Active substance: Azathioprine.
Excipients/Inactive Ingredients: Lactose, Maize Starch, Povidone, Microcrystalline Cellulose, Pregelatinised Starch, Colloidal Silicon Dioxide, Magnesium Stearate, Talc, Hypromellose, Macrogol 400, Titanium Dioxide, Quinoline Yellow E104.
Azathioprine, the active ingredient of Imuprin, belongs to the group of medicines known as immunosuppressants. It is used to reduce the body's natural immunity in transplant recipients. It is also used for the treatment of autoimmune conditions, usually when corticosteroid therapy alone provides inadequate control. It may also be used for the treatment of rheumatoid arthritis as well as in other conditions.
Imuprin, in combination with corticosteroids and/or other immunosuppressive agents is indicated to enhance the survival of organ transplants (kidney, heart, liver) and to reduce the corticosteroid requirements of renal transplant recipients.
Imuprin, either alone or more usually in combination with corticosteroids, is used for the treatment of the following conditions: Severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis and polymyositis, auto-immune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, auto-immune haemolytic anaemia, chronic refractory idiopathic thrombocytopenic purpura.
Transplantation - adults and children: Depending on the immunosuppressive regimen employed, a dosage of up to 5mg/kg body weight/day may be given on the first day of therapy.
Maintenance dosage should range from 1 to 4mg/kg body weight/day and must be adjusted according to clinical requirements and haematological tolerance. Imuprin therapy should be maintained indefinitely, even if only low doses are necessary because of the risk of graft rejection.
Dosage in other conditions - adults and children: In general, starting dosage is from 1 to 3mg/kg body weight/day, and should be adjusted, within these limits, depending on the clinical response and haematological tolerance.
The maintenance dosage required may range from less than 1mg/kg body weight/day to 3mg/kg body weight/day, depending on the clinical condition being treated and the individual patient response.
In patients with renal and/or hepatic insufficiency, dosages should be given at the lower end of the normal range.
Elderly: Dosage should be at the low end of the range.
If the patient forgot to take Imuprin: If the patient forgot to take a dose, take the missed dose as soon as possible. However, if it almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for a missed one. Consult the doctor in case the patient missed more than one dose.
If the patient received a larger dose of Imuprin than that recommended: In case the patient received accidentally a dose larger than the one recommended, contact the doctor immediately.
Symptoms of a single acute overdose: nausea, vomiting and diarrhoea, mild leucopenia and mild abnormalities in liver function.
Symptoms of chronic overdose: unexplained infection, ulceration of the throat, bruising, bleeding.
Treatment: There is no specific antidote. Gastric lavage. Subsequent monitoring, including haematological monitoring.
Hypersensitivity to azathioprine, to mercaptopurine or any of the excipients of the product, pregnancy, lactation.
Patients receiving azathioprine are prone to infections. Constant checking of blood counts is essential to monitor and adjust dosage for any bone-marrow toxicity.
Patients should be warned to report immediately any signs or symptoms of bone marrow suppression e.g. inexplicable bruising or bleeding, infection.
Patients with increased risk of skin cancer should avoid exposure to sunlight.
Administration of azathioprine to renal transplant recipients is accompanied by increased fertility.
This product contains lactose, so if the patient has been told by the doctor that he/she has an intolerance to some sugars, contact the doctor before taking this medicinal product.
Be particularly careful with Imuprin.
Inform the doctor: if the patient is allergic to azathioprine or any of the excipients of the product; if the patient is pregnant or intend to get pregnant or if the patient is breast-feeding; if the patient suffers from renal or liver impairment; if the patient has infection; if the patient suffers from Lesch-Nyhan syndrome; if the patient has deficiency of the enzyme TPMT.
Effects on ability to drive or operate machinery: Imuprin is unlikely to affect the ability to drive or operate machinery.
Pregnancy: Imuprin should not be given to patients who are pregnant or likely to become pregnant without careful assessment of risk versus benefit.
Consult the doctor or pharmacist for advice before taking any medicine.
Lactation: Mercaptopurine has been identified in breast-milk in women receiving azathioprine treatment. Imuprin is not recommended during lactation.
Consult the doctor or pharmacist for advice before taking any medicine.
Like all medicines, Imuprin can have undesirable effects.
Infections: Viral, fungal and bacterial infections.
Neoplasms benign and malignant: Neoplasms including lymphomas, skin cancers, acute myeloid leukaemia and myelodysplasia.
Blood and lymphatic system: Depression of bone marrow function, leucopenia, thrombocytopenia, anaemia, agranulocytosis, pancytopenia, aplastic anaemia, megaloblastic anaemia, erythroid hypoplasia.
Respiratory: Reversible pneumonitis.
Gastrointestinal disorders: Pancreatitis, colitis, diverticulitis and bowel perforation, severe diarrhoea, nausea.
Hepatic disorders: Cholestasis, life-threatening hepatic damage.
Skin: Alopecia.
Immune system disorders: Hypersensitivity reactions (including malaise, dizziness, vomiting, diarrhoea, fever, rigors, myalgia, arthralgia, disturbed liver function, cholestatic jaundice, arrhythmias, rash, hypotension and interstitial nephritis).
If the patient notices any undesirable effects not mentioned in this monograph, inform the doctor or pharmacist.
A number of medicines interact with azathioprine and should not be used concomitantly. However, a few of them can be used concomitantly under special precautions. In this case, the doctor may want to change the dose, or other precautions may be necessary. When the patient is taking Imuprin, it is especially important that the doctor and pharmacist know if the patient is taking any of the following: Allopurinol, oxipurinol, thiopurinol, succinylcholine, tubocurarine, warfarin, cytostatics, penicillamine, ACE inhibitors (captopril), cimetidine, indomethacin, vaccines, olsalazine, mesalazine, sulphasalazine, furosemide.
The immunosuppressive activity of Imuprin could result in an atypical and potentially deleterious response to live vaccines and so administration of live-vaccines to patients receiving Imuprin therapy is contra-indicated.
Product expiry date: In case the expiry date has lapsed, do not use.
Keep below 25°C, in a safe place, away from light and moisture.
L04AX01 - azathioprine ; Belongs to the class of other immunosuppressants.
Imuprin FC tab 50 mg
10 × 10's
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