Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Macleods Pharmaceuticals Limited
VALSARTAN
VALSARTAN 40 mg
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 Ed
Valsartan is available as tablets containing valsartan USP 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below. 40 mg tablets are oval, biconvex and scored on one side. 80 mg, 160 mg, and 320 mg tablets are biconvex, oval-shaped and unscored. 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 MACLEODS 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 DEATH TO THE DEVELOPING FETUS. (5.1) INDICATIONS AND USAGE Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) • Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (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 in adults (1.3) DOSAGE AND ADMINISTRATION INDICATION STARTING DOSE DOSE RANGE* Hypertension Adults (2.2) 80 -160 mg once daily 80-320 mg once daily 6-16 years (2.3) 1 mg/kg once daily Up to 40 mg daily 1-4 mg/kg once daily Up to 160 mg daily Heart Failure (2.4) 40 mg twice daily 40-160 mg twice daily Post-Myocardial Infarction (2.5) 20 mg twice daily 20-160 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 Hypert সম্পূর্ণ নথি পড়ুন