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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

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.

NDC 17478-307-03: 2.5 mL in 5 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided.

NDC 17478-307-04: 2.5 mL in 4 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided.

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.

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