VALSARTAN tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

American Health Packaging

INN (International Nazwa):

VALSARTAN

Skład:

VALSARTAN 80 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Valsartan tablets 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 the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. 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,

Podsumowanie produktu:

Valsartan Tablets USP, 80 mg are pale red colored, round, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '8' on other side. Unit dose packages of 100 (10 x 10) NDC 60687-128-01 Valsartan Tablets USP, 160 mg are grey-orange colored, ovaloid, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '67' on other side. Unit dose packages of 100 (10 x 10) NDC 60687-139-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

VALSARTAN- VALSARTAN TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN TABLETS.
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 VALSARTAN 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 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 to IV); valsartan tablets
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 DOSE
*
Adult Hypertension (2.1)
80 or 160 mg once daily
80 to 320 mg once daily
---
Pediatric Hypertension (6 to 16 years)
(2.2)
1.3 mg/kg once daily (up
to 40 mg total)
1.3 to 2.7 mg/kg once daily
(up to 40 to 160 mg total)
---
Heart Failure (2.3)
40 mg twice daily
40 to 160 mg twice daily
160 mg twice daily
Post-Myocardial Infarction (2.4)
20 mg twice daily
20 to 160 mg twice daily
160 mg twice daily
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg (scored), 80 mg, 160 mg, and 320 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component; Do not coadminister aliskiren
with valsartan tablets 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