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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/kg |
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Volume of suspension (4 mg/ml) to be withdrawn |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).