Losartan 25 mg Tablets — Generic For Cozaar — Cadista

These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS.

LOSARTAN POTASSIUM tablets, for oral use

Rx Only

Initial U.S. Approval: 1995

Warning: Fetal Toxicity

See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue Losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)

Recent Major Changes

Warnings and Precautions Hyperkalemia (5.4) 10/2018

Indications And Usage

Losartan potassium is 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)

Dosage And Administration

Hypertension

Hypertensive Patients with Left Ventricular Hypertrophy

blood pressure response is needed. (2.2, 14.2)

Nephropathy in Type 2 Diabetic Patients

Dosage Forms And Strengths

Tablets: 25 mg; 50 mg; and 100 mg. (3)

Contraindications

Hypersensitivity to any component. (4)

Coadministration with aliskiren in patients with diabetes. (4)

Warnings And Precautions

• Hyperkalemia (5.4) 10/2018 INDICATIONS AND USAGE Losartan potassium is 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) DOSAGE AND ADMINISTRATION Hypertension
• Usual adult dose: 50 mg once daily. (2.1)
• Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). (2.1) Hypertensive Patients with Left Ventricular Hypertrophy
• Usual starting dose: 50 mg once daily. (2.2)
• Add hydrochlorothiazide 12.5 mg and/or increase Losartan potassium to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. (2.2, 14.2) Nephropathy in Type 2 Diabetic Patients

• Hyperkalemia (5.4) 10/2018 INDICATIONS AND USAGE Losartan potassium is 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) DOSAGE AND ADMINISTRATION Hypertension
• Usual adult dose: 50 mg once daily. (2.1)
• Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). (2.1) Hypertensive Patients with Left Ventricular Hypertrophy
• Usual starting dose: 50 mg once daily. (2.2)
• Add hydrochlorothiazide 12.5 mg and/or increase Losartan potassium to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. (2.2, 14.2) Nephropathy in Type 2 Diabetic Patients

Hypotension: Correct volume or salt depletion prior to administration of Losartan potassium. (5.2)

Monitor renal function and potassium in susceptible patients. (5.3, 5.4)

Adverse Reactions

Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Jubilant Cadista Pharmaceuticals Inc. at 1-800­-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Agents Increasing Serum Potassium: Risk of hyperkalemia. (7.1)

Lithium: Risk of lithium toxicity. (7.2)

NSAIDs: Increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. (7.3)

Dual Inhibition of the Renin-Angiotensin System: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. (7.4)

Use In Specific Populations

Losartan potassium is not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2. (2.1, 8.4)

Hepatic Impairment: Recommended starting dose 25 mg once daily. (2.4, 8.8, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2024