くすりのしおり

Internal
Revised: 6/2018

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-1KK Combination Tablets T20
 Active ingredient:
Tegafur
Gimeracil
Oteracil potassium
 Dosage form:
oval, white tablet, major axis: approx. 9.7 mm, minor axis: approx. 5.1 mm, thickness: approx. 3.7 mm
 Print on wrapping:
(face)エスワンケーケー 配合錠T20, エスワンケーケー, 20mg
(reverse side)S-1KK Combination Tablets T20, エスワンケーケー, 20mg

Effects of this medicine

This medicine is biotransformed into fluorouracil (anticancer medicine) in the body, enhances the antitumor activity by increasing its concentration, and also relieves gastrointestinal toxicities (adverse reactions).
It is usually used for 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 or hepatic dysfunction, an infectious disease, diabetes, interstitial pneumonia or its past history, a heart disease or its past history, gastrointestinal ulcers or hemorrhage.
    If you are using fluoropyrimidine-group anti-cancer medicines. (This medicine and these medicines may interact strongly with each other and cause serious adverse reactions.)
    If your medication is changed from fluoropyrimidine-group anti-cancer medicine to this medicine.
    (An appropriate washout period must be provided in consideration of the influence of these prior agents.)
  • 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, this medicine is usually administered twice daily after breakfast and dinner for 28 consecutive days, followed by 14-day rest. This is repeated as one course but it may change according to the patient's condition.
    Initial standard dose of 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 dose may be decreased or increased to single dosing level of 40 mg, 50 mg, 60 mg, or 75 mg. The maximum single dose should not exceed 75 mg, with the minimum dose of 40 mg. This medicine contains 20 mg of tegafur in each tablet. Strictly follow the instruction.
  • This medicine must NOT be taken with other fluoropyrimidine-group anti-cancer medicines.
  • Record your medicine consumption, your physical condition and symptoms and show your records to your doctor or pharmacist on your next visit.
  • If you miss a dose, proceed with the prescribed schedule of medication starting from 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

  • During the treatment, laboratory tests (hematological, liver and renal function tests) are performed regularly at least once every 2 weeks to detect asymptomatic adverse reactions 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.
  • bleeding tendency, tiredness, fever, sore throat [bone marrow suppression, hemolytic anemia]
  • yellowing of the skin, tiredness, yellowing of the whites of the eyes, loss of appetite [severe hepatic dysfunction]
  • diarrhea, severe abdominal pain  [severe enteritis]
  • difficult breathing, fever, dry cough [interstitial pneumonia]
  • blood in stool, darkened stool, hematemesis, abdominal pain [severe stomatitis, gastrointestinal ulcer, gastrointestinal hemorrhage, gastrointestinal perforation]
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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