AVEROZOLID 60 ML SUSP; linezolid, oxazolidinone, antibacterials .
ACTIVE-INGREDIENT OF AVEROZOLID 60 ML SUSP
Linezolid 100 mg/5 ml granules for oral suspension .
INDICATION OF AVEROZOLID 60 ML SUSP
Pneumonia : nosocomial pneumonia caused by staphylococcus aureus ( methicilin-susceptible and -resistant isolates ) or streptococcus pneumonia . Community-acquired pneumonia caused by streptococcus pneumoniae including cases with concurrent bacteremia , or staphylococcus aureus ( methicilin-susceptible isolates only ) . – skin and skin structure infections complicated skin and skin structure infections , including diabetic foot infections , without concomitant osteomylitis , caused by staphylococcus aureus ( methicilin-susceptible and -resistant isolates ) , streptococcus pyogenes streptococcus agalactiae . linezolid has not been studied in the treatment of decubitus ulcers . uncomplicated skin and skin structure infections caused by staphylococcus aureus ( methicilli-susceptible isolate only ) or streptococcus pyogenes – vancomycin-resistant enterococcus faecium infections , including cases with concurrent bacteremia .
DOSAGE OF AVEROZOLID 60 ML SUSP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Infection of : 1-nosocomial pneumonia , community acquired pneumonia , including concurrent bacteremia and complicated skin and skin structure infections : ( -pediatric patient (birth through 11 years of age : 10 mg/kg oral every 8 hours -adults and adolescents(12 years and older ) : 600 mg oral every 12 hours . 2 -vancomycin-resistant entrococcus faecium infections , including concurrent bacteremia : ( -pediatric patient (birth through 11 years of age : 10 mg/kg oral every 8 hours -adults and adolescents(12 years and older ) : 600 mg oral every 12 hours . 3-uncomplicated skin and skin structure infections : -( -pediatric patient (birth through 11 years of age : -less than 5 years :10 mg/kg oral every 8 hours -5-11years : 10 mg/kg oral every 12 hours . adults and adolescents(12 years and older ) :1 -adults: 400mg oral every 12 hours 2- adolescents : 600 mg oral every 12 hours . Due to the designated pathogens. 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. Theses 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. Oral dosing using either Averozolid tablets or Averozolid for Oral suspension.
OVER-DOSAGE OF AVEROZOLID 60 ML SUSP
In the event of overdosage, supportive care is advised , with maintenance of glomerular filtration . Hemodialysis may facilitate more rapid elimination of linezolid . Data are not available for removal of linezolid with peritoneal dialysis or hemoperfusion .
CONTRA-INDICATION OF AVEROZOLID 60 ML SUSP
1-hypersensitivity : Avirozolid formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any product components 2-monoamine oxidase inhibitors : linezolid should not be use in patients taking any medicial product which inhibits monoamine oxidase A or B ( e.g .,phenelzine , isocarboxazid ) or within two weeks of takingany such medicine product .
STORAGE OF AVEROZOLID 60 ML SUSP
Store granules at temperature not exeeding 30 °C , in dry place. And after reconstitution store at temperature (2-8) °C and used within 10 days for 60 ml.
PACK OF AVEROZOLID 60 ML SUSP
Carton box contains opaque white (HDPE) plastic bottle marked with embossed line at 60 ml containing 26 gm of granular powder giving 60 ml suspension, with white (HDPE) plastic closure cap white foam liner (polyolefin) and the cap is connected to bottle neck by (HDPE) plastic seal off (red coloured) and transparent (LDPE) plastic measure cap, labeled with the product label + inner leaflet.
AVEROZOLID 60 ML SUSP MANUFACTURED BY
Produced by Averroes pharma for pharmaceutical industries Block NO .6048 6th industrial zone, Sadat city Egypt .