PENMIX DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** 1. Dosage in Adults for cSSSI: Administer Penmix Daptomycin Injection 500mg 4mg/kg to adult patients intravenously in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days over a 30-minute period or as an injection over 2 minutes. Unlike in adults, Penmix Daptomycin Injection 500mg should not be administered by injection over a two minute period in pediatric patients. 2. Dosage in Pediatric Patients (1 to 17 Years of Age) with Complicated Skin and Skin Structure Infections, Based on Age Penmix Daptomycin Injection 500mg should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 14 days. Unlike in adults, Penmix Daptomycin Injection 500mg should not be administered by injection over a two (2) minute period in pediatric patients.  3. Recommended Dosage of Penmix Daptomycin Injection 500mg in Pediatric Patients (1 to 17 Years of Age) with S. aureus Bloodstream Infections, Based on Age  4. Dosage in Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin- Resistant Isolates: Administer Penmix Daptomycin Injection 500mg 6 mg/kg to adult patients intravenously in 0.9% sodium chloride for injection once every 24 hours for 2 to 6 weeks over a 30-minute period or as an injection over 2 minutes. Unlike in adults, Penmix Daptomycin Injection 500mg should not be administered by injection over a two minute period in pediatric patients. There are limited safety data for the use of Penmix Daptomycin Injection 500mg for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 adult patients who were treated with daptomycin for more than 28 days. 5. Dosage in Patients with Renal Impairment: The recommended dosage regimen in adult patients with impaired renal functions as follows; When possible, for adult patients on hemodialysis administer Penmix Daptomycin Injection 500mg following the completion of dialysis on dialysis days.  In adult patients with renal impairment, monitor both renal function and CPK more frequently than once weekly. Due to limited clinical experience, daptomycin should only be used in adult patients with any degree of renal impairment (creatinine clearance<80 mL/min) when it is considered that the expected clinical benefit outweighs the potential risk. The response to treatment and renal function should be closely monitored in all adult patients with some degree of renal impairment. The dosage regimen for Penmix Daptomycin Injection 500mg in pediatric patients with renal impairment has not been established.