くすりのしおり

Internal
Revised: 1/2018

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 "TOWA" [for autoimmune disease]
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
light yellow tablet, diameter: 6.6 mm, thickness: 3.0 mm
 Print on wrapping:
タクロリムス錠1.5mg「トーワ」,タクロリムス,1.5mg,Tacrolimus 1.5

Effects of this medicine

This medicine acts on immune-related T cells and suppresses inflammation by inhibiting the production of cytokines associated with inflammation, which alleviates the following symptoms: muscle weakness in myasthenia gravis; swelling, pain, and stiffness in rheumatoid arthritis; renal symptoms such as albuminuria in lupus nephritis; symptoms of refractory ulcerative colitis.
It is usually used to treat myasthenia gravis, rheumatoid arthritis, lupus nephritis, ulcerative colitis.

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.
    If you have liver disorder, renal disorder, or 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 2 tablet (3 mg of tacrolimus) at a time once daily after supper.
    For rheumatoid arthritis: In general, for adults, take 2 tablet (3 mg of tacrolimus) at a time once daily after supper. In elderly patients, the dose starts with 1.5 mg, once daily after supper, and may be increased up to 2 tablet (3 mg) once daily, according to the patients symptoms.
    For ulcerative colitis: In general, for adults, initially take 0.025 mg/kg of tacrolimus at a time twice daily after meal in the morning/evening. For subsequent 2 weeks, the dosage may be adjusted according to the patients blood concentration.
    This medicine contains 1.5 mg of tacrolimus in a tablet. 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 at the next dosing time (after supper).
    For ulcerative colitis: Take a 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 or change the dosing schedule.
  • 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 medicines effect, resulting in renal disorder. Refrain from intake of grapefruit and its juice together with the medicine.
  • Foods/drinks containing Hypericum perforatum (St. Johns wort) may reduce this medicines effect. Refrain from intake of 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, general edema, thirst [acute renal failure, nephrotic syndrome]
  • palpitation, general edema, chest pain [heart failure, arrhythmia, myocardial infarction, angina pectoris, pericardial effusion standing, myocardial disorder]
  • convulsion, disturbance of consciousness, language disorder [central nervous system disorders including reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy]
  • bleeding tendency, getting tired easily, edema [thrombotic microangiopathy]
  • fever, erythema, blister/erosion [oculomucocutaneous syndrome]
  • respiratory distress, breathing difficulty [dyspnea]
  • fever, dry cough, difficulty with breathing [interstitial pneumonia (when being used for rheumatoid arthritis)]
  • fever, general malaise, cold-like symptoms [infections]
  • severe upper abdominal pain, fever, nausea [pancreatitis]
  • dry mouth, excessive drinking/urination, getting tired easily [diabetes mellitus, 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

  • Keep out of the reach of children. Store away from light, 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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