Cozalyn 100 Special Precautions

Fetal toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Losartan potassium as soon as possible.
Hypotension in volume- or salt-depleted patients: In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g. those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Losartan potassium.
Renal function deterioration: Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Losartan potassium. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Losartan potassium.
Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Dosage reduction or discontinuation of Losartan potassium may be required. Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia.