Amphotericin B Liposome For Injection

Lipos amphotericin B

Adults & childn 1 mth to 18 yr w/ systemic mycotic infections due to susceptible organisms eg, cryptococcosis, North American blastomycosis, disseminated candidiasis, coccidioidomycosis, aspergillosis, histoplasmosis, mucormycosis & some cases of American mucocutaneous leishmaniasis; fever of unknown origin (FUO) in neutropenic patients; visceral leishmaniasis as primary therapy in immunocompetent or immunocompromised (eg, HIV +ve) patients.

IV infusion Infuse over 30-60 min period, 2 hr for doses >5 mg/kg daily. Recommended conc: 0.2-2 mg/mL. 1 mg test dose should be slowly infused for up to 10 min & observe patient for 30 min afterwards. Systemic mycotic infections 1 mg/kg daily, increased stepwise to 3 mg/kg, as required. Mucormycosis Initially 5 mg/kg daily. Treatment duration: Individualized. Longer duration for deep seated infections or in prolonged courses of chemotherapy or neutropenia. FUO in neutropenic patients Initially 1 mg/kg daily, may be increased to 3 mg/kg. Visceral leishmaniasis 1-1.5 mg/kg daily for 21 days. Alternatively, 3 mg/kg daily for 10 days. Immunocompromised patients eg, HIV +ve 1-1.5 mg/kg daily for 21 days. Paed patient 1 mth to 18 yr Calculate dosage on the same per kg body wt basis as for adults.

Hypersensitivity to amphotericin B, peanut or soya.

Discontinue treatment immediately if severe anaphylactic/anaphylactoid reaction occurs. Consider dose reduction, treatment interruption or discontinuation if clinically significant reduction in renal function or worsening of other parameter occurs. Avoid treatment in patients undergoing haemodialysis or filtration procedures. Administer test dose to detect idiosyncratic anaphylactic reactions & minimize dose administered if a reaction occurs; slower infusion rates (>2 hr) or routine doses of diphenhydramine, paracetamol, pethidine, &/or hydrocortisone to prevent or treat severe infusion-related reactions. Renal adverse reactions; higher incidence rates of increased serum creatinine, hypokalaemia & hypomagnesaemia. Acute pulmonary toxicity in patients receiving amphotericin B (as Na deoxycholate complex) during or shortly after leukocyte transfusion; separate infusions by as long period as possible & monitor pulmonary function. Perform regular lab evaluation of serum electrolytes particularly K & Mg, as well as renal, hepatic & haematopoietic function. Give K supplements during the course of therapy. Diabetic patients. Not to be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose isomaltase insufficiency. May impact ability to drive & use machines. Pregnancy & lactation. Infant <1 mth.

Hypokalaemia; nausea, vomiting; rigors, pyrexia. Hypomagnesaemia, hypocalcaemia, hyperglycaemia, hyponatraemia; headache; tachycardia; vasodilatation, flushing, hypotension; dyspnoea; diarrhoea, abdominal pain; abnormal LFTs, hyperbilirubinaemia, increased alkaline phosphatase; rash; back pain; increased creatinine & blood urea; chest pain.

May enhance potential for drug-induced renal toxicity w/ other nephrotoxic agents eg, ciclosporin, aminoglycosides & pentamidine. May potentiate hypokalaemia w/ corticosteroids, ACTH & diuretics (loop & thiazide). Induced hypokalaemia w/ digitalis; skeletal muscle relaxants eg, tubocurarine. May potentiate digitalis toxicity. May enhance curariform effect of skeletal muscle relaxants eg, tubocurarine. May increase toxicity of flucytosine. May enhance potential for renal toxicity, bronchospasm & hypotension w/ antineoplastic agents. Acute pulmonary toxicity w/ leukocyte transfusions.

Antifungals

J02AA01 - amphotericin B ; Belongs to the class of antibiotics. Used in the systemic treatment of mycotic infections.

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