Medication info

Yutoral Injection (Fluorouracil)

Prescription medication정맥
Ingredient · strength
Fluorouracil›50mg / 1mL
Manufacturer / importer
한국유나이티드제약(주)
Appearance
A brown vial containing a colorless, transparent solution
Packaging
For domestic use - 5 milliliters/vial[x1], For domestic use - 5 milliliters/vial[x10], For domestic use - 10 milliliters/vial[x1], For domestic use - 10 milliliters/vial[x10], For domestic use - 10 milliliters/vial[x20], For domestic use - 20 milliliters/vial[x1], For domestic use - 20 milliliters/vial[x10], For export - 5 milliliters/vial[x1], For export - 5 milliliters/vial[x10], For export - 10 milliliters...
Approval status
Active

MFDS item code 199101483 · Notified 1991.07.30

Summary

Main use
Relief of self-reported and externally observed symptoms in various cancers (colon cancer, rectal cancer, etc.) and treatment effects on skin malignancies.
Who receives it
Adults
Adult administration
[Injection] 1. Intravenous injection (systemic administration): As monotherapy, administer fluorouracil at 5-15 mg per kg body weight daily for adults (not exceeding 1 g per dose), diluted in 300-500 mL of 5% dextrose injection and given by continuous IV infusion for 5 days. Thereafter, administer 5-7.5 mg per kg body weight by continuous IV infusion every other day. 2. Arterial injection: As monotherapy, administer this drug at 5-7.5 mg per kg body weight daily in adults, diluted in 20-100 mL of 5% dextrose injection and infused continuously over 10-20 days. 3. In combination with radiation therapy: Administer this drug at 5-10 mg per kg body weight daily for adults in conjunction with radiation therapy, following the same regimen as monotherapy. 4. In combination with other antitumor agents: Administer this drug at 5-10 mg per kg body weight daily for adults, either as monotherapy or intermittently once or twice weekly.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Relief of self-reported and externally observed symptoms in various cancers (colon cancer, rectal cancer, etc.) and treatment effects on skin malignancies.

  • Symptoms of colon cancer
  • rectal cancer
  • breast cancer
  • stomach cancer
  • liver cancer
  • pancreatic cancer
  • ovarian cancer
  • uterine cancer
  • esophageal cancer
  • lung cancer
  • malignant tumors
  • oral cancer
View approved original text

The injection is used to alleviate symptoms experienced by patients and external symptoms in cancers including 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 anticancer agents or radiation therapy to enhance efficacy for conditions such as esophageal cancer, lung cancer, malignant melanoma, and oral cancer. The cream formulation is used to treat malignant tumors of the skin such as squamous cell carcinoma, basal cell carcinoma, Bowen's disease, Paget's disease, radiation keratosis, and senile keratosis. These medications help improve cancer-related symptoms and treat skin cancers.

How it is given

Adult administration

[Injection] 1. Intravenous injection (systemic administration): As monotherapy, administer fluorouracil at 5-15 mg per kg body weight daily for adults (not exceeding 1 g per dose), diluted in 300-500 mL of 5% dextrose injection and given by continuous IV infusion for 5 days. Thereafter, administer 5-7.5 mg per kg body weight by continuous IV infusion every other day. 2. Arterial injection: As monotherapy, administer this drug at 5-7.5 mg per kg body weight daily in adults, diluted in 20-100 mL of 5% dextrose injection and infused continuously over 10-20 days. 3. In combination with radiation therapy: Administer this drug at 5-10 mg per kg body weight daily for adults in conjunction with radiation therapy, following the same regimen as monotherapy. 4. In combination with other antitumor agents: Administer this drug at 5-10 mg per kg body weight daily for adults, either as monotherapy or intermittently once or twice weekly.

