DAPTOMYCIN GH (Southern Cross Pharma Pty Ltd)

DAPTOMYCIN GH is not indicated for the treatment of pneumonia.

Adult Patients (≥18 years of age)

DAPTOMYCIN GH is indicated for the treatment of adults (≥18 years of age) with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

DAPTOMYCIN GH is indicated in adults (≥18 years of age) for Staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (RIE), caused by methicillin-susceptible and methicillin-resistant isolates.

The efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to S. aureus has not been demonstrated. In the setting of S. aureus bacteraemia (SAB), if a focus of infection is diagnosed as left-sided endocarditis after [TRADE NAME] therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see Section 4.4 Special Warnings and Precautions for Use).

Paediatric patients (1 to 17 years of age)

DAPTOMYCIN GH is not indicated for treatment of patients less than 1 year of age (see Section 4.4 Special Warnings and Precautions for Use - Paediatric Use). [TRADE NAME] has not been studied in treatment of infective endocarditis in children (see Section 5.1 Pharmacodynamic Properties - Clinical Trials and Section 4.4 Special Warnings and Precautions for Use).

Complicated Skin and Skin Structure Infections

DAPTOMYCIN GH is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.

S. aureus Bloodstream Infections (Bacteraemia)

DAPTOMYCIN GH is indicated in paediatric patients (1 to 17 years of age) with SAB not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally endorsed guidelines for the treatment of SAB.