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

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

5-FLUOROURACIL "EBEWE" 250mg/5ml is a potent chemotherapeutic agent used primarily in the treatment of various cancers. It is provided as a concentrated infusion solution in 5ml ampoules, typically supplied in packs of five. The active ingredient, fluorouracil, belongs to the antimetabolite class of drugs and works by interfering with the growth and replication of cancer cells. This medication is widely used for malignancies such as colorectal cancer, breast cancer, head and neck cancers, gastric cancer, and pancreatic cancer.

• Administered intravenously after appropriate dilution.
• Used alone or in combination with other chemotherapy agents or radiotherapy.
• Requires administration under specialist oncology care due to its narrow therapeutic index.
• Effective against rapidly dividing malignant cells by disrupting DNA and RNA synthesis.
• Important in both curative and palliative cancer treatment settings.

5-FLUOROURACIL "EBEWE" is a critical medication in modern oncology, offering a treatment option for several aggressive cancers.

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

Proper use and administration of 5-FLUOROURACIL "EBEWE" are vital to ensure safety and maximize therapeutic effect:

• Preparation: The concentrate must be diluted with an appropriate infusion fluid such as 0.9% sodium chloride or 5% dextrose solution before intravenous use.
• Administration: Given intravenously either as a slow bolus injection or continuous infusion over several hours to days, depending on the treatment protocol.
• Dosage: Varies based on cancer type, patient condition, and treatment regimen.
• Monitoring: Frequent blood tests (CBC, liver and kidney function tests) are mandatory to monitor for toxicity and guide dose adjustments.
• Handling: Healthcare professionals must use protective gloves and follow cytotoxic drug handling guidelines to avoid exposure.
• Patient Instructions: Patients should report any side effects promptly and adhere to scheduled lab monitoring.

This medication should only be administered by trained oncology professionals within a controlled medical environment.

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

5-FLUOROURACIL acts as a thymidylate synthase inhibitor and antimetabolite to halt cancer cell proliferation:

• Intracellular Metabolism: Converted inside cells to active metabolites such as fluorodeoxyuridine monophosphate (FdUMP) and fluorouridine triphosphate (FUTP).
• Thymidylate Synthase Inhibition: FdUMP forms a stable complex with thymidylate synthase, blocking synthesis of thymidine, an essential nucleotide for DNA replication.
• RNA Disruption: FUTP incorporates into RNA, interfering with RNA processing and protein synthesis.
• Selective Toxicity: Targets rapidly dividing cancer cells which depend heavily on DNA and RNA synthesis, leading to cell death (apoptosis).
• Effect Amplification: Often combined with leucovorin to enhance inhibition of thymidylate synthase and increase efficacy.

This dual mechanism makes 5-FLUOROURACIL a highly effective anticancer agent.

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

Drug interactions with 5-FLUOROURACIL can impact treatment safety and effectiveness:

• Leucovorin (Folinic Acid): Potentiates 5-FU’s cytotoxicity by stabilizing its binding to thymidylate synthase.
• Warfarin: Co-administration can increase bleeding risk due to enhanced anticoagulant effects.
• CYP2C9 Substrate Drugs: 5-FU may interfere with metabolism, necessitating monitoring of drugs like phenytoin.
• Other Chemotherapy Agents: Combined use can increase toxicity, requiring careful dose management.
• Radiotherapy: Concomitant use may enhance mucosal and skin toxicities.
• DPD Inhibitors: Co-administration with drugs affecting dihydropyrimidine dehydrogenase can increase 5-FU toxicity.

Always inform the healthcare team of all medications and supplements being taken to avoid harmful interactions.

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

Dosage of 5-FLUOROURACIL depends on multiple factors such as cancer type, patient health, and treatment regimen:

• Typical Dosage: Often ranges between 300-600 mg/m²/day, administered as intravenous bolus or continuous infusion.
• Cancer Type: Doses vary; for example, colorectal cancer protocols often use continuous infusion, while bolus regimens are used in other cancers.
• Combination Therapy: Dosage adjustments are necessary when combined with agents like leucovorin or cisplatin.
• Renal/Hepatic Impairment: Dose modification may be required due to altered metabolism or clearance.
• Cycle Length: Given in cycles, typically every 2-4 weeks, to allow recovery of normal tissues.
• Individualization: Dosing is tailored to patient tolerance and response, guided by clinical and lab monitoring.

Only oncology specialists should determine and adjust dosing.

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

Due to its cytotoxic nature, 5-FLUOROURACIL can cause a range of side effects:

• Hematologic Toxicity: Neutropenia, anemia, thrombocytopenia, increasing infection and bleeding risks.
• Gastrointestinal Symptoms: Nausea, vomiting, diarrhea, stomatitis, and mucositis are common and may be severe.
• Dermatologic Reactions: Hand-foot syndrome (palmar-plantar erythrodysesthesia), skin rash, and photosensitivity.
• Cardiotoxicity: Rare but possible; symptoms include chest pain and arrhythmias.
• Neurological Effects: Fatigue, headache, dizziness, and rarely cerebellar toxicity.
• Other: Alopecia, injection site reactions, and general malaise.

Early detection and management of side effects are crucial to continue therapy safely.

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

Key contraindications include:

• Hypersensitivity: Known allergy to fluorouracil or formulation ingredients.
• Pregnancy and Lactation: Contraindicated due to teratogenic and embryotoxic potential.
• Severe Bone Marrow Suppression: Increased risk of fatal hematologic toxicity.
• Active Severe Infection: Immunosuppression can worsen infections.
• Severe Cardiac Disorders: Risk of exacerbating cardiac issues.
• Dihydropyrimidine Dehydrogenase (DPD) Deficiency: Risk of severe, life-threatening toxicity.

Complete medical evaluation is essential before starting treatment.

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

Proper storage ensures drug stability and safety:

• Store ampoules in their original packaging to protect from light.
• Keep at controlled room temperature, typically 15°C to 25°C (59°F to 77°F).
• Do not freeze; freezing may degrade the product.
• Keep out of reach of children and unauthorized personnel.
• Use immediately after opening and dispose of any unused portion as per safety guidelines.
• Follow institutional and regulatory protocols for handling and disposing of cytotoxic agents.

Adherence to these storage recommendations preserves the medication's efficacy and reduces risk.