くすりのしおり

Internal
Revised: 7/2010

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 :
TS-1 combination granule T20
 Active ingredient:
Tegafur
Gimeracil
Oteracil potassium
 Dosage form:
granule, white
 Print on wrapping:
(front)ティーエスワン配合顆粒T20 20mg/0.2g包 TC451, (back)TS-1 T20 20mg

Effects of this medicine

TS-1 enhances the antitumor activity in proportion to the increase in the concentration of 5-fluorouracil (5-FU) in the body via the biotransformation of FT to 5-FU. Also, this medicine relieves gastrointestinal toxicities (side effects) through the effects of oteracil pottasium.
This drug is commonly 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 ever experienced any allergic reaction (itch, rash etc.) to any medicine.
    If you present a condition indicative of bone marrow suppression (including leukopenia).
    If you have renal or hepatic dysfunction.
    If you have an infectious disease or diabetes.
    If you have a current or past history of interstitial pneumonia.
    If you have a heart disease or a history of heart disease.
    If you have gastrointestinal ulcers or hemorrhage.
  • If you are using fluoropyrimidine-group anti-cancer drugs. (TS-1 and these medicines may interact strongly with each other and cause serious side effects.)
  • If you use TS-1 after withdrawal of other fluoropyrimidine-group anti-cancer drugs. (An appropriate washout period must be provided in consideration of the influence of these prior agents.)
  • If you are 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))
  • General dosage regimen: For adults, TS-1 is usually administered twice daily after breakfast and dinner for 28 consecutive days, followed by a 14-day rest, at a dose determined based on body surface area (BSA): BSA less than 1.25 m2, 40 mg; 1.25 m2 or less BSA less than 1.5 m2, 50 mg; BSA or over 1.5 m2, 60 mg of tegafur. This 6-week period is regarded as one course, which is repeated. However, the dose may be decreased or increased according to the patient's condition. The doses are staged thus: 40mg, 50mg, 60mg, and 75mg. The maximum single dose should not exceed 75 mg, with the minimum dose of 40 mg. Each package of TS-1 contains 20mg of tegafur. Strictly follow the instructions of your doctor/pharmacist.
  • TS-1 must NOT be taken with other fluoropyrimidine-group anti-cancer drugs.
  • Record your drug consumption, your physical condition and symptoms and show your records to your physician or pharmacist on your next visit.
  • Proceed with the prescribed schedule of medication starting from the next dose. DO NOT take double doses to make up for the missed dose.
  • If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
  • Do not change your dose and schedule of your chemotherapy without the instructions of your doctor.

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 consult your doctor.

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:
Anorexia, nausea, vomiting, diarrhea, tiredness, stomatitis, pigmentation, rash, lacrimation, etc.
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]
  • yellowing of the skin, tiredness, yellowing of the whites of the eyes, anorexia [severe hepatic dysfunction]
  • diarrhea, severe abdominal pain [severe enteritis]
  • difficult breathing, fever, dry cough [interstitial pneumonia]
  • blood in stool, darkened stool, hematemesis, abdominal pain [gastrointestinal ulcer / gastrointestinal hemorrhage / gastrointestinal perforation]
  • severe stomatitis, red rash, eyelid or eye redness [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 the medicine out of the reach of babies, infants, and children. Store away from direct sunlight, heat, and humidity.
  • Discard the remainder. Do not store them. Check with the pharmacy regarding how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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