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FML-S (Fluorometholone / Sulfacetamide Sodium Ophthalmic) - Summary

 
 



FML-S SUMMARY

FML-S®
(fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10%

FML-S® ophthalmic suspension is a topical anti-inflammatory/anti-infective product for ophthalmic use.

FML-S® 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, sulfacetamide, is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

This product does not provide adequate coverage against Neisseria species and Serratia marcescens. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.


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NEWS HIGHLIGHTS

Published Studies Related to FML-S (Fluorometholone / Sulfacetamide Ophthalmic)

A prospective study on ocular hypertensive and antiinflammatory response to different dosages of fluorometholone in children. [2001.11]
OBJECTIVE: To investigate the ocular hypertensive and antiinflammatory response to different dosages of fluorometholone (FML)... CONCLUSIONS: Ocular hypertension occurs in a dose-dependent manner in children treated with FML. Children in group 1 had a quicker onset and more severe ocular hypertensive response than those in group 2. It would be desirable to monitor the IOP regularly when FML is used with a high frequency and for a long duration in children.

Controlled comparison of two fluorometholone formulations in the antigen challenge model of allergic conjunctivitis. [1995.10]
We compared the safety and efficacy of MethaSite, a gel-forming suspension (0.1% fluorometholone), to a commercially available 0.1% fluorometholone ointment, FML S.O.P., using an antigen challenge model. Subjects with known allergic histories were exposed to increasing concentrations of cat dander, ragweed, or grass at visits 1 and 2...

Acylated and deacylated saponins of Quillaja saponaria mixture as adjuvants for the FML-vaccine against visceral leishmaniasis. [2006.05.01]
The adjuvant of the FML-vaccine against murine and canine visceral leishmaniasis, the Riedel de Haen saponin mixture, was fractionated by ion exchange chromatography on DEAE-cellulose to afford one TLC homogeneous Quillaja saponaria Molina QS21 saponin fraction (18.0%), a mixture of two deacylsaponins (19.4%), sucrose (39.9%), sucrose and glucose (19.7%), rutin (0.8%) and quercetin (2.2%), that were identified by comparison of 1H and 13C NMR spectroscopy...

Effective immunotherapy against canine visceral leishmaniasis with the FML-vaccine. [2004.06.02]
The potential effect of the fucose mannose ligand (FML)-vaccine on immunotherapy of canine visceral leishmaniasis was assayed on five mongrel dogs experimentally infected with Leishmania donovani and on 21 Leishmania chagasi naturally infected dogs when seropositive to FML but completely asymptomatic...

Immunotherapy against murine experimental visceral leishmaniasis with the FML-vaccine. [2003.12.01]
The fucose mannose ligand (Leishmania donovani FML)-saponin vaccine has earlier shown its immunoprophylactic potential against visceral leishmaniasis in the CB hamster (87.7% of parasite load reduction), Balb/c (84.4%) and Swiss albino mouse (85-93%) models.Our results indicate that the therapeutic FML-vaccine has a potent effect on modulation of the murine infection leading to the reduction of parasitic load and signs of disease, being a new potential tool in the therapy and control of visceral leishmaniasis.

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Page last updated: 2007-05-02

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