LINEZOLID- linezolid granule, for suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Camber Pharmaceuticals, Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Linezolid for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension has not been studied in the treatment of decubitus ulcers [ see Clinical Studies (14) ].  Linezolid for oral suspensi

ملخص المنتج:

Linezolid for oral suspension is available as a dry, white or off-white to brown 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 250 mL glass bottles NDC 31722-865-25 Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LINEZOLID - LINEZOLID GRANULE, FOR SUSPENSION
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LINEZOLID FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR LINEZOLID FOR
ORAL SUSPENSION.
LINEZOLID FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Myelosuppression (5.1) 7/2023
INDICATIONS AND USAGE
Linezolid for oral suspension 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):
• Linezolid for oral suspension 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 evaluated
in controlled clinical trials.
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
10 mg/kg intravenous
or oral every 8 hours
600 mg intravenous or oral
every 12 hours
10 to 14
Community-acquired
pneumonia,
including
concurrent bacteremia
Complicated
skin
and
skin structure infections
Vancomycin-resistant
_Enterococcus_
_faecium_infections,
including concurrent
bacteremia
10 mg/kg intravenous
or oral e