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  • Puri-Nethol
    / Perrigo


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    25 X 50 mg

    full basket chart 1907 16292

    Related information


    Dosage

    Adults and children: For adults and children the usual dose is 2.5 mg/kg bodyweight per day, or 50 to 75 mg/m² body surface area per day, but the dose and duration of administration depend on the nature and dosage of other
    cytotoxic agents given in conjunction with 6-mercaptopurine.
    The dosage should be carefully adjusted to suit the individual patient.
    6-mercaptopurine has been used in various combination therapy schedules for acute leukaemia and the literature should be consulted for details.
    Studies carried out in children with acute lymphoblastic leukemia suggested that administration of 6-mercaptopurine in the evening lowered the risk of relapse compared with morning administration.
    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.
    Elderly: It is advisable to monitor renal and hepatic function in these patients, and if there is any impairment, consideration should be given to reducing the 6-mercaptopurine dosage.
    Renal impairment: Consideration should be given to reducing the dosage in patients with impaired renal function.
    Hepatic impairment: Consideration should be given to reducing the dosage in patients with impaired hepatic function.
    Medicinal product interaction: When xanthine oxidase inhibitors, such as allopurinol, and 6-mercaptopurine are administered concomitantly it is essential that only 25 % of the usual dose of 6-mercaptopurine is given since
    allopurinol decreases the rate of catabolism of 6-mercaptopurine.
    TPMT-deficient patients: Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe 6-mercaptopurine toxicity from conventional doses of 6-mercaptopurine 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 6-mercaptopurine doses, but some may require dose reduction. Genotypic and phenotypic tests of TPMT are available.


    Indications

    6-Mercaptopurine is indicated for the treatment of acute leukaemia and also in cases of chronic myelogenous leukemia.


    Contra-Indications

    Hypersensitivity to any component of the preparation.


    Special Precautions

    Renal or hepatic impairment. Monitor liver function and bloods. Mutagenicity and carcinogenicity. Pregnancy. Lactose.


    Side Effects

    Very common: Bone marrow suppression; leucopenia and thrombocytopenia.
    Common: Nausea; vomiting; pancreatitis in the IBD population (an unlicensed indication), Biliary stasis; hepatotoxicity.
    See prescribing information for full details.


    Drug interactions

    Vaccinations with live organism vaccines are not recommended in immunocompromised individuals.
    Effect of concomitant medicinal products on 6-mercaptopurine: 
    Ribavirin, Myelosuppressive agents, Allopurinol/ oxipurinol/ thiopurinol,
    Aminosalicylates, Methotrexate.
    Effect of 6-mercaptopurine on other medicinal products: Anticoagulants.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Substantial transplacental and transamniotic transmission of 6-mercaptopurine and its metabolites from the mother to the foetus have been shown to occur.
    6-mercaptopurine is potentially teratogenic. The use of 6-mercaptopurine should be avoided whenever possible during pregnancy, particularly during the first trimester. In any individual case the potential hazard to the foetus must be balanced against the expected benefit to the mother.
    As with all cytotoxic chemotherapy, adequate contraceptive precautions should be advised if either partner is receiving 6-mercaptopurine tablets.
    Studies of 6-mercaptopurine in animals have shown reproductive toxicity. The potential risk for humans is largely unknown.
    Breast-feeding: 6-mercaptopurine has been detected in the breast milk of renal transplant patients receiving immunosuppressive therapy with a pro-drug of 6-mercaptopurine. It is recommended that 6- mercaptopurine should not be used during breast-feed.
    See prescribing information for full details.


    Overdose

    Symptoms and signs: Gastrointestinal effects, including nausea, vomiting and diarrhoea and anorexia may be early symptoms of overdosage having occurred. The principal toxic effect is on the bone marrow, resulting in myelosuppression. Haematological toxicity is likely to be more profound with chronic overdosage than with a single ingestion of 6-mercaptopurine. Liver dysfunction and gastroenteritis may also occur.
    The risk of overdosage is also increased when allopurinol is being given concomitantly with 6-mercaptopurine.
    Treatment: As there is no known antidote, the blood counts should be closely monitored and general supportive measures, together with appropriate blood transfusion, instituted if necessary. Active measures (such as the use of activated charcoal) may not be effective in the event of 6-mercaptopurine overdose unless the procedure can be undertaken within 60 min of ingestion.
    Further management should be as clinically indicated or as recommended by the national poisons centre, where available.


    Manufacturer
    Excella GmbH, Germany
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