AZITHROMYCIN

Posology Azithromycin 250 mg capsules should be given as a single daily dose. In common with many other antibiotics Azithromycin 250 mg capsules should be taken at least 1 hour before or 2 hours after food.

Children over 45 kg body weight and adults, including elderly patients:

The total dose of azithromycin is 1500 mg which should be given over three days (500 mg once daily). In 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 with 250 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 In children under 45 kg body weight:

Azithromycin 250 mg capsules are not suitable for children under 45 kg. Renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10 - 80 ml/min). 2). Hepatic impairment Since azithromycin is metabolised in the liver and excreted in the bile, the drug should not be given to patients suffering from severe liver disease.

4). Method of administration Azithromycin 250 mg capsules are for oral administration only.

Azithromycin 250 mg capsules is well tolerated with a low incidence of side effects. The section below lists the adverse reactions identified through clinical trial experience and postmarketing surveillance by system organ class and frequency.

Adverse reactions identified from post-marketing experience are included in italics.

The frequency grouping is defined using the following convention:

Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

4). 4) increased, blood bicarbonat e decreased se increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium abnormal *ADR identified post-marketing §ADR frequency represented by the estimated upper limit of the 95% confidence interval calculated using the “Rule of 3”.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Hypersensitivity As with erythromycin and other macrolides, serious allergic reactions including angioneurotic oedema and anaphylaxis (rarely fatal), Acute Generalized Exanthematous Pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported.

Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment. Hepatotoxicity Since the liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease.

8). Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. In case of signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/ investigations should be performed immediately.

Azithromycin administrationshould be stopped if liver dysfunction has emerged. Ergot derivatives In patients receiving ergot derivatives, ergotism has been precipitated by co-administration ofsome macrolide antibiotics. There are no data concerning the possibility of an interaction between ergot and azithromycin.

However, because of the theoretical possibility of ergotism,azithromycin and ergot derivatives should not be co-administrated. Prolongation of the QT interval Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides.

8); therefore caution is required when treating patients: • With congenital or documented QT prolongation • Currently receiving treatment with other active substance known to prolong QT intervalsuch as antiarrhythmics of Classes Ia and III, cisapride and terfenadine • With electrolyte disturbance, particularly in case of hypokalaemia and hypomagnesemia • With clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.

1).