FDA approved Linezolid Injection for Gram-Positive Infections Including Pneumonia and Skin InfectionsFDA approved new antibiotic injection for serious bacterial infections

FDA From the archive Source published June 18, 2015 Summary added June 13, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider linezolid for MRSA, VRE, and other Gram-positive infections, but not for Gram-negative coverage.

The FDA has approved linezolid injection (Linezolid In Sodium Chloride 0.9% In Plastic Container) for the treatment of several serious Gram-positive infections in adults and children. The drug is indicated for nosocomial pneumonia caused by Staphylococcus aureus (including MRSA) or Streptococcus pneumoniae; community-acquired pneumonia caused by S. pneumoniae or methicillin-susceptible S. aureus; complicated skin and skin structure infections (including diabetic foot infections without osteomyelitis) caused by S. aureus (including MRSA), Streptococcus pyogenes, or Streptococcus agalactiae; and vancomycin-resistant Enterococcus faecium infections. Linezolid is an oxazolidinone-class antibacterial and is not indicated for Gram-negative infections. The approval provides an important option for clinicians treating resistant Gram-positive pathogens, particularly MRSA and VRE. The safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Linezolid is an oxazolidinone-class antibacterial. It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing formation of the 70S initiation complex.

Indication & Patient Population

Linezolid injection is indicated in adults and children for: nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae; community-acquired pneumonia caused by S. pneumoniae (including cases with concurrent bacteremia) or S. aureus (methicillin-susceptible isolates only); complicated skin and skin structure infections, including diabetic foot infections without concomitant osteomyelitis, caused by S. aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae; and vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia. Limitations: Not indicated for Gram-negative infections; safety and efficacy beyond 28 days not evaluated.

Dosing & Administration

For adults and adolescents (12 years and older): 600 mg intravenously every 12 hours. For pediatric patients (birth through 11 years): 10 mg/kg intravenously every 8 hours. Neonates less than 7 days (especially preterm <34 weeks gestational age) should be initiated with 10 mg/kg every 12 hours; consider 10 mg/kg every 8 hours if suboptimal response. By 7 days of life, all neonates should receive 10 mg/kg every 8 hours. Maximum pediatric dose should not exceed adult dose. Linezolid injection in a single-dose container should be used only in pediatric patients who require the entire 600 mg dose. No dose adjustment needed when switching from IV to oral. Duration: 10 to 14 days for nosocomial pneumonia and community-acquired pneumonia; 14 to 28 days for complicated skin infections and VRE infections.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Linezolid is not indicated for Gram-negative infections. If concomitant Gram-negative pathogen is documented or suspected, specific Gram-negative therapy must be initiated immediately. To reduce drug-resistant bacteria, use only for proven or strongly suspected bacterial infections. Safety and efficacy beyond 28 days not established.

Place in Therapy

Linezolid injection provides an intravenous option for treating serious Gram-positive infections, including those caused by MRSA and VRE, in both adults and children. It is a valuable alternative when resistance or intolerance limits use of other agents. However, it should not be used for Gram-negative infections, and empiric Gram-negative coverage should be added if indicated.

The FDA has approved a new antibiotic called linezolid injection (Linezolid In Sodium Chloride 0.9% In Plastic Container) to treat several serious bacterial infections in adults and children. These include hospital-acquired pneumonia, community-acquired pneumonia, complicated skin infections, and infections caused by vancomycin-resistant Enterococcus faecium. The drug targets Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

This approval provides an important treatment option for patients with infections that are resistant to other antibiotics. Linezolid belongs to a class of drugs called oxazolidinones, which work by stopping bacteria from making proteins they need to grow. It is given as an injection into a vein.

It is important to know that linezolid is not effective against Gram-negative infections, which are another common type of bacteria. The safety and effectiveness of using this drug for longer than 28 days have not been studied in controlled trials.

If you or a loved one has a serious infection, talk to your doctor about whether linezolid might be an appropriate treatment. Your doctor can determine the right antibiotic based on the type of bacteria causing the infection and your medical history.

What this means for you:

Linezolid injection is a new option for serious Gram-positive infections, but it is not for all infections.

Study Details

Study typeFda approval

PublishedJun 2015

View Original Abstract ↓

1 INDICATIONS AND USAGE Linezolid injection 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 ( 1.2 ); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ( 1.3 ); Vancomycin-resistant Enterococcus faecium infections. ( 1.4 ) Limitations of Use: ( 1.5 ) • Linezolid injection is not indicated for the treatment of Gram-negative infections. • The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid injection formulations and other antibacterial drugs, Linezolid injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Nosocomial Pneumonia Linezolid injection is 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 injection is 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 injection is 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 injection has not been studied in the treatment of decubitus ulcers [ see Clinical Studies (14) ]. 1.4 Vancomycin-resistant Enterococcus faecium Infections Linezolid injection is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [ see Clinical Studies (14) ]. 1.5 Limitations of Use • Linezolid injection 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) ]. • The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials [ see Clinical Studies (14) ]. 1.6 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid injection and other antibacterial drugs, Linezolid injection 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.

FDA approved Linezolid Injection for Gram-Positive Infections Including Pneumonia and Skin InfectionsFDA approved new antibiotic injection for serious bacterial infections

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

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FDA approved Linezolid Injection for Gram-Positive Infections Including Pneumonia and Skin InfectionsFDA approved new antibiotic injection for serious bacterial infections

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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