DAPTOCCORD 500 POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**4.2 Posology and method of administration** Posology _Adults_ Complicated Skin and Skin Structure Infections Daptomycin 4mg/kg is administered intravenously in 0.9% sodium chloride once every 24 hours for 7 to 14 days, either by injection over a 2-minute period or by infusion over a 30-minute period. Do not dose Daptomycin more frequently than once a day, and measure creatine phosphokinase (CPK) levels at baseline and at regular intervals (at least weekly). Staphylococcus aureus Bloodstream Infections (Bacteremia) Daptomycin 6mg/kg is administered intravenously in 0.9% sodium chloride once every 24 hours for 2 to 6 weeks, either by injection over a 2-minute period or by infusion over a 30-minute period. Duration of treatment is based on the treating physician’s working diagnosis. Do not dose Daptomycin more frequently than once a day, and measure CPK levels at baseline and at regular intervals (at least weekly). _Renal impairment_ Daptomycin is eliminated primarily by the kidney. Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (CrCl< 80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk. The response to treatment, renal function and creatine phosphokinase (CPK) levels should be closely monitored in all patients with any degree of renal impairment (see also sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The dosage regimen for Daptomycin in paediatric patients with renal impairment has not been established. Dose adjustments in adult patients with renal impairment by indication and creatinine clearance.  _Hepatic impairment_ No dose adjustment is necessary when administering Daptomycin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data are available in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, caution should be exercised if Daptomycin is given to such patients. _Elderly patients_ The recommended doses should be used in elderly patients except those with severe renal impairment (see above and section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric patients_ Safety and effectiveness of daptomycin in patients under the age of 18 have not been established. Paediatric patients below the age of one year should not be given daptomycin due to the risk of potential effects on muscular, neuromuscular and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).