CUBICIN (DAPTOMYCIN FOR INJECTION) 500MG VIAL

Manufacturer
PATHEON ITALIA S.P.A.(ITALY)

Registraction Number
MAL19116032ACRZ

Content:
Each vial contains 500 mg of daptomycin, a cyclic lipopeptide antibacterial agent.
Indications:
CUBICIN is indicated for the treatment of:

• Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age).
• Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis in adult patients.

1. Dosage Regimen for Adults:
   • Creatinine Clearance (CLCR) ≥ 30 mL/min: 4 mg/kg once every 24 hours.
   • Creatinine Clearance (CLCR) < 30 mL/min: 4 mg/kg once every 48 hours.
   • Duration: For cSSSI, 7 to 14 days; for bacteremia, 2 to 6 weeks.
2. Administration:
   • Adults: Administer intravenously in 0.9% sodium chloride, either by injection over a 2-minute period or by infusion over a 30-minute period.
   • Pediatric Patients (1 to 17 years): Administer intravenously in 0.9% sodium chloride, by infusion over a 30- or 60-minute period, based on age.
3. Precautions:
   • Do not use in patients with known hypersensitivity to daptomycin.
   • Monitor for signs of muscle pain, weakness, or elevated CPK levels.
   • Avoid use in pediatric patients younger than 1 year due to potential nervous system and muscular effects.
4. Storage: Store below 30°C. Do not freeze.