Linezolid

LINEZOLID- linezolid tablet, film coated
Mylan Institutional Inc.

1 INDICATIONS AND USAGE

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)] .

1.1 Pneumonia

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)] .

1.2 Skin and Skin Structure Infections

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 Streptococcus agalactiae. Linezolid tablets have not been studied in the treatment of decubitus ulcers [see Clinical Studies (14)] .

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14)] .

1.3 Vancomycin-resistant Enterococcus faecium Infections

Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14)] .

1.4 Usage

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

The safety and efficacy of linezolid tablets given for longer than 28 days have not been evaluated in controlled clinical trials.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for linezolid for the treatment of infections is described in Table 1.

Table 1. Dosage Guidelines for Linezolid
*
Due to the designated pathogens [see Indications and Usage (1)]
Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)] .
Oral dosing using linezolid tablets [see How Supplied/Storage and Handling (16)] .

Infection *

Dosage and Route of Administration

Recommended Duration of Treatment (consecutive days)

Pediatric Patients (Birth through 11 Years of Age)

Adults and Adolescents (12 Years and Older)

Nosocomial pneumonia

10 mg/kg intravenously or oral every 8 hours

600 mg intravenously 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 intravenously or oral every 8 hours

600 mg intravenously 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

No dose adjustment is necessary when switching from intravenous to oral administration.

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