Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Aphena Pharma Solutions - Tennessee, LLC
VALSARTAN
VALSARTAN 80 mg
ORAL
PRESCRIPTION DRUG
Diovan® (valsartan) is 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 Diovan. 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, Evaluati
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Diovan (valsartan) is available as tablets containing valsartan 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) as described below. 40 mg tablets are scored on one side and ovaloid with bevelled edges. 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped with bevelled edges. Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
New Drug Application
DIOVAN- VALSARTAN TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIOVAN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIOVAN. DIOVAN (VALSARTAN) TABLETS INITIAL U.S. APPROVAL: 1996 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE DIOVAN 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 Diovan 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-IV); Diovan 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 INDIC ATIO N STARTING DOSE DOSE RANGE TARGET MAINTENANCE DO SE* Adult Hypertension (2.1) 80 or 160 mg once daily 80-320 mg once daily --- Pediatric Hypertension (6-16 years) (2.2) 1.3 mg/kg once daily (up to 40 mg total) 1.3-2.7 mg/kg once daily (up to 40- 160 mg total) --- Heart Failure (2.3) 40 mg twice daily 40-160 mg twice daily 160 mg twice daily Post-Myocardial Infarction (2.4) 20 mg twice daily 20-160 mg twice daily 160 mg twice daily * as tolerated by patient DOSAGE FORMS AND STRENGTHS Tablets (mg): 40 (scored), 80, 160, 320 (3) CONTRAINDICATIONS Known hypersensitivity to any component; Do not coadminister aliskiren with Diovan in patients with diabetes (4) WARNINGS AND PRECAUTIONS Observe for signs and symptoms of hypotension (5.2) Monitor renal function and potassium in susceptible patients (5.3, 5.4) ADVERSE REACTIONS HYPERTENSION: Most common adverse read_full_document