Imuran

Imuran

azathioprine

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Azathioprine
Indications/Uses
Organ transplantation, chronic active hepatitis, severe RA, SLE, dermatomyositis, pemphigus vulgaris, polyarteritis nodosa, acquired hemolytic anemia, ITP. Conditions other than transplantation: Refractory to corticosteroids alone, or controlled by corticosteroids in dosages producing or likely to produce severe side effects & the primary aim is to reduce the steroids requirement, or corticosteroids are contraindicated.
Dosage/Direction for Use
Adult & childn Prevention of transplant rejection & minimize toxicity Initial dose: 3-5 mg/kg daily, beginning at the time of transplant. Usually given as a single daily dose on the day of, & in minority of cases to 3 days before transplantation. Patients unable to tolerate oral medications, initiated w/ IV administration of the Na salt, w/ the subsequent use of FC tab (at the same dose level) after post-op period. Maintenance dose: 1-3 mg/kg daily. Treatment of most conditions Usual dose: 2-2.5 mg/kg/day orally. Chronic active hepatitis 1-1.5 mg/kg/day orally.
Administration
May be taken with or without food: Preferably taken w/ or after meals to reduce GI discomfort.
Contraindications
Hypersensitivity to azathioprine & 6-mercaptopurine (6-MP).
Special Precautions
Discontinue use if jaundice becomes apparent; if macrophage activation syndrome occurs or suspected. Not recommended in patients w/ hypersensitivity to 6-MP. Do not receive immunizations w/ live organism vaccine until at least 3 mth after end of treatment. Monitor haematological response; CBC including platelets during 1st 8 wk of therapy & repeat mthly or at intervals of ≤3 mth if high dosage is used or if severe renal &/or hepatic impairment are present; hepatotoxic & LFTs during treatment. Interrupt treatment immediately at 1st signs of an abnormal fall in blood counts. W/drawal of an effective dose in SLE w/ nephritis may result in a serious relapse w/ long-term use. Gradually w/draw treatment. Bone marrow depression; severe secondary infections; chromosomal abnormalities; hepatosplenic T-cell lymphoma; hepatitis B. Patients w/ inherited deficiency of the enzyme thiopurine methyltransferase (TPMT). Co-administration of ribavirin; drugs known to inhibit TPMT eg, olsalazine, mesalazine or sulphasalazine; cytostatic drugs or drugs w/ myelosuppression effect; xanthine oxidase inhibitors eg, allopurinol, oxipurinol &/or thiopurinol; neuromuscular-acting agents eg, tubocurarine or succinylcholine. Temporary impairment of immune function following exposure in utero w/ prednisone. 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; over-immunosuppression. Limit exposure to sunlight & UV light, wear protective clothing & use a sunscreen w/ a high protection factor for patients w/ increased risk for skin cancer. History of varicella zoster virus infection; avoid use in patients developing chickenpox or herpes zoster. W/hold therapy at 1st sign or symptoms suggestive of progressive multifocal leukoencephalopathy. Renal &/or hepatic impairment. Not to be given to patients who are pregnant or likely to become pregnant. Not recommended to breastfeed. Overwt childn. Elderly.
Adverse Reactions
Viral, fungal & bacterial infections in transplant patients (in combination w/ other immunosuppressants); bone marrow failure, 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. Antagonized effects of non-depolarising muscle relaxants eg, curare, d-tubocurarine, pancuronium. Potentiated neuromuscular blockade of succinylcholine. Inihibited TPMT enzyme w/ aminosalicylate derivatives eg, olsalazine, mesalazine or sulphasalazine. Transient increased 6-TGN levels & decreased mean leukocyte count w/ infliximab. 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.
Presentation/Packing
Form
Imuran FC tab 50 mg
Packing/Price
100's
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