AMPHOTERICIN B liposomal injectable

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    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 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    (4 mg/ml) to be withdrawn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

     

    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).