Daptomycin Eberth

Powder for solution for injection/infusion

Daptomycin Eberth

dosage/strength

dosage form

pack size

 

pharmaceutical registration number

SmPC

350 mg 

powder for solution for injection/infusion

1 vial

N1

19428605

500 mg 

powder for solution for injection/infusion

1 vial

N1

19428634

Active substance:
Daptomycin

Pharmacotherapeutic group:
Antibacterials for systemic use, Other antibacterials

ATC code: J01XX09

Mechanism of action:
Daptomycin is a cyclic lipopeptide natural product that is active against Gram-positive bacteria only.

The mechanism of action involves binding (in the presence of calcium ions) to bacterial membranes of both growing and stationary phase cells causing depolarisation and leading to a rapid inhibition of protein, DNA, and RNA synthesis. This results in bacterial cell death with negligible cell lysis.

Therapeutic indications:
Daptomycin Eberth is indicated for the treatment of the following infections:

  • Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
  • Adult patients with 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.
  • Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated 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, Daptomycin Eberth should be co-administered with appropriate antibacterial agent(s).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.