LINEZOLID tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Novel Laboratories, Inc.

INN (Internationale Bezeichnung):

LINEZOLID

Zusammensetzung:

LINEZOLID 600 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 pyo

Produktbesonderheiten:

Linezolid tablets, 600 mg, are white, oval, film-coated tablets, debossed with "n 022" on one side and plain on other side. They are available as follows: Package Size                                                   NDC Number Bottle of 20 Tablets                                        40032-022-02 Bottle of 500 Tablets                                      40032-022-05 Unit-Dose Package of 30 Tablets (3 x 10)      40032-022-30 Store at 25°C (77°F). Protect from light. Keep bottles tightly closed to protect from moisture.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

LINEZOLID- LINEZOLID TABLET
NOVEL LABORATORIES, 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 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 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. (1.4)
DOSAGE AND ADMINISTRATION
Infe ction
Dosage, Route and
Frequency of
Administration
Pediatric Patients
Adults and Adolescents
Duration
(days)
Nosocomial pneumonia
Community-acquired pneumonia,
including concurrent bacteremia
10 mg/kg oral every 8 hours
600 mg oral every 12 hours
10 to 14
Complicated skin and skin
structure infections
Vancomycin-resistant _Enterococcus _
_faecium _infections, including concurrent
bacte re mia
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. (4.1); Patients taking any monoamine
oxidase inhibitors (MAOI) or within two