LINEZOLID- linezolid tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

LINEZOLID

Composition:

LINEZOLID 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid 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 pyogenes , or Strept

Product summary:

Linezolid tablets are available as follows: 600 mg (white, capsule-shaped, film-coated tablet debossed with "LZD" on one side and "600" on the other.) Store at 25ºC (77ºF). Protect from light. Keep bottles tightly closed to protect from moisture.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

LINEZOLID- LINEZOLID TABLET, FILM COATED
APOTEX CORP.
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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
INFE C TIO N
PEDIATRIC PATIENTS (BIRTH
THROUGH11YEARS OF AGE)
ADULTS AND ADOLESCENTS
(12 YEARS AND OLDER)
DURATIO N
(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
infe ctions
Vancomycin-resistant _Enterococcus_
_faecium_ infections_, _including concurrent
bacte re mia
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
infe ctions
less than 5 yrs: 10 mg/kg oral
every 8 hours
5–11 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.
CONTRAINDICATIONS
Known hypersensitivity to linezolid or any of the other