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    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    10 x 20 ml

    partial basket chart 32789 9895

    Dosage

    This formulation is a sterile, pyrogen-free suspension which must be diluted for intravenous infusion only. The drug should be administered by intravenous infusion at 5 mg/kg at a rate of 2.5 mg/kg/hr. When commencing treatment with this formulation  for the first time it is recommended to administer a test dose immediately prior to the first infusion. The first infusion should be prepared according to the instructions then, over a period of approximately 15 minutes, 1mg of the infusion should be administered to the patient.
    After this amount has been administered the infusion should be stopped and the patient observed carefully for 30 minutes. If the patient shows no signs of hypersensitivity the infusion may be continued. As for use with all amphotericin B products, facilities for cardiopulmonary resuscitation should be readily at hand when administering this drug  for the first time, due to the possible occurrence of anaphylactoid reactions. For severe systemic infections treatment is generally recommended for at least 14 days. This formulation has been administered for as long as 28 months, and cumulative doses have been as high as 73.6 g without significant toxicity. An in-line filter may be used for intravenous infusion of the drug. The mean pore diameter of the filter should be no less than 15 microns.
    Use in diabetic patients: This formulation  may be administered to diabetic patients.
    Use in pediatric patients: Systemic fungal infections have been treated successfully in children ranging from 1 month to 16 years of age at doses comparable to the recommended adult dose on a bodyweight basis. Adverse events seen in paediatric patients are similar to those seen in adults.
    Use in elderly patients: Systemic fungal infections in elderly patients have been treated successfully with this drug at doses comparable to the recommended dose on a bodyweight basis.
    Use in neutropenic patients: This formulation has been used successfully to treat systemic fungal infections in patients who are severely neutropenic as a consequence of haematological malignancy or the use of cytotoxic or immunosuppressive drugs.
    Use in patients with renal or liver disease: Systemic fungal infections in patients with renal or liver disease have been treated successfully with this drug  at doses comparable to the recommended dose on a body weight basis.            


    Indications

    Treatment of severe invasive candidiasis. Indicated as second line therapy for the treatment of severe systemic fungal infections in patients who have not responded to conventional amphotericin B or other systemic antifungal agents, in those who have renal impairment or other contra-indications to conventional amphotericin B, or in patients who have developed amphotericin B nephrotoxicity. Second line treatment for invasive aspergillosis, cryptococcal meningitis and disseminated cryptococcosis in HIV patients, fusariosis, coccidiomycosis, zygomycosis and blastomycosis.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients , unless in the opinion of the physician the advantages of using this formulation outweigh the risks of hypersensitivity.


    Special Precautions

    In patients for whom sodium intake is of medical concern (e.g. patients with congestive heart failure, renal failure, nephrotic syndrome), the sodium content of this product should be taken into account.
    Infusion Hypersensitivity Reactions: Infusion related reactions (such as chills and pyrexia) recorded following the administration of the drug have generally been mild or moderate, and have mainly be recorded during the first 2 days of administration.  Premedication (e.g. paracetamol) may be administered for the prevention of infusion related adverse reactions.
    Systemic Fungal Infections: This formulation  should not be used for treating common or superficial, clinically inapparent fungal infections that are detectable only by positive skin or serologic tests.
    Patients with renal Disease: Since this drug is a potentially nephrotoxic drug, monitoring of renal function should be performed before initiating treatment in patients with pre-existing renal disease or who have already experienced renal failure, and at least once weekly during therapy. The formulation can be administered to patients during renal dialysis or haemofiltration. Serum potassium and magnesium levels should be monitored regularly.
    Patients with liver Disease: Patients with concurrent hepatic impairment due to infection, graft-versus-host disease, other liver disease or administration of hepatotoxic drugs have been successfully treated with this drug. In cases where serum bilirubin, alkaline phosphatase or serum transaminases increased, factors other than this formulation were present and possibly accounted for the abnormalities. These factors included infection, hyperalimentation, concomitant hepatotoxic drugs and graft-versus-host disease.
    See prescribing information for full details.


    Side Effects

    Renal impairment, rush, chills, abnormal liver function, pyrexia, increased blood creatinine.
    See prescribing information for full details.


    Drug interactions

    Nephrotoxic drugs: This drug is a potentially nephrotoxic drug, and particularly close monitoring of renal function is required in patients receiving nephrotoxic drugs concomitantly.
    Zidovudine: In dogs, exacerbated myelotoxicity and nephrotoxicity were observed when the drug was administered concomitantly with zidovudine. If concomitant treatment with zidovudine is required, renal and haematologic function should be closely monitored.
    Cyclosporin: Interaction data with amphotericin B containing products indicate that patients receiving amphotericin B concomitantly with high dose cyclosporine experience an increase in serum creatinine caused by simultaneous administration of these two compounds. However, the drug has been shown to be less nephrotoxic than conventional amphotericin B.
    Other drugs: The interaction of the drug with other drugs has not been studied to date. Conventional amphotericin B has been reported to interact with the following drugs, and caution should be exercised during concomitant use with the drug:  antineoplastic agents, corticosteroids and corticotrophin (ACTH), digitalis glycosides, flucytosine, and skeletal muscle relaxants.
    Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients receiving intravenous conventional amphotericin B and leukocyte transfusions. It is not recommended to administer the drug with leukocyte transfusions.


    Pregnancy and Lactation

    Pregnancy: Conventional amphotericin B has been used successfully to treat systemic fungal infections in pregnant women with no obvious effects on the foetus, but only a small number of cases have been reported.
    Lactation:It is unknown whether this drug passes into breast milk.
    See prescribing information for full details.


    Important notes

    Storage: Store at 2 – 8°C. Do not freeze. Keep vial in the outer carton.
    Compatibility: should not be mixed with other drugs or electrolytes.

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