LINEZOLID tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Teva Pharmaceuticals USA, Inc.

INN (nemzetközi neve):

LINEZOLID

Összetétel:

LINEZOLID 600 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablets are 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, without concomitant osteomyelitis , caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus py

Termék összefoglaló:

Linezolid tablets are available as follows: 600 mg – white, film-coated, modified capsule-shaped unscored tablets, debossed with “TV” on one side and with “7490” on the other side of the tablet, in bottles of 20 (NDC 0093-7490-34) and unit-dose boxes of 30 (6 x 5) (NDC 0093-7490-65). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LINEZOLID- LINEZOLID TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 tablets are 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 tablet formulations and
other antibacterial drugs, linezolid tablets 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
Infe ction
Pediatric Patients
(Birth through 11 years of
Age)
Adults and Adolescents
(12 years and Older)
Duration
(days)
Nosocomial pneumonia
10 mg/kg oral every 8 hours
600 mg oral every 12 hours
10 to 14
Community-acquire d
pneumonia, including
concurrent bacteremia
Complicated skin and skin
structure infections
Vancomycin-re sistant
_Enterococcus faecium_
infections, including
concurrent bacteremia
10 mg/kg oral every 8 hours
600 mg 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 to 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
DOSAGE FORMS AND STRENGTHS
Tablet: 600 mg linezolid (3)
CONTRAINDICATIONS
Known hypersensitivity to linezolid or any of the other product
components. (