5-FLUOROURACIL "EBEWE" 250mg/5ml Infusion/Concentrate for

What is 5-FLUOROURACIL "EBEWE" 250mg/5ml

5-FLUOROURACIL "EBEWE" 250mg/5ml is a chemotherapeutic medication supplied as a concentrate for infusion. The active ingredient, fluorouracil (5-FU), is an antimetabolite used primarily in oncology to treat various types of cancer. This injectable formulation is contained in a 5ml glass vial and is intended for intravenous administration after appropriate dilution.

• Belongs to the class of antimetabolites that inhibit DNA synthesis.
• Commonly used for cancers such as colorectal, breast, stomach, pancreatic, and head & neck cancers.
• Used in combination with other chemotherapy agents or radiation therapy for enhanced efficacy.
• Administered under strict medical supervision in specialized oncology settings.
• Requires careful dosing and monitoring due to its potent cytotoxic effects and narrow therapeutic window.

5-FLUOROURACIL "EBEWE" plays a crucial role in cancer management by targeting rapidly dividing malignant cells.

How to use 5-FLUOROURACIL "EBEWE" 250mg/5ml

Proper administration of 5-FLUOROURACIL "EBEWE" is critical to maximize therapeutic benefits while minimizing toxicity:

• Preparation: The concentrate must be diluted in an appropriate infusion fluid, usually 0.9% sodium chloride or 5% dextrose solution, before intravenous administration.
• Route: Administered intravenously either as a bolus injection or continuous infusion depending on the treatment protocol.
• Dosage Schedule: Dosing regimens vary widely depending on the cancer type, patient condition, and combination therapy used.
• Monitoring: Regular blood tests to monitor blood counts, liver and kidney function, and other parameters are mandatory during treatment.
• Supportive Care: Antiemetics and hydration may be used to manage side effects.
• Handling Precautions: Health professionals should use gloves and protective equipment to avoid exposure, as 5-FU is cytotoxic.

Only trained oncology healthcare providers should handle and administer this medication.

Mode of Action 5-FLUOROURACIL "EBEWE" 250mg/5ml

5-FLUOROURACIL exerts its anticancer effect by disrupting nucleic acid metabolism:

• Thymidylate Synthase Inhibition: 5-FU is converted intracellularly to fluorodeoxyuridine monophosphate (FdUMP), which inhibits thymidylate synthase, an enzyme critical for DNA synthesis.
• DNA Synthesis Interference: This inhibition leads to thymidine depletion, preventing DNA replication and repair in rapidly dividing cancer cells.
• RNA Incorporation: 5-FU metabolites can also incorporate into RNA, disrupting RNA processing and function, further impairing protein synthesis.
• Selective Cytotoxicity: Because cancer cells divide faster than normal cells, they are more affected by these disruptions, leading to cell cycle arrest and apoptosis.
• Enhancement with Combination Therapy: Often used with other agents to potentiate its cytotoxic effects.

Through these mechanisms, 5-FLUOROURACIL effectively inhibits tumor growth and proliferation.

5-FLUOROURACIL "EBEWE" 250mg/5ml Interactions 5-FLUOROURACIL "EBEWE" 250mg/5ml

Several drug interactions can impact the efficacy and safety of 5-FLUOROURACIL therapy:

• Leucovorin (Folinic Acid): Potentiates 5-FU’s effect by stabilizing the thymidylate synthase-FdUMP complex, enhancing cytotoxicity.
• Warfarin: Increased risk of bleeding due to 5-FU’s effect on vitamin K metabolism and platelet function.
• CYP2C9 Substrates: 5-FU may alter metabolism of drugs metabolized by CYP2C9, requiring monitoring.
• Other Chemotherapeutics: Combination regimens require careful monitoring to avoid additive toxicities.
• Phenytoin: Blood levels may be affected; monitoring required.
• Radiation Therapy: May increase mucositis and skin toxicity.

It is essential to inform healthcare providers about all concurrent medications for safe management.

Dosage of 5-FLUOROURACIL "EBEWE" 250mg/5ml

The dosage of 5-FLUOROURACIL varies depending on cancer type, treatment intent, and patient factors:

• Typical Adult Dose: Often ranges from 300 to 600 mg/m²/day, administered as bolus injections or continuous infusion over several days.
• Combination Protocols: Doses are adjusted when given with leucovorin or other agents.
• Renal and Hepatic Impairment: Dose modifications may be necessary due to altered drug clearance.
• Special Populations: Dose adjustments are required in elderly or debilitated patients to reduce toxicity risk.
• Treatment Cycles: Typically administered in cycles with rest periods for recovery of normal tissues.
• Close Monitoring: Frequent blood counts and clinical evaluation guide dose adjustments.

Dosing should always be individualized by an oncologist based on patient response and tolerability.

Possible side effects of 5-FLUOROURACIL "EBEWE" 250mg/5ml

5-FLUOROURACIL is associated with various adverse effects due to its cytotoxic action on both malignant and healthy rapidly dividing cells:

• Hematologic: Neutropenia, thrombocytopenia, and anemia leading to infection risk, bleeding, and fatigue.
• Gastrointestinal: Nausea, vomiting, diarrhea, mucositis, and stomatitis are common.
• Dermatologic: Hand-foot syndrome (palmar-plantar erythrodysesthesia), skin rash, and photosensitivity.
• Cardiotoxicity: Rare but may include chest pain or arrhythmias.
• Neurologic: Headache, dizziness, or cerebellar toxicity in rare cases.
• Other: Alopecia, fatigue, and injection site reactions.

Prompt reporting and management of side effects improve patient outcomes and therapy continuation.

5-FLUOROURACIL "EBEWE" 250mg/5ml Contraindications 5-FLUOROURACIL "EBEWE" 250mg/5ml

Contraindications for 5-FLUOROURACIL include:

• Known Hypersensitivity: Allergy to fluorouracil or formulation components.
• Pregnancy and Lactation: Teratogenic and embryotoxic; contraindicated unless benefits outweigh risks.
• Severe Bone Marrow Suppression: Risk of fatal myelosuppression.
• Active Infections: Increased risk of sepsis due to immunosuppression.
• Severe Cardiac Disease: Potential increased cardiotoxicity risk.
• Patients with Dihydropyrimidine Dehydrogenase (DPD) Deficiency: Increased risk of severe toxicity due to impaired drug metabolism.

Contraindications must be carefully assessed before therapy initiation.

Storage of 5-FLUOROURACIL "EBEWE" 250mg/5ml

To maintain stability and safety, proper storage conditions are vital:

• Store in a cool, dry place, ideally between 15°C and 25°C (59°F and 77°F).
• Protect from light by keeping the vial in its original carton.
• Do not freeze the vial; freezing can degrade the product.
• Keep out of reach of children and unauthorized persons.
• Once opened, use immediately or discard any unused portion as per institutional protocols to prevent contamination.
• Follow local regulations for the disposal of cytotoxic agents and their containers.

Adhering to these guidelines ensures the medication’s efficacy and safety during its shelf life.