AmBisome Dosage/Direction for Use

A test dose (1 mg) should be infused slowly for up to 10 min and the patient carefully observed for 30 min afterwards.
Adults and Children: AmBisome should be administered by IV infusion over a 30- to 60-min period. The recommended concentration for IV infusion is 0.2-2 mg/mL amphotericin (see Administration).
Dosage of amphotericin must be adjusted to the specific requirements of each patient.
AmBisome therapy has been administered for as long as 5 months with a cumulative dose of 30 g of amphotericin without significant toxicity.
Treatment of Systemic Mycotic Infections: Therapy is usually instituted at a daily dose of 1 mg/kg body weight and increased stepwise to 3 mg/kg, as required. A cumulative dose of 1-3 g of amphotericin over 3-4 weeks has been typical.
For fever of unknown origin in neutropenic patients, therapy should be initiated at 1 mg/kg/day; the dose may be raised to 3 mg/kg/day if indicated.
Visceral Leishmaniasis: A dose of 1-1.5 mg/kg/day for 21 days or alternatively, a dose of 3 mg/kg/day for 10 days. In immunocompromised patients (eg, HIV-positive), a dose of 1-1.5 mg/kg/day for 21 days may be used. Because of the risk of relapse, maintenance therapy or re-induction therapy may be necessary.
Pediatric Patients: Systemic fungal infections and fever of unknown origin have been successfully treated with AmBisome in pediatric patients, without reports of unusual adverse events. Pediatric patients have received AmBisome at doses comparable to those used in adults on a per kilogram body weight basis.
Elderly: No specific dosage recommendations or precautions.
Renal Impairment: AmBisome has been successfully administered to a large number of patients with preexisting renal impairment at starting doses ranging from 1-3 mg/kg/day in clinical trials and no adjustment in dose or frequency of administration was required.
Administration: Reconstitution: Add 12 mL of water for injection to each vial to yield a preparation containing 4 mg/mL of amphotericin. AmBisome must be reconstituted using water for injection (without bacteriostatic agent).
After the addition of water, immediately shake vials vigorously for 30 sec to completely disperse the AmBisome. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained.
Calculate the amount of reconstituted (4 mg/mL) AmBisome to be further diluted.
The infusion, providing from 2-0.2 mg amphotericin/mL, is obtained by dilution with 1-19 parts, respectively, by volume of 5% dextrose injection. Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe. Using the 5-micron filter provided, instill the AmBisome preparation into a sterile container with the correct amount of 5% dextrose injection.