Trade name: Linezolid, tablets.
International non- proprietary name: Linezolid.
Description: white to off-white round biconvex film-coated tablets. Inequality of the film coating surface is acceptable.
Composition: each tablet contains:
Active substance: linezolid – 300 mg or 600 mg.
Excipients: corn starch, sodium starch glycolate of type A, hydroxypropyl cellulose (E463), magnesium stearate (E572), microcrystalline cellulose (type 101) (E460), Opadry ll White (85F48105).
Composition of Opadry ll White (85F48105) per one tablet: partially hydrolyzed polyvinyl alcohol, macrogol/polyethylene glycol, talc (E553b), titanium hydroxide (E171).
Pharmacotherapeutic group: Antibacterial drugs for systemic use, linezolid.
ATC code: J01XX08.
Indications for use:
Treatment of infections caused by sensitive anaerobic or aerobic gram-positive strains, including the infections accompanied by bacteremia, in case of the conditions listed below. Linezolid is not indicated for treatment of gram-negative infections. It is very important to immediately initiate specific gram-negative therapy, if an infection with gram- negative bacteria is suspected or documentally confirmed.
► Pneumonia
Hospital- acquired pneumonia caused by Staphylococcus aureus (methicillin – sensitive and resistant isolates) or Streptococcus pneumonia.
Community- acquired pneumonia caused by Streptococcus pneumonia, including the cases with concomitant bacteremia, or Staphylococcus aureus (only methicillin-sensitive isolates).
► Skin and its structures infection
Complicated skin and its structures infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin- sensitive and resistant isolates), Streptococcus pyogenes or Staphylococcus agalactiae.
Linezolid is not studied with respect to bedsores treatment.
Uncomplicated skin and its structures infections caused by Staphylococcus aureus (only methicillin- sensitive isolates) or Streptococcus pyogenes.
► Vancomycin- resistant Enterococcus faecium infections Vancomycin- resistant Enterococcus faecium infections, including the cases of concomitant bacteremia.
► Administration
To reduce the growth of drug- resistant bacteria and to maintain the efficacy of linezolid and other antibacterial agents, linezolid should be used only for treatment or prevention of infections with proven or suspected sensitive microorganism, When the information about the culture and sensitivity is available, the conditions for selection or change of antibacterial therapy should be considered. If there is no such information, local epidemiological and sensitivity data may contribute to empiric choice of therapy.