Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Amneal Pharmaceuticals LLC
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 Education
Valsartan tablets, USP are available as tablets containing valsartan, USP 40 mg, 80 mg, 160 mg, or 320 mg. Valsartan tablets USP, 40 mg, are supplied as yellow, oval, film-coated scored tablets debossed with “3” bisect “7” on one side and “AN” on the other side. They are available as follows: Bottles of 30: NDC 65162-837-03 Bottles of 60: NDC 65162-837-06 Bottles of 500: NDC 65162-837-50 Valsartan tablets USP, 80 mg, are supplied as pink, oval, film-coated tablets with beveled edges, debossed with “838” on one side and “AN” on the other side. They are available as follows: Bottles of 90: NDC 65162-838-09 Bottles of 500: NDC 65162-838-50 Bottles of 1,000: NDC 65162-838-11 Valsartan tablets USP, 160 mg, are supplied as yellow, oval, film-coated tablets with beveled edges, debossed with “839” on one side and “AN” on the other side. They are available as follows: Bottles of 90: NDC 65162-839-09 Bottles of 500: NDC 65162-839-50 Bottles of 1,000: NDC 65162-839-11 Valsartan tablets USP, 320 mg, are supplied as brown, oval, film-coated tablets with beveled edges, debossed with “840” on one side and “AN” on the other side. They are available as follows: Bottles of 90: NDC 65162-840-09 Bottles of 500: NDC 65162-840-50 Bottles of 1,000: NDC 65162-840-11 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container with a child-resistant closure as defined in the USP.
Abbreviated New Drug Application
VALSARTAN- VALSARTAN TABLET AMNEAL PHARMACEUTICALS LLC ---------- 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 mg to 160 mg once daily 80 mg to 320 mg once daily 6 to 16 years (2.3) 1 mg/kg once daily Up to 40 mg daily1 to 4 mg/kg once daily Up to 160 mg daily Heart Failure (2.4) 40 mg twice daily 40 mg to 160 mg twice daily Post-Myocardial Infarction (2.5) 20 mg twice daily 20 mg to 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 co-administer 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 Đọc toàn bộ tài liệu