LINEZOLID suspension

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Greenstone LLC

INN (Alþjóðlegt nafn):

LINEZOLID

Samsetning:

LINEZOLID 100 mg in 5 mL

Stjórnsýsluleið:

ORAL

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 uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) o

Vörulýsing:

Linezolid for Oral Suspension is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL. Linezolid for Oral Suspension is supplied as follows: 100 mg/5 mL in 240 mL glass bottles        NDC 59762-1308-1 100 mg/5 mL in 240 mL glass bottles        NDC 59762-1308-4 Store at 25°C (77°F). Protect from light. Keep bottles tightly closed to protect from moisture.

Leyfisstaða:

New Drug Application Authorized Generic

Vara einkenni

LINEZOLID- LINEZOLID SUSPENSION
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 ORAL SUSPENSION
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 every 12
hours (