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DOSAGE
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Instill 1/2" ribbon ung qDay-TID, q4hrs in 1st 48 hrs if needed. Then Taper. If there is no improvement after 2 days, patient should be re-evaluated.
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Contact Dermatitis (skin): FML ung apply to periocular area BID-TID x 4-5 days
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GENERIC
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fluorometholone alcohol 0.1%
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SIZE
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3.5 gm tube
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INDICATIONS
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FML® ointment is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
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Use off-Label for: Gel often used for inflammatory dry eye, uveitis, inflamed pinguecula and pterygium. Ointment/Gel may be used for contact dermatitis.
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MECHANISM OF ACTION
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Ketone, alcohol derived, fluorinated "soft" steroid
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MICROBIOLOGY
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Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.
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CONTRAINDICATIONS & WARNINGS
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FML® ointment is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
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FML® ointment is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
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PEDIATRIC USE
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Safety and effectiveness in infants below the age of two years have not been established.
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PREGNANCY
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Teratogenic effects Category C Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6 - 18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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NOTE
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Fungal and bacterial overgrowth, IOP spike, delayed healing, cataract formation, globe perforation possible with long term use.
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Can cause significant IOP rise in as little as 1 week but somewhat less likely to do so than the other ketone based steroids so is sometimes used for longer term therapy.
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