Lizolix™ Powder for Suspension: Each bottle contains 100 ml suspension. Each 5 ml contains Linezolid USP 100 mg.
Lizolix TM is a preparation of Linezolid. Linezolid is a synthetic antibacterial agent of a new class of antibiotics, the oxazolidinones, which has clinical utility in the treatment of infections caused by aerobic Gram-positive bacteria. The in vitro spectrum of activity of Linezolid also includes certain Gram-negative bacteria and anaerobic bacteria. Linezolid inhibits bacterial protein synthesis through a mechanism of action different from that of other antibacterial agents; therefore, cross-resistance between Linezolid and other classes of antibiotics is unlikely. Linezolid binds to a site on the bacterial 23S ribosomal RNA of the 50S subunit and prevents the formation of a functional 70S initiation complex, which is an essential component of the bacterial translation process. The results of time-kill studies have shown Linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, Linezolid was found to be bactericidal for the majority of strains.
Patients who commence treatment on the parenteral formulation may be switched to either oral presentation when clinically indicated. In such circumstances, no dose adjustment is necessary when switching from intravenous to oral administration as Linezolid has an oral bioavailability of approximately 100%. The injection should be administered over a period of 30 to 120 minutes. The oral suspension may be taken with or without food.
Neonates <7 days: Most pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen 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 neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life.
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. * Lactation: It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.
Direction for Use:
Reconstitution of Oral Suspension: Shake the bottle to loosen the powder. Add 70 mL (7 cups of supplied measurement cup) of boiled and cooled water to the dry powder in the bottle for case of preperation, add water to the bottle in two portions. Shake well after each addition untill all the powder is in suspension. Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted.
suspension should be stored in a cool and dry place use within 21 days after reconstitution.
Lizolix™ Powder for Suspension: Do not store above 30°C temperature, keep away from light and wet place. Keep out of the reach of children.