Azithromycin (ophthalmic) how supplied: Difference between revisions

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==How Supplied==
==How Supplied==
ZITHROMAX (azithromycin for injection) is supplied in lyophilized form under a vacuum in a 10-mL vial equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains sodium hydroxide and 413.6 mg citric acid.


These are packaged as follows:
AzaSite is a sterile aqueous topical ophthalmic formulation of 1% azithromycin.


{|
* NDC 31357-040-25: 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.
|-
 
|[[File:Azithromycin 13.jpg|thumb|800px|left]]
* NDC 31357-040-03: 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.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  |title = AZASITE (AZITHROMYCIN) SOLUTION [INSPIRE PHARMACEUTICALS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5dc0f75a-1e14-469f-af4f-c668a32f2328 |publisher =  | date =  | accessdate = }}</ref>


|-
|}<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf | publisher = |date = | accessdate = }}</ref>
==References==
==References==
{{Reflist}}
{{Reflist}}

Latest revision as of 21:56, 5 January 2014

Azithromycin (ophthalmic)
AZASITE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

How Supplied

AzaSite is a sterile aqueous topical ophthalmic formulation of 1% azithromycin.

  • NDC 31357-040-25: 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 31357-040-03: 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.[1]

References

  1. ↑ "AZASITE (AZITHROMYCIN) SOLUTION [INSPIRE PHARMACEUTICALS, INC.]".

Adapted from the FDA Package Insert.

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