Linexil

Description

Linexil 300 ml Infusion

Pharmacology
Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with in vitro activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria and certain Gram negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome 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.

Indications
Arlin is indicated for the treatment of:
Nosocomial pneumonia
Community-acquired pneumonia
Complicated skin and skin structure infection including diabetic foot infections, without concomitant osteomyelitis
Uncomplicated skin and skin structure infections
Vancomycin-resistant Enterococcus faecium infections
Limitations of use: Arlin is not indicated for the treatment of Gram-negative infections. The safety and efficacy of Arlin given for longer than 28 days have not been evaluated in controlled clinical trials.

Dosage & Administration
Linezolid tablets should be taken in oral route with or without food. Linezolid IV infusion should be administered by intravenous infusion over a period of 30 to 120 minutes. The recommended daily dosage for Linezolid tablets and IV infusion is described in the following table:

Infection Dosage, route and frequency of administration
Pediatric patients*
(birth through 11 years of age) Adults and adolescent
(12 years and older) Recommended duration of treatment (consecutive days)
Nosocomial pneumonia 10 mg/kg orally or intravenously every 8 hours 600 mg orally or intravenously every
12 hours 10 to 14
Community-acquired pneumonia, including concurrent bacteremia
Complicated skin and skin structure infections
Complicated skin and skin structure infections 10 mg/kg orally or intravenously every 8 hours 600 mg orally or intravenously every 12 hours 14 to 28
Uncomplicated skin and skin structure infections less than 5 years: 10 mg/kg orally every 8 hours
5-11 years: 10 mg/kg orally every 12 hours Adults: 400 mg orally every 12 hours Adolescents: 600 mg orally every 12 hours 10 to 14
* Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 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.
No dose adjustment is necessary when switching from intravenous to oral administration.

Intravenous administration: Linezolid IV infusion should be inspected visually against a light source for particulate matter prior to administration. Linezolid IV infusion may exhibit a yellow color that can intensify over time without adversely affecting potency. Do not use this intravenous infusion vial in series connections. Additives should not be introduced into this solution. Discard unused portion after single use.

Hepatic impairment: No dose adjustment is recommended for patients with mild-to-moderate hepatic impairment. The pharmacokinetics of Linezolid in patients with severe hepatic impairment have not been evaluated.

Use in children and adolescents: The dose of linezolid for children and adolescents have been described in dose and administration section. The use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended