Medication info

K-Medif U Injection 500 mg

Prescription medicationInjections정맥
Ingredient · strength
Fluorouracil›50mg / 1mL
Manufacturer / importer
대구경북첨단의료산업진흥재단
Appearance
A colorless and transparent liquid contained in a brown vial
Packaging
10 milliliters/vial - 10 milliliters/vial
Approval status
Active

MFDS item code 202402958 · Approved 2024.12.16

Summary

Main use
(Cancer types) Relief of subjective and objective symptoms
Who receives it
Adults
Adult administration
1. Intravenous injection (systemic administration): As a single therapy, typically 5-15 mg of fluorouracil per kg body weight per day (not exceeding 1g per single infusion) is diluted in 300-500 mL of 5% dextrose solution and administered by slow intravenous drip daily for 5 days. After that, it is administered every other day at a dosage of 5-7.5 mg per kg body weight by slow intravenous drip. 2. Arterial injection: As a single therapy, typically 5-7.5 mg per kg body weight of this drug is administered per day.

Ingredients

Manufacturer
대구경북첨단의료산업진흥재단

Efficacy & effects

(Cancer types) Relief of subjective and objective symptoms

View approved original text

This medication is used to relieve subjective and objective symptoms in various types of cancer, such as colon cancer, rectal cancer, breast cancer, gastric cancer, liver cancer, pancreatic cancer, ovarian cancer, and uterine cancer. Additionally, it is effective when used in combination with other antitumor agents or radiation therapy for esophageal cancer, lung cancer, malignant tumors, and tongue cancer. This medication aids in improving patient symptoms and enhances therapeutic effectiveness.

How it is given

Adult administration

1. Intravenous injection (systemic administration): As a single therapy, typically 5-15 mg of fluorouracil per kg body weight per day (not exceeding 1g per single infusion) is diluted in 300-500 mL of 5% dextrose solution and administered by slow intravenous drip daily for 5 days. After that, it is administered every other day at a dosage of 5-7.5 mg per kg body weight by slow intravenous drip. 2. Arterial injection: As a single therapy, typically 5-7.5 mg per kg body weight of this drug is administered per day.

Precautions

This medication is used as an antitumor agent and should not be used in conjunction with certain antiviral agents or fluorouracil derivatives as it may cause serious blood disorders. During the administration of this drug, patients must be under strict medical supervision, and it is essential to carefully read the instructions before starting treatment. Regular liver function tests are required during treatment as liver function may be compromised, and attention should be paid to early symptoms of liver dysfunction such as loss of appetite or fatigue; if abnormal symptoms occur, drug administration should be stopped immediately. It should not be used in combination with specific combination regimens to avoid serious blood disorders. This drug should not be administered to specific patients, such as pregnant women or women of childbearing potential, patients with a history of severe hypersensitivity reactions, and patients with bone marrow suppression following certain chemotherapy treatments. Patients who are malnourished or have liver, kidney, or heart disease, as well as the elderly and children, should use this drug with increased caution, and careful monitoring for adverse reactions is necessary. Various adverse reactions may occur during the use of this medication, including psychiatric and neurological symptoms, gastrointestinal symptoms, blood disorders, liver and kidney dysfunction, skin reactions, and respiratory issues; patients should closely observe symptoms and immediately consult healthcare professionals if abnormalities arise. This drug may cause bone marrow suppression and severe diarrhea; thus, regular blood tests and liver and kidney function assessments are essential, and dosage adjustments or cessation of administration should occur if any warning signs are discovered. Additionally, this drug can interact with certain medications. If other drugs are being taken, patients must inform their doctor or pharmacist, especially when used with anticoagulants such as warfarin. Pregnant or breastfeeding women are advised not to use this medication, and care should be taken when administering it to children or the elderly, with careful monitoring of their condition. In case of overdose, symptoms like dizziness, movement disorders, and speech difficulties may occur, and immediate medical attention is required if such symptoms appear. This medication can cause skin damage at the injection site; therefore, monitoring the injection site frequently is necessary, and administration should be halted if any abnormalities occur. Finally, this drug may rarely cause serious blood disorders such as acute leukemia or myelodysplastic syndrome with long-term use, so regular check-ups are required.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/eye mucosa, severe allergic reactions, severe skin reactions, respiratory distress, asthma attacks, breathing abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and very severe headaches, thunderclap headaches, seizures

Mild side effects

Loss of appetite, nausea, vomiting, diarrhea, changes in taste, thirst, abdominal distension, abdominal pain, rectal bleeding, constipation, stomatitis, glossitis, fatigue, dizziness, headache, localized reactions due to extravasation (pain, swelling, redness), hair loss, maculopapular rash, itching, flushing, nail abnormalities, photosensitivity, skin pigmentation, conjunctivitis, tearing, rash, thrombosis, hypotension, hypertension, thrombocytopenia, leukopenia,

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. This helps maintain the drug's efficacy over time and prevents deterioration.

Appearance and packaging

Appearance

A colorless and transparent liquid contained in a brown vial

Package unit

10 milliliters/vial - 10 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.

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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.