Eurozart-Plus Special Precautions

Hypotension: Excessive fall of blood pressure can occur with amlodipine in some patients, especially the elderly. These conditions should be corrected prior to administration of Amlodipine + Losartan (EUROZART-PLUS).
Aggravation of Angina: Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy, or at the time of dosage increase.
Congestive Heart Failure: In general, calcium channel blockers should be used with caution in patients with heart failure. Placebo-controlled trials of amlodipine in patients with New York Heart Association (NYHA) Class III or IV heart failure showed no overall adverse effect on survival or cardiac morbidity. In NYHA Class II/III heart failure patients, there was no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms or left ventricular ejection fraction.
Electrolyte Imbalance: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
Renal Impairment: The combination should be used with caution in patients with severe renal disease. As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), changes in renal function have been reported in susceptible individuals treated with losartan; in some patients, these changes in renal function were reversible upon discontinuation of therapy. In patients whose renal function may depend on the activity of the RAAS (e.g., patients with severe congestive heart failure), losartan treatment has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Also, losartan treatment in patients with unilateral or bilateral renal artery stenosis was associated with increases in serum creatinine or blood urea nitrogen (BUN). In some patients, these effects were reversible upon discontinuation of therapy.
Hepatic Impairment: Caution should be exercised when administering the combination to patients with impaired hepatic function due to increase in the plasma concentration of the combination.
Use in Children: Safety and effectiveness in pediatric patients have not been established.