くすりのしおり

Internal
Published: 7/2017

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-1TAIHO combination OD tablets T25
 Active ingredient:
Tegafur
Gimeracil
Oteracil potassium
 Dosage form:
light blue-green tablet with a central white portion on one side, diameter: 7.5 mm, thickness: 3.5 mm
 Print on wrapping:
OT43 25 mg

Effects of this medicine

This medicine is biotransformed into fluorouracil (anticancer medicine) in the body, enhances antitumor activity by increasing its concentration and relieves gastrointestinal toxicities (adverse reactions).
It is usually used to treat stomach cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, inoperable or recurrent breast cancer, pancreatic cancer, and 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 (decrease in white blood cell count, etc.), renal disorder, liver disorder, infections, diabetes mellitus, or gastrointestinal ulcer/bleeding.
    If you have or have a history of interstitial pneumonia or heart disease.
    If you are on any other fluoropyrimidine medicine (fluoropyrimidine medicines may mutually interact to enhance medicinal effects and cause serious adverse reactions).
    If your medicine has been changed from another fluoropyrimidine (a washout period is required before this medicine is taken).
  • 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))
  • In general, for adults, take this medicine twice a day, after breakfast and dinner for 28 consecutive days, followed by a 14-day interval. This is counted as one course and repeated. Initial standard doses as tegafur are based on body surface area (BSA) as follows: 40 mg at a time for patients with a BSA of less than 1.25 m2; 50 mg at a time for patients with a BSA of 1.25 m2 or less than 1.5 m2; and 60 mg at a time for patients with a BSA of equal to or greater than 1.5 m2. The dosage may be adjusted according to your condition. Regarding steps of adjustments, dosage is increased or decreased to 40 mg, 50 mg, 60 mg or 75 mg per dose. The maximum single dose is 75 mg, and the minimum single dose is 40 mg. This medicine contains 25 mg as tegafur in a tablet. Strictly follow the instructions.
  • Moisten the tablet with saliva on your tongue, wait until it dissolves naturally and then swallow the tablet with saliva. You may also take this medicine with a glass of water or lukewarm water. Do not take the tablet without water when you are lying down.
  • You should never take this medicine with other fluoropyrimidine medicine.
  • Record the status of compliance to medication, your physical condition and symptoms that you have become aware of, and show the record to your doctor or pharmacist when you visit.
  • If you miss a dose, skip the missed dose and follow 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 change the dose or dosing schedule of this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • During the treatment, laboratory tests (blood, liver and renal function tests) are performed regularly (at least once every 2 weeks) to detect asymptomatic adverse reactions. 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, lacrimation, interstitial pneumonia and lung disorder (radiation pneumonitis/respiratory distress/respiratory failure). 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.
  • prolonged bleeding, general malaise, fever, sore throat [bone marrow suppression, hemolytic anemia]
  • yellow discoloration of the skin, general malaise, yellow discoloration of the white of eyes, loss of appetite [serious liver disorder]
  • diarrhea, severe abdominal pain [serious enterocolitis]
  • breathing difficulty, fever, dry cough [interstitial pneumonia]
  • bloody stool, black stool, vomiting of blood, abdominal pain [serious stomatitis, gastrointestinal ulcer, gastrointestinal bleeding, gastrointestinal perforation]
  • severe stomatitis, red rash, hyperemia of eyelids or eye [toxic epidermal necrolysis, mucocutaneous ocular syndrome]
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 your pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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