くすりのしおり

Internal
Revised: 4/2017

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 1mg "NIPRO" [for autoimmune disease]
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
white capsule, major axis: 11.0 mm, minor axis: 4.8 mm
 Print on wrapping:
(Face) タクロリムス1mg「ニプロ」, タクロリムス, 1mg, (Back)TACROLIMUS1mg「NIPRO」, タクロリムス, 1mg, 免疫抑制剤

Effects of this medicine

This medicine inhibits activation of T-cell related with immunity to suppress abnormal immune reactions.
It is usually used to treat myasthenia gravis, rheumatoid arthritis, lupus nephritis and intractable ulcerative colitis in active stage (moderate to severe).

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

  • If you have previously experienced any allergic reaction (itch, rash etc.) to any medicine.
    If you have: rheumatoid arthritis-associated interstitial pneumonia, 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))
  • For myasthenia gravis, lupus nephritis: In general, for adults, take 3 capsules (3 mg of tacrolimus) at a time, once a day, after dinner.
    For rheumatoid arthritis: In general, for adults, take 3 capsules (3 mg of tacrolimus) at a time, once a day, after dinner. For elderly, initially take 1.5 mg at a time, once a day, after dinner and the dosage may be increased up to 3 capsules (3 mg) once a day, according to the symptoms of the patient.
    For intractable ulcerative colitis in active stage (moderate to severe) : In general, for adults, take 0.025 mg of tacrolimus per kg of body weight at a time, twice a day, after breakfast and dinner in the early stage. The dosage may be adjusted according to blood concentration after 2 weeks from the start of taking this medicine. This preparation contains 1 mg of tacrolimus in a capsule. In any case, strictly follow the instructions.
  • If you miss a dose, follow the instructions below.
    For myasthenia gravis, rheumatoid arthritis: Take the missed dose as soon as possible.
    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 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 effusions, 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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