LINEZOLID injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Hospira, Inc.

INN (Alþjóðlegt nafn):

LINEZOLID

Samsetning:

LINEZOLID 2 mg in 1 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14

Vörulýsing:

Linezolid injection is available in a single-dose, ready-to-use flexible plastic container in a foil laminate overwrap. The container is available in the following package size: Unit of sale Concentration NDC 0409-4883-01 Case of 10 single-dose VisIVTM flexible plastic containers 600 mg/300 mL (2 mg/mL) NDC 0409-4883-10 Case of 10 single-dose freeflex® flexible plastic containers 600 mg/300 mL (2 mg/mL) Store at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light. It is recommended that the containers be kept in the overwrap until ready to use. Protect containers from freezing.

Leyfisstaða:

New Drug Application

Vara einkenni

LINEZOLID- LINEZOLID INJECTION, SOLUTION
HOSPIRA, INC.
----------
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)
9/2023
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);
Vancomycin-resistant _Enterococcus faecium_
infections. (1.4)
Limitations of Use: (1.5)
•
•
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. (1.6)
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 (1.1)
10 mg/kg
intravenously every
8 hours
600 mg
intravenously every
12 hours
10 to 14
Community-acquired pneumonia,
including concurrent bacteremia (1.2)
Complicated skin and skin structure
infections (1.3)
Vancomycin-resistant _Enterococcus_
_faecium_ infections, including concurrent
bacteremia (1.4)
10 mg/kg
intravenously every
8 hours
600 mg
intravenously every
12 hours
14 to 28
•
DOSAGE FORMS AND STRENGTHS
Injection: 600 mg/300 mL (2 mg/mL) linezolid. (3)
CONTRAINDICATIONS
•
•
Linezolid is not indicated for the treatment of Gram-negative
infections.
The safety and efficacy of Linezolid formulations given for longer
than 28 days have not been