Precautions

When using this drug in injection form, care must be taken when cutting the ampule as glass shards may cause side effects. Extra caution is needed when used on children or the elderly. This drug should not be used in conjunction with certain antiviral agents as it can lead to serious blood disorders. It should also be administered under strict medical supervision, with close monitoring of the patient's condition during and after administration. Regular liver function tests should be performed as issues may arise, and if initial symptoms of liver dysfunction such as loss of appetite or fatigue occur, administration should be stopped immediately and appropriate treatment sought. Co-administration with certain combinations poses a risk of serious blood disorders and should be avoided. It is generally not safe to administer this drug to pregnant women, breastfeeding women, and patients with certain enzyme deficiencies. Caution is also warranted for patients who are malnourished or have heart, liver, and kidney issues, as well as for the elderly and children. As this drug may cause diverse side effects, observations should focus on changes in mental state, digestive symptoms, blood abnormalities, liver and kidney function anomalies, skin reactions, and respiratory issues, and any abnormal symptoms should be reported to a physician immediately. Furthermore, this drug's use may increase the risk of infections or bleeding due to bone marrow suppression, necessitating regular blood tests and clinical examinations. Many drugs interact with this medication, so any concurrent medications should be discussed with a physician or pharmacist, particularly if those medications include specific antiviral agents, warfarin, or methotrexate. Pregnant or breastfeeding women should avoid using this drug unless advised otherwise by a healthcare provider. When administered to the elderly or children, careful attention to dose adjustment and patient condition monitoring is required. In cases of overdose, neurological symptoms such as dizziness, motor disability, or speech impairment may occur, necessitating immediate medical intervention. This drug can cause vasculitis or tissue damage at the injection site, so care should be taken with the injection method and site, and ampules should be cut properly to avoid glass shard contamination. Additionally, it should not be physically mixed with certain anticancer agents, and prepared solutions should not be mixed with acidic drugs. During the use of this drug, sun exposure should be avoided, and care should be taken to observe for any skin irritation or pigmentation when applied topically. Finally, monitoring for side effects through clinical examinations and patient condition is crucial for timely detection and appropriate management.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling
  • difficulty breathing
  • rash
  • blisters
  • skin peeling
  • mucosal pain in mouth/eyes
  • dyspnea
  • liver dysfunction (jaundice)
  • sudden and severe headache
Show 17 more
  • confusion
  • visual disturbances
  • paralysis
  • reduced urine output
  • generalized swelling
  • increased blood pressure
  • fulminant hepatitis
  • hemorrhagic colitis
  • ischemic colitis
  • necrotizing colitis
  • acute pancreatitis
  • hemolytic anemia
  • renal failure
  • anaphylaxis
  • interstitial pneumonia
  • Stevens-Johnson syndrome
  • toxicity.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • altered taste
  • dry mouth
  • abdominal bloating
  • abdominal pain
  • constipation
  • stomatitis
  • glossitis
Show 24 more
  • fatigue
  • dizziness
  • loss of appetite
  • headache
  • insomnia
  • emotional instability
  • hypersensitivity reactions
  • hair loss
  • swelling
  • ulceration
  • itching
  • flushing
  • nail abnormalities
  • photosensitivity reactions
  • conjunctivitis
  • tearing
  • nasal irritation
  • herpes simplex
  • local reactions due to extravasation
  • thrombocytopenia
  • anemia
  • eosinophilia
  • thrombocytopenic
  • toxic granulation.

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

Storage

This drug should be stored in a sealed container, protected from direct light exposure. It should not be frozen and should ideally be kept at temperatures between 10 and 30 degrees Celsius.

Appearance and packaging

Appearance

A brown vial containing a colorless, transparent solution

Package unit

For domestic use - 5 milliliters/vial[x1], For domestic use - 5 milliliters/vial[x10], For domestic use - 10 milliliters/vial[x1], For domestic use - 10 milliliters/vial[x10], For domestic use - 10 milliliters/vial[x20], For domestic use - 20 milliliters/vial[x1], For domestic use - 20 milliliters/vial[x10], For export - 5 milliliters/vial[x1], For export - 5 milliliters/vial[x10], For export - 10 milliliters...

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.