Azithromycin

The fetched SPC is the paediatric-oriented 200 mg/5 ml oral suspension, so its adult posology applies specifically to adults and adolescents weighing at least 45 kg who are unable to swallow solid pharmaceutical forms. Indications covered by the 500 mg/250 mg adult regimen: acute streptococcal tonsillitis and pharyngitis, acute bacterial sinusitis, acute bacterial otitis media, acute exacerbations of chronic bronchitis (adults only), community acquired pneumonia, and acute bacterial skin and skin structure infections. Urethritis and cervicitis caused by Chlamydia trachomatis: 1000 mg as a single dose. For community acquired pneumonia in adults, oral treatment may follow intravenous treatment if clinically indicated to complete a 7 to 10 day total course - refer to the SmPC of the azithromycin IV formulations for that detail. Consideration should be given to the treatment regimens, doses and duration recommended in updated treatment guidelines for each indication. MISSED DOSE: if 12 hours or less have passed, take as soon as possible and take the next dose at the regularly scheduled time; if more than 12 hours have passed, wait until the next scheduled dose. ELDERLY: no dose adjustment required, but particular caution is recommended because the elderly are more likely to experience proarrhythmic conditions (risk of cardiac arrhythmia and torsade de pointes). HEPATIC IMPAIRMENT: no adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; no data in severe (Child-Pugh C) - administer with caution.

Applies to paediatric patients aged 6 months and older weighing less than 45 kg. The 10 mg/kg/day figure in dosePerKg is the regimen for ACUTE BACTERIAL SINUSITIS, COMMUNITY ACQUIRED PNEUMONIA and ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS: 10 mg/kg/day for 3 days, or 10 mg/kg on day 1 followed by 5 mg/kg/day on days 2 to 5. OTHER INDICATIONS DIFFER: acute bacterial otitis media - a single dose of 30 mg/kg, or 10 mg/kg/day for 3 days, or 10 mg/kg on day 1 followed by 5 mg/kg/day on days 2 to 5. Acute streptococcal tonsillitis and pharyngitis - 20 mg/kg/day for 3 days, or 12 mg/kg/day for 5 days. The SPC contains per-weight maximum daily dose tables (Table 2) and suspension volume tables for the 20 mg/ml and 40 mg/ml strengths (Tables 3 and 4) - dispensing volumes must be read from the SPC for the strength being used. There is no relevant use of azithromycin for the treatment of acute exacerbations of chronic bronchitis in paediatric patients. Safety and efficacy have not been established in children under 6 months of age for any indication. Consideration should be given to the treatment regimens, doses and duration recommended in updated treatment guidelines for each indication. Clinician to verify all paediatric doses against a children's formulary before publication.