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TS-1 combination OD tablet T25(Tegafur/Gimeracil/Oteracil Potassium)
2015-06-29 20:35:41 来源: 作者: 【 】 浏览:465次 评论:0

TAIHO Pharmaceutical Co.,LTD.

Internal
Published: 6/2013

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 OD Tablet T25
 Active ingredient:
Tegafur
 
Gimeracil
 
Oteracil potassium
 
 Dosage form:
Pale orange-color tablet with white central part on one side, φ: 8.0 mm, thickness: 3.9 mm
 Print on wrapping:
TC43 25mg

Effects of this medicine

TS-1 is biotransformed into fluorouracil (anticancer drug) in the body, enhances antitumor activity by increased concentration and relieves gastrointestinal toxicities (side effects).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 are transferring the medicine 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, potentially 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>>
  • For adults, TS-1 is usually administered twice daily after breakfast and dinner for 28 consecutive days, followed by 14-day rest. This is repeated as one course butit may change according to the patient's condition. Initial standard dose of Tegafur is determined based on body surface area (BSA) as follows: 40mg 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 40mg, 50mg, 60mg, or 75mg. The maximum single dose should not exceed 75mg, with the minimum dose of 40mg. This medicine contains 25 mg of Tegafur in each tablet. Strictly follow the instruction of your doctor / pharmacist.
  • 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.
  • 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 a double dose to make up for the missed dose.
  • 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 ordered), 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 (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

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]
  • breathing difficulty, 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 [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 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.
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