Medication info
Tego Capsule 25

Tego Capsule 25

Prescription medicationHard capsuleOral
Ingredient · strength
Tegafur›25mg / 1 capsuleGimeracil›7.25mg / 1 capsuleOteracil Potassium›24.5mg / 1 capsule
Manufacturer / importer
Myungmoon Pharm. Co., Ltd.
Appearance
An opaque hard capsule with an upper orange part and a lower white part containing a white powder and particles.
Packaging
56 capsules (14 capsules/PTP x 4)
Approval status
Active

MFDS item code 201706903 · Approved 2017.08.31 · Insurance code 649807220

Summary

Main use
Treatment of gastric cancer and head and neck cancer
Who takes it
Adults
Adult dose
Usually, the initial dose (per dose) for adults is determined based on body surface area and administered orally twice daily, after breakfast and dinner, for 28 consecutive days, followed by a 14-day rest period. This is repeated as one cycle. However, if no abnormalities in clinical laboratory values (blood tests, liver and renal function tests) or gastrointestinal symptoms considered to be caused by administration of this medicine occur and there are no safety concerns, the rest period may be shortened, but even in that case, the rest period must be at least 7 days. The dose may be appropriately adjusted according to the patient's condition. Dose adjustment steps are 40,50,60,75mg/dose. As with the above, if it is determined that the dose can be increased without safety concerns, increase by one step from the initial reference dose, up to a maximum of 75mg/dose. Dose reduction is generally performed one step at a time, and the minimum dose is 40mg/dose. * Usually, when adjusting the dose according to the patient's condition, refer to the following doses. However, if increasing the dose, do so once per cycle and stop after one dose-increase step.

Ingredients

Importer
Myungmoon Pharm. Co., Ltd.

Efficacy & effects

Treatment of gastric cancer and head and neck cancer

  • Advanced stomach cancer
  • metastatic stomach cancer
  • recurrent stomach cancer
  • head and neck cancer
  • advanced head and neck cancer
  • recurrent head and neck cancer
View approved original text

This medication is used for the treatment of advanced, metastatic, or recurrent stomach cancer, and is also used as adjuvant chemotherapy after stomach cancer surgery. It is effective for the treatment of advanced or recurrent head and neck cancer. In summary, this drug is used for the treatment of stomach cancer and head and neck cancer.

How to take

Adult dose

Usually, the initial dose (per dose) for adults is determined based on body surface area and administered orally twice daily, after breakfast and dinner, for 28 consecutive days, followed by a 14-day rest period. This is repeated as one cycle. However, if no abnormalities in clinical laboratory values (blood tests, liver and renal function tests) or gastrointestinal symptoms considered to be caused by administration of this medicine occur and there are no safety concerns, the rest period may be shortened, but even in that case, the rest period must be at least 7 days. The dose may be appropriately adjusted according to the patient's condition. Dose adjustment steps are 40,50,60,75mg/dose. As with the above, if it is determined that the dose can be increased without safety concerns, increase by one step from the initial reference dose, up to a maximum of 75mg/dose. Dose reduction is generally performed one step at a time, and the minimum dose is 40mg/dose. * Usually, when adjusting the dose according to the patient's condition, refer to the following doses. However, if increasing the dose, do so once per cycle and stop after one dose-increase step.

Precautions

This drug is used for cancer chemotherapy and must be administered under the guidance of an experienced physician in a medical facility capable of responding to emergency situations. Before administration, the effects and risks of the drug should be thoroughly explained to the patient and their family, and consent obtained prior to use. This drug primarily causes myelosuppression as a side effect, and frequent clinical tests must be performed. Immediate action should be taken if any abnormal signs are detected. Patients with severely impaired liver function must regularly conduct liver function tests while using this drug to detect liver damage early. Serious side effects may occur when combined with other fluoropyrimidine-based anticancer agents or certain antifungal agents, so co-administration should be avoided. The dosage and administration of the drug must be strictly followed, and especially, those who are carriers of the hepatitis B virus or have a history of infection should check for infection beforehand as there is a risk of hepatitis reactivation. Patients with severe allergic reactions, myelosuppression, significantly impaired renal or liver function, pregnant women or those who may become pregnant, and patients with certain genetic issues should not use this drug. Caution should be exercised for patients with myelosuppression, renal or liver dysfunction, infectious diseases, blood sugar regulation issues, pulmonary diseases, heart diseases, gastrointestinal diseases, elderly patients, and those with specific allergies when administering this drug. This medication may cause various side effects, particularly hematological abnormalities, gastrointestinal disorders, liver function abnormalities, skin reactions, and neurological issues have been reported. Serious side effects include myelosuppression, hepatitis, dehydration, enteritis, pneumonia, heart disease, stomatitis, renal failure, skin and mucous membrane syndrome, neuropsychiatric disorders, and acute pancreatitis; if any symptoms occur, immediate consultation with medical staff is required. Furthermore, during administration, regular blood tests and liver and kidney function tests should be conducted to closely monitor the patient's condition. This drug is more effective and safe when taken after meals, and care should be taken regarding interactions with other anticancer drugs or medications. Elderly patients should be used more cautiously due to the possibility of decreased physiological function, and should not be used by pregnant or nursing women. The safety of this drug in children or newborns has not been established, so special caution is needed when administering. When taking medication, capsules should be taken out of their packaging, and care should be taken not to swallow the packaging. This drug has also been occasionally reported to cause serious side effects such as acute leukemia, myelodysplastic syndrome, and cerebral infarction; therefore, if any abnormal symptoms arise during use, consult with medical personnel immediately.

