Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)
Greenstone LLC
LINEZOLID
LINEZOLID 600 mg
ORAL
PRESCRIPTION DRUG
Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ]. Linezolid is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ]. Linezolid is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , or Streptococcus agalactiae . Linezolid has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14) ]. Linezolid is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) o
Linezolid Tablets are available as follows: 600 mg (white, capsule-shaped, film-coated tablet debossed with "ZYV" on one side and "600" on the other) 20 tablets in HDPE bottle NDC 59762-1307-1 Unit dose packages of 20 tablets NDC 59762-1307-2 Store at 25ºC (77ºF). Protect from light. Keep bottles tightly closed to protect from moisture.
New Drug Application Authorized Generic
LINEZOLID- LINEZOLID TABLET, FILM COATED GREENSTONE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LINEZOLID SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LINEZOLID. LINEZOLID TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Warnings and Precautions, Myelosuppression (5.1) 7/2023 INDICATIONS AND USAGE Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant _Enterococcus faecium_ infections. (1.5) Limitations of Use (1.6): • • To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.7) DOSAGE AND ADMINISTRATION DOSAGE, ROUTE, AND FREQUENCY OF ADMINISTRATION INFECTION PEDIATRIC PATIENTS (BIRTH THROUGH 11 YEARS OF AGE) ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) DURATION (DAYS) Nosocomial pneumonia (2) 10 mg/kg intravenous or oral every 8 hours (2) 600 mg intravenous or oral every 12 hours (2) 10 to 14 (2) Community-acquired pneumonia, including concurrent bacteremia (2) Complicated skin and skin structure infections (2) Vancomycin-resistant _Enterococcus faecium_ infections_,_ including concurrent bacteremia (2) 10 mg/kg intravenous or oral every 8 hours (2) 600 mg intravenous or oral every 12 hours (2) 14 to 28 (2) Uncomplicated skin and skin structure infections (2) less than 5 yrs: 10 mg/kg oral every 8 hours 5–11 yrs: 10 mg/kg oral every 12 hours (2) Adults: 400 mg oral every 12 hours Adolescents: 600 mg oral eve Przeczytaj cały dokument