Indications : התוויות

1      INDICATIONS AND USAGE

Daptomycin Medi-Market is indicated for the treatment of the infections listed below.
1.1    Complicated Skin and Skin Structure Infections

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).

1.2    Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates

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

Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram negative or anaerobic organism.

1.3    Limitations of Use

Daptomycin Medi-Market is not indicated for the treatment of pneumonia.
Daptomycin Medi-Market is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The clinical trial of Daptomycin for injection in adult patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor [see Clinical Studies (14.2)]. Daptomycin for injection has not been studied in patients with prosthetic valve endocarditis.

1.4    Usage

Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin Medi-Market and other antibacterial drugs, Daptomycin Medi-Market should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information is available, it should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results.