Losartan Potassium S 111 43547 0360 09 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Losartan potassium tablet 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)
What should I know before taking it?
Losartan potassium is contraindicated: • In patients who are hypersensitive to any component of this product. • For coadministration with aliskiren in patients with diabetes.
What important warnings are listed?
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 . 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.
How is this medication usually taken?
• Losartan potassium tablets, USP, 25 mg, are white, oval shaped, biconvex, film-coated tablets, debossed with “ML” on one side and “14” on other side. • Losartan potassium tablets, USP, 50 mg, are white, oval shaped, biconvex, film-coated tablets debossed with “M” and “L” separated by score line on one side and “15” on other side. • Losartan potassium tablets, USP, 100 mg, are white, teardrop shaped, biconvex, film-coated tablets debossed with “ML” on one side and “16” on other side.
What side effects are listed?
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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What interactions are listed?
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)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=05818573-0b40-4731-a9d1-152c708905bf
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.