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Zithrodose 500mg

Anti-infective
Product

Zithrodose 500mg Hard gelatin capsules

Active

Azithromycin dihydrate 524 mg eq.to Azithromycin 500 mg.

Category
Anti-infective
Indication

Zithrodose is indicated for the following bacterial infections induced by micro-organisms susceptible to Azithromycin (see sections Special warnings and precautions for use and Pharmacodynamic properties):

Acute bacterial sinusitis (adequately diagnosed)

Acute bacterial otitis media (adequately diagnosed)

Pharyngitis, tonsillitis (see section 4.4 regarding streptococcal infections)

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

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dose

Zithrodose 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:

Zithrodose 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 (see section Special warnings and precautions for use).

Patients with renal impairment:

Dose adjustment is not required in patients with mild to moderate renal impairment (GFR 10-80 ml/min). Caution should be exercised when Zithrodose is administered to patients with severe renal impairment (GFR < 10 ml/min) (see section Special warnings and precautions for use and section Pharmacokinetic properties).

Patients with hepatic impairment:

Since Zithrodose 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 Zithrodose (see section Special warnings and precautions for use).

Method of administration

Zithrodose Film-coated Tablets are for oral administration only. The tablets can be taken with or without food. The tablets should be taken with ½ glass of water.