Linezolid

LINEZOLID- linezolid tablet, film coated
Glenmark Pharmaceuticals Inc., USA

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 has 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 and other antibacterial drugs, linezolid tablets should be used only to treat 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 formulations 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 formulations for the treatment of infections is described in Table 1.

Table 1. Dosage Guidelines for Linezolid
Infection * Dosage, Route and Frequency of Administration Recommended Duration of Treatment (consecutive days)
Pediatric Patients (Birth through 11 Years of Age) Adults and Adolescents (12 Years and Older)
*
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) ].

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 hours5 to 11 yrs: 10 mg/kg oral every12 hours

Adults: 400 mg oral every12 hoursAdolescents: 600 mg oral every 12 hours

10 to 14

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

3 DOSAGE FORMS AND STRENGTHS

Linezolid Tablets 600 mg:

White to off-white, oval, biconvex, film-coated tablets with ‘G44’ debossed on one side and ‘600’ on the other side.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Linezolid formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.

4.2 Monoamine Oxidase Inhibitors

Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product.

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression.

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