LINEZOLID tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

LINEZOLID

Sammensetning:

LINEZOLID 600 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Linezolid Tablets, 600 mg are white to off-white, oval-shape, biconvex, film-coated tablets debossed with '413' on one side and plain on other side and are supplied as follows: NDC 68382-413-92 in bottle of 20 tablets NDC 68382-413-06 in bottle of 30 tablets NDC 68382-413-16 in bottle of 90 tablets NDC 68382-413-01 in bottle of 100 tablets NDC 68382-413-05 in bottle of 500 tablets NDC 68382-413-10 in bottle of 1000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LINEZOLID - LINEZOLID TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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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 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 11years 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 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
Linezolid Tablets, 600 mg.
CONTRAINDICATIONS
Known hypersensitivity to linezolid or any of