Fml
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Questions & Answers
Side Effects & Adverse Reactions
Prolonged use of corticosteroids may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.
If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
History
There is currently no drug history available for this drug.
Other Information
FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.
Chemical Name
Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.
Structural Formula
Contains
Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH. FML® suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.
Sources
Fml Manufacturers
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Allergan, Inc.
![Fml (Fluorometholone) Suspension/ Drops [Allergan, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fml | Allergan, Inc.
Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).
The dosing of FML® suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
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Allergan, Inc.
Fml | Allergan, Inc.
A small amount (approximately 1/2 inch ribbon) of ointment should be applied to the conjunctival sac one to three times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).
The dosing of FML® ointment may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
![Fml (Fluorometholone) Ointment [Allergan, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3102d420-8842-4809-9aa1-7be91ac7d0ab&name=carton.jpg)
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