oneal dialysis (CAPD). Whenever possible, Cubicin should be administered following the completion of dialysis on dialysis days.(3) There are insufficient data to support a dose recommendation for patients with RIE or cSSTI associated with Staphylococcus aureus bacteraemia who have a creatinine clearance < 50 ml/min. There are no data available to support the efficacy of 4 mg/kg daily in patients with RIE or cSSTI associated with Staphylococcus aureus bacteraemia whose creatinine clearance is between 3049 ml/min or to support the use of 4 mg/kg every 48 hours in such patients whose creatinine clearance is < 30 ml/min.Hepatic insufficiencyNo dose adjustment is necessary when administering Cubicin to patients with mild or moderate hepatic insufficiency (Child-Pugh Class B). No data are available in patients with severe hepatic insufficiency (Child-Pugh Class C). Therefore caution should be exercised if Cubicin is given to such patients.Elderly patientsThe recommended doses should be used in elderly patients except those with severe renal insufficiency. However, there are limited data on the safety and efficacy of daptomycin in patients aged > 65 years and caution should be exercised if Cubicin is given to such patients.Children and adolescents ( < 18 years old)Due to the lack of data on safety and efficacy Cubicin is not recommended for use in children and adolescents ( < 18 years of age).Method of administrationCubicin is given by intravenous infusion (see section 6.6) and administered over a 30 minute period.
Child Dosage
Children and adolescents ( < 18 years old) - Due to the lack of data on safety and efficacy Cubicin is not recommended for use in children and adolescents ( < 18 years of age).
Elderly Dosage
The recommended doses should be used in elderly patients except those with severe renal insufficiency (see above and Special Precautions). However, there are limited data on the safety and efficacy of daptomycin in patients aged> 65 years and caution should be exercised if Cubicin is given to such patients.
Contra Indications
Hypersensitivity to the active substance or excipient.
Special Precautions
If a focus of Staphylococcus aureus infection other than cSSTI or RIE is identified after initiation of Cubicin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.It has been demonstrated in clinical studies that Cubicin is not effective in the treatment of pneumonia.Clinical data on the use of Cubicin to treat RIE due to Staphylococcus aureus are limited to 19 patients.The efficacy of Cubicin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.Patients with deep-seated infections should receive any required surgical interventions (e.g. debridement, removal of prosthetic devices, valve replacement surgery) without delay.Creatine phosphokinase and myopathyIncreases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with Cubicin (See Interactions and Adverse Reactions). In clinical studies, marked increases in plasma CPK to> 5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in Cubicin-treated p
