Adult Dosing

Empirical treatment for presumed fungal infection

• 3 mg/kg/day IV infusion over a period of 1-2 hrs

Cryptococcal meningitis in HIV infected patients

• 6 mg/kg/day IV infusion over a period of 1-2 hrs

Systemic fungal infections

• 3-5 mg/kg/day IV infusion over a period of 1-2 hrs

Visceral leishmaniasis

• Immunocompetent patients:
• 3 mg/kg/day IV infusion over a period of 1-2 hrs on days 1-5 and on days 14, 21
• May repeat the course if parasitic clearance is not achieved

• Immunocompromised patients:
• 4 mg/kg/day IV infusion over a period of 1-2 hrs on days 1-5 and days 10, 17, 24, 31, 38
• For patients who do not achieve parasitic clearance or who experience relapses, expert advice regarding further treatment is recommended

• Reconstitute with Sterile Water for Injection; do not mix with saline or other drugs
• If an in-line membrane filter is used, its mean pore diameter should not be <1 micron
• Individualize dosing and rate of infusion to ensure maximum efficacy and minimum toxicity
• Flush an existing IV line with 5% dextrose prior to infusion of amphotericin B. if this is not feasible, administer amphotericin B through a separate line

Pediatric Dosing

• Safety and effectiveness in pediatric patients <1 month have not been established

Empirical treatment for presumed fungal infection

>1 month

• 3 mg/kg/day IV infusion over a period of 1-2 hrs

Cryptococcal meningitis in HIV infected patients

>1 month

• 6 mg/kg/day IV infusion over a period of 1-2 hrs

Systemic fungal infections

>1 month

• 3-5 mg/kg/day IV infusion over a period of 1-2 hrs

Visceral leishmaniasis

>1 month

• Immunocompetent patients:
• 3 mg/kg/day IV infusion over a period of 1-2 hrs on days 1-5 and days 14, 21
• May repeat the course if parasitic clearance is not achieved

• Immunocompromised patients:
• 4 mg/kg/day IV infusion over a period of 1-2 hrs on days 1-5 and days 10, 17, 24, 31, 38
• For patients who do not achieve parasitic clearance or who experience relapses, expert advice regarding further treatment is recommended

• Reconstitute with Sterile Water for Injection; do not mix with saline or other drugs
• If an in-line membrane filter is used, its mean pore diameter should not be <1 micron
• Individualize dosing and rate of infusion to ensure maximum efficacy and minimum toxicity
• Flush an existing IV line with 5% dextrose prior to infusion of amphotericin B. If this not feasible, administer amphotericin B through a separate line

[Outline]

• Adult Dosing
• Pediatric Dosing

• Empirical treatment for presumed fungal infection in febrile, neutropenic patients
• Treatment of cryptococcal meningitis in HIV infected patients
• Treatment of infections caused by Aspergillus, Candida and/or Cryptococcus species, unresponsive to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate
• Treatment of visceral leishmaniasis

• Hypersensitivity to amphotericin B deoxycholate or any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Anaphylaxis has been reported in patients treated with amphotericin B and other amphotericin B containing drugs. If a severe anaphylactic reaction occurs, discontinue therapy immediately and do not re-administer
• Amphotericin B liposomal infusion should be administered by trained health care providers (HCPs); observe the patients closely during the initial dosing period
• Monitor renal, hepatic and hematopoietic function, and serum electrolytes during treatment

Cautions: Use cautiously in

• Renal impairment
• Elderly patients

Pregnancy Category:B

Breastfeeding: No information is available regarding excretion of amphotericin B in breast milk. Amphotericin B is highly protein bound, has a large molecular weight, and is not absorbed orally; therefore, it is considered acceptable to use in nursing mothers by most reviewers. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 01 July 2011). As per manufacturer's data, because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• CV: Chest pain, hypertension, orthostatic hypotension, ventricular arrhythmias, cardiac arrest, asystole, tachycardia
• CNS: Headache, seizures, insomnia, anxiety, confusion
• GI: Abdominal pain, diarrhea, hemorrhagic gastroenteritis, nausea, vomiting, hepatocellular damage, hepatic impairment
• GU: Abnormal renal function, acute kidney failure, hematuria
• HEMA: Agranulocytosis, thrombocytopenia
• LABTEST: Elevated liver enzymes, bilirubinemia, elevated BUN and creatinine
• METABOLIC: Hypokalemia, hyperglycemia, hypervolemia, hypocalcemia, hypomagnesemia
• DERM: Pruritus, rash, sweating
• EENT: Epistaxis, rhinitis
• RESP: Increased cough, dyspnea, hypoxia, lung disorder, pleural effusion, respiratory failure
• MUSC: Back pain
• HYPERSENSITIVITY: Allergic reactions, anaphylaxis
• MISC: Asthenia, edema, blood product transfusion reaction, fever, chills, infection, pain, sepsis, multiple organ failure

• Antifungal antibiotic; binds to the sterol component of the fungal cell membrane causing alterations in cell permeability and cell death
• Metabolism: Unknown
• Excretion: Unknown
• Half-life
• 24 hrs after dosing: 7-10 hrs
• 49 days after dosing: 100-153 hrs

US Trade Name(s)

• AmBisome

US Availability

AmBisome

• PWDR for INJ: 50 mg/vial

Canadian Trade Name(s)

• AmBisome

Canadian Availability

AmBisome

• PWDR for INJ: 50 mg/vial (20, 30 mL vials)

UK Trade Name(s)

• AmBisome

UK Availability

AmBisome

• PWDR for INJ: 50 mg/vial

Australian Trade Name(s)

• AmBisome

Australian Availability

AmBisome

• PWDR for INJ: 50 mg/vial

[Outline]

Antimicrobials

Antifungals (Systemic)

Polyenes

Infectious Disease

Antifungals (Systemic)

Polyenes