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:

REMEDYREPACK INC.

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 320 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, Detect

Product summary:

Valsartan Tablets USP, 40 mg are yellow colored, ovaloid, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '73' on other side with a score line separating 7 & 3.          Bottles of 30                                                      NDC 65862-570-30          Bottles of 1,000                                                  NDC 65862-570-99          Cartons of 100 (10 x 10) Unit-dose Tablets       NDC 65862-570-10 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.          Bottles of 90                                                      NDC 65862-571-90          Bottles of 1,000                                                  NDC 65862-571-99          Cartons of 100 (10 x 10) Unit-dose Tablets       NDC 65862-571-10 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.          Bottles of 90                                                      NDC 65862-572-90          Bottles of 1,000                                                  NDC 65862-572-99          Cartons of 100 (10 x 10) Unit-dose Tablets       NDC 65862-572-10 Valsartan Tablets USP, 320 mg are dark grey-violet colored, ovaloid, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '76' on other side.          Bottles of 90                                                      NDC 65862-573-90          Bottles of 500                                                    NDC 65862-573-05 Store at 20° to 25°C (68° to 77°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
REMEDYREPACK 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 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
INDICATION
STARTING DOSE
DOSE RANGE
TARGET MAINTENANCE
DOSE*
* as tolerated by patient
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 su