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Azasite

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Azasite

INDICATIONS

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.

HOW SUPPLIED

Dosage Forms And Strengths

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

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.

Manufactured for: Inspire Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Catalent Pharma Solutions, LLC Woodstock, IL 60098. Revised: 07/2012.

Last reviewed on RxList: 9/4/2012
This monograph has been modified to include the generic and brand name in many instances.

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