LINEZOLID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)

Available from:

Mylan Institutional LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LINEZOLID- LINEZOLID INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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