くすりのしおり

Internal
Revised: 5/2017

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 :
S-1 NP COMBINATION CAPSULES T25
 Active ingredient:
Tegafur
Gimeracil
Oteracil potassium
 Dosage form:
orange opaque/ white opaque capsule, major axis: 14.6 mm, minor axis: 5.1 mm
 Print on wrapping:
(Face)エスワンエヌピー配合T25, (Back)S-1NP COMBINATION T25, エスワンエヌピー25, NP-141

Effects of this medicine

This medicine suppresses the growth of cancer cells (tumor) by suppressing nucleic acid (DNA) synthesis of cancer cells.
It is usually used in the treatment of gastric cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, unresectable or recurrent breast cancer, pancreatic cancer, or biliary tract cancer.

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 bone marrow suppression (including leukopenia), renal/hepatic disorder.
  • If you are pregnant, breastfeeding or possibly pregnant.
  • 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))
  • In general, for adults, the initial dose is determined based on body surface area as follows: 40 mg of Tegafur for patients with under 1.25 m2 of body surface area; 50 mg of Tegafur for patients with 1.25 to 1.5 m2 of body surface area; 60 mg of Tegafur for patients with over 1.5 m2 of body surface area. The medicine is administered twice daily after breakfast and dinner, for 28 consecutive days, followed by a 14-day rest. This is regarded as one course, which is repeated. The dose can be increased or decreased according to the patient's condition in steps of: 40, 50, 60, or 75 mg per dose. The increasing dose will not proceed from the first increased step, and the maximum dose is limited to 75 mg per dose. The decreasing dose is performed in steps, and the minimum dose is 40 mg per dose.
    This medicine contains 25 mg of Tegafur in a capsule. Strictly follow the instructions.
  • This medicine must NOT be taken with other fluoropyrimidine-group anticancer drugs.
  • If you miss a dose, skip the missed dose and continue your regular dosing schedule. 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

  • During the treatment, laboratory tests (hematological, liver and renal function tests) are performed regularly at least once every 2 weeks to detect asymptomatic side effects as early as possible. Be sure to keep your visiting schedule.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include loss of appetite, nausea/ vomiting, diarrhea, general malaise, stomatitis, pigmentation, rash and lacrimation. 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.
  • fever, sore throat, malaise [bone marrow depression, hemolytic anemia]
  • palpitation or shortness of breath, dizziness, ear ringing [disseminated intravascular coagulation syndrome]
  • general malaise, loss of appetite, yellowing of the skin and the whites of the eyes [serious liver disorder such as fulminant hepatitis etc.]
  • severe diarrhea, hyperventilation, consciousness disorder [dehydration]
  • severe stomachache, diarrhea, nausea [serious enteritis]
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.
  • Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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