Drug Class Description
Antibacterials for systemic use, Other antibacterials.

Generic Name
Daptomycin

Drug Description
Cubicin 350 mg powder for concentrate for solution for infusion: Each vial contains 350 mg daptomycin.One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution or water for injections.Cubicin 500 mg powder for concentrate for solution for infusion: Each vial contains 500 mg daptomycin.One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution or water for injections.

Presentation
Powder for concentrate for solution for infusion.A pale yellow to light brown lyophilised powder.

Indications
Cubicin is indicated for the treatment of the following infections in adultsComplicated skin and soft-tissue infections (cSSTI).Right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Adult Dosage
PosologycSSTI without concurrent Staphylococcus aureus bacteraemia: The recommended dose is 4 mg/kg administered once every 24 hours for 714 days or until the infection is resolved.cSSTI with concurrent Staphylococcus aureus bacteraemia: The recommended dose is 6 mg/kg administered once every 24 hours. See below for dose adjustments in patients with renal insufficiency. The duration of therapy may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.Known or suspected right-sided infective endocarditis due to Staphylococcus aureus: The recommended dose is 6 mg/kg administered once every 24 hours. See below for dose adjustments in patients with renal insufficiency. The duration of therapy should be in accordance with available official recommendations.Renal insufficiencyDaptomycin is eliminated primarily by the kidney.Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in patients with any degree of renal insufficiency (Cr Cl < 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 insufficiency.Dose adjustments in patients with renal insufficiency by indication and creatinine clearanceIndication for use (1)Creatinine clearance (1)Dose recommendation (1)CommentscSSTI without S. aureus bacteraemia 30 ml/min4 mg/kg once daily< 30 ml/min4 mg/kg every 48 hours(1,2)RIE or cSSTI associated with S. aureus bacteraemia 50 ml/min6 mg/kg once daily(3)(1) The safety and efficacy of the dose interval adjustment has not been clinically eva luated and the recommendation is based on pharmacokinetic modelling data.(2) The same dose adjustments, which are also based solely on modelling are recommended for patients on haemodialysis or continuous ambulatory perit