Posology : מינונים

2     DOSAGE AND ADMINISTRATION

Oral azithromycin should be administered as a single daily dose. The period of dosing with regard to infection is given below.

Administration of azithromycin capsules following a substantial meal reduces bioavailability by at least 50%.
Therefore, in common with many other antibiotics, each dose of the capsules should be taken at least 1 hour before or 2 hours after food.

Powder for oral suspension can be taken with or without food.

In Adults:
For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, the dose is 1000 mg as a single oral dose.

For all other indications in which the oral formulation is administered, the total dosage of 1500 mg should be given as 500 mg daily for 3 days. As an alternative, the same total dose can be given over 5 days with 500 mg given on day 1, then 250 mg daily on days 2 to 5.

In Children:
Children over 45kg body weight and adults, including elderly patients: The total dose of azithromycin is 1500mg which should be given over three days (500mg once daily).
In uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000mg as a single oral dose.

In general, the total dose in children is 30 mg/kg. Treatment for pediatric streptococcal pharyngitis should be dosed at a different regimen (see below).
The total dose of 30 mg/kg should be given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, then 5 mg/kg on days 2-5.

As an alternative to the above dosing, treatment for children with acute otitis media can be given as a single dose of 30 mg/kg.

For pediatric streptococcal pharyngitis, azithromycin given as a single dose of 10 mg/kg or 20 mg/kg for 3 days has been shown to be effective; however, a daily dose of 500 mg must not be exceeded. In clinical trials comparing these two dosage regimens, similar clinical efficacy was observed but greater bacteriologic eradication was evident at the 20 mg/kg per day dose. However, penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including prophylaxis of rheumatic fever.

For children weighing less than 15 kg, azithromycin suspension should be measured as closely as possible. For children weighing 15 kg or more, azithromycin suspension, should be administered according to the guide provided below.
There is no information on children less than 6 months of age.


AZITHROMYCIN SUSPENSION 30 mg/kg Total Treatment Dose
Weight                                                                                          Bottle Size (kg)                  3-Day Regimen                                5-Day Regimen                 (mg) < 15      10 mg/kg once daily on days 1-3.            10 mg/kg on day 1, then 5 mg/kg once daily on days 2-5.                         600
15-25      200 mg (5 ml) once daily on days 1-3.       200 mg (5 ml) on day 1, then 100 mg (2.5 ml) once daily on days 2-5.           600
26-35      300 mg (7.5 ml) once daily on               300 mg (7.5 ml) on day 1, then 150 mg days 1-3.                                   (3.75 ml) once daily on days 2-5.          900 36-45      400 mg (10 ml) once daily on                400 mg (10 ml) on day 1, then 200 mg 
days 1-3.                                (5 ml) once daily on days 2-5.             600x2 > 45      Dose as per adults.                      Dose as per adults.                       600+900 

Azithromycin capsules should only be administered to children weighing more than 45 kg.


SPECIAL POPULATIONS:
In the Elderly: The same dosage as in adult patients is used in the elderly. Elderly patients may be more susceptible to development of torsades de pointes arrhythmia than younger patients.

In Patients with 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) .

In Patients with Hepatic Impairment: The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate 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.