くすりのしおり

Internal
Published: 1/2016

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 0.5mg "AYUMI" [for transplantation]
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
white tablet, diameter: 5.6 mm
 Print on wrapping:
(face) タクロリムス, 0.5mg,AY0.5, (back) タクロリムス「あゆみ」, 0.5mg,AY0.5

Effects of this medicine

This medicine prevents the rejection by suppressing the production of proteins called cytokines related to the post-transplantation rejection.
It is usually used to prevent the post-transplantation (kidney, liver, heart, lung, pancreas, small intestine, bone marrow) rejection and graft-versus-host disease (bone marrow transplantation only).

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: liver/renal disorder, infection.
  • If you are pregnant, possibly pregnant, or breastfeeding.
  • 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 renal transplantation: In general, take 0.15 mg/kg of tacrolimus at a time, twice a day, 2 days before the transplantation. In the early stage after surgery, take 0.15 mg/kg at a time, twice a day. After that the dosage should be gradually decreased. The standard of maintenance dosage is 0.06 mg/kg at a time, twice a day. The dosage may be adjusted according to your symptoms.
    For liver transplantation: In general, take initially 0.15 mg/kg of tacrolimus at a time, twice a day. After that, the dosage should be gradually decreased. The standard of maintenance dose is 0.10 mg/kg per day. The dosage may be adjusted according to your symptoms.
    For heart transplantation: In general, take initially 0.03 to 0.15 mg/kg of tacrolimus at a time, twice a day. If tacrolimus is used after an episode of rejection, in general, take 0.075 to 0.15 mg/kg of tacrolimus at a time, twice a day. After that, the dosage may be adjusted according to your symptoms. The dosage should be gradually decreased and maintained at the minimum effective dose after stable condition.
    For lung transplantation: In general, take initially 0.05 to 0.15 mg/kg of tacrolimus at a time, twice a day. After that, the dosage may be adjusted according to your symptoms. The dosage should be gradually decreased and maintained at the minimum effective dose after stable condition.
    For pancreas transplantation: In general, take initially 0.15 mg/kg of tacrolimus at a time, twice a day. After that, the dosage should be gradually decreased and maintained at the minimum effective dose.
    For small intestine transplantation: In general, take initially 0.15 mg/kg of tacrolimus at a time, twice a day. After that, the dosage should be gradually decreased and maintained at the minimum effective dose.
    For bone marrow transplantation: In general, take 0.06 mg/kg of tacrolimus at a time, twice a day, a day before the transplantation. In the initial stage of transplantation, take 0.06 mg/kg at a time, twice a day. After that the dosage should be gradually decreased. If tacrolimus is used after an episode of graft-versus-host disease, in general, take 0.15 mg/kg of tacrolimus at a time, twice a day. The dosage may be adjusted according to your symptoms.
    This preparation contains 0.5 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, take the missed dose as soon as possible. However, the next dose should be at least 5 hours apart. 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 increased blood pressure, tremor (tremble of hands/feet), diarrhea, fever, vomiting and headache. 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 renal failure, 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, 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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