DIOVAN valsartan tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Cardinal Health

INN (International Name):

VALSARTAN

Sammensetning:

VALSARTAN 80 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

DIOVAN- VALSARTAN TABLET
CARDINAL HEALTH
----------
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: 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: Benefits of lowering blood pressure (1) 12/2011
Dosage and Administration:
Pediatric Hypertension 6-16 years of age (2.2) 02/2012
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) (2.2)
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 (2.3)
40 mg twice daily
40-160 mg twice daily
160 mg twice daily
Post-Myocardial Infarction
(2.4)
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 seve