Question

Give an example of a Liposomal Amphotericin preparation.

Answer 1

EXAMPLE FOR LIPOSOMAL AMPHOTERICIN B

Name of the preparation

AmBisome Liposomal 50 milligram powder for dispersion for intravenous infusion.

Composition

One vial contains 50 mg of amphotericin (50,000 units) encapsulated in liposomes.

The concentrate will contain 4 mg/mL of amphotericin B following reconstitution.

Pharmaceutical form

Sterile powder for dispersion for intravenous infusion.  

Therapeutic indications

AmBisome is used in adults and children aged 1 month to 18 years for treatment of :

• Severe systemic and/or deep mycoses
• Visceral leishmaniasis in immunocompetent patients.
• Presumed fungal infections in febrile neutropenic patients .

Infections successfully treated with AmBisome include: disseminated candidiasis, aspergillosis, mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral leishmaniasis.

Posology

Test dose

A small amount of an AmBisome infusion (e.g. 1 mg) is given for ten minutes, following which the patient is monitored for the next thirty minutes.

If there have been no severe allergic or anaphylactic reactions, the infusion of AmBisome dose can be continued.

AmBisome should be administered by IV infusion over 30 - 60 minutes.

For doses greater than 5mg/kg/day, IV infusion over two hours is recommended .

The recommended concentration for IV infusion is 0.20 mg/ml to 2.00 mg/ml amphotericin B as AmBisome.