Mysteclin-F is frequently the only effective treatment available for potentially life-threatening fungal
disease. In each case, its possible life-saving benefit must be balanced against its untoward and dangerous
Mysteclin-F should be administered intravenously under close clinical observation by medically trained
personnel. It should be reserved for treatment of patients with progressive, potentially life-threatening
fungal infections due to susceptible organisms.
Acute reactions including fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, and tachypnea
are common 1 to 3 hours after starting an intravenous infusion. These reactions are usually more severe with the
first few doses of amphotericin B and usually diminish with subsequent doses.
Rapid intravenous infusion has been associated with hypotension, hypokalemia, arrhythmias, and shock and
should, therefore, be avoided.
Mysteclin-F should be used with care in patients with reduced renal function; frequent monitoring of renal
function is recommended (see Laboratory Tests below and ADVERSE REACTIONS). In some patients hydration
and sodium repletion prior to amphotericin B administration may reduce the risk of developing nephrotoxicity.
Supplemental alkali medication may decrease renal tubular acidosis complications.
Since acute pulmonary reactions have been reported in patients given amphotericin B during or shortly after
leukocyte transfusions, it is advisable to temporarily separate these infusions as far as possible and to monitor
Leukoencephalopathy has been reported following use of amphotericin B. Literature reports have suggested that
total body irradiation may be a predisposition.
Whenever medication is interrupted for a period longer than seven days, therapy should be resumed by starting with
the lowest dosage level, e. g., 0.25 mg/kg of body weight, and increased gradually as outlined under DOSAGE AND
Renal function should be monitored frequently during amphotericin B therapy. It is also advisable to monitor on a
regular basis liver function, serum electrolytes (particularly magnesium and potassium), blood counts, and hemoglobin
concentrations. Laboratory test results should be used as a guide to subsequent dosage adjustments.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to evaluate carcinogenic potential. There also have
been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
Pregnancy: Teratogenic Effects, Pregnancy Category B
Reproduction studies in animals have revealed no evidence of harm to the fetus due to amphotericin B for
injection. Systemic fungal infections have been successfully treated in pregnant women with amphotericin B for
injection without obvious effects to the fetus, but the number of cases reported has been small. Because animal
reproduction studies are not always predictive of human response, and adequate and well-controlled studies
have not been conducted in pregnant women, this drug should be used during pregnancy only if clearly indicated.
It is not know whether amphotericin B is excreted in human milk. Because many drugs are excreted in human milk and
considering the potential toxicity of amphotericin B, it is prudent to advise a nursing mother to discontinue