Cryptococcal meningitis, when conventional amphotericin B is contra-indicated (severe pre- existingrenal 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-vialin 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Volume of suspension (4 mg/ml) to be withdrawn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).
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 bettertolerated and less nephrotoxic than conventional amphotericin B.
Do not add other drugs in the infusion bottle or bag; donot 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).