Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)
Mylan Institutional LLC
INTRAVENOUS
PRESCRIPTION DRUG
Linezolid injection 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 injection 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 injection 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 injection has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14)] . Linezolid injection is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus
Linezolid injection is available in single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are not made with natural rubber latex. The infusion bags are available in the following package sizes: 200 mg/100 mL (2 mg/mL) NDC 67457-324-00 200 mg/100 mL (2 mg/mL) x 10 NDC 67457-324-10 600 mg/300 mL (2 mg/mL) NDC 67457-843-00 600 mg/300 mL (2 mg/mL) x 10 NDC 67457-843-30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.
Abbreviated New Drug Application
LINEZOLID- LINEZOLID INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LINEZOLID INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LINEZOLID INJECTION. LINEZOLID INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Warnings and Precautions, Myelosuppression (5.1) 7/2023 INDICATIONS AND USAGE Linezolid injection 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 formulation 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 (2) INFECTION (2) PEDIATRIC PATIENTS (BIRTH THROUGH 11 YEARS OF AGE) (2) ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) (2) DURATION (DAYS) (2) Nosocomial pneumonia (2) 10 mg/kg intravenous every 8 hours (2) 600 mg intravenous 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 every 8 hours (2) 600 mg intravenous every 12 hours (2) 14 to 28 (2) DOSAGE FORMS AND STRENGTHS • Injection: 200 mg/100 mL (2 mg/mL) and 600 mg/300 mL (2 mg/mL) linezolid. (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • Linezolid Soma hati kamili