Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Torrent Pharmaceuticals Limited
VALSARTAN
VALSARTAN 40 mg
ORAL
PRESCRIPTION DRUG
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,
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.
Abbreviated New Drug Application
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 Pročitajte cijeli dokument