Emlor Plus Special Precautions

Drug Interactions: Rifampin: Rifampin, an inducer of drug metabolism, decreased the concentrations of losartan and its active high metabolite.
Fluconazole: Fluconazole, an inhibitor of P450 2C9, decreased active metabolite concentration and increased losartan concentration.
Agents That Increase Serum Potassium: As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium may lead to increase in serum potassium.
Lithium: Losartan reduces lithium excretion; hence, serum lithium levels should be monitored carefully if lithium salts are to be co-administered with Amlodipine + Losartan.
Non-Steroidal Anti-inflammatory Agents (NSAIDs) including Selective Cyclooxygenase-2 Inhibitors: In some patients with compromised renal function who are being treated with NSAIDs, including those that selectively inhibit cyclooxygenase-2 inhibitors (COX-2 inhibitors), the co-administration of losartan may result in a further deterioration of renal function. These effects are usually reversible. Reports suggest that NSAIDs, including selective COX-2 inhibitors, may diminish the antihypertensive effect of losartan. This interaction should be given consideration in patients taking NSAIDs, including selective COX-2 inhibitors, concomitantly with Amlodipine + Losartan.
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.
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 Ill 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 Pregnancy: Drugs that act directly on the RAAS can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, Amlodipine + Losartan should be discontinued as soon as possible. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function.
Use in Lactation: It is not known whether losartan or amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing may be discontinued while the combination is administered.
Use in Children: Safety and effectiveness in pediatric patients have not been established.