Side effects

  • Leukopenia
  • neutropenia
  • hemoglobin decrease
  • thrombocytopenia
  • AST elevation
  • ALT elevation
  • decreased appetite
  • nausea
  • vomiting
  • diarrhea
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  • generalized fatigue
  • stomatitis
  • pigmentation
  • rash
  • anemia
  • hair loss
  • fatigue
  • increased bilirubin
  • increased creatinine
  • myocardial infarction
  • angina
  • arrhythmia
  • heart failure
  • dehydration symptoms
  • severe enteritis
  • interstitial pneumonia
  • severe stomatitis
  • gastrointestinal ulcer
  • gastrointestinal bleeding
  • gastrointestinal perforation
  • acute renal failure
  • nephritic syndrome
  • mucocutaneous syndrome
  • toxic epidermal necrolysis
  • leucodystrophy
  • altered consciousness
  • sensory loss
  • drowsiness
  • memory decline
  • extrapyramidal symptoms
  • speech impairment
  • limb paralysis
  • gait impairment
  • urinary incontinence
  • perceptual disorders
  • acute pancreatitis
  • rhabdomyolysis
  • loss of smell
  • tear duct obstruction
  • fever
  • systemic heat sensation
  • rhinitis
  • pharyngitis
  • phlegm
  • diabetes
  • elevated blood sugar levels
  • edema
  • myalgia
  • CK elevation
  • arthralgia
  • electrolyte imbalance
  • weight loss
  • elevated serum amylase
  • insomnia
  • depression
  • anxiety
  • dizziness
  • headache
  • sensory abnormalities
  • neuropathy
  • decreased consciousness
  • peripheral neuropathy
  • hoarseness
  • hypotension
  • hypertension
  • abnormal ECG
  • Raynaud's syndrome
  • tearing
  • conjunctivitis
  • keratitis
  • corneal erosion
  • ocular pain
  • decreased vision
  • dry eyes
  • corneal ulcer
  • corneal limbal stem cell deficiency
  • LDH elevation
  • decreased total protein
  • decreased albumin
  • rash
  • pruritus
  • abnormal hemoglobin
  • hemoglobinopathies
  • erythrocytopenia
  • pancytopenia
  • leukopenia
  • leukocyte abnormalities
  • leukocytosis
  • neutrophil abnormalities
  • febrile neutropenia
  • lymphocytopenia
  • thrombocytopenia
  • platelet abnormalities
  • dyspnea
  • pneumonia
  • increased phlegm
  • sore throat
  • runny nose
  • pleural effusion
  • nosebleed
  • cold
  • upper respiratory infection
  • hemoptysis
  • blood-streaked sputum
  • aspiration pneumonia
  • itching
  • excessive skin pigmentation
  • hand-foot syndrome
  • skin shedding
  • urticaria
  • itchy rash
  • skin dryness
  • nail changes
  • erythema
  • dermatitis
  • hair loss
  • abnormalities of nails
  • paronychia
  • herpes simplex
  • skin dryness
  • roughness
  • photosensitivity
  • DLE-like lesions
  • metastatic neoplasms
  • carcinoma syndrome
  • carbohydrate antigen 19-9 increase
  • tumor bleeding
  • increased carcinoembryonic antigen
  • recurrent cancer
  • jaundice
  • positive urobilinogen in urine
  • liver dysfunction
  • increased liver enzymes
  • abnormal ALT
  • abnormal AST
  • abnormal bilirubin
  • elevated BUN
  • proteinuria
  • hematuria
  • dysuria
  • oliguria
  • hydronephrosis
  • facial edema
  • acute renal failure
  • hematuria
  • nocturia
  • neck and shoulder pain
  • body pain
  • myalgia
  • arthralgia
  • skeletal pain
  • sepsis
  • septic shock
  • shingles
  • hypotension
  • cerebral hemorrhage
  • vaginal bleeding
  • fatty liver
  • dysphagia
  • tinnitus
  • agitation
  • elevated serum uric acid levels
  • gynecomastia

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored at room temperature between 1 degree and 30 degrees Celsius, and it is important to keep it in a tightly sealed container to prevent air from entering. Doing so will help maintain the drug's efficacy and prevent deterioration.

Appearance and packaging

Appearance

An opaque hard capsule with an upper orange part and a lower white part containing a white powder and particles.

Package unit

56 capsules (14 capsules/PTP x 4)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.