DIOVAN- valsartan tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

PD-Rx Pharmaceuticals, Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Diovan ® is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. 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 Progr

Sommarju tal-prodott:

Diovan (valsartan) is available as tablets containing valsartan 80 mg. Are packaged in bottles as described below. The 80 mg tablets are unscored and almond-shaped with beveled-edges. the tablets have NVR on one side and DV on the other side. Supplied in bottles of: 20 tablets NDC 55289-825-20 30 tablets NDC 55289-825-30 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).

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

DIOVAN- VALSARTAN TABLET
PD-RX PHARMACEUTICALS, 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE DIOVAN 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
Indications and Usage ( 1.1)
4/2021
Dosage and Administration ( 2.1, 2.3)
4/2021
INDICATIONS AND USAGE
Diovan is an angiotensin II receptor blocker (ARB) indicated for:
Hypertension, to lower blood pressure in adults and children 1 year
and older. Lowering blood pressure
reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial
infarctions ( 1.1)
Heart failure (NYHA class II-IV), to reduce hospitalization for heart
failure in adults ( 1.2)
Post-myocardial infarction, for the reduction of cardiovascular
mortality in clinically stable patients with
left ventricular failure or left ventricular dysfunction following
myocardial infarction in adults ( 1.3)
DOSAGE AND ADMINISTRATION
*As tolerated by patient
INDICATION
STARTING DOSE
DOSE RANGE*
Hypertension
Adults ( 2.2)
80 -160 mg once daily
80-320 mg once daily
1-16 years ( 2.3)
1 mg/kg once daily
Up to 40 mg daily
1-4 mg/kg once daily
Up to 160 mg daily
Heart Failure ( 2.4)
40 mg twice daily
40-160 mg twice daily
Post-Myocardial Infarction ( 2.5)
20 mg twice daily
20-160 mg twice daily
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320 (3)
CONTRAINDICATIONS
Known hypersensitivity to any component.
Do not coadminister aliskiren with Diovan in patients with diabetes (
4)
WARNINGS AND PRECAUTIONS
Observe for signs and symptoms of hypotension ( 5.2)
Monitor renal function and potassium in susceptible patients ( 5.3,
5.4)