Adult Dosing
Vancomycin-resistant enterococcus faecium infections including concurrent bacteremia
- 600 mg PO q12 hrs for 14-28 days
Community acquired pneumonia including concurrent bacteremia, Nosocomial pneumonia
- 600 mg PO q12 hrs for 10-14 days
Skin/Skin structure infections, complicated
- 600 mg PO q12 hrs for 10-14 days
Skin/Skin structure infections, uncomplicated
- 400 mg PO divided q12 hrs for 10-14 days
Note: Limit tyramine food content < 100 mg/meal
Pediatric Dosing
Vancomycin-resistant enterococcus faecium infections including concurrent bacteremia
- Preterm neonates, < 7 days old: 10 mg/kg PO q12 hrs for 14-28 days
- Consideration may be given to the use of 10 mg/kg q8h (30 mg/kg/day) regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg q8h by 7 days of life
- Preterm neonates, > 7 days old: 10 mg/kg PO divided q8 hrs for 14-28 days
- 0-11 yrs: 10 mg/kg PO q8 hrs for 14-28 days
- >12 yrs: 600 PO q12 hrs for 14-28 days
Community acquired pneumonia including concurrent bacteremia, Nosocomial pneumonia
- Preterm neonates, < 7 days old: 10 mg/kg PO q12 hrs for 10-14 days; Increase dose to q8h (30 mg/kg/day) by 7 days old or earlier on development of suboptimal response
- Preterm neonates, > 7 days old: 10 mg/kg PO q8 hrs for 10-14 days
- 0-11 yrs: 10 mg/kg PO q8 hrs for 10-14 days
- >12 yrs: 600 PO q12 hrs for 10-14 days
Skin/Skin structure infections, complicated
- Preterm neonates, < 7 days old: 10 mg/kg PO q12 hrs for 10-14 days; Increase dose to q8h (30 mg/kg/day) by 7 days old or earlier on development of suboptimal response
- Preterm neonates, > 7 days old: 10 mg/kg PO q8 hrs for 10-14 days
- 0-11 yrs: 10 mg/kg PO q8 hrs for 10-14 days
- >12 yrs: 600 PO q12 hrs for 10-14 days
Skin/Skin structure infections, uncomplicated
- Preterm neonates, < 7 days old: 10 mg/kg PO q12 hrs for 10-14 days; Increase dose PO q8h by 7 days old or earlier on development of suboptimal response
- Preterm neonates, > 7 days old: 10 mg/kg PO q8 hrs for 10-14 days
- 0-5 yrs: 10 mg/kg PO q8 hrs for 10-14 days
- 5-11 yrs: 10 mg/kg PO q12 hrs for 10-14 days
- Adolescents: 600 mg PO q12 hrs for 10-14 days
Note: Limit tyramine food content < 100 mg/meal
[Outline]
- Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has occurred
- Affected hematologic parameters have risen toward pretreatment levels on discontinuation of therapy
- 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
- 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
- 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 it for the treatment of patients with catheter-related bloodstream infections or catheter-site infections
- Not indicated for the treatment of Gram-negative infections. Immediately initiate gram-negative therapy on documentation or suspicion of gram-negative pathogen
- 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 cause 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
- 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
- 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, delirium, 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
- 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 - Convulsions have occurred in patients when treated with this drug
- 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
- Oral suspension contains phenylalanine (20 mg per 5 ml)
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 25 March 2011. Manufacturer advises to exercise caution when this drug is administered to a nursing woman.
Drug Name: Zyvox 400 MG Oral Tablet
Ingredient(s): Linezolid
Imprint: ZYVOX;400mg
Color(s): White
Shape: Oval
Size (mm): 15.00
Score: 1
Inactive Ingredient(s): starch, corn / cellulose, microcrystalline / hydroxypropyl cellulose / magnesium stearate / hypromellose / polyethylene glycol / titanium dioxide / carnauba wax
Drug Label Author:
Pharmacia and Upjohn Company
DEA Schedule:
Non-Scheduled
Drug Name: Zyvox 600 MG Oral Tablet
Ingredient(s): Linezolid
Imprint: ZYVOX;600mg
Color(s): White
Shape: Oval
Size (mm): 18.00
Score: 1
Inactive Ingredient(s): starch, corn / cellulose, microcrystalline / hydroxypropyl cellulose / magnesium stearate / hypromellose / polyethylene glycol / titanium dioxide / carnauba wax
Drug Label Author:
Pharmacia and Upjohn Company
DEA Schedule:
Non-Scheduled
