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Azasite (Azithromycin Ophthalmic) - Summary

 
 



AZASITE SUMMARY

AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite® (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of approximately 290 mOsm/kg. Preservative: 0.003% benzalkonium chloride. Inactives: mannitol, citric acid, sodium citrate, poloxamer 407, polycarbophil, edetate disodium (EDTA), sodium chloride, water for injection, and sodium hydroxide to adjust pH to 6.3. Azithromycin is a macrolide antibiotic with a 15-membered ring.

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.

See all Azasite indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Azasite (Azithromycin Ophthalmic)

Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis. [2011.01]
CONCLUSION: ST provides a fast and effective treatment of acute blepharitis compared to azithromycin. Initial therapy with the combination of tobramycin/dexamethasone provides faster inflammation relief than azithromycin for moderate to severe blepharitis/blepharoconjunctivitis.

Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. [2010.11]
PURPOSE: To evaluate the ocular pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor in subjects undergoing cataract surgery. DESIGN: Multicenter, open-label, randomized study... CONCLUSIONS: Azithromycin 1% demonstrated high, therapeutic levels in the conjunctiva that were maintained up to 7 days after completion of a 1-week dosing regimen. Aqueous humor levels, however, were subtherapeutic with this dosing regimen. In comparison, moxifloxacin achieved lower conjunctival tissue levels, but higher aqueous humor levels. Copyright (c) 2010 Elsevier Inc. All rights reserved.

[Efficacy assessment of azithromycin 1.5% eye drops versus tobramycin 0.3% on clinical signs of purulent bacterial conjunctivitis] [2010.04]
INTRODUCTION: Bacterial conjunctivitis is characterized by hyperemia and discharge of one or both eyes. These clinical signs appear quickly and are contagious. This study compares the clinical efficacy (signs and symptoms) and safety of azithromycin 1.5% eye drops with tobramycin 0.3%... CONCLUSIONS: Azithromycin 1.5% for 3 days (six drops) was as effective as tobramycin for 7 days (36 drops). Furthermore, patients on azithromycin presented earlier clinical cure on Day 3 than patients on tobramycin. Azyter, with its convenient dosing (bid for 3 days), is a step forward in the management of purulent bacterial conjunctivitis. Copyright 2010 Elsevier Masson SAS. All rights reserved.

Efficacy and safety of azithromycin 1.5% eye drops for purulent bacterial conjunctivitis in pediatric patients. [2010.03]
BACKGROUND: Purulent bacterial conjunctivitis affects all ages with high frequency in newborns and children. In a subset of 150 children included in a large study having enrolled 1043 patients, our aim was to analyze in children, the efficacy and safety of azithromycin 1.5% eye-drops in the treatment of this disease... CONCLUSIONS: Azithromycin 1.5% eye drops leads to a rapid clinical and microbiological cure.

Complete local elimination of infectious trachoma from severely affected communities after six biannual mass azithromycin distributions. [2009.11]
OBJECTIVE: To determine whether infectious trachoma can be completely eliminated from severely affected villages. DESIGN: Cross-sectional survey of 2 villages previously enrolled and monitored over 42 months as part of a larger, group-randomized clinical trial. PARTICIPANTS: A total of 758 individuals residing in 2 villages with high baseline trachoma prevalence, of a total population of 768 (98.7%)... CONCLUSIONS: Biannual mass distribution of azithromycin can locally eliminate ocular chlamydial infection from severely affected communities.

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Clinical Trials Related to Azasite (Azithromycin Ophthalmic)

Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers [Completed]

Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) [Completed]
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1. 0 % AzaSite or Vehicle. Three visits will be required for this study.

Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) [Completed]
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis [Completed]

Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis [Completed]
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.

more trials >>

Reports of Suspected Azasite (Azithromycin Ophthalmic) Side Effects

NO Adverse Event (31)Drug Dose Omission (24)Product Quality Issue (19)Product Packaging Quantity Issue (13)Eye Irritation (10)Inappropriate Schedule of Drug Administration (9)Incorrect Drug Administration Duration (8)Eye Pain (5)Drug Ineffective (4)OFF Label USE (4)more >>


Page last updated: 2011-12-09

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