ZITHROMAX

Posology Zithromax should be given as a single daily dose. Zithromax Suspension can be taken with or without 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: Zithromax Suspension should be used for children under 45 kg. There is no information on children less than 6 months of age.

The dose in children is 10 mg/kg as a single daily dose for 3 days:

Up to 15 kg (less than 3 years): Measure the dose as closely as possible using the 10 ml oral dosing syringe provided. 25 ml divisions, providing 10 mg of azithromycin in every graduation. For children weighing more than 15 kg, Zithromax Suspension should be administered using the spoon provided according to the following guidance: 15-25 kg (3-7 years): 5 ml (200 mg) given as 1 x 5 ml spoonful, once daily for 3 days.

5 ml spoonful, once daily for 3 days. 36-45 kg (12-14 years): 10 ml (400 mg) given as 1 x 10 ml spoonful, once daily for 3 days.

Over 45 kg:

Dose as per adults. 5 for appropriate pack size to use depending on age/body weight of child. The specially supplied measure should be used to administer Zithromax suspension to children.

Renal impairment:

No dose adjustment is necessary in patients with 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 Zithromax Suspension is for oral administration only.

Zithromax 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) *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 administration should be stopped if liver dysfunction has emerged. Infantile hypertrophic pyloric stenosis (IHPS) Following the use of azithromycin in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis (IHPS) has been reported.

Parents and caregivers should be informed to contact their physician if vomiting or irritability with feeding occurs. Ergot derivatives In patients receiving ergot derivatives, ergotism has been precipitated by co- administration of some 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.

1).