くすりのしおり

Internal
Revised: 12/2019

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 T20
 Active ingredient:
Tegafur
Gimeracil
Oteracil potassium
 Dosage form:
light blue-green tablet with white central part on one side, diameter: 7.5 mm, thickness: 3.5 mm
 Print on wrapping:
OT41 20 mg

Effects of this medicine

This medicine is biotransformed into fluorouracil (anticancer drug) in the body, enhances antitumor activity by increased concentration and relieves gastrointestinal toxicities (adverse reactions).
It is usually used to treat gastric cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, inoperable 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 reaction (itch, rash etc.) to any medicines.
    If you have bone marrow suppression (decrease in white blood cell count, etc.), renal or hepatic disorder, infections, diabetes mellitus or gastrointestinal ulcer/bleeding.
    If you have or have a history of interstitial pneumonia or heart disease.
    If you are using fluoropyrimidine-group medicines (S-1TAIHO and these medicines may interact strongly with each other and cause serious adverse reactions).
    If your medicine has been changed from another fluoropyrimidine medicine to S-1TAIHO (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 S-1TAIHO twice a day, after breakfast and dinner for 28 consecutive days, followed by 14-day rest. This is counted as one course and is repeated. Initial standard dose as Tegafur is determined based on body surface area (BSA) as follows: 40 mg per dose for patients with a BSA less than 1.25 m2, 50 mg per dose for patients with a BSA 1.25 to less than 1.5 m2. and 60 mg per dose for patients with a BSA equal to or greater than 1.5 m2. The dosage may be adjusted according to the patient's condition. Regarding steps of adjustments, dosage is increased or decreased to 40 mg, 50 mg, 60 mg, or 75 mg.The maximum single dose should not exceed 75 mg, and the minimum single dose is 40 mg. This medicine contains 20 mg as Tegafur in each tablet. Strictly follow the instructions.
  • Place the tablet in your mouth and wait until it dissolves naturally by saliva, then swallow with saliva. You may also take this medicine with a glass of water or warm water. Do not take the medicine without water while in lying position.
  • S-1TAIHO must NOT be taken with other fluoropyrimidine-group medicine.
  • Record your drug consumption, your physical condition and symptoms and show your records to your physician or pharmacist on your next visit.
  • If you missed a dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.
  • If you took too much of this medicine (more than prescribed), check with your doctor/pharmacist.
  • Do not change the amount of your dose or your dosing schedule without the instruction of your doctor.

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 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.
  • prolonged bleeding, general malaise, fever, sore throat [bone marrow suppression]
  • yellowing of the skin, general malaise, yellowing of the white of the eyes, loss of appetite [severe hepatic disorder]
  • diarrhea, severe abdominal pain [severe enteritis]
  • breathing difficulty, fever, dry cough [interstitial pneumonia]
  • blood in stool, darkened stool, hematemesis, abdominal pain [severe stomatitis, gastrointestinal ulcer / gastrointestinal hemorrhage / gastrointestinal perforation]
  • severe stomatitis, red rash, eyelid or eye redness [toxic epidermal necrolysis, muco-cutaneo-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 dicard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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