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  • Imuran 25 mg, 50 mg
    / Perrigo


    Active Ingredient
    Azathioprine 25 mg, 50 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    100 X 25 mg

    full basket chart 7860 9157

    Film Coated Tablets

    100 X 50 mg

    full basket chart 1020 9021

    Related information


    Dosage

    General: When the oral route is impractical azathioprine injection may be administered by the i.v. route only, however, this route should be discontinued as soon as oral therapy can be tolerated once more. Imuran tablets should be administered at least 1 hour before or 3 hours after food or milk.
    Dosage in transplantation – adults: Depending on the immunosuppressive regimen employed, a dosage of up to 5mg/kg bodyweight/day may be given on the first day of therapy, either orally or intravenously. Maintenance dosage should range from 1-4mg/kg bodyweight/day and must be adjusted according to clinical requirements and haematological tolerance. Corticosteroid therapy is usually given concomitantly with Imuran. Evidence indicates that Imuran therapy should be maintained indefinitely, even if only low doses are necessary, because of the risk of graft rejection.
    Dosage in other conditions – adults: In general, starting dosage is from 1- mg/kg bodyweight/day, and should be adjusted, within these limits, depending on the clinical response (which may not be evident for weeks or months) and
    haematological tolerance. In general, starting dosage rarely exceeds 3mg/kg bodyweight/day, and should be reduced, depending on the clinical response (which may not be evident for weeks or months) and haematological tolerance.
    When therapeutic response is evident, consideration should be given to reducing the maintenance dosage to the lowest level compatible with the maintenance of that response. If no improvement occurs in the patient’s condition within 3 months, consideration should be given to withdrawing Imuran. The maintenance dosage required may range from less than l mg/kg bodyweight/day to 3 mg/kg bodyweight/day, depending on the clinical condition being treated and the individual patient response, including haematological tolerance.
    Paediatric population
    Transplants: See Dosage in transplantation – adults.
    Overweight children: Children considered to be overweight may require doses at the higher end of the dose range and therefore close monitoring of response to treatment is recommended.
    Use in the elderly: The rapid in vivo cleavage of the azathioprine molecule followed by tissue fixation makes it impossible to relate plasma drug levels to toxicity. There are no specific data as to the tolerance of Imuran in elderly patients. There is limited experience of the administration of Imuran to elderly patients. Although the available data do not provide evidence that the incidence of side effects among elderly patients is higher than that among other patients treated with Imuran, it is advisable to monitor renal and hepatic function, and to consider dosage reduction if there is impairment.
    The dosage is adjusted on the basis of the clinical state and the response of the individual patient. If no improvement has occurred after 3 months, consideration should be given to discontinuing the drug.
    Renal and/or hepatic impairment: In patients with renal and/or hepatic insufficiency, consideration should be given to reducing the dosage.
    Drug interactions: When xanthine oxidase inhibitors, such as allopurinol, and azathioprine are administered concomitantly it is essential that only 25% of the usual dose of azathioprine is given since allopurinol decreases the rate of catabolism of azathioprine.
    TPMT-deficient patients: Patients with inherited little or no thiopurine S- ethyltransferase (TPMT) activity are at increased risk for severe azathioprine toxicity from conventional doses of azathioprine and generally require substantial dose reduction. The optimal starting dose for homozygous deficient patients has not been established.
    Most patients with heterozygous TPMT deficiency can tolerate recommended azathioprine doses, but some may require dose reduction. Genotypic and phenotypic tests of TPMT are available.


    Indications

    Renal, cardiac and hepatic transplants, rheumatoid arthritis.


    Contra-Indications

    Liver damage, history of hepatitis, pregnancy, except in special circumstances.


    Special Precautions

    During the first 8 weeks of therapy, complete blood counts, including platelets, should be performed weekly or more frequently if high dosage is used or if severe renal and/or hepatic disorder is present. Complete blood counts are repeated monthly, or at least at intervals of not longer than 3 months. Patients should be instructed to report immediately any evidence of infection, unexpected bruising or bleeding or other manifestations of bone marrow depression. Serious infections are a constant hazard for patients receiving chronic immunosuppression. Fungal, viral, bacterial and protozoal infections may be fatal and should be treated vigorously. Therapy may increase the patient’s risk of neoplasia. Transplant patients who receive multiple immunosuppressive agents may be at risk for over-immunosuppression. Therefore, immunosuppressive drug therapy should be maintained at the lowest effective levels. Renal and/or hepatic insufficiency: It is recommended that the dosages used should be at the lower end of the normal range and that hematological response should be carefully monitored. Regular complete blood counts and liver function tests should be undertaken. Limited evidence suggests that therapy is not beneficial to patients with Lesch-Nyhan syndrome. Pregnancy and lactation: Should not be given during pregnancy without careful assessment of risk versus benefit.
    See prescribing information for full details.


    Side Effects

    Hematopoiesis. Susceptibility to infection. Serious complications, including colitis, diverticulitis and bowel perforation, have been described in transplant recipients receiving immunosuppressive therapy. Pancreatitis. Cholestasis and deterioriation for liver function.
    See prescribing information for full details.


    Drug interactions

    Coumarin anticoagulants, uricosuric agents, methotrexate, spironolactone, antacids, acetazolamide, oral hypoglycemics, other salicylates and NSAID’s, corticosteroids, dipyridamole, streptokinase, mifepristone.


    Manufacturer
    Excella GmbH, Germany
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