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Tobradex (Tobramycin / Dexamethasone Ophthalmic) - Summary

 
 



TOBRADEX SUMMARY

TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

TOBRADEX Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.


See all Tobradex indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Tobradex (Tobramycin / Dexamethasone 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.

Ketorolac plus tobramycin/dexamethasone versus tobramycin/dexamethasone after uneventful phacoemulsification surgery: a randomized controlled trial. [2011]
BACKGROUND/AIMS: To evaluate the benefit of adding a nonsteroid agent to an antibiotic/steroid combination after uneventful phacoemulsification, adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist... CONCLUSION: The addition of ketorolac did not seem to offer any additional benefit in terms of inflammation-related signs. Four weeks appeared as an adequate treatment interval. Special attention should be paid to patients with pseudoexfoliation. Copyright (c) 2010 S. Karger AG, Basel.

Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. [2008.01]
CONCLUSIONS: LE/T satisfied the condition of non-inferiority to DM/T in decreasing the signs and symptoms of ocular inflammation associated with blepharokeratoconjunctivitis. Subjects treated with DM/T experienced more of an increase in IOP. Limitation: Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked.

Collagen shield delivery of tobramycin to the human eye. [1998.07]
PURPOSE: The purpose of this study was to determine the ocular penetration of tobramycin into the anterior chamber of the human eye when delivered by a pre-soaked collagen shield... CONCLUSIONS: Perioperative use of a pre-soaked collagen shield utilizing a commercially available preparation of tobramycin-dexamethasone combination drops appears safe. However, the use of this system to prevent endophthalmitis is not warranted based on the concentrations obtained from the aqueous humor.

Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. [2008.08]
CONCLUSIONS: LE/T satisfied all conditions of noninferiority to DM/T in comfort and tolerability. Subjects receiving LE/T were more likely to report better ocular comfort/tolerability ratings relative to baseline artificial tears than subjects receiving DM/T. LIMITATIONS: The study population consisted of healthy volunteers.

more studies >>

Clinical Trials Related to Tobradex (Tobramycin / Dexamethasone Ophthalmic)

Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle [Withdrawn]
The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation

Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis [Not yet recruiting]
The primary objective of this study is to evaluate, through clinical parameters, the

comparative efficacy between topical Tobracort ® (tobramycin 0. 3% dexamethasone + 1% -

Chemistry Lab Union) and TOBRADEX ® (tobramycin 0. 3% dexamethasone + 1 % - Alcon Lab), using

the percentage of improvement (sustained response rate) at the end of treatment.

A Bioequivalence Study of Tobradex AF [Completed]

Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex [Completed]
Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.

A Clinical Study of Tobradex AF [Completed]

more trials >>

Reports of Suspected Tobradex (Tobramycin / Dexamethasone Ophthalmic) Side Effects

Lipogranuloma (8)OFF Label USE (7)Wrong Drug Administered (3)Ulcerative Keratitis (3)Anterior Chamber Cell (3)Conjunctival Hyperaemia (3)Ocular Hyperaemia (3)Corneal Perforation (2)Diplopia (2)Corneal Opacity (2)more >>


Page last updated: 2011-12-09

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