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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 320 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 is available as tablets containing valsartan, USP 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below. 40 mg tablets are yellow colored, film-coated, oval-shaped tablets debossed with 'RX121 ' on one side and break line on the other side NDC 51660-140-03 Bottles of 10 NDC 51660-140-30 Bottles of 30 NDC 51660-140-05 Bottles of 500 80 mg tablets are yellowish brown colored, film-coated, oval-shaped tablets debossed with 'RX124 ' on one side and plain on the other side NDC 51660-141-03 Bottles of 10 NDC 51660-141-90 Bottles of 90 NDC 51660-141-05 Bottles of 500 160 mg tablets are pink colored, film-coated, oval-shaped tablets debossed with 'RX125 ' on one side and plain on the other side NDC 51660-142-03 Bottles of 10 NDC 51660-142-90 Bottles of 90 NDC 51660-142-05 Bottles of 500 320 mg tablets are brown colored, film-coated, oval-shaped tablets debossed with 'RX126 ' on one side and plain on the other side NDC 51660-143-03 Bottles of 10 NDC 51660-143-90 Bottles of 90 NDC 51660-143-05 Bottles of 500 Store at 20o - 25o C (68o - 77o 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
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN TABLETS,
USP.
VALSARTAN TABLETS, USP, 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 tablets, USP are an angiotensin II receptor blocker (ARB)
indicated for: (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) (1)
• Treatment of HEART FAILURE (NYHA class II-IV); Valsartan tablets,
USP significantly reduced hospitalization for heart
failure (1.2) (1)
DOSAGE AND ADMINISTRATION
*as tolerated by patient
INDICATION (2)
STARTING DOSE (2)
DOSE RANGE (2)
TARGET MAINTENANCE
DOSE* (2)
Adult Hypertension (2.1) (2)
80 or 160 mg once daily (2)
80 to 320 mg once daily (2)
--- (2)
Pediatric Hypertension (6 to 16
years) (2.2) (2)
1.3 mg/kg once daily (up to
40 mg total) (2)
1.3 to 2.7 mg/kg once daily (up to
40 to 160 mg total) (2)
--- (2)
Heart Failure (2.3) (2)
40 mg twice daily (2)
40 to 160 mg twice daily (2)
160 mg twice daily (2)
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320 (3) (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) (5)
• Monitor renal function and potassium in susceptible patients (5.3,
5.4) (5)
ADVERSE REACTIONS
HYPERTENSION: Most common adverse reactions are headache, dizziness,
viral