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Author: Admin | 2025-04-28
Back to top About Medicine Prescription only medicine My Account Area 1. Name of the medicinal product Azithromycin 250 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 250 mg of azithromycin (as dihydrate). Excipient with known effect: Each film-coated tablet contains 5.13 mg of lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Azithromycin 250 mg film-coated tablets: White to off-white, oblong shaped, film coated biconvex tablets, debossed with “66” on one side and “D” on other side. The size is 13.5 mm x 6.6 mm 4. Clinical particulars 4.1 Therapeutic indications Azithromycin is indicated for the following bacterial infections induced by microorganisms susceptible to azithromycin (see sections 4.4 and 5.1): • 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 • Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas • Uncomplicated genital infections due to Chlamydia trachomatis and Neisseria gonorrhoeae. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology Azithromycin should be given as a single daily dose. Duration of the treatment for the different infection diseases is given below. Children over 45 kg body weight and adults, including elderly patients: The total dose is 1500 mg, administered as 500 mg once daily for 3 days. Alternatively, the same total dose (1500 mg) can be administered in a period of 5 days, 500 mg on the first day and 250 mg on day 2 to 5. In the case of uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a single oral dose. For susceptible Neisseria gonorrhoeae the recommended dose is 1000 mg or 2000 mg of azithromycin in combination with250 mg or 500 mg ceftriaxone according to local clinical treatment guidelines. For patients who are allergic to penicillin and/or cephalosporins, prescribers should consult local treatment guidelines. Paediatric population: Children and adolescents with
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