Linezolid Dosing Regimen and Treatment Duration
Linezolid dosing for treatment of labeled infections is weight-based for pediatric patients (birth through 11 years) and fixed-dose for adults and adolescents (12 years and older) based on the infection type. (accessdata.fda.gov) Treatment duration is determined by indication and is listed as consecutive days in the FDA-approved dosing table. (accessdata.fda.gov)
Medication Selection Algorithm
- Pediatric patients (birth through 11 years of age)
- 10 mg/kg per dose for all listed infection indications that use weight-based dosing. (accessdata.fda.gov)
- Dosing interval is every 8 hours for nosocomial pneumonia and complicated skin and skin structure infections, and every 8 hours for vancomycin-resistant Enterococcus faecium infections, unless the neonate dosing note applies. (accessdata.fda.gov)
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Dosing interval for uncomplicated skin and skin structure infections is age-stratified: every 8 hours for less than 5 years and every 12 hours for 5-11 years. (accessdata.fda.gov)
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Adults and adolescents (12 years and older)
- 600 mg per dose for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections. (accessdata.fda.gov)
- Dosing interval is every 12 hours for these indications. (accessdata.fda.gov)
- Uncomplicated skin and skin structure infections dosing is 400 mg orally every 12 hours for adults and 600 mg orally every 12 hours for adolescents. (accessdata.fda.gov)
Treatment Duration
- Nosocomial pneumonia
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Pediatric and adult/adolescent treatment duration is 10 to 14 consecutive days. (accessdata.fda.gov)
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Community-acquired pneumonia (including concurrent bacteremia)
- Adult/adolescent treatment duration is not listed in the provided dosing table section. (accessdata.fda.gov)
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Pediatric and adult/adolescent treatment duration is listed for the consolidated “community-acquired pneumonia” row that does not display a duration value in the captured table excerpt. (accessdata.fda.gov)
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Complicated skin and skin structure infections
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Pediatric and adult/adolescent treatment duration is 14 to 28 consecutive days. (accessdata.fda.gov)
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Uncomplicated skin and skin structure infections
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Pediatric and adult/adolescent treatment duration is 10 to 14 consecutive days. (accessdata.fda.gov)
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Vancomycin-resistant Enterococcus faecium infections (including concurrent bacteremia)
- Pediatric and adult/adolescent treatment duration is 14 to 28 consecutive days. (accessdata.fda.gov)
Renal Impairment Adjustments
No dose adjustment is recommended for patients with any degree of renal impairment. (accessdata.fda.gov) Pharmacokinetics of linezolid are not altered in renal impairment, but accumulation of two primary metabolites occurs with increasing severity of renal dysfunction. (accessdata.fda.gov) Both linezolid and its metabolites are eliminated by hemodialysis. (accessdata.fda.gov) Linezolid should be administered after hemodialysis because approximately 30% of a dose was eliminated in a 3-hour hemodialysis session beginning 3 hours after dosing. (accessdata.fda.gov) No information is available on the effect of peritoneal dialysis on linezolid pharmacokinetics. (accessdata.fda.gov)
Hepatic Impairment Adjustments
No dose adjustment is recommended for patients with mild-to-moderate hepatic impairment (Child-Pugh class A or B). (accessdata.fda.gov) Pharmacokinetics of linezolid are not altered in mild-to-moderate hepatic impairment. (accessdata.fda.gov) Pharmacokinetics of linezolid in severe hepatic impairment have not been evaluated. (accessdata.fda.gov)
Pediatric Dosing Nuances in Neonates
Neonates less than 7 days of age (especially pre-term neonates with gestational age less than 34 weeks) have lower systemic linezolid clearance and larger AUC values than many full-term neonates and older infants. (accessdata.fda.gov) These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. (accessdata.fda.gov) Consideration may be given to using a 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. (accessdata.fda.gov) All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life. (accessdata.fda.gov)
Intravenous-to-Oral Dosing Conversion
Oral and intravenous administration use the same recommended dose and frequency. (accessdata.fda.gov) No dose adjustment is necessary when switching from intravenous to oral administration. (accessdata.fda.gov)