AZITHROMYCIN FOR

General Due to lack of data, AZITHROMYCIN FOR INJECTION should be used with caution in patients with hepatic and/or renal impairment (including patients on dialysis). Recommended Dose and Dosage Adjustment ADULTS AZITHROMYCIN FOR INJECTION must be reconstituted and diluted as directed, and administered as an intravenous infusion over at least 60 minutes.

Do not administer as an intravenous bolus or an intramuscular injection (see WARNINGS AND PRECAUTIONS). Intravenous therapy should be followed by oral azithromycin. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.

The infusate concentration and rate of infusion of AZITHROMYCIN FOR INJECTION should be either 1 mg/mL over 3 hours, or 2 mg/mL over 1 hour. V. as a single daily infusion for at least 2 days followed by oral therapy at 500 mg daily to complete a 7-10 day course of therapy.

V. as a single daily infusion for at least 1 day followed by oral therapy at 250 mg daily to complete a 7 day course of therapy.

Note:

If anaerobic organisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with AZITHROMYCIN FOR INJECTION. 8 mL of Sterile Water for Injection to the 500 mg vial.

Shake the vial until all of the drug is dissolved. 8 mL is dispensed. Each mL of reconstituted solution contains azithromycin monohydrate equivalent to 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C.

The reconstituted solution must be further diluted prior to administration. 45% Sodium Chloride Injection Normosol-M in 5% Dextrose Diluted solutions prepared in this manner are stable for 24 hours at or below room temperature (30°C), or for 72 hours if stored under refrigeration (5°C).

As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should be discarded.

Only limited data are available on the compatibility of AZITHROMYCIN FOR INJECTION with other intravenous substances, therefore additives or other medications should not be added to AZITHROMYCIN FOR INJECTION or infused simultaneously through the same intravenous line.