AzaSite- Topical solution for bacterial conjunctivitis

Company:

Inspire

Pharmacologic class:

Antibiotic (macrolide)

Active ingredient:

Azithromycin 1%; ophthalmic solution; contains benzalkonium chloride.

Indication:

Susceptible bacterial conjunctivitis.

Pharmacology:

AzaSite is an ophthalmic solution formulation of the macrolide antibiotic azithromycin, for the topical treatment of bacterial conjunctivitis caused by CDC coryneform group G, Hemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.

AzaSite offers an advantage in that it is dosed less frequently than other products used to treat bacterial conjunctivitis. Like other macrolides, azithromycin exerts its antibacterial effect by binding to the 50S ribosomal subunits of susceptible bacteria.

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.

Clinical trials:

The results of a randomized, placebo- controlled, double-blind, multicenter clinical study indicated that AzaSite was more effective than placebo in treating bacterial conjunctivitis. In this study, 685 patients (aged 1-96 years) were dosed twice daily for the first two days, then once daily on Days 3, 4, and 5. In patients who had a confirmed clinical diagnosis of bacterial conjunctivitis, treatment with AzaSite was superior to treatment with vehicle on Days 6-7.

Clinical resolution was attained in 63% of patients treated with AzaSite compared with 50% of patients treated with vehicle. The microbiologic success rate for the eradication of baseline pathogens was about 88%, compared with 66% of patients treated with vehicle.

A randomized, double-blind study conducted in the United States and Latin America involving 743 patients (aged 1-87 years) with presumed bacterial conjunctivitis compared treatment with AzaSite with treatment with tobramycin 0.3% ophthalmic solution. Positive bacterial cultures were established for 316 of the enrollees. AzaSite was dosed twice daily for the first two days, then once daily for the next three days. Tobramycin was dosed at four times daily for five days. The results of this study showed that treatment with AzaSite was equivalent to treatment with tobramycin, with clinical resolution rates of 80% and 78%, respectively.

Adults and children:

<1year: not recommended. ≥1year: 1 drop in affected eye(s) twice daily (8-12 hrs apart) for two days, then once daily for the next five days.

Precautions:

Remove contact lenses during therapy. Pregnancy (Cat. B). Nursing mothers.

Adverse reactions:

Eye irritation, superinfection; rare: contact dermatitis, corneal erosion, dysgeusia, dry eye, punctate keratitis, others.

Additional patient info:

Wash hands before use. Do not touch dropper tip to eye, fingers, or other objects. Shake bottle once before each use. Tilt head back, invert bottle, remove cap, and gently squeeze bottle over eye to instill 1 drop in each affected eye. Report any signs of allergic reaction to prescriber. Complete full course of therapy.

Storage:

Refrigerate until opened; discard after 14 days.

How supplied:

Solution—2.5 mL

For more information, call 888.881.4696 or visit www.AzaSite.com.

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