Medication info

Cheonbok Fluorouracil 250mg (Fluorouracil)

Prescription medicationInjections정맥Expired
Ingredient · strength
Fluorouracil›50mg / 1mL
Manufacturer / importer
대구경북첨단의료산업진흥재단
Appearance
A clear, colorless liquid in a colorless, transparent vial injection
Packaging
5 milliliters/vial - 5 milliliters/vial
Approval status
Expired

MFDS item code 201904804 · Notified 2019.07.18

This product's status changed to Expired on 2024.07.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of subjective and objective symptoms associated with cancer types (colon cancer, rectal cancer, etc.)
Who receives it
Adults
Adult administration
1. Intravenous injection (systemic administration): As a monotherapy, generally, for adults, administer Fluorouracil at a dose of 5 to 15 mg/kg (not exceeding 1 g per single infusion) diluted in 300 to 500 mL of 5% dextrose injection, infused daily for 5 days. After that, administer 5 to 7.5 mg/kg via continuous intravenous infusion every other day. 2. Arterial injection: As a monotherapy, generally, for adults, administer this drug at a dose of 5 to 7.

Ingredients

Manufacturer
대구경북첨단의료산업진흥재단

Efficacy & effects

Relief of subjective and objective symptoms associated with cancer types (colon cancer, rectal cancer, etc.)

  • Subjective symptoms
  • Objective symptoms
View approved original text

This medication is used to relieve subjective and objective symptoms occurring in various cancers such as colon cancer, rectal cancer, breast cancer, stomach cancer, liver cancer, pancreatic cancer, ovarian cancer, and uterine cancer. It is also used in conjunction with other antitumor agents or radiotherapy to enhance therapeutic effects for specific cancers such as esophageal cancer, lung cancer, sarcoma, and oral cancer. It plays a significant role in effectively managing the symptoms of various cancer types and assisting in treatment.

How it is given

Adult administration

1. Intravenous injection (systemic administration): As a monotherapy, generally, for adults, administer Fluorouracil at a dose of 5 to 15 mg/kg (not exceeding 1 g per single infusion) diluted in 300 to 500 mL of 5% dextrose injection, infused daily for 5 days. After that, administer 5 to 7.5 mg/kg via continuous intravenous infusion every other day. 2. Arterial injection: As a monotherapy, generally, for adults, administer this drug at a dose of 5 to 7.

Precautions

This drug may cause serious blood disorders when used in conjunction with specific antiviral agents, so co-administration should be strictly avoided. During administration, it should be under strict supervision by a physician, and it should only be administered in a medical facility equipped for emergencies with experienced doctors. Regular liver function tests should be conducted, and attention should be paid to early symptoms of liver impairment, as liver function may be affected. Coadministration with certain combination drugs may also lead to serious blood disorders and should be avoided. Some patients, especially women who are pregnant or may become pregnant, nursing mothers, patients with severe bone marrow suppression, and those with specific enzyme deficiencies should not use this drug. Patients with poor nutritional status, liver, kidney, or heart diseases, elderly patients, and children should use this drug carefully, with special attention to adverse reactions. This drug can cause various adverse reactions affecting multiple systems such as the central nervous system, digestive system, circulatory system, blood, liver, kidneys, and skin; any symptoms should be carefully observed, and use should be discontinued immediately if problems arise. Regular blood tests and liver and kidney function tests should be performed during treatment to promptly detect and take appropriate actions for any adverse reactions. Particular attention is needed for drugs that interact with this medication, and consultations with a doctor or pharmacist about other medications being used are essential. It is preferable for women who are pregnant or nursing not to use this drug, and careful administration is also needed for children and the elderly. In case of overdose, symptoms like dizziness and movement disorders may occur, requiring immediate treatment. This drug can cause damage to the skin or blood vessels upon injection, so the injection site should be monitored closely, and administration should be discontinued if abnormalities are observed. This drug should not be mixed physically with certain chemotherapeutic agents, and caution is needed during preparation.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor → severe allergic reactions
  • High fever with severe rash, blisters, skin peeling, oral/eye mucosal pain → severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, cough with fever → respiratory issues
  • Yellowing of the skin or eyes (jaundice), extreme malaise → liver toxicity (jaundice)
  • Sudden

Mild side effects

  • Central Nervous System: Fatigue, dizziness, hallucinations, memory loss, decreased spontaneity, incontinence, ataxia, tremors, speech disorders, facial paralysis, disorientation, numbness in limbs, Parkinsonian symptoms, etc.
  • Gastrointestinal: Loss of appetite, nausea, vomiting, diarrhea, changes in taste, thirst, abdominal distension, abdominal pain, rectal bleeding, constipation, angular cheilitis, glossitis, stomatitis, gastrointestinal ulcers, hair loss, edema, erythema, itching, nail abnormalities, photophobia.

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

Storage

This medication should be stored in a sealed container to prevent contact with air, away from direct sunlight, and at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

A clear, colorless liquid in a colorless, transparent vial injection

Package unit

5 milliliters/vial - 5 milliliters/vial

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.