Linezolid
Linezolid Prescribing Information
Warnings and Precautions, 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. Thrombocytopenia has been reported more often in patients with severe renal impairment, whether or not on dialysis, and in patients with moderate to severe hepatic impairment. 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 with severe renal impairment or moderate to severe hepatic impairment, 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 [ see Adverse Reactions (6.2) ]. | 7/2023 |
Warnings and Precautions, Rhabdomyolysis ( Rhabdomyolysis has been reported with the use of linezolid, including Linezolid for Oral Suspension [ .see Adverse Reactions (6.2)]. If signs or symptoms of rhabdomyolysis such as muscle pain, tenderness or weakness, dark urine or elevated creatine phosphokinase are observed, discontinue Linezolid for Oral Suspension and initiate appropriate therapy | 6/2024 |
Linezolid 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 (
Linezolid is indicated for the treatment of nosocomial pneumonia caused by
Linezolid is indicated for the treatment of community-acquired pneumonia caused by
Linezolid is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by
Linezolid is indicated for the treatment of uncomplicated skin and skin structure infections caused by
Linezolid is indicated for the treatment of vancomycin
• Linezolid 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)].
• Linezolid 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 formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid 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.
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 intravenous or oral every 8 hours | 600 mg intravenous 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 intravenous or oral every 8 hours | 600 mg intravenous 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 | Adults: 400 mg oral every 12 hours | 10 to 14 |
Linezolid for Oral Suspension: dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL.
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. When administered during organogenesis, linezolid did not cause malformations in mice, rats, or rabbits at maternal exposure levels approximately 6.5 times (mice), equivalent to (rats), or 0.06 times (rabbits) the clinical therapeutic exposure, based on AUCs. However, embryo fetal lethality was observed in mice at 6.5 times the estimated human exposure. When female rats were dosed during organogenesis through lactation, postnatal survival of pups was decreased at doses approximately equivalent to the estimated human exposure based on AUCs (see
The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
• Known hypersensitivity to linezolid or any of the other product components. ()4.1 HypersensitivityLinezolid formulations are contraindicated for use in patients who have 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. ()4.2 Monoamine Oxidase InhibitorsLinezolid 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.