-17       Unit Dose (blister pack)       NDC 0078-0383-06       Box of 100 (strips of 10)       Unit Dose (blister pack of 30)       NDC 0078-0383-15 320/12.5 mg Tablet  - Pink, ovaloid, with beveled edge, debossed NVR on 1 side and HIL on the other side.       Bottles of 90       NDC 0078-0471-34       Bottles of 3,500       NDC 0078-0471-11       Unit Dose (blister pack)       NDC 0078-0471-06       Box of 100 (strips of 10)       Unit Dose (blister pack of 30)       NDC 0078-0471-15 320/25 mg Tablet  - Yellow, ovaloid, with beveled edge, debossed NVR on 1 side and CTI on the other side.       Bottles of 90       NDC 0078-0472-34       Bottles of 3,500       NDC 0078-0472-11       Unit Dose (blister pack)       NDC 0078-0472-06       Box of 100 (strips of 10)       Unit Dose (blister pack of 30)       NDC 0078-0472-15 Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

authorization_status:

New Drug Application

SPC

DIOVAN HCT- VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
DISPENSING SOLUTIONS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USEDIOVANHCTSAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FORDIOVANHCT.
DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE USP) TABLETS
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)
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
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
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
com