Losartan Potassium 50 MG Oral Tablet
INDICATIONS AND USAGE Hypertension Losartan potassium tablets, USP are indicated for the treatment of hypertension. Losartan potassium may be used alone or in combination with other antihypertensive agents, including diuretics. Nephropathy in Type 2 Diabetic Patients Losartan potassium tablets, USP are indicated for the Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium 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 PHARMACOLOGY, Pharmacodynamics and Clinical Effects ).
Virtus Pharmaceuticals LLC
ROUND WHITE 12
12 ROUND WHITE
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HOW SUPPLIED Losartan Potassium Tablets, USP are available as follows: 25 mg – Each white, round, biconvex film coated tablets debossed with "II" on one side and plain on other side contains 25 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 76439-140-30), 90 (NDC 76439-140-90), 500 (NDC 76439-140-50), 1000 (NDC 76439-140-11), and 10 × 10 (unit-dose tablets) (NDC 76439-140-10). 50 mg – Each white, round, biconvex, film coated tablets debossed with "I2" on scoreline side and plain on other side contains 50 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 76439-141-30), 90 (NDC 76439-141-90), 1000 (NDC 76439-141-11), and 10 × 10 (unit-dose tablets) (NDC 76439-141-10). 100 mg – Each white, oval, biconvex film coated tablets debossed with "I3" on one side and plain on other side contains 100 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 76439-142-30), 90 (NDC 76439-142-90), 1000 (NDC 76439-142-11), and 10 × 10 (unit-dose tablets) (NDC 76439-142-10). Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container as defined in USP.
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