5-FLUOROURACIL "EBEWE" 500mg/10ml Infusion/Concentrate for

What is 5-FLUOROURACIL "EBEWE" 500mg/10ml

5-FLUOROURACIL "EBEWE" 500mg/10ml is a chemotherapeutic agent used primarily in the treatment of various malignancies. It is supplied as a concentrated infusion solution in 10ml ampoules and contains fluorouracil as the active ingredient, a widely used antimetabolite medication in oncology.

• Fluorouracil is a pyrimidine analog, classified as an antineoplastic drug that interferes with DNA and RNA synthesis in cancer cells.
• It is effective in treating solid tumors such as colorectal cancer, breast cancer, head and neck cancers, gastric cancer, and pancreatic cancer.
• The drug targets rapidly dividing cancer cells by disrupting their ability to replicate and grow.
• Available only as an intravenous formulation, it requires dilution before administration.
• Often used alone or in combination with other chemotherapy agents like leucovorin or oxaliplatin.
• Because of its potent cytotoxic effects, its administration is closely supervised by oncology specialists.

5-FLUOROURACIL "EBEWE" plays a critical role in modern chemotherapy protocols, balancing efficacy and toxicity with precise dosing and careful patient monitoring.

How to use 5-FLUOROURACIL "EBEWE" 500mg/10ml

p>The proper use of 5-FLUOROURACIL "EBEWE" requires careful preparation and administration by trained healthcare professionals:

• Dilution: The concentrated solution must be diluted with appropriate IV fluids such as 0.9% sodium chloride or 5% dextrose before administration.
• Administration Route: Administered intravenously, either as a slow bolus injection or continuous infusion over several hours or days depending on the protocol.
• Dosage Determination: Dosage is calculated based on body surface area (mg/m²) and tailored to the specific cancer type, patient’s general condition, and concurrent therapies.
• Monitoring: Vital signs and blood counts should be monitored closely before, during, and after administration to detect toxicities early.
• Preparation Precautions: Healthcare staff must wear protective equipment to avoid exposure, as fluorouracil is cytotoxic and can be harmful upon contact or inhalation.
• Patient Counseling: Patients should be informed about the treatment schedule, potential side effects, and the importance of reporting any symptoms promptly.
• Storage Before Use: Store unopened ampoules at room temperature and protect from light until ready for dilution.

Due to its complexity and risks, 5-FLUOROURACIL "EBEWE" must only be used under the supervision of an oncology specialist or in a hospital setting equipped for chemotherapy administration.

Mode of Action 5-FLUOROURACIL "EBEWE" 500mg/10ml

5-FLUOROURACIL exerts its anticancer effects through multiple mechanisms that disrupt DNA and RNA synthesis:

• Metabolic Activation: After cellular uptake, 5-FU is metabolized into active forms such as fluorodeoxyuridine monophosphate (FdUMP) and fluorouridine triphosphate (FUTP).
• Thymidylate Synthase Inhibition: FdUMP irreversibly binds to thymidylate synthase, a key enzyme required for thymidine nucleotide synthesis, thus preventing DNA replication.
• RNA Disruption: FUTP is incorporated into RNA instead of uracil, leading to defective RNA processing and function.
• Selective Cytotoxicity: The drug preferentially affects rapidly dividing cancer cells due to their increased demand for DNA and RNA synthesis.
• Apoptosis Induction: By impairing nucleic acid synthesis, 5-FU triggers programmed cell death in malignant cells.
• Enhanced Effect with Leucovorin: Co-administration with leucovorin stabilizes the FdUMP-thymidylate synthase complex, increasing the drug’s effectiveness.

Through these mechanisms, 5-FLUOROURACIL disrupts cancer cell proliferation, making it an effective chemotherapy agent.

5-FLUOROURACIL "EBEWE" 500mg/10ml Interactions 5-FLUOROURACIL "EBEWE" 500mg/10ml

Interactions with other medications can influence both the efficacy and toxicity of 5-FLUOROURACIL:

• Leucovorin: Enhances 5-FU activity by stabilizing its binding to thymidylate synthase; often used concomitantly in chemotherapy regimens.
• Warfarin: 5-FU may increase the anticoagulant effects of warfarin, raising the risk of bleeding; frequent INR monitoring is necessary.
• Phenytoin: Levels may increase when given with 5-FU, heightening the risk of phenytoin toxicity; serum levels should be closely observed.
• Other Chemotherapeutics: Combined use with drugs like cisplatin, methotrexate, or irinotecan can potentiate side effects requiring dosage adjustments.
• Radiotherapy: Concurrent radiation can increase local toxicity, such as mucositis and skin irritation.
• DPD Inhibitors: Agents that inhibit dihydropyrimidine dehydrogenase (DPD), the enzyme responsible for 5-FU metabolism, can cause severe toxicity due to reduced drug clearance.

