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Tobrex (Tobramycin Ophthalmic) - Summary



Tobrex® (tobramycin ophthalmic ointment) 0.3%

TOBREX® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each gram of TOBREX® (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX® (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

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Published Studies Related to Tobrex (Tobramycin 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.

[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.

Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers. [2008.01]
PURPOSE: To compare the steroid-induced intraocular pressure (IOP) and other ocular adverse effects of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension with those of dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension... CONCLUSIONS: Loteprednol/tobramycin was significantly less likely to produce elevations in IOP than was dexamethasone/tobramycin in healthy subjects treated for 28 days. Both loteprednol etabonate/tobramycin and dexamethasone/tobramycin were well tolerated with low risks for systemic AEs and ocular AEs other than elevation in IOP for dexamethasone/tobramycin.

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.

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Clinical Trials Related to Tobrex (Tobramycin Ophthalmic)

Tobramycin Tear Concentrations [Completed]

Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection [Not yet recruiting]
The use of inhaled medications for the treatment of pulmonary diseases allows for the delivery of a high concentration of a drug at the site of disease with reduced systemic absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully used in the maintenance treatment of CF patients with chronic colonization with PA (Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung functions, decrease the density of the PA in the sputum, decrease hospitalizations, and reduce the risk of mortality. Non CF Bronchiectasis share many features in common with CF, including frequent colonization with PA that leads to deterioration in lung function and increased morbidity. A recent Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics in the treatment of bronchiectasis, however further randomized controlled trials with adequate power and standardized end points are required. There have been reports in the literature describing the efficacy of inhaled tobramycin the treatment of patients with non CF bronchiectasis with eradication of PA, and significant improvement in respiratory symptoms. There were however patients who discontinued treatment due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest 2005). TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry powder formulation has not yet been trialed in patients with non CF bronchiectasis. The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in patients with non CF bronchiectasis, and to gather more data on the benefit of continuous antibiotic therapy in patients with non CF bronchectais.

Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis [Completed]
Bronchiectasis is a persistent and frequently progressive condition characterized by dilated and thick-walled bronchi retaining sputum. The main symptoms of bronchiectasis are cough and chronic sputum production. Until now, most patients with non-CF bronchiectasis receive inhaled tobramycin every other month, by use of a nebulizer. However, this delivery system has several disadvantages, like a low lung deposition and pollution with tobramycin in the surrounding environment. With an efficient dry powder inhaler (DPI), a three to six fold higher lung deposition compared to a nebulizer can be obtained. Therapy with a DPI is also less time consuming compared to nebulisation. We will investigate dry powder tobramycin (DP tobramycin) in a novel device in patients with non-CF bronchiectasis. The main objectives of this study are to investigate the pharmacokinetic properties of DP tobramycin at different dosages together with the local tolerability of DP tobramycin via the Cyclops® at different dosages.

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis [Completed]
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

A Study Comparing the Efficacy and Tolerability of Tobrineb/Actitob/Bramitob Versus TOBI [Completed]
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.

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Reports of Suspected Tobrex (Tobramycin Ophthalmic) Side Effects

Wrong Drug Administered (3)Anterior Chamber Cell (2)Conjunctival Hyperaemia (2)Swelling Face (2)Uveitis (2)Dermatitis Allergic (1)Device Material Issue (1)Post Procedural Complication (1)Anaphylactic Shock (1)Disease Progression (1)more >>

Page last updated: 2011-12-09

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