VALSARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Valsartan Tablets, USP are available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. 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).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

VALSARTAN- VALSARTAN TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VALSARTAN.
VALSARTAN TABLETS, USP
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 Tablets, USP are 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); Valsartan Tablets, USP
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
INDICATION
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
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320 (3)
CONTRAINDICATIONS
Known hypersensitivity to any component; Do not coadminister aliskiren
with valsartan 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)
ADVERSE R