LINEZOLID tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Greenstone LLC

INN (Tarptautinis Pavadinimas):

LINEZOLID

Sudėtis:

LINEZOLID 600 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Linezolid Tablets are available as follows: 600 mg (white, capsule-shaped, film-coated tablet debossed with "ZYV" on one side and "600" on the other) 20 tablets in HDPE bottle NDC 59762-1307-1 Unit dose packages of 20 tablets NDC 59762-1307-2 Store at 25ºC (77ºF). Protect from light. Keep bottles tightly closed to protect from moisture.

Autorizacija statusas:

New Drug Application Authorized Generic

Prekės savybės

LINEZOLID- LINEZOLID TABLET, FILM COATED
GREENSTONE LLC
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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 TABLETS, FOR ORAL USE
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 eve