Zolidon 400 Tablet: Each film-coated tablet contains Linezolid USP 400 mg.
Zolidon 600 Tablet: Each film-coated tablet contains Linezolid USP 600 mg.
Zolidon 600 IV Infusion: Each 300 ml sterile solution contains Linezolid USP 600 mg (2 mg/ml).
Zolidon Powder for Suspension: After reconstitution, according to direction, each 5 ml suspension contains Linezolid USP 100 mg.
Linezolid is a synthetic antibiotic of the Oxazolidinone class. It is active against most Gram-positive bacteria that cause disease including Streptococci, Vancomycin-Resistant Enterococci (VRE) and Methicillin-Resistant Staphylococcus aureus (MRSA). Linezolid works by inhibiting bacterial protein synthesis.
Infection.
Pediatric Patients:
Adults and Adolescents.
Duration (days).
Nosocomial pneumonia.
10 mg/kg IV or oral every 8 hours.
600 mg IV or oral every 12 hours.
10-14.
Community-acquired pneumonia, including concurrent bacteremia.
Complicated skin and skin structure infections.
Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia.
10 mg/kg IV or oral every 8 hours.
600 mg IV or oral every 12 hours.
14-28.
Uncomplicated skin and skin 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.
10-14.
Neonates (<7 days): Neonates should be initiated with a dose of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonates should receive dose of 10 mg/kg every 8 hours by 7 days of life. No dose adjustment is necessary when switching from IV to oral administration.
Hepatic Impaired patients: No dose adjustment is recommended for patients with mild-to-moderate hepatic impairment. Zolidon 600 IV Infusion should be administered over a period of 30 to 120 minutes. May exhibit a yellow color that can intensify over time without adversely affecting potency. Should be inspected visually for particulate matter prior to administration.
With medicine: Linezolid is a reversible, nonselective monoamine oxidase inhibitor. Linezolid has the potential for interaction with adrenergic and serotonergic agents.
With food & others: Linezolid may be taken with or without food. Large quantities of foods or beverages with high tyramine content should be avoided while taking Linezolid.
Overdose:
In the event of overdose, supportive care is advised with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of Linezolid.
Pregnancy: 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.
Lactation: It is not known whether Linezolid is excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.
Linezolid can be prescribed to pediatric patients ranging in age from birth through 11 years (Except in case of uncomplicated skin and skin structure infections; ranging in age from 5 through 17 years).
No significant differences were found between the elderly and younger patients regarding the safety, effectiveness and clinical response of Linezolid.
Store below 30°C temperature and dry place, protected from light. Keep all medicines out of reach of children.