Averozolid 100 mg/5 ml Suspension 150 ml
Averroes Pharma
Averroes Pharma
Composition
Each 5 ml suspension contains
Linezolid 100 mg.
Indications
Averozolid is indicated for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as:
Pneumonia - community-acquired and nosocomial pneumonia
Skin and soft tissue infections
Enterococcal infections.
Dosage and Method of administration
Adults and children 12 years or older
The recommended dosage should be administered orally twice daily.
Duration of treatment is variable. It is dependent on the pathogen, the site of infection and its severity, and on the patient's clinical response.
To date, the maximum treatment duration in controlled clinical trials has been 28 days.
Adults
Community-acquired pneumonia, Nosocomial pneumonia : 600 mg IV or orally.
Skin and soft tissue infections: 400 mg to 600 mg orally or 600 mg IV depending on clinical severity
Enterococcal infections: 600 mg IN or orally.
For pediatric patients from birth to 11 years of age
Community-acquired pneumonia, Nosocomial pneumonia
Skin and soft tissue infections
10 mg/kg IV or orally* once every 8 hours.
Enterococcal infections
10 mg/kg IV or orally* every 8 hours.
How to Use
Shake the bottle well before use.
Add sterile water in 2 portions and shake well after each addition to powder till the mark on the plastic bottle.
Contraindications
Hypersensitivity to linezolid or to any of the excipients.
Monoamine oxidase inhibitors
Linezolid should not be used in patients taking any medicina! product which inhibits monoamine oxidases A or B (e.g., phenelzine) or within two weeks of taking any such medicinal product.
Potential interactions producing elevation of blood pressure
Unless patients are monitored for potential increases in blood pressure, linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma.
Potential serotonergic interactions
Linezolid should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT receptor agonists (triptans), pethidine or buspirone.
Precautions
It is recommended that therapy with Averozolid should be initiated in a hospital environment following guidance from appropriate specialists.
If symptoms of visual impairment appear such as changes in in visual acuity, changes in color vision, blurred vision, or visual field defect, prompt ophthalmic evaluation is i commended.
Lactic acidosis
Lactic acidosis has been reported with the use of linezolid. Patients who develop recurrent nausea or vomiting, unexplained acidosis,or a low bicarbonate level while receiving linezolid should receive immediate medical attention.
Superinfection
The use of antibiotics may occasionally result in an overgrowth of non-susceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.
Use in renal impairment
Linezolid should be used with special caution in patients with severe renal impairment and only when the anticipated benefit is considered to outweigh the theoretical risk.
Use in hepatic impairment
It is recommended that linezolid should be used in patients with severe hepatic impairment only when the anticipated benefit is considered to outweigh the theoretical risk.
Side Effect
Those most commonly reported were headache, diarrhea, nausea and candidiasis, vomiting, Special senses, Taste perversion, Urogenital Vaginal, candidiasis.
Storage Method
Store at a temperature not exceeding 30°C in a dry place.
After reconstitution: used within 10 days when stored at temperature (2-8)°C.
Keep out of reach of children.
Package
A carton box contains granules for oral suspensions 150 ml after reconstitution + Measuring cap and leaflet.