ZITHROMAX Capsule, hard Ref.[6353] Active ingredients: Azithromycin

Posology

Zithromax capsules should be given as a single daily dose.

In common with many other antibiotics Zithromax 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: Zithromax 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). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR <10 ml/min) (see section 4.4 and section 5.2).

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. No studies have been conducted regarding treatment of such patients with azithromycin (see section 4.4).

Method of administration

Zithromax Capsules are for oral administration only.

Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhoea. In the event of overdose, the administration of medicinal charcoal and general symptomatic treatment and supportive measures are indicated as required.

Shelf life

Aluminium/PVC blister strips in carton boxes: 5 years

Polythene capsule container with child resistant cap: 4 years

None.

Zithromax Capsules are available as:

Packs of 2 capsules. Aluminium/PVC blister strips, 2 capsules per strip, 1 strip in a carton box.

Packs of 4 capsules. Aluminium/PVC blister strips, 4 capsules per strip, 1 strip in a carton box.

Pack of 6 capsules. Aluminium/PVC blister strips, 6 capsules per strip, 1 strip in a carton box.

Polythene capsule container with child resistant cap, 100 capsules per container.

Not all pack sizes may be marketed.

No special requirements

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.