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Azasite (Azithromycin Ophthalmic) - Summary

 
 



AZASITE SUMMARY

AZASITE® (azithromycin ophthalmic solution) 1%
Sterile topical ophthalmic drops

AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite (polycarbophil, edetate disodium, sodium chloride).

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.


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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)

Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis [Not yet recruiting]

Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine or Chloroquine/Azithromycin Prophylaxis [Not yet recruiting]
This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.

Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea [Recruiting]
The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (<2. 5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.

Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation [Recruiting]

Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection [Not yet recruiting]
To evaluate the efficacy and safety of fixed combination of azithromycin 1. 5% + 0. 5% Loteprednol eye drops for the treatment of ocular inflammation and infection associated bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual administration of azithromycin 1. 5% and 0. 5% Loteprednol (separately).

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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