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Tobraflex (Tobramycin / Fluorometholone Acetate Ophthalmic) - Summary

 
 



TOBRAFLEX SUMMARY

Tobraflex™ (tobramycin and fluorometholone acetate ophthalmic suspension, USP) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

Tobraflex™ Ophthalmic Suspension 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 anti-infective drug in this product, tobramycin, 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, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species.


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NEWS HIGHLIGHTS

Published Studies Related to Tobraflex (Tobramycin / Fluorometholone Ophthalmic)

Ketorolac-tobramycin combination vs fluorometholone-tobramycin combination in reducing inflammation following phacoemulsification cataract extraction with scleral tunnel incision. [2000.11]
OBJECTIVE: The objective of this study was to compare the efficacy of ketorolac-tobramycin combination with fluorometholone-tobramycin combination in the control of ocular inflammation after endocapsular phacoemulsification cataract surgery with scleral tunnel incision... CONCLUSIONS: This study suggests that ketorolac may be an alternative to some corticosteroids (fluorometholone). It is generally accepted that fluorometholone is not as potent an anti-inflammatory as prednisolone the most commonly used steroid following cataract extraction.

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Clinical Trials Related to Tobraflex (Tobramycin / Fluorometholone Ophthalmic)

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

Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study [Completed]
This study assesses the aerosol delivery characteristics (measured by in vivo lung deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic parameters) and safety of tobramycin inhalation solution administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in healthy subjects and in subjects with cystic fibrosis.

Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin [Recruiting]
This study is designed to provide data about the pharmacokinetics (PK), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last 8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1<80% predicted).

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study [Completed]
This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.

The Tobramycin Study [Completed]
Evaluate if tobramycin given once a day is at least as efficacious as the traditional tobramycin given three times a day, given with penicillin G, til patients with febrile neutropenia.

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Page last updated: 2006-01-31

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