Amphotericin B conventional injectable

Therapeutic action

Antifungal.

Indications

• Cryptococcal meningitis induction phase, in combination with flucytosine or fluconazole.
• Severe histoplasmosis or penicilliosis.

Forms and strengths, route of administration

• Powder for injection, in 50 mg vial, dissolved in 10 ml water for injection to obtain a concentrated solution containing 5 mg/ml.
• The concentrated solution must be diluted in 500 ml of 5% glucose to obtain a solution containing 0.1 mg/ml, for slow IV infusion.

Dose

• Child and adult: 0.7 to 1 mg/kg once daily over 4 to 6 hours depending on tolerance.

Duration

• Cryptococcal meningitis: one week if in combination with flucytosine, or 2 weeks if in combination with fluconazole.
• Histoplasmosis: 1 to 2 weeks.
• Penicilliosis: 2 weeks.

Contra-indications, adverse effects, precautions

• Due to numerous and potentially severe adverse effects, patients should be kept under close surveillance.
• Administer with caution to patients with renal impairment.
• May cause intolerance reactions during administration, local thrombophlebitis, allergic reactions, muscle or joint pain, cardiovascular disorders, neurologic disorders, haematological or hepatic disorders, and renal-function disturbances including hypokalaemia and hypomagnesiemia.
• Avoid combination with drugs causing hypokalaemia, nephrotoxic drugs, digoxin, and zidovudine.
• To prevent renal toxicity, administer 500 ml to 1 litre of 0.9% sodium chloride or Ringer lactate prior to each infusion.
• Monitor serum creatinine and, if possible, serum potassium throughout treatment.
• If renal function deteriorates, increase preventive hydration or stop treatment, then resume at the lowest effective dose or on alternate days after improvement.
• Pregnancy: check for renal dysfunction in the neonate if administered during the last month of pregnancy.
• Breast-feeding: avoid, except if vital.
• Only use 5% glucose for administration and do not add other drugs in the infusion bottle or bag.