VALSARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years 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 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 P

Product summary:

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. Valsartan tablets USP, 40 mg: Yellow colored, oval shaped, biconvex, film coated tablets, debossed with L128 and breakline on one side and 40 on the other side. NDC 62332-044-30    bottle of 30 tablets NDC 62332-044-90    bottle of 90 tablets NDC 62332-044-71    bottle of 500 tablets NDC 62332-044-91    bottle of 1000 tablets NDC 62332-044-10    cartons of 100 (10X10 unit-dose blisters)    Valsartan tablets USP,  80 mg: Pink colored, oval shaped, biconvex, film coated tablets, debossed with L129 on one side and 80 on the other side. NDC 62332-045-30    bottle of 30 tablets NDC 62332-045-90    bottle of 90 tablets NDC 62332-045-71    bottle of 500 tablets NDC 62332-045-91    bottle of 1000 tablets NDC 62332-045-10    cartons of 100 (10X10 unit-dose blisters)    Valsartan tablets USP, 160 mg: Yellow colored, oval shaped, biconvex, film coated tablets, debossed with L130 on one side and 160 on the other side. NDC 62332-046-30    bottle of 30 tablets NDC 62332-046-90   bottle of 90 tablets NDC 62332-046-71    bottle of 500 tablets NDC 62332-046-91    bottle of 1000 tablets NDC 62332-046-10    cartons of 100 (10X10 unit-dose blisters) Valsartan tablets USP, 320 mg: Purple colored, oval shaped, biconvex, film coated tablets, debossed with L127 on one side and 320 on the other side. NDC 62332-047-30    bottle of 30 tablets NDC 62332-047-90    bottle of 90 tablets NDC 62332-047-71    bottle of 500 tablets  NDC 62332-047-91    bottle of 1000 tablets 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:

Abbreviated New Drug Application

Summary of Product characteristics

VALSARTAN - VALSARTAN TABLET
ALEMBIC PHARMACEUTICALS INC.
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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 TABLETS AS SOON AS
POSSIBLE.
(5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND EVEN
DEATH TO THE DEVELOPING FETUS. (5.1)
INDICATIONS AND USAGE
Valsartan tablets are an angiotensin II receptor blocker (ARB)
indicated for:
• Hypertension, to lower blood pressure in adults and children 6
years 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) (1)
DOSAGE AND ADMINISTRATION
(2)
INDICATION
STARTING DOSE
DOSE RANGE*
Hypertension Adults (2.2)
80 to 160 mg once daily
80 to 320 mg once daily
6 to 16 years (2.3)
1 mg/kg once daily
Up to 40 mg daily
1 to 4 mg/kg once daily
Up to 160 mg daily
Heart Failure (2.4)
40 mg twice daily
40 to 160 mg twice daily
Post-Myocardial Infarction (2.5)
20 mg twice daily
20 to 160 mg twice daily
* As tolerated by patient (2)
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320 (3)
CONTRAINDICATIONS
Known hypersensitivity to any component. Do not coadminister aliskiren
with valsartan tablets in patients
with diabetes (4) (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