Posology : מינונים

3. DOSAGE AND ADMINISTRATION

For the treatment of adult patients with CAP due to the indicated organisms, the recommended dose of intravenous azithromycin is 500 mg as a single daily dose by the IV route for at least two days. Intravenous therapy should be followed by oral azithromycin at a single daily dose of 500 mg to complete a 7 to 10 day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response.

For the treatment of adult patients with PID due to the indicated organisms, the recommended dose of intravenous azithromycin is 500 mg as a single dose by the IV route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy. The timing of the conversion to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial anaerobic agent may be administered in combination with azithromycin.

After reconstitution and dilution, the recommended route of administration for intravenous azithromycin is by IV infusion only.
Do not administer as an intravenous bolus or an intramuscular injection.
The infusate concentration and rate of infusion for azithromycin intravenous (IV) should be either 1 mg/ml over 3 hours or 2 mg/ml over 1 hour. An intravenous dose of 500 mg azithromycin should be infused for a minimum duration of one (1) hour.

In Children:
The safety and efficacy of intravenous azithromycin for the treatment of infections in children has not been established.

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 (see 6 Warnings and Precautions [6.4]).

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) (see 12 Clinical Pharmacology [12.3]).


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 (see Contraindications [5.2]).
3.1.             Preparation of the Solution for Intravenous Administration Reconstitution: Prepare the initial IV solution for infusion. The use of a standard 5 ml syringe (non-automated) is recommended so as to ensure exact addition of 4.8 ml of sterile water. Water for Injection is dispensed. Each ml of reconstituted solution contains 100 mg azithromycin.

The reconstituted solution should be used immediately or stored between 2-8°C not more than 24 hours, the diluted solution should be used immediately after dilution.

Dilute this solution further prior to administration as instructed below: Dilution: To provide azithromycin over a concentration range of 1.0-2.0 mg/ml, transfer 5 ml of the 100 mg/ml azithromycin solution into the appropriate amount of any of the diluents listed below: 
Final Infusion Solution Concentration (mg/ml)     Amount of Diluent (ml)            Recommended time for infusion 1.0 mg/ml                                         500 ml                            3 hours 2.0 mg/ml                                         250 ml                            1 hours


The reconstituted solution can be diluted with:
Normal saline (0.9% sodium chloride)
½ normal saline (0.45% sodium chloride)
5% dextrose in water
Lactated Ringer’s solution
5% dextrose in ½ normal saline (0.45% sodium chloride) with 20 mEq KCl 5% dextrose in Lactated Ringer’s solution
5% dextrose in 1/3 normal saline (0.3% sodium chloride)
5% dextrose in ½ normal saline (0.45% sodium chloride)

Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solution should be discarded.

After dilution, unused solution should be discarded.

4. DOSAGE FORMS AND STRENGTHS
Azithromycin is supplied in a 10 ml vial equivalent to 500 mg azithromycin for intravenous administration. Upon reconstitution, azithromycin powder yields a solution containing the equivalent of 100 mg azithromycin per 1 ml.