VALSARTAN- valsartan tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
31-03-2018
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Active ingredient:
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Available from:
Torrent Pharmaceuticals Limited
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. 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, Detection,
Product summary:
Valsartan tablets are available as tablets containing valsartan, USP 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) and 320 mg are also packaged in 10 strips of 8 tablets as described below. 40 mg tablets are white to off white, oval shaped, biconvex, film coated tablets debossed with '1067' on one side and break line on other side. Bottle of 30 NDC 13668-067-30 Bottle of 90 NDC 13668-067-90 Bottle of 500 NDC 13668-067-05 100 Unit Dose Tablets NDC 13668-067-74 80 mg tablets are brick red colored, oval shaped, biconvex, film coated tablets debossed with '1068' on one side and plain on other side. Bottle of 30 NDC 13668-068-30 Bottle of 90 NDC 13668-068-90 Bottle of 500 NDC 13668-068-05 100 Unit Dose Tablets NDC 13668-068-74 160 mg tablets are yellow colored, oval shaped, biconvex, film coated tablets debossed with '1069' on one side and plain on other side. Bottle of 30 NDC 13668-069-30 Bottle of 90 NDC 13668-069-90 Bottle of 500 NDC 13668-069-05 100 Unit Dose Tablets NDC 13668-069-74 320 mg tablets are yellow colored, oval shaped, biconvex film coated tablets debossed with '1070' on one side and plain on other side. Bottle of 30 NDC 13668-070-30 Bottle of 90 NDC 13668-070-90 Bottle of 500 NDC 13668-070-05 100 Unit Dose Tablets NDC 13668-070-74 80 Unit Dose Tablets NDC 13668-070-23 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container with a child-resistant closure.
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
VALSARTAN- VALSARTAN TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
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: (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 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
* as tolerated by patient (2)
INDICATION
STARTING DOSE
DOSE RANGE
T ARG E T
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 to 160 mg twice daily
160 mg twice daily
Post-Myocardial Infarction (2.4) 20 mg twice daily
20 to 160 mg twice daily
20-160 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)
(4)
WARNINGS AND PRECAUTIONS
Observe for signs and symptoms of hypotension (5.2)
Monitor renal
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