VALSARTAN- valsartan tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

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, D

Product summary:

Valsartan tablets, USP are available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below. 80 mg are pink round convex tablets, imprinted VS over 80 on one side and  on the other side. Available in: Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6594-61 160 mg are orange oval tablets, imprinted VS 160 on one side and  on the other side. Available in: Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6595-61 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 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, FILM COATED
MAJOR PHARMACEUTICALS
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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, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Valsartan tablets, USP are an angiotensin II receptor blocker (ARB)
indicated for:
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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 to160 mg twice daily
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 valsartan tablets in patients with diabetes (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
HYPERTENSION: Most common adverse reactions are headache, dizziness,
viral infection, fatigue and abdominal pain (6.1)
HEART FAILURE: Most common adverse reactions are dizziness,
hypotension, diarrhea, arthralgia, back pain, fatigue and
hyperkalemia (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WATSON LABORATORIES,
INC. AT 1-800-272-5525 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
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 FAI