くすりのしおり

Internal
Revised: 4/2020

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 :
Sandimmun Oral Solution 10% [for transplantation]
 Active ingredient:
Ciclosporin
 Dosage form:
yellow solution
 Print on wrapping:

Effects of this medicine

This medicine shows specific and reversible immunosuppressive effect on lymphocytes, and mainly suppresses activation of T-helper cells. It consequently suppresses abnormal immune reactions.
It is usually used for inhibition of the rejection of organ transplantation (kidney, liver, heart, lung, pancreas), or inhibition of the rejection and graft-versus-host disease following bone-marrow transplantation.

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: neural Behcet's disease, renal dysfunction, hepatic dysfunction, infection, malignant tumor or its history.
  • 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 kidney transplantation: In general, take 0.09 to 0.12 mL/kg of body weight (9 to 12 mg/kg of the active ingredient) [4.5 to 6 mL for 50 kg of body weight (450 to 600 mg)] a day in 1 to 2 divided doses, started on the day before transplantation. After transplantation, reduce gradually and as maintenance dosage take 0.04 to 0.06 mL/kg (4 to 6 mg/kg) [2 to 3 mL for 50 kg of body weight (200 to 300 mg)] a day in 1 to 2 divided doses.
    For liver transplantation
    : In general, take 0.07 to 0.08 mL/kg of body weight (7 to 8 mg/kg of the active ingredient) [3.5 to 4 mL for 50 kg of body weight (350 to 400 mg)] at a time, twice a day, started on the day before transplantation. After transplantation, reduce gradually and as maintenance dosage take 0.025 to 0.05 mL/kg (2.5 to 5 mg/kg) [1.25 to 2.5 mL for 50 kg of body weight (125 to 250 mg)] at a time, twice a day.
    For heart/lung/pancreas transplantation
    : In general, take 0.05 to 0.075 mL/kg of body weight (5 to 7.5 mg/kg of the active ingredient) [2.5 to 3.75 mL for 50 kg of body weight (250 to 375 mg)] at a time, twice a day, started on the day before transplantation. After transplantation, reduce gradually and as maintenance dosage take 0.01 to 0.03 mL/kg (1 to 3 mg/kg) [0.5 to 1.5 mL for 50 kg of body weight (50 to 150 mg)] at a time, twice a day.
    For bone-marrow transplantation
    : In general, take 0.06 to 0.12 mL/kg of body weight (6 to 12 mg/kg of the active ingredient) [3 to 6 mL for 50 kg of body weight (300 to 600 mg)] a day in 1 to 2 divided doses, started on the day before transplantation. After transplantation, maintain the dosage for 3 to 6 months and then gradually reduce until discontinuation.
    This preparation contains 100 mg of the active ingredient in 1 mL. The dosage should be adjusted according to the symptoms after transplantation. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. However, take the next dose 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. Do not take Neoral instead of the medicine.

Precautions while taking this medicine

  • While taking this medicine, your natural immunity will be reduced. To prevent infections, often wash your hands, gargle, and brush your teeth.
  • Consult with your doctor or pharmacist when you receive a vaccination.
  • Grapefruit juice may intensify the effect of the medicine by increasing its blood level. Health foods containing St. Jone's wart may reduce the effect of the medicine by decreasing its blood level. Avoid taking these foods and drinks.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include renal disorder (decrease of urine output, edema), liver disorder (malaise, yellowness of hand or in conjunctiva), nausea, vomiting, infection, excessive hair growth, tremor (trembling of limbs), gum hyperplasia, increased blood pressure, and hyperglycemia (thirst, excessive fluid intake). 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.
  • convulsion, disturbed consciousness, visual disorder [central nervous system disorder such as reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy]
  • severe pain in upper abdomen, fever, nausea [acute pancreatitis]
  • bleeding tendency, malaise, edema [thrombotic microangiopathy]
  • pain/stiffness of muscle, muscle weakness [rhabdomyolysis]
  • enlargement of lymph nodes, fever, loss of appetite [malignant tumor]
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 the reach of children. Store away from direct sunlight, heat and moisture.
  • Storage at a low temperature (5℃ or lower) may produce precipitation. Dissolve it at room temperature before use.
  • Discard the remainder. Do not store them. Ask the pharmacy or medical institution how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.