LINEZOLID — linezolid tablet, film coated
Alembic Pharmaceuticals Inc.


1.1 Nosocomial Pneumonia

Linezolid tablets are indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ].

1.2 Community-acquired Pneumonia

Linezolid tablets are indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ].

1.3 Complicated Skin and Skin Structure Infections

Linezolid tablets are indicated for the treatment of 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) ].

1.4 Uncomplicated Skin and Skin Structure Infections

Linezolid tablets are indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14) ].

1.5 Vancomycin-resistant Enterococcus faecium Infections

Linezolid tablets are indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14) ].

1.6 Limitations of Use

  • 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) ].
  • The safety and efficacy of linezolid tablets formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see Clinical Studies (14) ].

1.7 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid tablets and other antibacterial drugs, linezolid 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.


2.1 General Dosage and Administration

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

Table 1. Dosage Guidelines for Linezolid Tablets

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)
Nosocomial pneumonia 10 mg/kg oral every 8 hours 600 mg 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 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

*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) ].

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


Linezolid tablets 600 mg are available as “White to off white, oval shaped, film-coated tablets debossed with “L340” on one side and plain on the other side.


4.1 Hypersensitivity

Linezolid tablets 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.


5.1 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 antibacterial drug therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression.

5.2 Peripheral and Optic Neuropathy

Peripheral and optic neuropathies have been reported in patients treated with linezolid, primarily in those patients treated for longer than the maximum recommended duration of 28 days. In cases of optic neuropathy that progressed to loss of vision, patients were treated for extended periods beyond the maximum recommended duration. Visual blurring has been reported in some patients treated with linezolid for less than 28 days. Peripheral and optic neuropathy has also been reported in children.

If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision, or visual field defect, prompt ophthalmic evaluation is recommended. Visual function should be monitored in all patients taking linezolid for extended periods (≥ 3 months) and in all patients reporting new visual symptoms regardless of length of therapy with linezolid. If peripheral or optic neuropathy occurs, the continued use of linezolid in these patients should be weighed against the potential risks.

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