Drug Detail:Linezolid (monograph) (Zyvox)
Drug Class:
Usual Adult Dose for Bacteremia
600 mg IV or orally every 12 hours
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant Enterococcus faecium infections: 14 to 28 consecutive days
Uses: For the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (including cases with concurrent bacteremia) or Staphylococcus aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Adult Dose for Pneumonia
600 mg IV or orally every 12 hours
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant Enterococcus faecium infections: 14 to 28 consecutive days
Uses: For the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (including cases with concurrent bacteremia) or Staphylococcus aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Adult Dose for Bacterial Infection
600 mg IV or orally every 12 hours
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant Enterococcus faecium infections: 14 to 28 consecutive days
Uses: For the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (including cases with concurrent bacteremia) or Staphylococcus aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Adult Dose for Nosocomial Pneumonia
600 mg IV or orally every 12 hours
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant Enterococcus faecium infections: 14 to 28 consecutive days
Uses: For the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (including cases with concurrent bacteremia) or Staphylococcus aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Adult Dose for Skin and Structure Infection
Complicated infections: 600 mg IV or orally every 12 hours
Uncomplicated infections: 400 mg orally every 12 hours
Duration of therapy: 10 to 14 consecutive days
Uses: For the treatment of complicated skin and skin structure infections (including diabetic foot infections, without concomitant osteomyelitis) due to S aureus (methicillin-susceptible and -resistant isolates), S pyogenes, or S agalactiae; for the treatment of uncomplicated skin and skin structure infections due to S aureus (methicillin-susceptible isolates only) or S pyogenes
Usual Pediatric Dose for Bacteremia
Less than 7 days, gestational age less than 34 weeks: 10 mg/kg IV or orally every 12 hours
Less than 7 days, gestational age at least 34 weeks: 10 mg/kg IV or orally every 8 hours
7 days through 11 years: 10 mg/kg IV or orally every 8 hours
12 years or older: 600 mg IV or orally every 12 hours
Maximum dose: 600 mg/dose
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant E faecium infections: 14 to 28 consecutive days
Comments:
- In preterm neonates younger than 7 days (gestational age less than 34 weeks) with suboptimal clinical response, may consider using 10 mg/kg every 8 hours
- Maximum pediatric dose should not exceed recommended adult dose.
Uses: For the treatment of community-acquired pneumonia due to S pneumoniae (including cases with concurrent bacteremia) or S aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Pediatric Dose for Pneumonia
Less than 7 days, gestational age less than 34 weeks: 10 mg/kg IV or orally every 12 hours
Less than 7 days, gestational age at least 34 weeks: 10 mg/kg IV or orally every 8 hours
7 days through 11 years: 10 mg/kg IV or orally every 8 hours
12 years or older: 600 mg IV or orally every 12 hours
Maximum dose: 600 mg/dose
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant E faecium infections: 14 to 28 consecutive days
Comments:
- In preterm neonates younger than 7 days (gestational age less than 34 weeks) with suboptimal clinical response, may consider using 10 mg/kg every 8 hours
- Maximum pediatric dose should not exceed recommended adult dose.
Uses: For the treatment of community-acquired pneumonia due to S pneumoniae (including cases with concurrent bacteremia) or S aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Pediatric Dose for Bacterial Infection
Less than 7 days, gestational age less than 34 weeks: 10 mg/kg IV or orally every 12 hours
Less than 7 days, gestational age at least 34 weeks: 10 mg/kg IV or orally every 8 hours
7 days through 11 years: 10 mg/kg IV or orally every 8 hours
12 years or older: 600 mg IV or orally every 12 hours
Maximum dose: 600 mg/dose
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant E faecium infections: 14 to 28 consecutive days
Comments:
- In preterm neonates younger than 7 days (gestational age less than 34 weeks) with suboptimal clinical response, may consider using 10 mg/kg every 8 hours
- Maximum pediatric dose should not exceed recommended adult dose.
Uses: For the treatment of community-acquired pneumonia due to S pneumoniae (including cases with concurrent bacteremia) or S aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Pediatric Dose for Nosocomial Pneumonia
Less than 7 days, gestational age less than 34 weeks: 10 mg/kg IV or orally every 12 hours
Less than 7 days, gestational age at least 34 weeks: 10 mg/kg IV or orally every 8 hours
7 days through 11 years: 10 mg/kg IV or orally every 8 hours
12 years or older: 600 mg IV or orally every 12 hours
Maximum dose: 600 mg/dose
Duration of therapy:
- Pneumonia: 10 to 14 consecutive days
- Vancomycin-resistant E faecium infections: 14 to 28 consecutive days
Comments:
- In preterm neonates younger than 7 days (gestational age less than 34 weeks) with suboptimal clinical response, may consider using 10 mg/kg every 8 hours
- Maximum pediatric dose should not exceed recommended adult dose.
