Azasite (Azithromycin ophthalmic solution) is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:

The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye (s) once daily for the next five days.

5 mL bottle containing 2.5 mL of a 1% sterile topical ophthalmic solution.

None

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Azasite (Azithromycin ophthalmic solution) in 698 patients. The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction reported in patients receiving Azasite (Azithromycin ophthalmic solution) was eye irritation. This reaction occurred in approximately 1-2% of patients. Other adverse reactions associated with the use of Azasite (Azithromycin ophthalmic solution) 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 non-ocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).

Drug interaction studies have not been conducted with Azasite (Azithromycin ophthalmic solution) ophthalmic solution.

Azasite (Azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite (polycarbophil, edetate disodium, sodium chloride). Azasite (Azithromycin ophthalmic solution) is an off-white, viscous liquid with an osmolality of approximately 290 mOsm/kg.

Azithromycin is a macrolide antibiotic with a 15-membered ring. Its chemical name is (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-aza-cyclopentadecan-15-one, and the structural formula is:

Azithromycin has a molecular weight of 749, and its empirical formula is CHNO.

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 and clinically in conjunctival infections as described in the section:

The following data are also available, The safety and effectiveness of Azasite (Azithromycin ophthalmic solution) 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 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 minimal inhibitory concentrations (MICs) of equal or less (systemic susceptible breakpoint) against most (≥90%) of isolates of the following ocular pathogens:

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

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 (Azithromycin ophthalmic solution) 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 (Azithromycin ophthalmic solution) 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<.001 confidence interval around the difference was to microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.>

Azasite (Azithromycin ophthalmic solution) is a sterile aqueous topical ophthalmic formulation of 1% azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a natural LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident overcap is provided.

2.5 mL in 5 mL bottle containing a total of 25 mg of azithromycin(NDC-31357-040-25)

Patients should be advised to avoid contaminating the applicator tip by allowing it to touch the eye, fingers or other sources.

Patients should be directed to discontinue use and contact a physician if any signs of an allergic reaction occur.

Patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Azasite (Azithromycin ophthalmic solution) (azithromycin ophthalmic solution) or other antibacterial drugs in the future.

Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Patients are advised to thoroughly wash hands prior to using Azasite (Azithromycin ophthalmic solution) .

Invert closed bottle (upside down) and shake once before each use. Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye (s).

Inspire Pharmaceuticals, Inc. Licensee of InSite Vision Incorporated Manufactured by Catalent Pharma Solutions, LLC

U.S. PAT NO. 6,159,458; 6,239,113; 6,569,443; 6,861,411; 7,056,893; and Patents Pending

ISV06-42-0005