Granules for oral suspension
Trade name: Linezolid, granules for oral suspension.
International non- proprietary name: Linezolid.
Description: mixture of granules and powder of white to almost white or light yellow colour with vanilla flavour.
Composition: each bottle contains:
Active substance: linezolid 2 g.
Excipients: microcrystalline cellulose of type 101 (E 460), sodium citrate (E 331), citric acid monohydrate (E 330), methyl cellulose (E 461), mannit (E 421), xanthan gum (E 415), sodium benzoate (E 211), anhydrous colloidal silicon dioxide of type 300 (E 551), sodium chloride, ammonium glycyrizinate, aspartame (E 951), ʺVanilla AN 1361ʺ flavouring, ʺRefreshing GX 1422ʺ flavouring, sucrose.
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 pneumoniae.
Community- acquired pneumonia caused by Streptococcus pneumonia, including the cases with concomitant bacteremia, or Staphylococcus aureus (only methicillin-sensitive isolates).
► Skin and its structures infections
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.
Safety and efficacy of Linezolid course for more than 28 days were not evaluated in controlled clinical trials.
