Each 5 ml tablet contains Azithromycin Dihydrate 524 mg Eq. to Azithromycin 500 mg.
- Azithromycin is indicated for the treatment of the following infections, when caused by microorganisms sensitive to azithromycin: – upper respiratory tract infections: sinusitis, pharyngitis, tonsilitis. -acute otitis media.
- lower respiratory tract infections: acute bronchitis and mild to moderately severe community acquired pneumonia.
- skin and soft tissue infections.
- uncomplicated Chlamydia trachomatis urethritis and cervicitis Considerations should be given to offixial guidance on the appropriate use of antibacterial agents.
- Azithromycin is not the first choice for the empiric treatment of infections in areas where the prevalence of resistant isolates is 10 % or more.
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The recommended dose is : –
- Adults: In uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dosage is 1000 mg in one single oral dose.
- For all other indications the dosage is 1500 mg to be administered as 500 mg per day for three consecutive days. Alternatively thae same total dosage (1500mg) can also be given over a period of 5 days with 500 mg on the first day and then 250 mg on days 2 to 5.
- Elderly: In the elderly the same dosage as for adults can be given. Children and adolescents (< 18 years): The total dosage in children aged 1 year and older is 30 mg/kg administered as 10 mg/kg once daily for three days, or over a period of five days starting with a single dose of 10 mg/kg on the first day, followed by doses of 5 mg/kg per day for the following 4 days, according to the tables shown below .
- There are limited data on use in children younger than 1 year. In case of children 10 kg 2.5 ml for 3-day therapy or 2.5 ml (day 1) for 5-day therapy , 1.25 ml (day 2-5) 5-day therapy. In case of children 12 kg 3 ml for 3-day therapy or 3 ml (day 1) for 5-day therapy , 1.5 ml (day 2-5) 5-day therapy.
- In case of children 14 kg 3.5 ml for 3-day therapy or 3.5 ml (day 1) for 5-day therapy , 1.75 ml (day 2-5) 5-day therapy.
- In case of children 16 kg 4 ml for 3-day therapy or 4 ml (day 1) for 5-day therapy , 2 ml (day 2-5) 5-day therapy.
- In case of children 17-25 kg 5 ml for 3-day therapy or 5 ml (day 1) for 5-day therapy ,2.5 ml (day 2-5) 5-day therapy.
- In case of children 26-35 kg 7.5 ml for 3-day therapy or 7.5 ml (day 1) for 5-day therapy ,3.75 ml (day 2-5) 5-day therapy.
- In case of children 36-45 kg 10 ml for 3-day therapy or 10 ml (day 1) for 5-day therapy , 5 ml (day 2-5) 5-day therapy.
- In case of children >45 kg 12.5 ml for 3-day therapy or 12.5 ml (day 1) for 5-day therapy , 6.25 ml (day 2-5) 5-day therapy.
- The dosage for the treatment of pharyngitis caused by Streptococcus pyogenes in an exception: in the treatment of pharyngitis caused by Streptococcus pyogenes.
- Azithromycin has proved to be effective when it is administered to children as a single dose of 10 mg/kg or 20 mg/kg for 3 days with a maximum daily dosage of 500 mg.
- At these two dosages a comparable clinical effect was observed, even if the eradication of the bacteria was more significant at a daily dosage of 20 mg/kg.
- Penicillin is however the drug of first choice in the treatment of pharyngitis caused by Streptococcus pyogenes and the prevention of subsequent rheumatic fever.
- Patients with renal impairment: No dose adjustement is necessary in patients with mild to moderate renal impairment (GFR 10-80 ml/min).
- Patients with hepatic impairment: A dose adjustement is Not necessary for patients with mild to moderately impaired liver function.
OVER-DOSAGE OF XITHRONE 500MG
- The symptoms that occurred at higher than recommended dosages were equivalent to known undesirable effects at normal dosage.
- Charachteristic symptoms of overdose with macrolide antibiotics are : reversible loss of hearing, serious nausea, vomiting and diarrhoea.
- In cases of overdose, gastric lavage and general supportive measures are indicated.
CONTRA-INDICATION OF XITHRONE 500MG
- Hypersensitivity to azithromycin, to other macrolide antibiotics, or to any of the excipients.
- Xithrone is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with proir use of Xithrone.
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