Product image of Imuran Mitis (Azathioprine) supplied by GNH India

Imuran Mitis

Active Ingredient:
Azathioprine
Origin:
EU

Imuran Mitis (Azathioprine)

Azathioprine, the active ingredient in Imuran Mitis, is an immunosuppressant presented as an oral formulation for oral use. It is used to suppress the immune response in conditions such as organ transplantation, rheumatoid arthritis, inflammatory bowel disease, and systemic lupus erythematosus.

GNH India supplies Imuran Mitis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aspen Pharma Trading Limited

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Indications & Clinical Uses

Azathioprine is employed in several immune‑mediated conditions to reduce abnormal immune activity.

  • Organ transplantation: helps prevent graft rejection by suppressing T‑cell activation.
  • Rheumatoid arthritis: reduces joint inflammation and slows disease progression.
  • Inflammatory bowel disease (Crohn's disease, ulcerative colitis): diminishes intestinal inflammation and maintains remission.
  • Systemic lupus erythematosus: controls systemic autoimmune activity and reduces flare severity.

How It Works

  • Azathioprine is a prodrug that is converted intracellularly to 6‑mercaptopurine, which interferes with de novo purine synthesis. By inhibiting the formation of adenine and guanine nucleotides, it limits DNA and RNA production in rapidly dividing cells, particularly T and B lymphocytes. This suppression of lymphocyte proliferation leads to reduced immune responses and provides immunosuppression in transplant and autoimmune settings.

Side Effects

Azathioprine may cause a range of adverse reactions, varying from mild to potentially life‑threatening.

Common Side Effects

  • Nausea or vomiting: gastrointestinal discomfort that may occur early in therapy.
  • Loss of appetite: reduced desire to eat, sometimes with weight loss.
  • Fatigue or weakness: general feeling of tiredness.
  • Mild liver enzyme elevation: transient increase in ALT/AST.

Serious or Rare Side Effects

  • Severe bone marrow suppression: pancytopenia or aplastic anemia.
  • Hepatotoxicity: significant liver injury or hepatitis.
  • Increased risk of infections: opportunistic or severe bacterial infections.
  • Possible malignancies: rare development of lymphomas or skin cancers.

Precautions & Warnings

Before initiating azathioprine therapy, several precautions should be observed to ensure patient safety.

  • Baseline laboratory testing: obtain complete blood count and liver function tests prior to treatment.
  • Monitor blood counts regularly: check CBC every 1–2 weeks initially, then monthly.
  • Assess liver function: repeat LFTs periodically to detect hepatotoxicity.
  • Screen for TPMT activity: consider testing for thiopurine methyltransferase deficiency to adjust dose.
  • Avoid use in active infection: postpone initiation if patient has uncontrolled infection.
  • Store at ambient temperature: keep tablets in original container, protect from moisture and heat below 25°C.

Avoid Interactions

Azathioprine interacts with several medicines that can alter its efficacy or safety.

Major Interactions (Avoid)

  • Allopurinol or febuxostat: potentiate azathioprine toxicity, may require dose reduction.
  • Live vaccines: increased risk of infection, should be avoided during therapy.
  • Antithymocyte globulin: additive immunosuppression, heightening infection risk.

Moderate Interactions (Monitor Closely)

  • Warfarin: azathioprine may enhance anticoagulant effect, monitor INR.
  • Ribavirin: combined use can increase bone marrow suppression.
  • Mycophenolate mofetil: overlapping immunosuppressive effects, monitor blood counts.

Frequently Asked Questions

Imuran Mitis, containing azathioprine, is prescribed to prevent organ transplant rejection, to manage rheumatoid arthritis, to maintain remission in inflammatory bowel disease such as Crohn's disease and ulcerative colitis, and to control systemic lupus erythematosus. These indications reflect its role as a broad immunosuppressive agent.

Azathioprine is a prodrug that is converted inside cells to 6‑mercaptopurine. This metabolite blocks the synthesis of purine nucleotides, which are essential for DNA and RNA production. By limiting nucleotide availability, the drug reduces the proliferation of T and B lymphocytes, thereby dampening the immune response.

The dose of Imuran Mitis is individualized by the prescribing clinician. Factors such as the specific disease being treated, patient weight, renal and hepatic function, and the activity of the enzyme thiopurine methyltransferase (TPMT) are considered. Dose adjustments are made based on laboratory monitoring and clinical response.

Data on azathioprine use in pregnancy and lactation are limited. The drug crosses the placenta and is excreted in breast milk, so it is generally avoided unless the therapeutic benefit outweighs potential risks. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives and risk assessment with their healthcare provider.

To request Imuran Mitis, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details and any necessary import documentation.

Both azathioprine (Imuran Mitis) and mycophenolate mofetil are immunosuppressants used in transplant and autoimmune settings, but they act via different pathways. Azathioprine interferes with purine synthesis through 6‑mercaptopurine, while mycophenolate inhibits inosine monophosphate dehydrogenase. Their side‑effect profiles differ; azathioprine is more associated with bone‑marrow suppression, whereas mycophenolate often causes gastrointestinal upset.

Imuran Mitis tablets should be stored at ambient temperature, below 25 °C. Keep them in the original packaging to protect from moisture and light. Do not store in areas of high humidity or near heat sources, and keep out of reach of children.

Imuran Mitis is taken orally as a tablet. The tablet should be swallowed whole with a glass of water, preferably with food or a light snack to lessen gastrointestinal irritation. The exact dosing schedule is determined by the prescribing clinician.

The most serious adverse effects of azathioprine include severe bone‑marrow suppression leading to pancytopenia, hepatotoxicity that can progress to hepatitis or liver failure, heightened susceptibility to serious infections, and a rare increased risk of certain malignancies such as lymphoma or skin cancer. Regular laboratory monitoring is essential to detect these complications early.

Imuran Mitis should be avoided in individuals with known hypersensitivity to azathioprine or its metabolites, those with severe hepatic impairment, active uncontrolled infections, or significant bone‑marrow deficiency. Caution is also advised for patients with TPMT deficiency, as they are at higher risk for toxicity. Pregnant or breastfeeding women should only use it when clearly indicated by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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