Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. 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 Educa
Valsartan is available as tablets containing valsartan USP 320 mg. All strengths are packaged in bottles as described below. 320 mg tablets are biconvex, oval-shaped and unscored. Tablet Color Deboss NDC 71205-###-## Side 1 Side 2 Bottle of 30 60 90 320 mg Dark grey-violet L15 -- 301-30 301-60 301-90 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
VALSARTAN- VALSARTAN TABLET, FILM COATED PROFICIENT RX LP ---------- 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 INDICATIONS AND USAGE Valsartan tablets are 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); valsartan tablets significantly reduced hospitalization for heart failure (1.2) • Post-myocardial infarction; for the 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* 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 * 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 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 susceptible patients (5.3, 5.4) ADVERSE REACTIONS HYPERTENSION: MOST COMMON ADVERSE REACTIONS ARE HEADACHE, DIZZINESS, VIRAL INFECTION, FATIGUE AND ABDOMINAL PAIN (6.1)HEART FAILURE: MOST COMMON ADVERSE REACTIONS ARE DIZZINESS, HYPOTENSION, DIAR Прочитайте повний документ