Generic Name and Formulations:
Amphotericin B (as liposome) 50mg/vial; pwd for IV infusion after reconstitution, filtration, and dilution.
Astellas Pharma US, Inc.
Indications for AMBISOME:
Empiric treatment of presumed fungal infections in febrile, neutropenic patients. Treatment of cryptococcal meningitis in HIV-infected patients. Aspergillus, Candida, or Cryptococcus infections in patients who are refractory to or intolerant of amphotericin B deoxycholate. Treatment of visceral leishmaniasis.
Adults and Children:
Give by IV infusion over 2hrs; may reduce duration to 1 hr if well-tolerated or increase if discomfort occurs. Stop infusion immediately if severe anaphylactic reaction occurs. <1 month: consult manufacturer. ≥1 month: Empiric therapy in febrile neutropenia: 3mg/kg per day. Cryptococcal meningitis: 6mg/kg per day. Aspergillus, Candida or Cryptococcus: 3–5mg/kg per day. Visceral leishmaniasis: immunocompetent: 3mg/kg per day on days 1–5, and 14, 21 (may repeat if parasites remain); immunocompromised: 4mg/kg per day on days 1–5, and 10, 17, 24, 31, 38 (obtain consult if parasites remain or relapse occurs).
Administer only by appropriately trained personnel. Be fully familiar with this drug's toxicity before use. Monitor renal and hepatic function, CBCs, and electrolytes (esp. K+, Mg++). Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Caution with antineoplastics (renal toxicity, bronchospasm, hypotension), corticosteroids and ACTH (monitor electrolytes, cardiac function), azole antifungals (resistance), leukocyte transfusions (acute pulmonary toxicity), other nephrotoxic agents. May potentiate skeletal muscle relaxants, digitalis (monitor K+). May increase flucytosine toxicity. Azoles may increase fungal resistance. May cause false elevations of serum phosphate with the PHOSm assay analyzer.
Infusion reactions, chills, bronchospasm, hypotension, GI disturbances, electrolyte disturbances; cardiovascular, respiratory, and dermatological effects; renal dysfunction, edema, increased liver enzymes, anaphylaxis, others.