Systemic Fungal Infections: Ampholip should not be used for treating common or superficial, inapparent fungal infections that are detectable only by positive skin or serologic tests.
Renal Disease: Since amphotericin B is potentially nephrotoxic drug, monitoring of renal function should be performed before initiating treatment in patients with preexisting renal disease and at least once weekly during therapy. Ampholip should be administered to patients undergoing renal dialysis only after the completion of dialysis. Serum potassium and magnesium levels should be monitored regularly.
Liver Disease: Patients with concurrent hepatic impairment due to infection, graft-versus-host disease, other liver disease or administration of hepatotoxic drugs have been successfully treated with Ampholip. In cases where serum bilirubin alkaline phosphatase or serum transaminase is increased, factors other than Ampholip were present and possibly accounted for the abnormalities. These factors included infection, hyperalimentation, concomitant hepatotoxic drugs and graft-versus-host disease.
Effects on the Ability to Drive or Operate Machinery: Ampholip is unlikely to affect the ability of an individual to drive or use machines, since adverse reactions are usually infusion-related. However, the clinical condition of patients who require Ampholip generally precludes driving or operating machinery.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Since conventional amphotericin B first became available, there have been no reports of drug-related carcinogenicity, mutagenicity, teratogenicity or adverse effect on fertility. Ampholip has not been shown to be mutagenic by in vivo mouse micronucleus assay. It has not been shown to be teratogenic in mice and rabbits.
Phospholipids are essential constituents of human cell membranes. The average diet provides several grams of phospholipids each day. There is no evidence that phospholipids, including DMPC and DMPG are carcinogenic, mutagenic or teratogenic.
Use in pregnancy & lactation: Conventional amphotericin B has been used successfully to treat systemic fungal infections in pregnant women with no obvious effects on the fetus, but only a small number of cases have been reported. Reproductive toxicity studies of amphotericin B in rats and rabbits showed no evidence of embryotoxicity, fetotoxicity or teratogenicity. However, safety for use in pregnant or lactating women has been established to pregnant or lactating women only for life-threatening disease when the likely benefit exceeds the risk to the mother and fetus.