Adult Dosing
Community acquired pneumonia including concurrent bacteremia, Nosocomial pneumonia
- 600 mg IV q12 hrs for 10-14 days
Skin/Skin structure infections, uncomplicated
- 400 mg IV divided q12 hrs for 10-14 days
Skin/Skin structure infections, complicated
- 600 mg IV q12 hrs for 10-14 days
Vancomycin-resistant enterococcus faecium infections including concurrent bacteremia
- 600 mg IV q12 hrs for 14-28 days
Note: Limit tyramine food content < 100 mg/meal
Pediatric Dosing
Community acquired pneumonia including concurrent bacteremia, Nosocomial pneumonia
- Preterm neonates, < 7 days old: 20 mg/kg/day IV divided q12 hrs for 10-14 days; Increase dose to 30 mg/kg/day IV div q8h by 7 days old or earlier on development of suboptimal response
- Preterm neonates, > 7 days old: 30 mg/kg/day IV divided q8 hrs for 10-14 days
- 0-11 yrs: 30 mg/kg/day IV divided q8 hrs for 10-14 days
- >12 yrs: 600 IV q12 hrs for 10-14 days
Skin/Skin structure infections, uncomplicated
- Preterm neonates, < 7 days old: 20 mg/kg/day IV divided q12 hrs for 10-14 days; Increase dose to 30 mg/kg/day IV div q8h by 7 days old or earlier on development of suboptimal response
- Preterm neonates, > 7 days old: 30 mg/kg/day IV divided q8 hrs for 10-14 days
- 0-5 yrs: 30 mg/kg/day IV divided q8 hrs for 10-14 days
- 5-11 yrs: 20 mg/kg/day IV divided q12 hrs for 10-14 days
- Adolescents: 600 mg IV q12 hrs for 10-14 days
Skin/Skin structure infections, complicated
- Preterm neonates, < 7 days old: 20 mg/kg/day IV divided q12 hrs for 10-14 days; Increase dose to 30 mg/kg/day IV div q8h by 7 days old or earlier on development of suboptimal response
- Preterm neonates, > 7 days old: 30 mg/kg/day IV divided q8 hrs for 10-14 days
- 0-11 yrs: 30 mg/kg/day IV divided q8 hrs for 10-14 days
- >12 yrs: 600 IV q12 hrs for 10-14 days
Vancomycin-resistant enterococcus faecium infections including concurrent bacteremia
- Preterm neonates, < 7 days old: 20 mg/kg/day IV divided q12 hrs for 14-28 days; Increase dose to 30 mg/kg/day IV div q8h by 7 days old or earlier on development of suboptimal response
- Preterm neonates, > 7 days old: 30 mg/kg/day IV divided q8 hrs for 14-28 days
- 0-11 yrs: 30 mg/kg/day IV divided q8 hrs for 14-28 days
- >12 yrs: 600 IV q12 hrs for 14-28 days
Note: Limit tyramine food content < 100 mg/meal
Orbital cellulitis [Non-FDA Approved]
- 10 mg/kg IV q8h [Max 1200 mg/day]
[Outline]
Renal Dose Adjustment
- Renal impairment: Use with caution; no dose adjustments
- Hemodialysis: 20 mg/kg/day div q12 hr
Hepatic Dose Adjustment
- Child-Pughs A/B (mild/moderate impairment) : No dose adjustments
- Child-Pugh C (severe impairment): Dose adjustments not defined
Note: Dose adjustment not needed when switching from IV to PO
- Mortality imbalance has been reported in an investigational study in patients with catheter-related bloodstream infections, including those with catheter-site infections. Linezolid is unapproved and avoid using for the treatment of patients with catheter-related bloodstream infections or catheter-site infections
- Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has occurred
- Weekly monitor CBC in patients receiving linezolid, particularly those receiving this drug for >2 wks, those with pre-existing myelosuppression, those receiving concurrent drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibiotic therapy
- Affected hematologic parameters have risen toward pretreatment levels on discontinuation of therapy
- Consider discontinuation of therapy on developing or having worsening of myelosuppression
- Myelosuppression, reduced extramedullary hematopoiesis in spleen and liver, and lymphoid depletion of thymus, lymph nodes, and spleen has occurred
- Lactic acidosis is associated with the use of this drug. Cases of repeated episodes of nausea and vomiting have occurred. Provide immediate medical evaluation for patients with recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level
