Medication info

Azathioprine Tablet 25 mg (Azathioprine)

Prescription medicationTabletOralExpired
Ingredient · strength
Azathioprine›25mg / 1 tablet
Manufacturer / importer
McNulty Pharmaceutical Co., Ltd.
Appearance
Light yellow, round film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle, PTP - 100 tablets/box [10 tablets/PTP x 10 pieces]
Approval status
Expired

MFDS item code 202003058 · Approved 2020.04.27

This product's status changed to Expired on 2025.04.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of autoimmune diseases and 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 per day. In patients with creatinine clearance of 20 mL/min or less, the dose must not exceed 1.5mg/kg of body weight per day. Autoimmune diseases: For conditions other than chronic active arthritis, administer 2.0-2.5 mg/kg of body weight per day. For chronic active arthritis, administer 1.0-1.5mg/kg of body weight per day. The tolerated and effective doses vary among patients; therefore, the dose should be carefully adjusted to achieve the optimal therapeutic effect. If the condition does not improve after 12 weeks, consider discontinuing treatment. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
McNulty Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of autoimmune diseases and prevention of rejection after kidney transplantation

  • Rejection
  • autoimmune diseases
View approved original text

This medication is used to suppress the rejection that may occur after kidney transplantation, helping the transplanted kidney to function well, and to alleviate symptoms caused by 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 per day. In patients with creatinine clearance of 20 mL/min or less, the dose must not exceed 1.5mg/kg of body weight per day. Autoimmune diseases: For conditions other than chronic active arthritis, administer 2.0-2.5 mg/kg of body weight per day. For chronic active arthritis, administer 1.0-1.5mg/kg of body weight per day. The tolerated and effective doses vary among patients; therefore, the dose should be carefully adjusted to achieve the optimal therapeutic effect. If the condition does not improve after 12 weeks, consider discontinuing treatment. Adjust the dose as appropriate according to age and symptoms.

Precautions

This drug should not be given to certain patients. For example, it should not be used in patients who are allergic to this drug or have had hypersensitivity reactions to 6-mercaptopurine, in rheumatoid arthritis patients who have previously taken alkylating agents, and in patients with severe liver, kidney, or bone marrow diseases. Additionally, it should not be administered to patients with severe infectious diseases or pancreatitis, patients with very low white blood cell counts, pregnant women or women who may become pregnant, and nursing mothers. This drug contains lactose and is unsuitable for patients with lactose intolerance or related genetic disorders. Caution should be exercised when administering this medication to patients with decreased bone marrow function, those with infections or bleeding tendencies, patients with liver or kidney function issues, patients with chickenpox, and patients taking specific medications. This medication can lower resistance to infections, increasing the risk of serious infections such as chickenpox, shingles, and hepatitis B. Furthermore, long-term use may increase the risk of tumors such as skin cancer and lymphomas, necessitating regular check-ups. Hematologic side effects may include leukopenia, thrombocytopenia, and anemia, while gastrointestinal side effects may include nausea, vomiting, diarrhea, and pancreatitis. Rarely, serious adverse reactions such as skin rashes, hair loss, liver dysfunction, and pneumonia have also been reported. Patients should have regular blood tests and liver and kidney function tests while using this drug, and should consult medical staff immediately if any abnormal symptoms occur. Treatment should be discontinued if liver function worsens. This drug can interact with several other medications; therefore, patients taking other medications should inform their doctor or pharmacist. Caution is required when used in conjunction with medications such as allopurinol, cimetidine, methotrexate, and warfarin. Pregnant or breastfeeding women should avoid taking this medication, and if it is absolutely necessary to take it, breastfeeding should be discontinued. Extra caution is required for pediatric and elderly patients, especially considering that elderly patients may require dose adjustments due to impaired liver and kidney function. In cases of overdose, nausea, vomiting, diarrhea, blood and liver function abnormalities may occur, requiring immediate medical attention. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or deterioration in quality. Lastly, this medication may increase the risk of tumor development with prolonged use, necessitating regular examinations and careful monitoring during treatment.

Side effects

  • Varicella-zoster virus infection
  • hepatitis B infection
  • atypical infections
  • progressive non-Hodgkin lymphoma
  • skin cancer
  • sarcoma
  • cervical cancer
  • hepatic and splenic T-cell lymphoma
  • bone marrow dysfunction
  • leukopenia
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  • thrombocytopenia
  • anemia
  • granulocytopenia
  • pancytopenia
  • aplastic anemia
  • megaloblastic anemia
  • erythropoietic failure
  • nausea
  • vomiting
  • loss of appetite
  • diarrhea
  • pancreatitis
  • colitis
  • diverticulitis
  • intestinal perforation
  • hypersensitivity reactions
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • drug fever
  • skin rash
  • hair loss
  • cholestasis
  • liver function deterioration
  • increased liver enzymes
  • liver dysfunction
  • jaundice
  • cough
  • dyspnea
  • interstitial pneumonia
  • chills
  • shivering
  • hypotension
  • infectious diseases
  • myalgia
  • arthralgia
  • acute kidney failure
  • acute pulmonary disease
  • meningitis
  • malaise
  • dizziness
  • stomatitis
  • glossitis
  • palpitations
  • rigidity
  • hypotension
  • Sweet's syndrome
  • bone marrow suppression
  • pharyngeal ulcer
  • contusion
  • bleeding
  • mild leukopenia
  • mild liver function abnormalities
  • increased AST
  • increased ALT
  • increased bilirubin
  • renal function abnormalities

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

Storage

This medication may be sensitive to air or light and should be stored in a well-sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature, and it is advisable to keep it in a dark place away from direct sunlight.

Appearance and packaging

Appearance

Light yellow, round film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle, PTP - 100 tablets/box [10 tablets/PTP x 10 pieces]

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.