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.
AzaSite is contraindicated in patients with hypersensitivity to any component of this product.
AzaSite is NOT FOR INJECTION. AzaSite is for topical ophthalmic use only and should not be administered systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.
In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely. Although rare, fatalities have been reported.
As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy.
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse reaction reported in clinical trials was eye irritation, which occurred in 1% to 2% of patients. Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and nonocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).
There are no adequate and well-controlled studies in pregnant women. Azithromycin should be used during pregnancy only if clearly needed.
It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.
Safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Instill 1 drop in the affected eye(s) twice daily, 8 to 12 hours apart, for the first 2 days and then instill 1 drop in the affected eye(s) once daily for the next 5 days.
Store unopened bottle under refrigeration at 2°C to 8°C (36°F–46°F). Once the bottle is opened, store at 2°C to 25°C (36°F–77°F) for up to 14 days. Discard after the 14 days.