Amlife Special Precautions

Hypotension: Excessive fall of blood pressure can occur with amlodipine in some patients, especially the elderly. In patients who are intravascularly volume-depleted (eg, those treated with diuretics), symptomatic hypotension may occur after initiation of therapy with losartan. These conditions should be corrected prior to administration of this combination of losartan and amlodipine.
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.
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 rennin-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.
Hepatic Impairment: Caution should be exercised when administering losartan plus amlodipine to patients with impaired hepatic function due to increase in the plasma concentration of the combination.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles and operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.
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, this combination of losartan and amlodipine should be discontinued as soon as possible. Oligohydramnios has also been reported, presumably reporting 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.