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Therapeutic action
- Antifungal
Indications
- Cryptococcal meningitis, when conventional amphotericin B is contra-indicated (severe pre-existing renal impairment or amphotericin B induced renal impairment)
- Mucocutaneous or visceral leishmaniasis
- Severe histoplasmosis
Forms and strengths, route of administration
- Powder for injection, in 50 mg vial, to be dissolved in 12 ml of water for injection, to obtain a concentrated suspension containing 4 mg/ml
- With a syringe, withdraw the required dose of concentrated suspension. Attach the filter provided with the vial to the syringe; inject the contents of the syringe, through the filter, into the volume of 5% glucose (50 ml, 250 ml, 500 ml) needed to obtain a solution containing between 0.2 to 2 mg/ml, for IV perfusion.
Dosage and duration
Cryptococcal meningitis, severe histoplasmosis
Child over 1 month and adult: 3 mg/kg once daily over 30 to 60 minutes for 2 weeks
| Weight | Liposomal amphotericin B, 50 mg-vial in 12 ml | G5% | ||
|---|---|---|---|---|
| Daily dose in mg | Nb of vials | Volume of suspension (4 mg/ml) to be withdrawn | Volume required for administration | |
| 4 kg | 12 | 1 | 3 ml | 50 ml |
| 5 kg | 15 | 4 ml | ||
| 6 kg | 18 | 4.5 ml | ||
| 7 kg | 21 | 5 ml | ||
| 8 kg | 24 | 6 ml | ||
| 9 kg | 27 | 7 ml | ||
| 10 kg | 30 | 7.5 ml | ||
| 15 kg | 45 | 11 ml | ||
| 20 kg | 60 | 2 | 15 ml | 250 ml |
| 25 kg | 75 | 19 ml | ||
| 30 kg | 90 | 23 ml | ||
| 35 kg | 105 | 3 | 26 ml | 500 ml |
| 40 kg | 120 | 30 ml | ||
| 45 kg | 135 | 34 ml | ||
| 50 kg | 150 | 38 ml | ||
| 55 kg | 165 | 4 | 41 ml | 500 ml |
| 60 kg | 180 | 45 ml | ||
| 65 kg | 195 | 50 ml | ||
| 70 kg | 210 | 5 | 53 ml | 500 ml |
Mucocutaneous or visceral leishmaniasis
Follow the recommended protocol, which varies from one region to another (exact dose, administration schedule, etc.). For information, the total dose in children over 1 month and adults is 15 to 30 mg/kg.
Contra-indications, adverse effects, precautions
- May cause:
- intolerance reactions during administration: fever, chills, headache, nausea, vomiting, hypotension; local reaction: pain and thrombophlebitis at injection site; allergic reactions;
- gastrointestinal disturbances, disturbances in renal function (raised creatinine or urea levels, renal impairment), hypokalaemia, hypomagnesiemia, elevated liver enzymes; rarely, haematological disorders (thrombocytopenia, anaemia).
- Avoid combination with: drugs causing hypokalaemia (furosemide, corticosteroids), nephrotoxic drugs (amikacin, ciclosporine, tenofovir); digoxin, zidovudine.
- The infusion may be administered over 2 hours if necessary to prevent or minimize adverse effects.
- Monitor serum creatinine levels, and if possible, serum potassium levels (once to twice weekly) throughout treatment; adapt adjunctive therapy (potassium and magnesium supplementation) according to the results.
- If renal function deteriorates, reduce the dose by half for a few days.
- Pregnancy: check for renal dysfunction in the neonate if administered during the last month of pregnancy.
- Breast-feeding: avoid, except if vital
Remarks
- Liposomal amphotericin B is better tolerated and less nephrotoxic than conventional amphotericin B.
- Do not add other drugs in the infusion bottle or bag; do not use the preparation if there is visible precipitation.
- Before each infusion, rinse the IV catheter with 5% glucose.
Storage
- Vial of powder: must be kept refrigerated (between 2 °C and 8 °C) or below 25 °C.
- Solutions (reconstituted and for infusion): be kept refrigerated 24 hours (between 2 °C and 8 °C).