LINEZOLID tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Chartwell RX, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [ see Warnings and Precautions (5.4) ]. Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [ see Clinical Studies (14) ]. Community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [ see Clinical Studies (14) ]. Complicated skin and skin structure infections, including diabetic foot infections,

Produkt oppsummering:

Linezolid Tablets are available as follows: 600 mg (white, oval shape, film-coated tablets debossed with "CIC" on one side and "1" on the other side) Bottles of 20:                                                                                     NDC 62135-442-20 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Keep bottles tightly closed to protect from moisture.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LINEZOLID- LINEZOLID TABLET
CHARTWELL RX, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
LINEZOLID TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LINEZOLID TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LINEZOLID
TABLETS.
LINEZOLID TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
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 ( 1.1); Complicated skin and skin
structure infections, including diabetic
foot infections, without concomitant osteomyelitis ( 1.2);
Uncomplicated skin and skin structure infections (
1.2); Vancomycin-resistant _Enterococcus faecium_ infections. ( 1.3)
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 infections that are proven
or strongly suspected to be caused by bacteria. ( 1.4)
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 every 8 hours
600 mg intravenous
or oral every 12
hours
14 to 28
Uncomplicated skin and skin structure
infections
less than 5 yrs: 10 mg/kg
oral every 8 hours
5–11 yrs: 10 mg/kg oral
every 12 hours
Adults: 400 mg oral
every 12 hours
Adolescents: 600
mg oral every 12
hours
10 to 14
(2)
DOSAGE FORMS AND STRENGTHS
Tablet: 600 mg linezolid. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to linezolid