AMPHOTERICIN B liposomal injectable

Prescription under medical supervision

Therapeutic action

– Antifungal

Indications

– Cryptococcal meningitis, when conventional amphotericin B is contra-indicated (severe pre-existing renal impairment or amphotericin B induced renal impairment)
– Cutaneomucous 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 mlG5%

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(4 mg/ml) to be withdrawn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

60 kg

180

45 ml

65 kg

195

50 ml

70 kg

210

5

53 ml

– Cutaneomucous 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); 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 newborn 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).