Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. 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 1 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, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with diff
NDC: 71335-1263-1: 30 Tablets in a BOTTLE NDC: 71335-1263-2: 60 Tablets in a BOTTLE NDC: 71335-1263-3: 90 Tablets in a BOTTLE
Abbreviated New Drug Application
IRBESARTAN- IRBESARTAN TABLET BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IRBESARTAN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IRBESARTAN TABLETS. IRBESARTAN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN TABLETS AS SOON AS POSSIBLE. (5.1, 8.1) • DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1, 8.1) INDICATIONS AND USAGE Irbesartan 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 diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2) DOSAGE AND ADMINISTRATION INDICATION DOSE Hypertension (2.2) 150 mg to 300 mg once daily Diabetic Nephropathy (2.3) 300 mg once daily DOSAGE FORMS AND STRENGTHS • Tablets: 75 mg, 150 mg, 300 mg (3) CONTRAINDICATIONS • Hypersensitivity to any component of this product. (4) • Coadministration with aliskiren in patients with diabetes. (4) WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration. (5.2) • Monitor renal function and serum potassium. (5.3) ADVERSE REACTIONS • Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MACLEODS PHARMA USA, INC. AT 1-888- 943-3210 OR 1-855-926-3384 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • Lithium: Risk of lithium toxicity. (7) • Nonsteroidal Anti-inflammatory Drugs (NSA Lire le document complet