くすりのしおり

Internal
Published: 6/2015

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 CAPSULES 0.5mg "NIPRO" [for transplantation]
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
pale yellow capsule, major axis: 11.0 mm, minor axis: 4.8 mm
 Print on wrapping:
(Face) タクロリムス0.5mg「ニプロ」, タクロリムス, 0.5mg, (Back)TACROLIMUS0.5mg「NIPRO」, タクロリムス, 0.5mg, 免疫抑制剤

Effects of this medicine

This medicine prevents rejection by suppressing factors related to rejection after transplantation, among the proteins called cytokines.
It is usually used to inhibit the rejection of organ transplantation (renal/liver/heart/lung/pancreas/small intestine/bone marrow) 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 disorder, renal disorder, infections.
  • 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))
  • Renal transplantation: In general, take 0.15 mg of tacrolimus per 1 kg of body weight (mg/kg) at a time, twice a day, from 2 days prior to transplantation. In the early stage after transplantation, take 0.15 mg/kg at a time, twice a day. Then the dosage will be gradually decreased. The standard maintenance dosage is 0.06 mg/kg at a time, twice a day. The dosage may be adjusted according to symptoms of the patient.
    Liver transplantation: In general, take 0.15 mg/kg of tacrolimus at a time, twice a day, in the early stage. Then the dosage will be gradually decreased. The standard maintenance dosage is 0.10 mg/kg a day. The dosage may be adjusted according to symptoms of the patient.
    Heart transplantation: In general, take 0.03 to 0.15 mg/kg of tacrolimus at a time, twice a day, in the early stage. If the dose is to be started after an episode of rejection, take 0.075 to 0.15 mg/kg at a time, twice a day in general. The dosage may be adjusted according to the symptoms of the patient and will be gradually decreased and maintained at minimum effective dose after stable state.
    Lung transplantation: In general, take 0.05 to 0.15 mg/kg of tacrolimus at a time, twice a day. The dosage may be adjusted according to symptoms of the patient and will be gradually decreased and maintained at minimum effective dose after stable state.
    Pancreas transplantation: In general, take 0.15 mg/kg of tacrolimus at a time, twice a day in the early stage. The dosage may be gradually decreased and maintained at minimum effective dose.
    Small intestine transplantation: In general, take 0.15 mg/kg of tacrolimus at a time, twice a day in the early stage. The dosage may be decreased gradually and maintained at minimum effective dose.
    Bone marrow transplantation: In general, take 0.06 mg/kg of tacrolimus at a time, twice a day, from the day prior to transplantation. In the early stage of transplantation, take 0.06 mg/kg at a time, twice a day. The dosage will be gradually decreased. If the dose is to be started after an episode of graft-versus-host disease, take 0.15 mg/kg at a time, twice a day in general.
    The dosage may be adjusted to symptoms of the patient.
    This preparation contains 0.5 mg of tacrolimus in a capsule. Strictly follow the instructions in any case.
  • If you miss a dose, take a dose as soon as you remember. 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 unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Since you are likely to become infected, wash hands and gargle and regulate your daily life.
  • Grapefruit (juice) may enhance this medicine's effect, resulting in renal disorder. Refrain from taking it together with the medicine.
  • Foods/drinks containing Hypericum perforatum (St. John's wort) may reduce this medicine's effect. Refrain from taking these foods/drinks together with the 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 flush, paraesthesia 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.
  • decrease in urinary output, edema, abdominal enlarged feeling [acute renal failure, nephrotic syndrome]
  • palpitation, edema, chest pain [heart failure, arrhythmia, myocardial infarction, angina pectoris, pericardial effusion standing, myocardial disorder]
  • cramps or spasms, disturbance of consciousness, language disorder [central nervous system disorders including reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy]
  • headache, nausea, temporary disturbance of consciousness [cerebrovascular disorder]
  • nasal/gum bleeding, purpura, hematuria [thrombotic microangiopathy]
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

  • Keep out of the reach of infants and children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard them.
  • Do not receive vaccination without an approval of your doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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