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Ganciclovir for Injection 500mg
Composition:
Each vial contains:
- Ganciclovir (as Ganciclovir Sodium) 500mg
Description:
Ganciclovir is an antiviral medication belonging to the nucleoside analog class, specifically designed to treat cytomegalovirus (CMV) infections in immunocompromised patients. It inhibits viral DNA replication and is used primarily for CMV retinitis in AIDS patients and CMV prophylaxis in transplant recipients.
Indications:
Ganciclovir for Injection 500mg is indicated for:
- Treatment of CMV retinitis in immunocompromised patients (e.g., AIDS, organ transplant recipients).
- CMV prophylaxis in patients undergoing solid organ or bone marrow transplantation.
- Other severe CMV infections (e.g., CMV pneumonia, CMV esophagitis).
Dosage & Administration:
1. Induction Therapy (CMV Retinitis & Severe CMV Infections):
- Adults:
- 5 mg/kg IV every 12 hours for 14-21 days
- Administer slow IV infusion over 1 hour
- Maintenance Therapy (to prevent relapse):
- 5 mg/kg IV once daily, 5-7 days per week
2. CMV Prophylaxis (Transplant Patients):
- 5 mg/kg IV once daily for 7-14 days, followed by 5 mg/kg IV 5-7 days per week
3. Pediatric Patients (≥3 months):
- Induction: 5 mg/kg IV every 12 hours for 14-21 days
- Maintenance: 5 mg/kg IV once daily, 5-7 days per week
4. Renal Impairment:
- Creatinine Clearance (CrCl) 50-69 mL/min: 2.5 mg/kg every 12 hours
- CrCl 25-49 mL/min: 2.5 mg/kg every 24 hours
- CrCl 10-24 mL/min: 1.25 mg/kg every 24 hours
Administration:
- IV Infusion ONLY (Do NOT administer as an IV bolus).
- Dilute with 0.9% Sodium Chloride (NS) or 5% Dextrose (D5W).
- Infuse over at least 1 hour to avoid toxicity.
Contraindications:
- Hypersensitivity to Ganciclovir or Acyclovir.
- Severe neutropenia (ANC <500/mm³) or thrombocytopenia (platelets <25,000/mm³).
Precautions:
- Hematologic toxicity: Can cause severe neutropenia, anemia, and thrombocytopenia.
- Renal toxicity: Monitor renal function; adjust dose if needed.
- Carcinogenic & Teratogenic risks: Avoid use in pregnant women and advise contraception during and after treatment.
- Use with caution in elderly patients due to renal function decline.
Adverse Reactions:
- Hematologic: Neutropenia, thrombocytopenia, anemia.
- Gastrointestinal: Nausea, vomiting, diarrhea.
- Renal: Increased serum creatinine, nephrotoxicity.
- Neurologic: Headache, seizures, confusion.
- Injection Site Reactions: Phlebitis, pain.
Drug Interactions:
- Zidovudine & Myelosuppressive agents: Increased risk of hematologic toxicity.
- Probenecid & NSAIDs: May increase ganciclovir levels and renal toxicity.
- Imipenem-cilastatin: Risk of seizures.
Storage Conditions:
- Store below 25°C, protect from light.
- Reconstituted solution should be used within 24 hours if refrigerated (2-8°C).
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