It is vital to review all medications a patient is taking to avoid harmful interactions and ensure safe chemotherapy administration.

Dosage of 5-FLUOROURACIL "EBEWE" 500mg/10ml

The dosing of 5-FLUOROURACIL is highly individualized and depends on multiple factors:

• Body Surface Area-Based Dosing: Typical doses range from 300 to 600 mg/m² per day, administered as intravenous bolus or continuous infusion.
• Type and Stage of Cancer: Dosing regimens vary by cancer type (e.g., colorectal, breast) and whether 5-FU is used as monotherapy or in combination.
• Administration Schedule: May be given daily for a few days, weekly, or continuously over several days, according to treatment protocols.
• Adjustment for Toxicity: Dose reductions are necessary in patients experiencing severe side effects like myelosuppression or mucositis.
• Renal and Hepatic Function: Though metabolism is primarily hepatic, impaired organ function warrants cautious dosing and close monitoring.
• Elderly Patients: May require dose adjustment due to increased sensitivity and comorbidities.

Strict oncologist supervision is essential to optimize dosing, balancing efficacy and safety.

Possible side effects of 5-FLUOROURACIL "EBEWE" 500mg/10ml

5-FLUOROURACIL is associated with several adverse effects, mainly due to its impact on rapidly dividing cells:

• Hematologic Toxicity: Neutropenia, anemia, thrombocytopenia increasing susceptibility to infections, fatigue, and bleeding.
• Gastrointestinal Effects: Nausea, vomiting, diarrhea, mucositis, stomatitis, and abdominal pain are common and can affect patient quality of life.
• Dermatologic Reactions: Hand-foot syndrome (palmar-plantar erythrodysesthesia), skin rash, photosensitivity, and alopecia.
• Cardiotoxicity: Rare but serious effects include chest pain, arrhythmias, and myocardial ischemia.
• Neurological Symptoms: Headache, dizziness, fatigue, and in rare cases, cerebellar ataxia or encephalopathy.
• Local Reactions: Phlebitis or irritation at the infusion site.
• Other: Fever, weakness, and general malaise.

Monitoring and timely management of side effects are crucial to minimize complications and continue treatment safely.

5-FLUOROURACIL "EBEWE" 500mg/10ml Contraindications 5-FLUOROURACIL "EBEWE" 500mg/10ml

p>There are several important contraindications to consider before prescribing 5-FLUOROURACIL:

• Hypersensitivity: Known allergy to fluorouracil or any formulation components.
• Pregnancy and Breastfeeding: Contraindicated due to teratogenic and toxic effects on the fetus and infant.
• Severe Bone Marrow Suppression: Use is contraindicated in patients with existing severe neutropenia, thrombocytopenia, or anemia.
• Active Severe Infections: Immunosuppressed patients are at increased risk of life-threatening infections.
• Cardiac Disease: Caution or contraindication in patients with unstable angina or recent myocardial infarction due to potential cardiotoxicity.
• DPD Deficiency: Genetic deficiency of dihydropyrimidine dehydrogenase enzyme can lead to fatal toxicity and is a contraindication.

Careful patient evaluation and history-taking are essential to avoid use in contraindicated situations.

Storage of 5-FLUOROURACIL "EBEWE" 500mg/10ml

Proper storage of 5-FLUOROURACIL ensures its stability and safety:

• Store the ampoules at controlled room temperature, generally between 20°C and 25°C (68°F to 77°F).
• Protect from light and moisture to prevent degradation.
• Do not freeze or refrigerate the concentrate.
• Keep the ampoules in their original packaging until use to minimize contamination risks.
• Once diluted for infusion, use the solution within the recommended time frame (usually a few hours) as per institutional protocols.
• Store away from children and unauthorized personnel.
• Dispose of unused or expired medication according to hazardous drug waste guidelines.