AZITHROMYCIN TABLET 500MG

Azithromycin Tablet Indications:

Azithromycin is indicated for the following bacterial infections induced by micro-organisms susceptible to azithromycin:

- 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 Chlamydia trachomatis urethritis and cervicitis

Azithromycin Tablet Dosage and Administration:

Posology

Azithromycin should be given as a single daily dose. Duration of the treatment for the different infection diseases is given below.

Adults, children and adolescents with a body weight of 45 kg or over:

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 Chlamydia trachomatis urethritis and cervicitis, the dosage is 1000 mg as a single oral dose.

Children and adolescents with a body weight below 45 kg:

Azithromycin tablets are not suitable for patients under 45 kg body weight. Other dosage forms are available for this group of patients.

Elderly patients

For elderly patients the same dose as for adults can be applied. Since elderly patients can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes.

Method of administration

Azithromycin Tablets are for oral administration only. The tablets can be taken with or without food. The tablets should be taken with water.

Azithromycin Tablet Precautions & Warning:

Hypersensitivity

Hepatotoxicity

Ergot derivatives

Prolongation of the QT interval

lWith congenital or documented QT prolongation.

lCurrently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classes Ia and III, cisapride and terfenadine.

lWith electrolyte disturbance, particularly in cases of hypokalaemia and hypomagnesaemia

lWith clinically relevant bradycardia, cardiac arrhythmia or severe cardiac insufficiency.

Superinfection:

lClostridium difficile associated diarrhoea

lStreptococcal infections

Renal impairment

Myasthenia gravis

Co-administration with hydroxychloroquine or chloroquine

Azithromycin Tablet Contra-indications:

Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipient.

Azithromycin Tablet Storage instructions:

Do not store above 25°C. Store in the original packaging to protect from moisture.