くすりのしおり

Internal
Revised: 4/2020

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Tacrolimus tablets 1.5mg "AYUMI" [for autoimmune disease]
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
pale yellow tablet, diameter: 6.6mm
 Print on wrapping:
(face) タクロリムス, 1.5mg, AY1.5, (back) タクロリムス「あゆみ」, 1.5mg, AY1.5

Effects of this medicine

This medicine prevents inflammation by acting on T-cell related to the immunity and suppressing the production of cytokines related to the inflammation. It consequently improves various symptoms such as muscle weakness in myasthenia gravis, swelling/pain/stiffness in the joint of rheumatoid arthritis, renal symptoms such as albuminuria in lupus nephritis or refractory ulcerative colitis. In case of rheumatoid arthritis, it may take 4 to 8 weeks until the effect of the medicine is obtained.
It is usually used to treat myasthenia gravis, rheumatoid arthritis, lupus nephritis and ulcerative colitis.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have: rheumatoid arthritis associated with interstitial pneumonia.
    If you have: liver/renal disorder, infection or fever/cough/breathing difficulty.
  • If you are pregnant, breastfeeding, or possibly pregnant.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • For myasthenia gravis, lupus nephritis: In general, for adults, take 2 tablets (3 mg of tacrolimus) at a time, once a day (after dinner).
    For rheumatoid arthritis: In general, for adults, take 2 tablets (3 mg of tacrolimus) at a time, once a day (after dinner). For elderly patient, be initiated with doses of 1 tablets (1.5 mg) at a time, once a day (after dinner), and the dosage may be increased by 2 tablets (3 mg) at a time, once a day, according to your symptoms.
    For ulcerative colitis: In general, for adults, take initially 0.025 mg/kg of tacrolimus at a time, twice a day (after breakfast and dinner). After initiation of taking medicine, the dosage may be adjusted according to your blood concentration. The maximum daily dose is up to 0.3 mg/kg.
    This preparation contains 1.5 mg of tacrolimus (active ingredient) in a tablet. In any case, strictly follow the instructions.
  • If you are an elderly patient, you should especially follow your doctor's instructions.
  • If you miss a dose,
    (for myasthenia gravis, lupus nephritis or rheumatoid arthritis) skip the missed dose and continue your regular dosing schedule.
    (for ulcerative colitis) take the missed dose as soon as possible. However, the next dose should be at least 5 hours apart.
    In any case, you should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine or change the dosage unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Because you are likely to become infected, wash hands and gargle, and regulate your daily life.
  • Grapefruits juice and some citrus (Buntan, Hassaku, etc.) may heighten the effect of this medicine. Avoid taking them with this medicine.
  • The foods containing hypericum perforatum (St. John's wort) may counteract the effect of this medicine. Avoid taking them with this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include abdominal pain, diarrhea, increased blood pressure, tremor (tremble of hands/feet), hot flash, paresthesia and nausea. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • decreased urine output, general edema, thirst [acute kidney disease, nephrotic syndrome]
  • palpitation, general edema, chest pain [heart failure, arrhythmia, myocardial infarction, angina pectoris, pericardial effusion, myocardial damage]
  • convulsion, disturbance of consciousness, language disorder [central nervous system disorder such as reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy]
  • bleeding tendency, getting tired easily, edema [thrombotic microangiopathy]
  • fever, erythema, blister/ erosion [oculomucocutaneous syndrome]
  • respiratory distress, breathing difficulty [respiratory distress]
  • fever, dry cough, respiratory distress [interstitial pneumonia (when tacrolimus is used for rheumatoid arthritis)]
  • fever, general malaise, cold-like symptoms [infection]
  • severe upper abdominal pain, fever, nausea [pancreatitis]
  • dry mouth, polydipsia/ polyuria, getting tired easily [diabetes, hyperglycemia]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Do not get vaccination without your doctor 's permission.
  • Keep out of reach of children. Store away from light, heat and moisture.
  • Discard the remainder. Do not store them. Ask your pharmacy or medical institution how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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