Uses: For the treatment of community-acquired pneumonia due to S pneumoniae (including cases with concurrent bacteremia) or S aureus (methicillin-susceptible isolates only); for the treatment of nosocomial pneumonia due to S aureus (methicillin-susceptible and -resistant isolates) or S pneumoniae; for the treatment of vancomycin-resistant E faecium infections (including cases with concurrent bacteremia)
Usual Pediatric Dose for Skin and Structure Infection
Complicated infections:
Less than 7 days, gestational age less than 34 weeks: 10 mg/kg IV or orally every 12 hours
Less than 7 days, gestational age at least 34 weeks: 10 mg/kg IV or orally every 8 hours
7 days through 11 years: 10 mg/kg IV or orally every 8 hours
12 years or older: 600 mg IV or orally every 12 hours
Uncomplicated infections:
Less than 7 days, gestational age less than 34 weeks: 10 mg/kg orally every 12 hours
Less than 7 days, gestational age at least 34 weeks: 10 mg/kg orally every 8 hours
7 days to less than 5 years: 10 mg/kg orally every 8 hours
5 through 11 years: 10 mg/kg orally every 12 hours
12 years or older: 600 mg orally every 12 hours
Maximum dose: 600 mg/dose
Duration of therapy: 10 to 14 consecutive days
Comments:
- In preterm neonates younger than 7 days (gestational age less than 34 weeks) with suboptimal clinical response, may consider using 10 mg/kg every 8 hours
- Maximum pediatric dose should not exceed recommended adult dose.
Uses: For the treatment of complicated skin and skin structure infections (including diabetic foot infections, without concomitant osteomyelitis) due to S aureus (methicillin-susceptible and -resistant isolates), S pyogenes, or S agalactiae; for the treatment of uncomplicated skin and skin structure infections due to S aureus (methicillin-susceptible isolates only) or S pyogenes
Renal Dose Adjustments
No adjustment recommended.
Comments:
- Use in patients with renal dysfunction should be weighed against the potential risks of accumulation of the metabolites; clinical significance of such accumulation has not been established.
Liver Dose Adjustments
Mild to moderate hepatic insufficiency (Child-Pugh class A or B): No adjustment recommended.
Severe hepatic impairment: Data not available
Precautions
Consult WARNINGS section for additional precautions.
Dialysis
Hemodialysis: Dose should be administered after dialysis.
Peritoneal dialysis: Data not available
Comments:
- About 30% of dose removed in 3-hour hemodialysis session beginning 3 hours after dose administered.
Other Comments
Administration advice:
- IV injection: Administer via IV infusion over 30 to 120 minutes; do not use this IV infusion bag in series connections.
- IV injection: When using concomitantly with another drug, administer each drug separately (as appropriate for each drug); if the same IV line is used for sequential infusion of several drugs, flush the line with a compatible infusion solution before and after infusion of this drug.
- Do not adjust dose when switching from IV to oral administration (no adjustments needed).
- Oral: May administer without regard to food
- Oral suspension: Before use, gently mix by inverting the bottle 3 to 5 times; do not shake.
- Do not use this drug for the treatment of gram-negative infections; if concomitant gram-negative pathogen verified/suspected, it is crucial that specific gram-negative therapy is started immediately.
Storage requirements:
- Store at 25C (77F) and protect from light.
- Keep bottles closed tightly to protect from moisture.
- Keep infusion bags in overwrap until ready to use; protect from freezing.
- Discard the oral suspension 21 days after constitution.
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted.
IV compatibility:
- Compatible IV solutions: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; Lactated Ringer's Injection, USP
- Chemically incompatible: Ceftriaxone sodium
- Physically incompatible: Amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium, sulfamethoxazole-trimethoprim
- Additives should not be added to this IV solution.
General:
- To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria. This drug has no clinical activity against gram-negative organisms.
- Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
- The safety and efficacy of this drug beyond 28 days have not been established.
Monitoring:
- Cardiovascular: For potential blood pressure increases (the manufacturer product information should be consulted regarding patient population)
- Hematologic: CBC (weekly)
- Nervous System: For signs/symptoms of serotonin syndrome or neuroleptic malignant syndrome-like reactions (the manufacturer product information should be consulted regarding patient population and monitoring duration)
- Ocular: Visual function (the manufacturer product information should be consulted for further guidance)
Patient advice:
- Avoid missing doses and complete the entire course of therapy.
- Avoid ingesting large amounts of foods or beverages with high tyramine content (e.g., aged cheese, fermented or air-dried meats, sauerkraut, soy sauce, tap beer, red wines) while using this drug.
- Consult physician if changes in vision occur.
- If you have phenylketonuria, be aware that the oral suspension contains 20 mg phenylalanine/5 mL; consult your healthcare provider.
- Consult physician at once if watery and bloody stools (with or without stomach cramps and fever) develop.
- Consult healthcare provider if hypoglycemic reactions occur during therapy.
