くすりのしおり

Internal
Revised: 2/2020

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 :
CICLOSPORIN Capsules 25mg "Pfizer" [For transplantation]
 Active ingredient:
Ciclosporin
 Dosage form:
pale yellow capsule, major axis: 9.7 mm, minor axis: 6.8 mm
 Print on wrapping:
(Face) シクロスポリンカプセル25mg「ファイザー」, シクロスポリン, 25mg, MH177
(Back) Ciclosporin 25mg[Pfizer], シクロスポリン, 25mg, MH177

Effects of this medicine

This medicine shows specific and reversible immunosuppressive effect for lymphocytes and suppresses abnormal immunoreaction by mainly suppressing activation of T-helper cells.
It is usually used to suppress rejection of organ (renal/liver/heart/lung/pancreas/small intestine) transplantation, bone marrow transplantation and suppress graft-versus-host disease.

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: neuro-Behcet's disease, renal dysfunction, liver dysfunction, infection, malignant tumor or history of it.
  • 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 4.5 to 6 mg of the active ingredient /kg of the body weight (225 to 300 mg for 50 kg body weight) at a time twice a day from 1 day before transplantation. The dosage will be decreased by 2 mg/kg of the body weight (100 mg for 50 kg) a day afterward. The standard maintenance dosage is 4 to 6 mg/kg of the body weight (200 to 300 mg for 50 kg) a day. The dosage may be adjusted according to the symptoms.
    Liver transplantation: In general, take 7 to 8 mg of the active ingredient /kg of the body weight (350 to 400 mg for 50 kg) at a time twice a day from 1 day before transplantation. The dosage will be decreased gradually. The standard maintenance dosage is 5 to 10 mg/kg of the body weight (250 to 500 mg for 50 kg) a day. The dosage may be adjusted according to the symptoms.
    Heart transplantation, lung transplantation, pancreas transplantation: In general, take 5 to 7.5 mg of the active ingredient /kg of the body weight (250 to 375 mg for 50 kg) at a time twice a day from 1 day before transplantation. The dosage will be decreased gradually. The standard maintenance dosage is 2 to 6 mg/kg of the body weight (100 to 300 mg for 50 kg) a day. The dosage may be adjusted according to the symptoms.
    Small intestine transplantation: In general, take 7 to 8 mg of the active ingredient /kg of the body weight (350 to 400 mg for 50 kg) at a time twice a day. The dosage will be decreased gradually. The standard maintenance dosage is 5 to 10 mg/kg of the body weight (250 to 500 mg for 50 kg) a day. The dosage may be adjusted according to the symptoms. But in general, start treatment with ciclosporin injection from 1 day before transplantation and it is to be switched to internal use medicine as soon as the patient becomes ready.
    Bone marrow transplantation: In general, take 3 to 6 mg of the active ingredient /kg of the body weight (150 to 300 mg for 50 kg) at a time twice a day from 1 day before transplantation. The dosage will be decreased gradually and stopped after 3 to 6 months continuation.
    The preparation contains 25 mg of the active ingredient in a capsule. You may take it in combination with various content capsules.
    In any case, strictly follow the instructions.
  • Do not switch to Sandimmun.
  • If you miss a dose, take a dose as soon as possible when you noticed. Wait at least 5 hours to take the next dose. 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

  • Blood level should be measured frequently just after transplantation and once a month afterwards as an indication in order to protect onset of adverse reaction by overdose or of rejection by low dosage.
  • Keep in mind to cleanly wash your hands frequently, gargle and brush your teeth to avoid infection due to suppressed immunity.
  • Avoid taking grapefruit juice, it may intensify medicinal effects.
  • Avoid taking any food containing Saint John's wort (a kind of herb), it may diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, increased blood pressure, anemia, nausea, hirsutism, tremor (trembling of limbs), tinnitus, muscle pain and gum hyperplasia. 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.
  • general convulsion, conscious disorder, visual disorder [central nervous system disorder such as reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy etc.]
  • fever, breathing difficulty, rash [infection]
  • upper abdominal severe pain, fever, dry mouth [acute pancreatitis]
  • bleeding tendency, get tired easily, edema [thrombotic microvascular disorder, hemolytic anemia, thrombocytopenia]
  • muscle pain, lassitude, reddish brown urine [rhabdomyolysis]
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 direct sunlight, heat and moisture. Store in a PTP package until just before taking, the capsule may soften by moisture absorption.
  • Discard the remainder. Do not store them. Consult with the pharmacy that you have received your medicine or medical institution about disposal.
  • If you are scheduled to receive vaccination, consult with your doctor or pharmacist.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

Keywords Search

 

 

 

 

Advanced Search

Browse by drug name A-Z
Browse by drug name A-Z