April 29, 2017
Recommended Topic Related To:


"The US Food and Drug Administration (FDA) today approved the VisuMax Femtosecond Laser (Carl Zeiss Meditec) to remove a sliver of corneal tissue to reduce or eliminate myopia in certain adults aged 22 years or older, the agency announced today./"...




Mechanism Of Action

Azithromycin is a macrolide antibiotic [see Microbiology].


The plasma concentration of azithromycin following ocular administration of AzaSite (azithromycin ophthalmic solution) in humans is unknown. Based on the proposed dose of one drop to each eye (total dose of 100 mcL or 1 mg) and exposure information from systemic administration, the systemic concentration of azithromycin following ocular administration is estimated to be below quantifiable limits ( ≤ 10 ng/mL) at steady-state in humans, assuming 100% systemic availability.


Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis.

Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in conjunctival infections [see INDICATIONS AND USAGE].

CDC coryneform group G*

Haemophilus influenzae
Staphylococcus aureus

Streptococcus mitis
Streptococcus pneumoniae

*Efficacy for this organism was studied in fewer than 10 infections.

The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of AzaSite in treating ophthalmological infections due to these microorganisms have not been established.

The following microorganisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. This list of microorganisms is provided as an aid only in assessing the potential treatment of conjunctival infections. Azithromycin exhibits in vitro minimal inhibitory concentrations (MICs) of equal or less (systemic susceptible breakpoint) against most ( ≥ 90%) of isolates of the following ocular pathogens:

Chlamydia pneumoniae
Chlamydia trachomatis

Legionella pneumophila

Moraxella catarrhalis

Mycoplasma hominis

Mycoplasma pneumoniae

Neisseria gonorrhoeae

(Groups C, F, G)
Streptococcus pyogenes

Streptococcus agalactiae

Ureaplasma urealyticum

group streptococci

Animal Toxicology And/Or Pharmacology

Phospholipidosis (intracellular phospholipid accumulation) has been observed in some tissues of mice, rats, and dogs given multiple systemic doses of azithromycin. Cytoplasmic microvacuolation, which is likely a manifestation of phospholipidosis, has been observed in the corneas of rabbits given multiple ocular doses of AzaSite. This effect was reversible upon cessation of AzaSite treatment. The significance of this toxicological finding for animals and for humans is unknown.

Clinical Studies

In a randomized, vehicle-controlled, double-blind, multicenter clinical study in which patients were dosed twice daily for the first two days, then once daily on days 3, 4, and 5, AzaSite solution was superior to vehicle on days 6-7 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis. Clinical resolution was achieved in 63% (82/130) of patients treated with AzaSite versus 50% (74/149) of patients treated with vehicle. The p-value for the comparison was 0.03 and the 95% confidence interval around the 13% (63%-50%) difference was 2% to 25%. The microbiological success rate for the eradication of the baseline pathogens was approximately 88% compared to 66% of patients treated with vehicle (p < 0.001, confidence interval around the 22% difference was 13% to 31%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

Last reviewed on RxList: 1/15/2016
This monograph has been modified to include the generic and brand name in many instances.

Azasite - User Reviews

Azasite User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Azasite sorted by most helpful. Patient Discussions FAQs

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.

WebMD Daily

Get breaking medical news.

Related Drugs
Health Resources
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations