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

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**4.2 Posology and method of administration** Daptomycin is given by intravenous (IV) administration. Daptomycin is a sterile product contained in a single-dose vial. _**Adults**_ Complicated skin and skin structure infections Daptomycin 4 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride solution for injection 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). Refer to section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Staphylococcus aureus_ bloodstream infections (bacteraemia) Daptomycin 6 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride solution for injection 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) Refer to section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _**Paediatric patients (1 to 17 years of age)**_ Complicated skin and skin structure infections The recommended dose regimens based on age for paediatric patients with cSSSI are shown in Table 1. Daptomycin should be administered intravenously in 0.9% sodium chloride solution for injection once every 24 hours for up to 14 days. Unlike in adults, Daptomycin should not be administered by injection over a 2-minute period in paediatric patients.  _Staphylococcus aureus_ bloodstream infections (bacteraemia) The recommended dose regimens based on age for paediatric patients with _S. aureus_ bloodstream infections (bacteraemia) are shown in Table 2. Daptomycin should be administered intravenously in 0.9% sodium chloride solution for injection once every 24 hours for up to 42 days.  **Special population** _**Renal impairment**_ Daptomycin is eliminated primarily by the kidney; therefore, an adjustment of daptomycin dosage interval is recommended for adult patients with creatinine clearance (CLCR) < 30 mL/min, including patients receiving haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). The recommended dosing regimen for these adult patients is 4 mg/kg (cSSSI) or 6 mg/kg ( _S. aureus_ bloodstream infections) once every 48 hours. When possible, administer daptomycin following the completion of haemodialysis on haemodialysis days. In adult patients with renal impairment, monitor both renal function and CPK more frequently than once weekly. No dosage interval adjustment is required for adult patients with CLCR ≥ 30 mL/min. Due to limited clinical experience, daptomycin should only be used in adult patients with any degree of renal impairment (CLCR < 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 patients with some degree of renal impairment. Dose adjustments in adult patients with renal impairment by indication and creatinine clearance:  The dose regimen for daptomycin in paediatric patients with renal impairment has not been established.