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.
Additional Azasite Information
Azasite - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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