Linezolid

What it is and how it works

Mechanism of Action Linezolid is an antibacterial drug [ see Microbiology ].

Indications

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 ; Community-acquired pneumonia ; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ; Uncomplicated skin and skin structure infections ; Vancomycin-resistant Enterococcus faecium infections. Limitations of Use : • Linezolid tablets are 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 formulations 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.

Dosage and administration (summary)

Dosage, Route, and Frequency of Administration Infection Pediatric Patients (Birth through 11 years of Age) Adults and Adolescents (12 years and Older) Duration (days) 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 5-11 yrs: 10 mg/kg oral every 12 hours Adults: 400 mg oral every 12 hours Adolescents: 600 mg …

Contraindications

• Known hypersensitivity to linezolid or any of the other product components. • Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. Hypersensitivity Linezolid formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.

Warnings and precautions

• Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. • Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended.

Pregnancy

Pregnancy Risk Summary Available data from published and postmarketing case reports with linezolid use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage and supply

Tablets Linezolid Tablets, 600 mg are white to off white, oval shaped, bevel edged, biconvex film coated tablets, debossed with ‘I’ on one side and ‘22’ on other side. 20 tablets in HDPE bottle NDC 31722-749-20 30 tablets in HDPE bottle NDC 31722-749-30 100 tablets in HDPE bottle NDC 31722-749-01 Unit-dose packages of 150 (15x10) tablets NDC 31722-…

Source: Linezolid (Linezolid) — US FDA prescribing information, 2025-09-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.