Medication info
Imutera 25mg (Azathioprine)

Imutera 25mg (Azathioprine)

Prescription medicationTabletOral
Ingredient · strength
Azathioprine›25mg / 1 tablet
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
Pale yellow round tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202005873 · Approved 2020.08.18 · Insurance code 693903270

Summary

Main use
Treatment of autoimmune diseases; prevention of rejection after kidney transplantation
Who takes it
Adults
Adult dose
After kidney transplantation: Administer azathioprine orally at an initial dose of 3-5 mg/kg of body weight per day and a maintenance dose of 0.5-2 mg/kg of body weight. For creatinine clearance of 20 mL/min or less, the dose should not exceed 1.5mg/kg of body weight per day. Autoimmune diseases: Administer 2.0-2.5 mg/kg of body weight per day for treatment of diseases other than chronic active arthritis. For treatment of chronic active arthritis, administer 1.0-1.5 mg/kg of body weight per day. Tolerated and effective doses vary among patients; therefore, adjust the dose 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

Treatment of autoimmune diseases; prevention of rejection after kidney transplantation

  • Rejection
  • autoimmune diseases
View approved original text

This medication is used to suppress possible rejection after kidney transplantation and to treat autoimmune diseases.

How to take

Adult dose

After kidney transplantation: Administer azathioprine orally at an initial dose of 3-5 mg/kg of body weight per day and a maintenance dose of 0.5-2 mg/kg of body weight. For creatinine clearance of 20 mL/min or less, the dose should not exceed 1.5mg/kg of body weight per day. Autoimmune diseases: Administer 2.0-2.5 mg/kg of body weight per day for treatment of diseases other than chronic active arthritis. For treatment of chronic active arthritis, administer 1.0-1.5 mg/kg of body weight per day. Tolerated and effective doses vary among patients; therefore, adjust the dose 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 medication should not be used in patients with certain allergic reactions or with severe liver, kidney, or bone marrow diseases. Women who are pregnant or breastfeeding should not take this medication. Patients with very low blood cell counts need to be more careful when taking this medication. This medication has an immunosuppressive effect, which may increase the risk of infection; therefore, it should be used cautiously in patients with infections or at risk of bleeding. Patients with liver or kidney dysfunction require regular monitoring, and should consult a doctor immediately if any abnormal symptoms occur. During the use of this medication, regular blood tests and liver function tests should be conducted, and administration may be discontinued in the event of adverse reactions. Long-term use may increase the risk of malignant tumors, such as skin cancer or lymphoma; thus, sun exposure should be avoided and skin condition should be checked regularly. When used in combination with other medications, interactions may occur, so it is essential to consult a doctor or pharmacist, especially when taking immunosuppressants, anticoagulants, or certain antibiotics. The safety of this medication in children has not been adequately established, and the elderly may require dosage adjustments due to decreased physical function. In cases of overdose, symptoms such as vomiting, diarrhea, and decreased blood cells may occur; therefore, the dosage must be strictly adhered to, and if any abnormal symptoms arise, medical personnel should be informed immediately. Store in a place out of reach of children, and keep in its original container to maintain quality.

Side effects

  • Varicella-Zoster virus infection
  • hepatitis B
  • other viral fungal bacterial infections
  • progressive non-Hodgkin lymphoma
  • skin cancer
  • sarcoma
  • hepatosplenic T-cell lymphoma
  • bone marrow dysfunction
  • leukopenia
  • thrombocytopenia
Show 55 more
  • anemia
  • agranulocytosis
  • pancytopenia
  • aplastic anemia
  • megaloblastic anemia
  • erythropoiesis 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 dysfunction
  • jaundice
  • non-cirrhotic portal hypertension
  • portal vein vascular disease
  • cough
  • dyspnea
  • interstitial pneumonia
  • chills
  • shivering
  • hypotension
  • infectious disease
  • myalgia
  • arthralgia
  • acute renal failure
  • acute pulmonary disease
  • meningitis
  • fatigue
  • dizziness
  • stomatitis
  • glossitis
  • palpitations
  • rigidity
  • hypotension
  • Sweet's syndrome
  • thrombocytopenia
  • bruising
  • bleeding
  • throat ulcer
  • increased AST
  • increased ALT
  • increased 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 protect it from air and moisture. It is also recommended to store the medication at room temperature, between 1 degree and 30 degrees, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

Pale yellow round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.