Introduction

Flurotor 500 mg (Fluorouracil) Injection is a high-quality antineoplastic medication manufactured by Eskayef Pharmaceuticals Ltd., one of Bangladesh’s premier pharmaceutical companies. As part of Orio Pharma’s oncology portfolio, this powerful cytotoxic agent provides crucial therapeutic intervention for patients battling various forms of cancer.

What is Flurutor?

Flurutor contains Fluorouracil (5-FU), a pyrimidine analog that functions as an antimetabolite, disrupting essential cellular processes in rapidly dividing cancer cells. This versatile chemotherapeutic agent has become a cornerstone in cancer treatment protocols worldwide due to its proven efficacy across multiple tumor types.

Therapeutic Applications

Flurutor demonstrates remarkable versatility in treating numerous cancer types, making it an essential component in modern oncology practice. It is indicated either as monotherapy or in combination with other antineoplastic agents for:

1. Gastrointestinal Cancers
   • Carcinoma of the colon or rectum
   • Carcinoma of the stomach
   • Carcinoma of the exocrine pancreas
   • Carcinoma of the liver
2. Breast Cancer
   • Both as adjuvant therapy and for metastatic disease
3. Genitourinary Cancers
   • Carcinoma of the bladder
   • Epithelial ovarian carcinoma
   • Cervical carcinoma
4. Respiratory System
   • Carcinoma of the lung

This broad spectrum of applications makes Flurutor an invaluable asset in comprehensive cancer treatment strategies.

Mechanism of Action

Fluorouracil works through a sophisticated mechanism that targets rapidly dividing cells:

Metabolic Activation: Though inactive in its original form, Fluorouracil undergoes conversion within mammalian cells to its active metabolite, 5-fluorodeoxyuridine monophosphate (FdUMP).

Enzymatic Inhibition: The active metabolite forms a stable complex with the folate cofactor N-5, 10-methylene tetrahydrofolate, effectively inactivating thymidylate kinase—an enzyme crucial for DNA synthesis.

RNA Disruption: Additionally, Fluorouracil as FdUMP incorporates into RNA, causing fluorination that further disrupts cellular processes.

Cell Cycle Effects: While cells in the G2 and S phases are most vulnerable to Fluorouracil’s effects, the drug can impact cells at any stage of the cell cycle, making it effective against various tumor cell populations.

Dosage Guidelines

Flurutor administration requires careful consideration of patient factors and specific cancer protocols:

Standard Intravenous Administration:

• Rapid IV bolus injection: 12-13.5 mg/kg (500 mg/m²) daily for 5 days, repeated at 4-week intervals
• Slow IV infusion: Diluted in 500 ml of 5% dextrose solution and infused over 2-3 hours for 5 consecutive days

For Palliative Cancer Management:

• Initial dose: 12 mg/kg intravenously once daily for 4 successive days (maximum 800 mg/day)
• If no toxicity appears, 6 mg/kg may be administered on days 6, 8, 10, and 12
• Treatment discontinues after day 12, even without apparent toxicity

For High-Risk Patients:

• Initial dose: 6 mg/kg/day for 3 days (maximum 400 mg/day)
• If well-tolerated, 3 mg/kg may be administered on days 5, 7, and 9
• Treatment discontinues after day 9

Maintenance Therapy Options:

• Repeat initial course every 30 days after the previous course’s completion, or
• Administer 10-15 mg/kg weekly as a single dose (maximum 1g/week) after initial toxicity resolves

Special Administration Routes:

• Intra-arterial infusion: 5-7.5 mg/kg dissolved in 20-100 ml of 5% dextrose solution, administered over 10-20 days
• Combination with radiation: 5-10 mg/kg daily alongside radiotherapy
• Combination with other anticancer drugs: 5-10 mg/kg daily, either continuously or intermittently (once or twice weekly)

All dosing should be supervised by experienced oncologists who can adjust protocols based on individual patient response and tolerance.

Quality Assurance

Flurotor 500 mg Injection exemplifies Eskayef Pharmaceuticals’ commitment to manufacturing excellence. Each batch undergoes rigorous quality control procedures to ensure sterility, potency, and consistency. Orio Pharma maintains strict adherence to international standards for storage, handling, and distribution of this critical medication.

Safety Considerations

Healthcare professionals should exercise appropriate caution when prescribing and administering Flurutor:

Monitoring Requirements:

• Complete blood counts should be performed regularly during treatment
• Treatment should be discontinued promptly if any of these toxicity signs appear:
  • Leukopenia (WBC under 3500/mm³)
  • Thrombocytopenia (platelets under 100,000/mm³)
  • Stomatitis (ulceration at inner margin of lips)
  • Severe diarrhea
  • Gastrointestinal ulceration or bleeding

Special Patient Populations:

• Dosage adjustments for elderly patients based on weight and height
• Not established for use in children or neonates
• Contraindicated in pregnancy and breastfeeding

Potential Interactions and Side Effects

Drug Interactions:

• Pre-treatment with cimetidine may increase plasma concentrations of Fluorouracil due to hepatic enzyme inhibition and reduced hepatic blood flow

Common Side Effects:

• Hematological: Bone marrow suppression, leukopenia, thrombocytopenia
• Gastrointestinal: Nausea, vomiting, stomatitis, diarrhea
• Dermatological: Hand-foot syndrome, rash, temporary hair loss
• Neurological: Cerebellar symptoms, confusion, balance problems
• Ocular: Conjunctivitis, tear duct stenosis with prolonged use
• Cardiac: Rare ischemic cardiac events

Handling and Reconstitution

As a cytotoxic agent, Flurutor requires special handling procedures:

• Preparation should be performed by trained personnel in designated areas
• Appropriate protective equipment must be used during handling
• Accidental skin contact requires immediate washing with soap and water
• Pregnant women should avoid handling the medication
• Contaminated materials must be disposed of according to proper cytotoxic waste protocols

Storage Requirements

To maintain product stability and efficacy:

• Store in original carton at temperatures not exceeding 25°C
• Do not refrigerate
• Protect from light

Global Availability

Orio Pharma ensures reliable worldwide delivery of Flurotor 500 mg within 3 to 7 working days. This commitment to rapid delivery acknowledges the time-sensitive nature of cancer treatment and the importance of maintaining consistent therapy protocols.

Expert Support

Orio Pharma’s dedicated oncology specialists are available to provide comprehensive information about Flurutor, including guidance on:

• Appropriate patient selection
• Dosage optimization
• Management of potential side effects
• Integration into combination therapy protocols

Manufacturer Information

Eskayef Pharmaceuticals Limited began its journey in 1990 when Transcom Group acquired the Bangladesh operation of SK&F, USA. With over three decades of experience, Eskayef has established itself as a premier pharmaceutical manufacturer, delivering world-class medicines to patients domestically and internationally.