- Peripheral and optic neuropathy has occurred in patients. Promptly consider ophthalmic evaluation on experiencing symptoms of visual impairment. Monitor visual function in all patients having therapy for extended periods (
3 months) and in all patients reporting new visual symptoms regardless of duration of therapy. On occurrence of peripheral or optic neuropathy the continued use of this drug should be weighed against the potential risks - Not recommended for pediatric CNS infections due to variable cerebrospinal concentrations
- Not indicated for the treatment of Gram-negative infections. Immediately initiate gram-negative therapy on documentation or suspicion of gram-negative pathogen
- Convulsions have occurred in patients when treated with this drug
- Clostridium difficile associated diarrhea (CDAD) which may range from mild diarrhea to fatal colitis has been reported. Therapy is associated with alteration of the normal flora of the colon leading to overgrowth of C. difficile
- Antibiotic may alter colon flora, leading to C. difficile overgrowth. C. difficile produces toxins A and B which contribute to CDAD. Hypertoxin producing strains causes increased morbidity and mortality since these infections can be refractory to antibiotic therapy and may require colectomy
- On suspicion/confirmation of CDAD discontinue use. Patients may need fluid, electrolyte, and protein supplementation along with antibiotics for C. difficile and surgical evaluation as needed
- Spontaneous reports of serotonin syndrome associated with the co-administration of this drug and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors has occurred
- Patients on linezolid therapy already receiving serotonergic agents should be closely monitored for signs and symptoms of serotonin syndrome such as hyperthermia, rigidity, myoclonus, autonomic instability, and altered mental status including agitation, delerium, and coma
- The monitoring period is ideally 2 weeks (5 weeks for fluoxetine) or until 24 hours following the last dose of linezolid
- On occurrence of signs or symptoms, consider discontinuation of the serotonergic agent. On withdrawal of serotonergic agent, discontinuation symptoms can be observed
- Safety and efficacy have not been established in patients with uncontrolled hypertension, pheochromocytoma, carcinoid syndrome, or untreated hyperthyroidism
- Safety and efficacy of this drug given for >4wks have not been evaluated
- Symptomatic hypoglycemia has been reported in diabetic patients receiving insulin or oral hypoglycemic agents and concurrent linezolid therapy
- Overgrowth of nonsusceptible organisms may occur; take appropriate measures on occurrence of superinfections
- Using this drug in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Myelosuppression
- Thrombocytopenia
- Uncontrolled hypertension (extreme caution required, monitor BP)
- Pheochromocytoma (extreme caution required, monitor BP)
- Thyrotoxicosis (extreme caution required, monitor BP)
- Sympathomimetic agents (extreme caution required, monitor BP)
- Vasopressive agents (extreme caution required, monitor BP)
- Diabetics receiving insulin or oral hypoglycemic agents
- Carcinoid syndrome
- Seizure disorder
- Risk of seizures
- Use >28 days
Pregnancy Category:C
Breastfeeding: Linezolid is excreted into breastmilk in concentration likely to be effective against staphylococcal strains found in mastitis. Limited literature indicates that the maximum dose an infant would receive through breastmilk would be less than the standard infant dose. If therapy is required by the mother not a reason to discontinue breastfeeding. Monitor the infant for possible effects on the gastrointestinal tract, such as diarrhea, vomiting, and candidiasis (e.g., thrush, diaper rash). As there is no literature during breastfeeding, prefer an alternate drug especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 February 2011. Manufacturer advises to exercise caution when this drug is administered to a nursing woman.
