DOSAGE AND ADMINISTRATION
Am B isome should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes.
An in-line membrane filter may be used for the intravenous infusion of Am B isome; provided THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN 1 MICRON. NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of AmBisome. If this is not feasible, AmBisome must be administered through a separate line.
Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased.
The recommended initial dose of Am B isome for each indication for adult and pediatric patients is as follows:
| Indication |
Dose (mg/kg/day) |
|
Empirical therapy
|
3
|
|
Systemic fungal infections:
|
3-5
|
|
Aspergillus |
|
|
Candida |
|
|
Cryptococcus |
|
Cryptococcal meningitis
in HIV infected patients
(see DESCRIPTION OF CLINICAL STUDIES) |
6
|
|
Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events.
Doses recommended for visceral leishmaniasis are presented below:
| Visceral Leishmaniasis |
Dose (mg/kg/day) |
|
Immunocompetent patients
|
3 (days 1-5) and
3 on days 14, 21
|
|
Immunocompromised patients
|
4 (days 1-5) and 4
on days 10, 17, 24, 31, 38
|
|
For immunocompetent patients who do not achieve parasitic clearance with the recommended dose, a repeat course of therapy may be useful. For immunocompromised patients who do not clear parasites or who experience relapses, expert advice regarding further treatment is recommended. For additional information see DESCRIPTION OF CLINICAL STUDIES. Directions for Reconstitution, Filtration and Dilution Read This Entire Section Carefully Before Beginning Reconstitution
Am B isome must be reconstituted using Sterile Water for Injection, USP (without a bacteriostatic agent). Vials of Am B isome containing 50 mg of amphotericin B are prepared as follows: Reconstitution
-
Aseptically add 12 mL of Sterile Water for Injection, USP to each Am B isome vial to yield a preparation containing 4 mg amphotericin B/mL.
CAUTION: DO NOT RECONSTITUTE WITH SALINE OR ADD SALINE TO THE RECONSTITUTED CONCENTRATION, OR MIX WITH OTHER DRUGS. The use of any solution other than those recommended, or the presence of a bacteriostatic agent in the solution, may cause precipitation of Am B isome. - Immediately after the addition of water, SHAKE THE VIAL VIGOROUSLY for 30 seconds to completely disperse the Am B isome. Am B isome forms a yellow, translucent suspension. Visually inspect the vial for particulate matter and continue shaking until completely dispersed.
Filtration and Dilution -
Calculate the amount of reconstituted (4 mg/mL) Am B isome to be further diluted.
-
Withdraw this amount of reconstituted Am B isome into a sterile syringe.
-
Attach a 5-micron filter, provided, to the syringe. Inject the syringe contents through the filter, into the appropriate amount of 5% Dextrose Injection. (Use only one filter per vial of Am B isome.)
-
Am B isome must be diluted with 5% Dextrose Injection to a final concentration of 1 to 2 mg/mL prior to administration. Lower concentrations (0.2 to 0.5 mg/mL) may be appropriate for infants and small children to provide sufficient volume for infusion. DISCARD PARTIALLY USED VIALS.
STORAGE OF AMBISOME
Unopened vials of lyophilized materials are to be stored at temperatures up to 25° C (77° F).
Storage of Reconstituted Product Concentrate
The reconstituted product concentrate may be stored for up to 24 hours at 2°-8° C (36°-46° F) following reconstitution with Sterile Water for Injection, USP. Do not freeze. Storage of Diluted Product
Injection of Am B isome should commence within 6 hours of dilution with 5% Dextrose Injection.
As with all parenteral drug products, the reconstituted Am B isome should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use material if there is any evidence of precipitation or foreign matter. Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in Am B isome or in the materials specified for reconstitution and dilution.
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