WARNINGS AND PRECAUTIONS
Topical Ophthalmic Use Only
NOT FOR INJECTION. AzaSite is indicated for topical ophthalmic use only, and should not be administered systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.
Anaphylaxis and Hypersensitivity with Systemic Use of Azithromycin
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 in patients on azithromycin therapy. Although rare, fatalities have been reported. The potential for anaphylaxis or other hypersensitivity reactions should be considered since patients with a known hypersensitivity to azithromycin or erythromycin were excluded from study.
Growth of Resistant Organisms with Prolonged Use
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and where appropriate, fluorescein staining.
Avoidance of Contact Lenses
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
USE IN SPECIFIC POPULATIONS
Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 200 mg/kg/d. The highest dose was associated with moderate maternal toxicity. These doses are estimated to be approximately 5000 times, the maximum human ocular daily dose of 2 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, 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.
The safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials. [see Clinical Studies].
No overall differences in safety or effectiveness have been observed between elderly and younger patients.