AzaSite (azithromycin 1%)

Warnings & Precautions

Topical ophthalmic use only: Not for injection, subconjunctival administration or introduction into the anterior chamber.
Systemic azithromycin hypersensitivity: Angioedema, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in patients taking the drug systemically, with fatalities reported; weigh a known systemic hypersensitivity before ocular use.
Resistant organism overgrowth: Prolonged use may cause overgrowth of non-susceptible organisms including fungi; discontinue and start alternative therapy if super-infection occurs.
Contact lens wear: Not appropriate while signs or symptoms of bacterial conjunctivitis are present.

Common Side Effects

Ocular: Eye irritation 1% to 2%, the most frequent reaction across 698 treated patients.
Ocular, under 1%: Blurred vision, burning or stinging on instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, reduced visual acuity.
Systemic, under 1%: Dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria.

Pregnancy & Lactation

Pregnancy: Category B; rat and mouse reproduction studies at up to 200 mg/kg/day, roughly 5,000 times the 2 mg maximum human ocular daily dose, showed no fetal harm, with moderate maternal toxicity at the highest dose; no adequate studies in pregnant women.