1 INDICATIONS AND USAGE Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3 ) 1.1 Hypertension Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal 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 losartan. 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 Programâ€™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 different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. 1.3 Nephropathy in Type 2 Diabetic Patients Losartan potassium tablets are indicated for the Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio â‰¥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3) ].
Aurobindo Pharma Limited
16 HOW SUPPLIED/STORAGE AND HANDLING
LOSARtan POTASSIUM tablets USP are supplied as follows:
LOSARtan POTASSIUM Tablets USP, 25 mg are green colored, oval shaped, biconvex film-coated tablets debossed with â€˜Eâ€™ on one side and â€˜45â€™ on other side. Bottles of 30 NDC 65862-201-30 Bottles of 90 NDC 65862-201-90 Bottles of 500 NDC 65862-201-05 Bottles of 1,000 NDC 65862-201-99
LOSARtan POTASSIUM Tablets USP, 50 mg are green colored, oval shaped, biconvex film-coated tablets debossed with â€˜Eâ€™ on one side and â€˜4â€™ and â€˜6â€™ separated by scoreline on other side. Bottles of 30 NDC 65862-202-30 Bottles of 90 NDC 65862-202-90 Bottles of 1,000 NDC 65862-202-99
LOSARtan POTASSIUM Tablets USP, 100 mg are green colored, oval shaped, biconvex film-coated tablets debossed with â€˜Eâ€™ on one side and â€˜47â€™ on other side. Bottles of 30 NDC 65862-203-30 Bottles of 90 NDC 65862-203-90 Bottles of 1,000 NDC 65862-203-99 Store at 20Â° to 25Â°C (68Â° to 77Â°F); excursions permitted to 15Â° to 30Â°C (59Â° to 86Â°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
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