"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
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AzaSite® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:
CDC coryneform group G*
Streptococcus mitis group
*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.
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
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
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