Ambisomex

Ambisome

CLINICAL USE

Antifungal agent: Systemic fungal infections (yeasts and yeast-like fungi including Candida albicans) Treatment of visceral leishmaniasis

DOSE IN NORMAL RENAL FUNCTION

1–3 mg/kg/day, maximum 5 mg/kg (unlicensed dose) Visceral leishmaniasis: total dose of 21–30 mg/kg given over 10–21 days

PHARMACOKINETICS

Molecular weight : 924.1

%Protein binding : 90

%Excreted unchanged in urine : 2–5

Volume of distribution (L/kg) : 0.1–0.44

half-life – normal/ESRD (hrs) : 6.3–10.7/Unchanged

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 : Dose as in normal renal function

10 to 20 : Dose as in normal renal function

<10 : Dose as in normal renal function

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD : Not dialysed. Dose as in normal renal function

HD : Not dialysed. Dose as in normal renal function

HDF/high flux : Unknown dialysability. Dose as in normal renal function

CAV/VVHD : Not dialysed. Dose as in normal renal function

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs Ciclosporin: increased nephrotoxicity Tacrolimus: increased nephrotoxicity Increased risk of nephrotoxicity with aminoglycosides and other nephrotoxic agents and cytotoxics Cardiac glycosides: increased toxicity if hypokalaemia occurs Corticosteroids: increased risk of hypokalaemia (avoid concomitant use unless corticosteroids are required to control reactions) Flucytosine: enhanced toxicity in combination with amphotericin

ADMINISTRATION

Reconstition

See SPC. Prepare intermittent infusion in glucose 5% (incompatible with sodium chloride 0.9%, electrolytes or other drugs). Reconstitute vial contents with water for injection Dilute to a concentration of 0.2–2 mg/mL

Route

IV infusion

Rate of Administration

30–60 minutes

Comments

Paracetamol and parenteral pethidine may alleviate rigors associated with amphotericin administration. Antihistamines can also be administered to control reactions Flush existing IV line with glucose 5% before and after infusion administration For patients on CAV/VVHD, amphotericin should be given into the venous return of the dialysis circuit Should be given post dialysis

OTHER INFORMATION

*** AMPHOTERICIN IS HIGHLY NEPHROTOXIC *** Can cause distal tubular acidosis May cause polyurea, hypovolaemia, hypokalaemia and acidosis. Amphotericin and flucytosine act synergistically when co-administered enabling lower doses to be used effectively A test dose of amphotericin is recommended at the beginning of a new course (1 mg over 10 minutes then stop and observe for next 30 minutes) Monitor renal function, full blood count, potassium, magnesium and calcium levels Liposomal amphotericin is considerably less nephrotoxic compared with amphotericin, but is considerably more expensive

See how to identify renal failure stages according to GFR calculation

See how to diagnose irreversible renal disease

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