Zuellig Pharma
Concise Prescribing Info
Monotherapy or in combination w/ corticosteroids & procedures as immunosuppressant antimetabolite. In combination w/ corticosteroids &/or other immunosuppressive agents & procedures to enhance survival of organ transplants. Monotherapy or in combination w/ corticosteroids &/or other drugs & procedures in patients w/ severe RA, SLE, dermatomyositis & polymyositis, autoimmune haemolytic anaemia & chronic active hepatitis, chronic refractory ITP, pemphigus vulgaris, polyarteritis nodosa.
Dosage/Direction for Use
Organ transplants Loading dose: 5 mg/kg daily. Maintenance: 1-4 mg/kg daily. Other indications Initially, 1-3 mg/kg daily. Maintenance: <1-3 mg/kg daily, depending on patient's individual response.
Should be taken on an empty stomach: Take at least 1 hr before or 3 hr after meals/milk.
Hypersensitivity to azathioprine or 6-mercaptopurine (6-MP).
Special Precautions
Discontinue use if jaundice occurs. Not recommended in patients w/ hypersensitivity to 6-MP. Increased risk of developing lymphoproliferative disorders & other malignancies, skin cancers (eg, melanoma & non-melanoma), sarcomas (eg, Kaposi's & non-Kaposi's) & uterine cervical cancer in situ; EBV-associated lymphoproliferative disorders; macrophage activation syndrome. Patients w/ inherited deficiency of enzyme thiopurine methyltransferase (TPMT), mutated NUDT15 gene; hypoxanthine-guanine-phosphoribosyltransferase deficiency (Lesch-Nyhan syndrome); mutagenicity. Bone marrow depression; varicella zoster virus, hepatitis B; progressive multifocal leukoencephalopathy. Avoid use in patients developing chickenpox or herpes zoster. Perform CBC including platelets wkly during 1st 8 wk of therapy. Routinely monitor LFTs during treatment. Limit sun or UV exposure. Not to be co-administered w/ ribavirin. Not recommended w/ live organism vaccine at least 3 mth after treatment. Concomitant use w/ neuromuscular-acting agents eg, tubocurarine or succinylcholine; xanthine oxidase inhibitors eg, allopurinol, oxipurinol &/or thiopurinol; olsalazine, mesalazine or sulphasalazine. Renal &/or hepatic impairment. Not to be used during pregnancy & lactation. Overwt childn. Elderly.
Adverse Reactions
Viral, fungal & bacterial infections; leukopenia. Thrombocytopenia; nausea.
Drug Interactions
Diminished response to killed vaccine w/ corticosteroids. Severe myelosuppression w/ ribavirin. Serious haematological abnormalities w/ cytostatic or myelosuppressive agents, ACE inhibitors. Enhanced myelosuppressive effects w/ cimetidine & indomethacin. Inihibited xanthine oxidase activity by allopurinol, oxipurinol & thiopurinol. Decreased metabolism by other xanthine oxidase inhibitors eg, febuxostat. Inihibited TPMT enzyme w/ aminosalicylate derivatives eg, olsalazine, mesalazine or sulphasalazine. Increased 6-MP AUC w/ MTX. Transient increased 6-TGN levels & decreased mean leukocyte count w/ infliximab. Antagonized effect of non-depolarising muscle relaxants eg, curare, d-tubocurarine, pancuronium. Potentiated neuromuscular blockade of succinylcholine. Inhibited anticoagulant effect of warfarin & acenocoumarol.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AX01 - azathioprine ; Belongs to the class of other immunosuppressants.
Imuran FC tab 50 mg
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