DIOVAN- valsartan tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

متاح من:

Physicians Total Care, Inc.

INN (الاسم الدولي):

VALSARTAN

تركيب:

VALSARTAN 40 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Diovan® (valsartan) 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 the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan. 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 Committee on Prevention, Detection, Evaluati

ملخص المنتج:

Diovan (valsartan) is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below. 40 mg tablets are scored on one side and ovaloid with bevelled edges. 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped with bevelled edges. 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).

الوضع إذن:

New Drug Application

خصائص المنتج

DIOVAN - VALSARTAN TABLET
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIOVAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DIOVAN.
DIOVAN (VALSARTAN) TABLETS
INITIAL U.S. APPROVAL: 1996
WARNING: USE IN PREGNANCY
WHEN PREGNANCY IS DETECTED, DISCONTINUE DIOVAN 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
INDICATIONS AND USAGE
Diovan is an angiotensin II receptor blocker (ARB) indicated for:
Treatment of HYPERTENSION, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial infarctions
(1.1)
Treatment of HEART FAILURE (NYHA class II-IV); Diovan significantly
reduced hospitalization for heart failure (1.2)
Reduction of cardiovascular mortality in clinically stable patients
with left ventricular failure or left ventricular
dysfunction FOLLOWING MYOCARDIAL INFARCTION (1.3)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
STARTING DOSE
DOSE RANGE
TARGET MAINTENANCE
DO SE*
Adult Hypertension (2.1)
80 or 160 mg once daily
80-320 mg once daily
---
Pediatric Hypertension (6-16
years) (2.1)
1.3 mg/kg once daily (up to 40
mg total)
1.3-2.7 mg/kg once daily (up to 40-
160 mg total)
---
Heart Failure (2.2)
40 mg twice daily
40-160 mg twice daily
160 mg twice daily
Post-Myocardial Infarction
(2.3)
20 mg twice daily
20-160 mg twice daily
160 mg twice daily
* as tolerated by patient
No initial dosage adjustment is required for elderly patients, for
patients with mild or moderate renal impairment, or for
patients with mild or moderate liver insufficiency. Care should be
exercised with dosing of Diovan in patients with hepatic
or severe renal impairment. Diovan may be administered with or without
food. In HEART FAILURE patients, consideration
should be given to r