Medication info

Azathioprine Tablets 50 mg (Azathioprine)

Prescription medicationTabletOralExpired
Ingredient · strength
Azathioprine›50mg / 1 tablet
Manufacturer / importer
Macknulty Pharmaceutical Co., Ltd.
Appearance
Pale 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 202003057 · 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
Macknulty Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of autoimmune diseases and prevention of rejection after kidney transplantation

  • Rejection
  • autoimmune diseases
View approved original text

This medicine helps to suppress rejection that may occur after kidney transplantation, allowing the transplanted kidney to function properly. It is also used for autoimmune diseases, preventing the immune system from attacking its own tissues. Thus, it is effective in maintaining the health of kidney transplant patients and improving the symptoms of 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 medication should not be used in certain patients. For example, patients who are allergic to this drug or similar drugs, or who have experienced allergic reactions in the past, or those with severe liver or kidney diseases, bone marrow dysfunction, severe infections, or pancreatitis should not take this medication. Additionally, patients with very low white blood cell counts, pregnant women, women who may become pregnant, or nursing mothers should not use this medication. Patients with genetic lactose metabolism issues should also avoid this drug. This drug should be administered with caution in patients with reduced bone marrow function, infections, bleeding tendencies, or liver or kidney disorders. Caution is also necessary in patients with chickenpox or those taking certain medications. During treatment with this drug, patients may become more susceptible to infections, so if symptoms of infection appear, they should consult their doctor immediately. Additionally, this drug may decrease blood cell counts, increasing the risk of anemia or bleeding, and a variety of side effects such as liver dysfunction, pancreatitis, skin rash, and respiratory issues may occur. Regular blood tests and liver function tests should be conducted during treatment, and immediate consultation with a doctor is required if abnormal signs are detected to consider dosage adjustment or discontinuation. Prolonged use of this medication may increase the risk of side effects, thus it should be managed carefully, particularly due to an increased risk of infections or tumor development. Pregnant or nursing women should not take this medication, and if it is absolutely necessary to use it, breastfeeding should be discontinued. Special attention is needed for children and the elderly, adjusting the dosage while closely monitoring kidney and liver function status. In case of overdose, symptoms such as blood cell reduction, infections, bleeding, vomiting, and diarrhea may occur, and immediate medical treatment should be sought. This medication has many drug interactions, so if other medications are being taken, it is essential to inform the doctor or pharmacist, particularly when used in combination with certain antibiotics, immunosuppressants, or anticoagulants. Finally, this medication should be kept out of reach of children and stored in its original container to prevent quality deterioration or misuse.

Side effects

  • Infection
  • progressive non-Hodgkin lymphoma
  • skin cancer
  • sarcoma
  • cervical cancer
  • bone marrow dysfunction
  • leukopenia
  • thrombocytopenia
  • anemia
  • neutropenia
Show 47 more
  • 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
  • liver enzyme elevation
  • liver dysfunction
  • jaundice
  • cough
  • dyspnea
  • interstitial pneumonia
  • chills
  • tremors
  • hypotension
  • shock-like symptoms
  • myalgia
  • arthralgia
  • acute renal failure
  • acute lung disease
  • meningitis
  • malaise
  • dizziness
  • stomatitis
  • glossitis
  • palpitations
  • rigidity
  • hypotension
  • Sweet's syndrome
  • nausea
  • diarrhea
  • leukopenia
  • abnormal liver function

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

Storage

This drug should be stored in a sealed container to protect it from air and moisture, and it is recommended to keep it at a temperature between 1 to 30 degrees Celsius at room temperature. It is also helpful to store it in a dark place away from direct sunlight to maintain the efficacy of the medication.

Appearance and packaging

Appearance

Pale 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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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.