LINEZOLID tablet film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

American Health Packaging

INN (Isem Internazzjonali):

LINEZOLID

Kompożizzjoni:

LINEZOLID 600 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

LINEZOLID- LINEZOLID TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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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
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
ADM INISTRATIO N
INFE C TIO N
PEDIATRIC PATIENTS
ADULTS AND
ADO LE SC E NTS
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 every 12 hours
(2)
10 to 14 (2)
DOSAGE FORMS AND STRENGTHS
Tablet: 600 mg linezolid. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to linezolid or any o