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:

Mylan Institutional Inc.

INN (International Name):

LINEZOLID

Composition:

LINEZOLID 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Linezolid Tablets are available containing 600 mg of linezolid. The 600 mg tablets are yellow, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and L77 on the other side. They are available as follows: NDC 42292-008-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LINEZOLID- LINEZOLID TABLET, FILM COATED
MYLAN INSTITUTIONAL 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 tablets and other
antibacterial drugs, linezolid tablets 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
Dosage, Route, and Frequency of Administration
Infe ction
Pediatric Patients
Adults and Adolescents
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-acquire d
pneumonia, including
concurrent bacteremia
Complicated skin and skin
structure infections
Vancomycin-re sistant
_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
Tablet: 600 mg linezolid. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to linezolid or any of the other product
compon