VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Physicians Total Care, Inc.

ИНН (Международная Имя):

VALSARTAN

состав:

VALSARTAN 320 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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 1 side and HGH on the other side. 160/12.5 mg Tablet - Dark red, ovaloid, with slightly convex faces debossed CG on 1 side and HHH on the other side. 160/25 mg Tablet - Brown orange, ovaloid, with slightly convex faces debossed NVR on 1 side and HXH on the other side. 320/12.5 mg Tablet - Pink, ovaloid, with beveled edge, debossed NVR on 1 side and HIL on the other side.     Bottles of 30............................................................................................... NDC 54868-6440-0 320/25 mg Tablet - Yellow, ovaloid, with beveled edge, debossed NVR on 1 side and CTI on the other side. 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). Distributed by: Physicians Total Care, Inc. Tulsa, OK  74146

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
PHYSICIANS TOTAL CARE, 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)
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 FORMS AND STRENGTHS
Valsartan and Hydrochlorothiazide Tablets, USP: 80/12.5 mg, 160/12.5
mg, 160/25 mg, 320/12.5 mg and, 320/25 mg (3)
CONTRAINDICATIONS
Anuria; Hypersensitivity to any sulfonamide-derived drugs or any
component; Do not coadminister aliskiren with Valsartan
and Hydrochlorothiazide Tablets, USP in patients with diabetes (4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volu