Amphotericin B

Antifungal, Systemic · Polyene antibiotic antifungal

Indications

Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B desoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B desoxycholate. Treatment of cryptococcal meningitis in HIV-infected patients. Treatment of visceral leishmaniasis.

Dosage

Children and Adults: IV infusion: Initial test dose 1 mg over 10 min (see literature). Empiric therapy: Recommended initial dose: 3 mg/kg/day. Systemic fungal infections (Aspergillus, Candida, Cryptococcus): Recommended initial dose of 3-5 mg/kg/day. Cryptococcal meningitis in HIV-infected patients: 6 mg/kg/day. Treatment of visceral leishmaniasis: Immunocompetent patients: 3 mg/kg/day on days 1-5 and 3 mg/kg/day on days 14 and 21; a repeat course may be given in patients who do not achieve parasitic clearance. Immunocompromised patients: 4 mg/kg/day on days 1-5 and 4 mg/kg/day on days 10, 17, 24, 31 and 38.

Administration

To make 5 mg/mL reconstitute with 10 mL of SWFI without preservatives and shake until a clear colloidal dispersion is obtained. For infusion, must be further diluted with D5W with a pH above 4.2. Administered by slow IV infusion over approx 2 to 6 hours. The recommended concentration of infusion is 0.1 mg/mL. The drug has also been given intra-articularly, intrathecally, intrapleurally and by irrigation. Compatibility: Amino acids 4.25%, dextrose 25%/ 15%/ 10%/ 5%, NaCl 0.9%, fat emulsion 10%/ 20%. Stability: Reconstituted vial stored in the dark is stable for 24 hours at room temperature and 7 days under refrigeration.

Adverse Effects

When given parenterally, anorexia, nausea and vomiting, diarrhoea, epigastric pain; febrile reactions, headache, muscle and joint pain; anaemia; disturbances in renal function (including hypokalaemia and hypomagnesaemia) and renal toxicity; also cardiovascular toxicity (including arrhythmias, blood pressure changes), blood disorders, neurological disorders (including hearing loss, diplopia, convulsions, peripheral neuropathy, encephalopathy), abnormal liver function (discontinue treatment), rash, anaphylactoid reactions; pain and thrombophlebitis at injection site.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Positive evidence of risk: Use only when no safer alternative exists for a serious problem. Lactation: Caution advised or effect undetermined. Contraindications: Hypersensitivity to amphotericin B or any component of the formulation unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk. Precautions: Cautions when given parenterally, toxicity common (close supervision necessary and test dose required); hepatic and renal function tests, blood counts and plasma electrolyte monitoring required; corticosteroids (avoid except to contra reactions); avoid rapid infusion (risk of arrhythmias). Anaphylaxis risk.

Interactions

Corticosteroids, corticotropin, aminoglycosides, polymyxins, vancomycin, other antifungals, cardiac glycosides, cyclosporin, diuretics, tacrolimus, pentamidine, antineoplastic agents, leukocyte transfusions, muscle relaxants.

Advice to Patient

Shake bottle of oral suspension well before each dose. Contact prescriber if there is chest pain, palpitations, skin rash, chills, CNS disturbances, fever, constant nausea, vomiting or abdominal pain, sore throat, increased fatigue, swelling of ankles/hands/feet, unusual weight gain, difficulty in breathing, pain at infusion site, muscle cramps, weakness. Complete full course of therapy even if you feel better. Change position slowly. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber. Keep yourself in a hygienic condition to prevent spreading and recurrence of lesions.

Pharmacokinetics

Half-life elimination: 7-10 hrs (following a single 24-hr dosing interval); Terminal half-life: 100-153 hrs (following multiple dosing up to 49 days).

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.