LINEZOLID injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

linezolid (UNII: ISQ9I6J12J) (linezolid - UNII:ISQ9I6J12J)

متاح من:

Sagent Pharmaceuticals

INN (الاسم الدولي):

linezolid

تركيب:

linezolid 2 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Linezolid Injection is supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in overwrap until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container and container closure are not made with natural rubber latex.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LINEZOLID- LINEZOLID INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
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 ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome (5.3)
9/2021
Warnings and Precautions, Hyponatremia and/or Syndrome of
Inappropriate
Antidiuretic Hormone Secretion (SIADH) (5.10)
10/2021
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):
Linezolid injection is not indicated for the treatment of
Gram-negative infections.
The safety and efficacy of linezolid injection 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 injection
formulations and other antibacterial drugs, linezolid injection 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
every 8 hours
600 mg intravenous every
12 hours
10 to 14
Community-acquired
pneumonia, including concurrent
bacteremia
Complicated skin and skin
structure infections
Vancomycin-resistan