tegafur + gimeracil + oteracil




Concise Prescribing Info
Per 20-mg cap Tegafur 20 mg, gimeracil 5.8 mg, oteracil K 19.6 mg. Per 25-mg cap Tegafur 25 mg, gimeracil 7.25 mg, oteracil K 24.5 mg.
Gastric, colorectal, head & neck, non-small cell lung, inoperable or recurrent breast, pancreatic & biliary tract cancer.
Dosage/Direction for Use
Adult BSA ≥1.5 m2 Standard initial dose: 60 mg (equiv to tegafur) bd for 28 consecutive days followed by a 14-day rest. 1.25-<1.5 m2 Standard initial dose: 50 mg (equiv to tegafur) bd for 28 consecutive days followed by a 14-day rest. <1.25 m2 Standard initial dose: 40 mg (equiv to tegafur) bd for 28 consecutive days followed by a 14-day rest.
Should be taken with food: Take after breakfast & evening meals.
Severe hypersensitivity. Patients w/ severe bone marrow depression. Concomitant use w/ other fluoropyrimidine-group anti-cancer drugs & flucytosine. Severe renal & hepatic impairment. Women of childbearing potential. Pregnancy.
Special Precautions
Discontinue w/ occurrence of jaundice. Potential serious blood dyscrasias in combination w/ other fluoropyrimidine-group anti-cancer drugs & flucytosine. Laboratory tests should be conducted frequently. Periodic hepatic function tests to detect hepatic disorder early. Patients w/ bone marrow depression, infectious disease, abnormal glucose tolerance, current or previous history of interstitial pneumonia, current or previous history of heart disease, GI ulcer or hemorrhage. May cause or aggravate interstitial pneumonia w/ a possible fatal outcome. Potential gonadic effects to reproducible patients. Confirm status of previous exposure to hepatitis infection prior to administration. Caution for signs & symptoms of Hepatitis B reactivation; monitor hepatic function tests or viral markers. Lactation. Childn. Elderly.
Adverse Reactions
Bone marrow depression, hemolytic anemia; disseminated IV coagulation; severe hepatic disorder eg, fulminant hepatitis; dehydration; severe enteritis; interstitial pneumonia; MI, angina pectoris, arrythmia & cardiac failure; severe stomatitis; GI ulcer, hemorrhage & perforation; acute renal failure & nephrotic syndrome; toxic epidermal necrolysis, mucocutaneoocular syndrome (Stevens-Johnson syndrome); psychoneurologic disorders including leukoencephalopathy or other symptoms; acute pancreatitis; rhabdomyolysis; anosmia; lacrimal duct obstruction. Potentially, hepatic cirrhosis (prolonged prothrombin time, decreased albumin & cholinesterase).
Drug Interactions
Increased blood conc of fluorouracil, phenytoin. Caution in concomitant use w/ warfarin & K.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC53 - tegafur, combinations ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
TS-One cap 20 mg
4 × 14's
TS-One cap 25 mg
4 × 14's
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