Azasite (Azithromycin Ophthalmic) - Indications and Dosage

INDICATIONS AND USAGE

AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:

• CDC coryneform group G^*
• Haemophilus influenzae
• Staphylococcus aureus
• Streptococcus mitis group
• Streptococcus pneumoniae

^*Efficacy for this organism was studied in fewer than 10 infections.

DOSAGE AND ADMINISTRATION

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye (s) once daily for the next five days.

DOSAGE FORMS AND STRENGTHS

5 mL bottle containing 2.5 mL of a 1% sterile topical ophthalmic solution.

HOW SUPPLIED/STORAGE AND HANDLING

AzaSite is a sterile aqueous topical ophthalmic formulation of 1% azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a natural LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident overcap is provided.

2.5 mL in 5 mL bottle containing a total of 25 mg of azithromycin
(NDC-31357-040-25)

Storage and Handling:
Store unopened bottle under refrigeration at 2°C to 8°C (36°F to 46°F). Once the bottle is opened, store at 2°C to 25°C (36°F to 77°F) for up to 14 days. Discard after the 14 days.