Jungwoo 5-FU Injection (Fluorouracil)

Adult administration

(Injection) 1. Intravenous injection (systemic administration): As a monotherapy, the typical adult dose of fluorouracil is 5-15 mg per kg body weight (less than 1 g per injection) dissolved in 300-500 mL of 5% dextrose injection, administered via continuous intravenous infusion daily for 5 days. Following that, it is administered via continuous intravenous infusion every other day at a dose of 5-7.5 mg per kg body weight. 2. Arterial injection: As a monotherapy, the typical adult dose of this medication is calculated based on body weight.

This medication should be handled with extreme care when opening the ampule as glass fragments may be mixed in, especially for children and the elderly. Do not use this medication in combination with certain antiviral drugs as it may cause severe blood abnormalities. Patients should be under strict medical supervision during administration and should only be used in medical facilities equipped for emergencies with experienced staff. Regular liver function tests should be conducted as liver function may be affected; if symptoms such as loss of appetite or fatigue indicative of liver dysfunction occur, administration should be stopped immediately and treatment sought. May cause severe blood abnormalities if used with certain combination drugs, thus it should not be administered with them. Women who are pregnant or may become pregnant, nursing mothers, patients taking certain medications, and those with severe bone marrow suppression should not use this drug. Patients who are malnourished or have liver, kidney, or heart diseases, as well as the elderly and children should be especially cautious while using this medication and carefully monitored for adverse reactions. This medication may cause various side effects such as neurological symptoms, gastrointestinal disturbances, blood abnormalities, liver and kidney dysfunction, and skin or eye-related reactions; thus, symptoms should be carefully monitored and addressed immediately if abnormalities occur. Severe side effects such as bone marrow suppression and severe diarrhea may occur; regular blood tests and liver and kidney function tests should be performed, and if abnormal findings are confirmed, adjustments in dosage or cessation of administration should be considered. This medication may interact with other medications, exacerbating effects or side effects; therefore, inform your doctor or pharmacist of any concurrent medications. Pregnant or nursing women are advised not to use this medication, and women who could become pregnant must confirm their pregnancy status before administration. Children and elderly patients may experience more severe side effects from this medication, requiring closer observation and management during use. Overdosage may result in symptoms such as dizziness, movement disorders, speech difficulties, and Parkinsonism; report any such symptoms to medical staff immediately. There may be skin damage or inflammation at the injection site, so care should be taken regarding injection methods and sites, particularly with arterial administration, as severe skin or organ damage may occur. When using this drug, it is advisable to slow the injection speed to prevent venous inflammation or pain. This medication may be sensitive to ultraviolet light; therefore, it should be stored in a light-blocking container and exposure to sunlight should be avoided during and after topical application. If severe pain occurs at the application site, corticosteroid ointment may be used or application should be stopped, and skin reactions such as hair loss, rashes, and itching should be closely monitored. This medication should not be used directly on mucous membranes such as the eyes, nose, or mouth, and hands should be washed thoroughly after applying. It is recommended to check for the deficiency of the enzyme that degrades fluorouracil, dihydropyrimidine dehydrogenase (DPD), before using this drug, as toxicity risk increases with deficiency and dosage adjustments or cessation of administration may be needed. During administration, the cardiovascular and neurological symptoms should be regularly monitored; if abnormal symptoms arise, administration should be stopped immediately, and appropriate treatment obtained.

Serious side effects

• Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction
• Severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin reactions
• Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanying cough and fever
• Yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice)
• Sudden and severe headache,

Mild side effects

• Dizziness
• malaise
• nausea
• vomiting
• diarrhea
• altered taste
• dry mouth
• abdominal bloating
• abdominal pain
• constipation

This medication should be stored in a light-resistant, tightly sealed container at room temperature between 1°C and 30°C. This storage condition helps maintain the drug’s efficacy and safety.

Appearance

A transparent injection solution that is colorless to light yellow, contained in a brown ampule or vial

Package unit

5 milliliters, 10 milliliters, 20 milliliters