Zolivox™ 400 Tablet: Each tablet contains Linezolid USP 400 mg.
Zolivox™ 600 Tablet: Each tablet contains Linezolid USP 600 mg.
Zolivox™ Powder for Suspension: After reconstitution of suspension, each 5 ml contains Linezolid USP 100 mg.
Zolivox™ is an antibiotic in the oxazolidinone class. Zolivox™ is bacteriostatic with a unique mechanism of action. It inhibits protein synthesis by binding to a site on the bacterial 23S ribosomal RNA of the 50S subunit.
Zolivox™ is indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and structure infections including Diabetic foot infections without concomitant osteomyelitis; Uncomplicated skin and structure infections, Vancomycin-resistant Enterococcus faecium infections.
Infection.
Dosage, Route and Frequency of Administration.
Duration (days).
Pediatric Patients.
Adults and Adolescents.
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 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 structure infections.
<5 yrs: 10 mg/kg oral every 8 hours.
5-11 yrs: 10 mg/kg oral every 12 hours.
Adults: 400 mg oral every 12 hours.
Adolescents: 600 mg oral every 12 hours.
10 to 14.
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents.
Pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. * Nursing Mothers: Linezolid and its metabolites are excreted in the milk of lactating rats. It is not known whether Linezolid is excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.
Overdose In the event of overdose, hemodialysis may facilitate more rapid elimination of Linezolid.
Zolivox™ Tablet: should be stored below 30° C. Protect from light & moisture. Keep out of children. Zolivox™ Powder for Suspension: should be stored below 25°C, protect from light & moisture. After reconstitution, the suspension should be stored at normal temperature (below 25° C) and used within 21 days.