INDICATION:
Azithromycin powder for oral suspension is indicated for the treatment of the following infections, when caused by micro-organisms sensitive to azithromycin:
- Acute bacterial sinusitis (adequately diagnosed)
- Acute bacterial otitis media (adequately diagnosed)
- Pharyngitis, tonsillitis
- Acute exacerbation of chronic bronchitis (adequately diagnosed)
- Mild to moderately severe community-acquired pneumonia
- Skin and soft tissue infections
- Uncomplicated Chlamydia trachomatis urethritis and cervicitis
Considerations should be given to official guidance on the appropriate use of antibacterial agents.
DOSAGE AND ADMINISTRATION:
Adults:
- Uncomplicated Chlamydia trachomatis urethritis and cervicitis: The dose is 1,000 mg in one single oral dose.
- For all other indications: The dose is 1,500 mg, to be administered as 500 mg per day for three consecutive days. Alternatively, the same total dose (1,500 mg) 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.
To treat these patients, other pharmaceutical forms are also available.
Elderly people:
The same dose as in adult patients is used in older people. Since older patients can be patients with ongoing proarrhythmic conditions, particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes.
Children and adolescents (< 18 years):
The total dose 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.
| Weight (kg) | 3-day therapy (Day 1-3: 10 mg/kg/day) | 5-day therapy (Day 1: 10 mg/kg/day; Day 2-5: 5 mg/kg/day) |
| 10 kg | 100 mg | Day 1: 100 mg; Day 2-5: 50 mg |
| 12 kg | 120 mg | Day 1: 120 mg; Day 2-5: 60 mg |
| 14 kg | 140 mg | Day 1: 140 mg; Day 2-5: 70 mg |
| 16 kg | 160 mg | Day 1: 160 mg; Day 2-5: 80 mg |
| 17–25 kg | 200 mg | Day 1: 200 mg; Day 2-5: 100 mg |
| 26–35 kg | 300 mg | Day 1: 300 mg; Day 2-5: 150 mg |
| 36–45 kg | 400 mg | Day 1: 400 mg; Day 2-5: 200 mg |
| > 45 kg | 500 mg | Day 1: 500 mg; Day 2-5: 250 mg |
The dose for the treatment of pharyngitis caused by Streptococcus pyogenes is 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 dose of 500 mg. At these two doses, a comparable clinical effect was observed, even if the eradication of the bacteria was more significant at a daily dose 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.
SHELF LIFE: 36 months since manufacture date.
STORAGE: Dry and cool place, below 30°C, protect from sunlight, heat, and moisture.
