Medication info
Imuthera Tablets (Azathioprine)

Imuthera Tablets (Azathioprine)

Prescription medicationTabletOral
Ingredient · strength
Azathioprine›50mg / 1 tablet
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
Light yellow round tablets
Packaging
Domestic use - 100 tablets/bottle, Domestic use - 100 tablets/box [(20 tablets/PTP*5 packs)], Export use - 100 tablets/bottle, Export use - 30 tablets/bottle, Export use - 20 tablets/box [(20 tablets/PTP*1 pack)]
Approval status
Active

MFDS item code 202100575 · Approved 2021.01.20 · Insurance code 693903430

Summary

Main use
Prevention of rejection after kidney transplantation and treatment of autoimmune diseases
Who takes it
Adults
Adult dose
After kidney transplantation: The initial oral dose of azathioprine is 3-5 mg/kg of body weight per day, and the maintenance dose is 0.5-2 mg/kg of body weight per day. In patients with a creatinine clearance of 20mL/min or less, the daily dose should not exceed 1.5 mg/kg of body weight. Autoimmune diseases: For treatment of conditions other than chronic active arthritis, administer 2.0-2.5 mg/kg of body weight per day. For treatment of chronic active arthritis, administer 1.0-1.5 mg/kg of body weight per day. The tolerated and effective doses vary among patients; therefore, the dose should be adjusted carefully to achieve the optimal therapeutic effect. Consider discontinuing treatment if the condition has not improved after 12 weeks. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention of rejection after kidney transplantation and treatment of autoimmune diseases

  • Rejection
  • autoimmune diseases
View approved original text

This medication helps prevent rejection that may occur after kidney transplantation, allowing the transplanted kidney to function well. It is also used for autoimmune diseases, controlling the immune system's attack on the body. This helps stabilize the patient's immune status and alleviate disease progression.

How to take

Adult dose

After kidney transplantation: The initial oral dose of azathioprine is 3-5 mg/kg of body weight per day, and the maintenance dose is 0.5-2 mg/kg of body weight per day. In patients with a creatinine clearance of 20mL/min or less, the daily dose should not exceed 1.5 mg/kg of body weight. Autoimmune diseases: For treatment of conditions other than chronic active arthritis, administer 2.0-2.5 mg/kg of body weight per day. For treatment of chronic active arthritis, administer 1.0-1.5 mg/kg of body weight per day. The tolerated and effective doses vary among patients; therefore, the dose should be adjusted carefully to achieve the optimal therapeutic effect. Consider discontinuing treatment if the condition has not improved after 12 weeks. Adjust the dose appropriately according to age and symptoms.

Precautions

This medicine should not be administered to certain patients. For example, patients with allergies or hypersensitivity reactions to this medication or similar drugs, patients with severe liver, kidney, or bone marrow diseases, and pregnant or breastfeeding women should not be treated with it. Furthermore, patients with weakened bone marrow function or infections, those with bleeding tendencies, patients with liver or kidney issues, individuals recovering from chickenpox, and patients taking certain other medications should use this medication with extreme caution. Since this medicine suppresses the immune system, it may increase the risk of infections, and there may be a higher possibility of severe infections or tumor development. Therefore, if any symptoms of infection or unusual bleeding appear, medical advice should be sought immediately. Various side effects such as reduced blood cell count, liver function deterioration, pancreatitis, skin rash, and pneumonia may occur, so regular blood tests and liver function tests are necessary during treatment. The risk of side effects may increase with long-term use, so the minimum effective dose should be used, and blood parameters should be checked frequently at the beginning of treatment. Women who are pregnant or may become pregnant should not take this medication, and breastfeeding should be discontinued or this medication should be avoided during breastfeeding. Particularly, sensitivity to this medication may vary due to genetic factors, so genetic testing may be necessary to adjust the appropriate dosage. This medication interacts with many other drugs, so dosage adjustments or careful monitoring are required based on the other medications being taken. For example, concurrent use with certain antibiotics, antiviral drugs, immunosuppressants, or anticoagulants may worsen side effects. In case of overdose, severe bone marrow suppression and increased risk of infections occur, and symptoms like vomiting, diarrhea, and abnormal liver and kidney function may present, requiring immediate treatment. Lastly, this medication should be kept out of reach of children and stored well sealed in its original container.

Side effects

  • Infection
  • progressive non-Hodgkin lymphoma
  • skin cancer
  • sarcoma
  • cervical cancer
  • bone marrow dysfunction
  • leukopenia
  • thrombocytopenia
  • anemia
  • granulocytopenia
Show 53 more
  • pancytopenia
  • aplastic anemia
  • megaloblastic anemia
  • erythropoietic failure
  • nausea
  • vomiting
  • loss of appetite
  • diarrhea
  • pancreatitis
  • colitis
  • diverticulitis
  • intestinal perforation
  • hypersensitivity reaction
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • drug fever
  • skin rash
  • hair loss
  • cholestasis
  • worsening liver function
  • increased liver enzymes
  • liver disorder
  • jaundice
  • non-cirrhotic portal hypertension
  • portal vein thrombosis
  • cough
  • shortness of breath
  • interstitial pneumonia
  • chills
  • shivering
  • hypotension
  • shock-like symptoms
  • myalgia
  • arthralgia
  • acute kidney failure
  • acute lung disease
  • meningitis
  • malaise
  • dizziness
  • stomatitis
  • glossitis
  • palpitations
  • rigidity
  • hypotension
  • Sweet's syndrome
  • bone marrow suppression
  • throat ulcer
  • bruise
  • bleeding
  • elevated AST
  • elevated ALT
  • elevated bilirubin
  • renal dysfunction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to keep out air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Light yellow round tablets

Package unit

Domestic use - 100 tablets/bottle, Domestic use - 100 tablets/box [(20 tablets/PTP*5 packs)], Export use - 100 tablets/bottle, Export use - 30 tablets/bottle, Export use - 20 tablets/box [(20 tablets/PTP*1 pack)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.