Cytosor 500 mg (Cytarabine) Injection

Overview

Cytosor 500 mg (Cytarabine Injection) is a premium anti-neoplastic medication manufactured by Eskayef Pharmaceuticals Ltd and distributed globally by Saif Pharma. This high-quality oncology medicine plays a critical role in the treatment of various forms of leukemia, including leukemic meningitis and acute leukemias, functioning as both an induction and maintenance therapy agent.

Therapeutic Applications

Cytosor 500 mg is specifically indicated for:

• Leukemic meningitis (cancer affecting the fluid and tissues that cover the brain and spinal cord)
• Induction of remission in acute leukemias
• Maintenance of remission in acute leukemias

The active ingredient, Cytarabine, belongs to the antimetabolite class of antineoplastic agents, making it highly effective against rapidly dividing cancer cells, particularly those found in leukemic conditions.

Mechanism of Action

Cytarabine works through specific biological mechanisms to combat leukemic cells:

• Inhibits deoxyribonucleic acid (DNA) synthesis, specifically during the S-phase of the cell cycle
• Blocks DNA polymerase, preventing cancer cells from duplicating their genetic material
• Incorporates into both DNA and RNA, disrupting cellular function
• Possesses antiviral and immunosuppressant activity

This targeted approach effectively disrupts cancer cell replication, leading to leukemic cell death and preventing disease progression.

Dosage and Administration Guidelines

Cytosor 500 mg administration varies based on the condition being treated and the administration route. The medication can be administered intrathecally (into the spinal fluid) or parenterally (intravenous or subcutaneous).

Intrathecal Administration (Adult):

• For Leukemic Meningitis: 5-75 mg/m² or 30-100 mg administered once every 2-7 days, or once daily for 4-5 days
• For Lymphomatous Meningitis: 50 mg every 2 weeks for 5 doses, followed by every 4 weeks for 5 additional doses

Parenteral Administration (Adult):

• Induction and Maintenance of Remission in Acute Leukemias:
  • As Monotherapy: 200 mg/m² daily by continuous IV infusion for 5 days, at intervals of approximately 2 weeks
  • In Combination Therapy: 100 mg/m² twice daily by rapid IV injection or 100 mg/m² daily by continuous IV infusion, both regimens continuing for 7 days
  • Maintenance Therapy: 1-1.5 mg/kg once or twice weekly via IV or subcutaneous administration

All dosages should be administered under the supervision of qualified physicians experienced in chemotherapy protocols, with appropriate monitoring and supportive care.

Reconstitution Guidelines

Proper reconstitution is critical for ensuring the safety and efficacy of Cytosor 500 mg:

For Intravenous Administration:

• Reconstitute with bacteriostatic water for injection (standard-dose)
• Further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion

For Intrathecal Administration:

• Reconstitute with preservative-free NaCl 0.9%
• Further dilute with Elliot’s B solution, NaCl 0.9%, or lactated Ringer’s injection to preferred final volume (up to 12 ml)

Following proper reconstitution procedures ensures optimal drug delivery and minimizes the risk of adverse reactions.

Drug Interactions

Healthcare providers should be aware of important drug interactions with Cytosor 500 mg:

• Reduced Efficacy: May decrease the effectiveness of 5-fluorocytosine, digoxin, and gentamicin
• Increased Risk: May elevate the risk of neurotoxicity when administered intrathecally with other cytotoxic agents
• Synergistic Toxicity: May enhance bone marrow suppression when used with other myelosuppressive medications

Close monitoring is essential when Cytosor is administered concurrently with other medications, particularly those affecting bone marrow function or with known neurotoxic properties.

Contraindications

Cytosor 500 mg is contraindicated in patients with active meningeal infection, as administration in these cases could exacerbate the infection or lead to severe complications.

Safety Profile and Adverse Effects

Common adverse effects associated with Cytosor 500 mg include:

• Gastrointestinal Effects: Nausea, vomiting, diarrhea, anorexia, oral and anal inflammation or ulceration
• Hematological Effects: Thrombocytopenia (low platelet count), bone marrow suppression
• Hepatic Effects: Hepatic dysfunction with elevated liver enzymes
• Neurological Effects: Headache, weakness, confusion
• Constitutional Symptoms: Fever, fatigue, rash

The severity and incidence of these adverse effects may vary based on dosage, administration route, and individual patient factors.

Special Population Considerations

Several patient populations require special attention when receiving Cytosor 500 mg:

Patients with Previous Drug-Induced Bone Marrow Suppression:

• Careful monitoring of blood counts before and during therapy
• Consideration of dose reductions or extended intervals between doses

Patients with Renal or Hepatic Impairment:

• Possible dose adjustments based on organ function
• More frequent monitoring of drug levels and toxicity

Pregnancy and Lactation:

• Pregnancy Category D medication
• Positive evidence of human fetal risk exists
• Use during pregnancy only when benefits clearly outweigh risks
• Not recommended during breastfeeding due to potential serious adverse effects in nursing infants

Overdose Management

In cases of overdose, patients may experience:

• Irreversible CNS toxicity
• Severe arachnoiditis including encephalopathy
• Death in extreme cases

Management protocol includes:

1. Immediate therapy cessation
2. Treatment of ensuing bone marrow depression
3. Whole blood or platelet transfusions as needed
4. Antibiotic therapy to prevent or treat infections
5. Supportive measures to maintain vital functions

Healthcare providers should implement these measures promptly to minimize complications associated with overdose.

Storage and Handling

Proper storage is essential for maintaining Cytosor 500 mg’s potency and safety:

• For IV/SC Formulations: Store between 15-25°C (59-77°F)
• For Intrathecal Formulations: Store between 2-8°C (36-46°F)
• Avoid freezing all formulations
• Protect from light
• Keep out of reach of children
• Follow proper handling and disposal procedures for cytotoxic drugs

Healthcare professionals should follow institutional guidelines for handling cytotoxic medications to minimize exposure risks.

Quality Assurance

As a product of Eskayef Pharmaceuticals Ltd., one of Bangladesh’s leading pharmaceutical companies with over 31 years of experience, Cytosor 500 mg adheres to the highest quality standards. Eskayef has established itself as a producer of world-class medicines, while Saif Pharma has built a reputation as a trusted global distributor of oncology medications since 2014.

Global Availability

Through Saif Pharma’s extensive distribution network, Cytosor 500 mg is available in over 60 countries worldwide, including the United States, Canada, Saudi Arabia, UAE, China, India, and Pakistan. Saif Pharma’s commitment to providing affordable, high-quality oncology medications ensures that patients globally can access this essential leukemia treatment.

Treatment Protocols

Cytosor 500 mg is frequently incorporated into comprehensive leukemia treatment protocols, often combined with other antineoplastic agents for enhanced efficacy. Treatment regimens are tailored to individual patient factors, disease characteristics, and response to therapy. Regular monitoring of hematological parameters, liver and kidney function, and clinical symptoms is essential for optimizing outcomes and minimizing adverse effects.

Conclusion

Cytosor 500 mg (Cytarabine Injection) represents a cornerstone therapy in the management of leukemic meningitis and acute leukemias. Its specific mechanism of action, flexible administration routes, and established efficacy make it an invaluable component of modern oncology practice. Through Saif Pharma’s global distribution network, this high-quality product manufactured by Eskayef Pharmaceuticals is accessible to patients worldwide, contributing to improved outcomes in leukemia treatment.

For more information about Cytosor 500 mg or other oncology medications, visit www.saifpharma.com or contact the manufacturer at www.skfbd.com.