The most frequent infusion-related events after initial dosages were chills and fever. Frequency and severity of adverse events decreased in subsequent dosing.

Warnings and precautions for use in the treatment of diabetic patients It should be noted that each vial of AMPHOCIL contains lactose monohydrate. In the treatment of renal dialysis patients AMPHOCIL should be administered only at the end of each dialysis period. Serum electrolytes, particularly potassium and magnesium, should be regularly monitored.

Interactions with other medicaments and other forms of interaction There have been no reported interactions between AMPHOCIL and other drugs including cyclosporine, However, caution should be used in patients receiving concomitant therapy with drugs known to interact with conventional amphotericin B such as nephrotoxic drugs (aminoglycosides, cisplatin, and pentamidine), corticosteroids, and corticotrophin (ACTH) that may potentiate hypokalaemia and digitalis glycosides, muscle relaxants and antiarrhythmic agents whose effects may be potentiated in the presence of hypokalaemia. The use of flucytosine with AMPHOCIL has not been studied. While the synergy between amphotericin B and flucytosine has been reported, amphotericin B may enhance the toxicity of flucytosine by increasing its cellular uptake and impeding its renal excretion.

Pregnancy and lactation Pregnancy Animal reproductive toxicology studies with AMPHOCIL have shown no evidence of harm to the fetus. Although the active ingredient, amphotericin B, has been in wide use for many years without apparent ill consequence, there is inadequate evidence of safety of AMPHOCIL in human pregnancy. Therefore, it is recommended that administration of AMPHOCIL is avoided in pregnancy unless the anticipated benefit to the patient outweighs the potential risk to the fetus.

Nursing mothers It is not known whether amphotericin B is excreted in human milk. Consideration should be given to discontinuation of nursing during treatment with AMPHOCIL.

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