País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
AZITHROMYCIN DIHYDRATE
Pfizer Limited
AZITHROMYCIN DIHYDRATE
250 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azithromycin Pfizer 250 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains azithromycin dihydrate equivalent to 250 mg azithromycin. Also contains 151.55 mg lactose anhydrous For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard White, hard gelatin capsules marked ‘Pfizer’ and ‘ZTM 250’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms (see section 5.1 Pharmacodynamic properties): bronchitis community-acquired pneumonia sinusitis pharyngitis/tonsillitis (see section 4.4 Special warnings and precautions for use, regarding streptococcal infections) otitis media skin and soft tissue infections uncomplicated genital infections due to _Chlamydia trachomatis._ Considerations should be given to official guidance regarding the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Azithromycin Pfizer should be given as a single daily dose. In common with many other antibiotics Azithromycin Pfizer Capsules should be taken at least 1 hour before or 2 hours after food. CHILDREN OVER 45KG BODY WEIGHT AND ADULTS, INCLUDING ELDERLY PATIENTS: The total dose of azithromycin is 1500mg which should be given over three days (500mg once daily). In uncomplicated genital infections due to _Chlamydia_ _trachomatis_, the dose is 1000mg as a single oral dose. IN CHILDREN UNDER 45KG BODY WEIGHT: Azithromycin Pfizer Capsules are not suitable for children under 45kg. RENAL FAILURE: No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10 - 80 ml/min). Cauti Leia o documento completo