DAPTOCCORD 500 POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL [SIN16071P]

Product Info

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

[SIN16071P]

4.1 Therapeutic indications
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

• Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis (SAB/RIE), caused by methicillin-susceptible and methicillin resistant isolates.

Daptomycin is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The efficacy of Daptomycin in patients with left-sided infective endocarditis due to S.aureus has not been demonstrated. The clinical trial of Daptomycin in patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor. Daptomycin has not been studied in patients with prosthetic valve endocarditis.
Daptomycin is not indicated for the treatment of pneumonia.
Daptomycin is active against Gram-positive bacteria only (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In mixed infections where Gram-negative and/or certain types of anaerobic bacteria are suspected, Daptomycin should be co-administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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).

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.