How to Compound a 500 mg Dose of AmBisome
To compound a 500 mg dose of AmBisome, reconstitute 10 vials (each containing 50 mg) with 12 mL of sterile water for injection per vial to achieve 4 mg/mL, then filter and dilute the total 125 mL of reconstituted solution in 5% dextrose to a final concentration of 1-2 mg/mL for infusion. 1
Step-by-Step Compounding Instructions
Reconstitution Phase
Gather materials: You need 10 vials of AmBisome (50 mg each), sterile water for injection USP (without bacteriostatic agent), and the 5-micron filters provided with the vials 1
Add sterile water: Aseptically add exactly 12 mL of sterile water for injection to each of the 10 vials. This yields 4 mg amphotericin B per mL in each vial 1
Shake vigorously: Immediately after adding water, shake each vial vigorously for 30 seconds to completely disperse the AmBisome. The solution should appear yellow and translucent. Continue shaking until no particulate matter is visible 1
Filtration and Dilution Phase
Calculate volume needed: For 500 mg at 4 mg/mL concentration, you need 125 mL total of reconstituted solution (all 10 vials) 1
Filter the solution: Withdraw the reconstituted AmBisome from each vial into a sterile syringe, attach the provided 5-micron filter to the syringe, and inject through the filter into your final container. Use only one filter per vial 1
Final dilution: Dilute the filtered 125 mL of reconstituted AmBisome with 5% dextrose injection to achieve a final concentration of 1-2 mg/mL. For a 500 mg dose at 1 mg/mL, add enough 5% dextrose to reach 500 mL total volume; for 2 mg/mL, add to 250 mL total volume 1
Critical Warnings and Pitfalls
Never use saline: Do not reconstitute with saline or add saline to the reconstituted solution, as this will cause precipitation 1
No bacteriostatic agents: Only use sterile water for injection without bacteriostatic agents, as these will cause precipitation 1
Filter pore size matters: If using an in-line filter during infusion, ensure the mean pore diameter is not less than 1.0 micron 1
Flush IV lines: Any existing IV line must be flushed with 5% dextrose injection before infusing AmBisome, or use a separate dedicated line 1
Discard partial vials: Do not save or reuse partially used vials 1
Lower concentrations for pediatrics: For infants and small children, concentrations of 0.2-0.5 mg/mL may be more appropriate to provide sufficient infusion volume 1
Administration Parameters
Infuse over approximately 120 minutes using a controlled infusion device. Infusion time may be reduced to 60 minutes in patients tolerating treatment well, or increased if the patient experiences discomfort 1