What is FML®?
FML® is an ophthalmic topical anti-inflammatory suspension for ocular use.
How Does FML® Work?
FML® is thought to work by phospholipase A2 inhibitory proteins. These proteins are felt to control the biosynthesis of mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. The result is that FML® inhibits the edema, capillary dilation, capillary proliferation, fibroblast proliferation, deposition of collagen, scar formation and edema.
Reason for Use of FML®
FML® is indicated for the treatment of inflammation of the conjunctiva, cornea, and anterior portion of the eye.
Side Effects and Precautions for FML®
FML® may cause an elevation of the intraocular pressure which could result in glaucoma with permanent loss of vision. Patients using for longer than 10 days should have their eye pressure checked.
FML® may cause posterior subcapsular cataracts with prolonged use.
FML® may cause thinning of the cornea or sclera with prolonged use.
FML® may mask active infections.
FML® may activate herpes infections or exacerbate the severity of the infection.
FML® may delay the healing response.
FML® may allow a fungal infection to develop while using it.
FML® should not be used by pregnant and nursing women unless the benefits outweigh the risks.
FML® has not been studied in children under age 2.
Loss of vision from increased eye pressure and resulting in glaucoma secondary to using FML® can occur.
Systemic side effects are very rare but should be watched for with prolonged use.
FML® may cause acute uveitis and perforation of the eye.
Conjunctivitis, redness, corneal ulcers, keratitis, blurred vision, dilated pupil, and drooping of the eyelid (ptosis) have been reported.
Secondary infections from bacteria, fungus, and viral have been reported.
Stinging, burning, and ocular irritation may occur on instillation.
Administration and Dosage of FML®
FML® 0.1% suspension is instilled into the affected eye or eyes 4 times per day.
How is FML® Supplied?
FML® is supplied in sterile ophthalmic dispensing bottles in the following sizes:
1mL, 5mL, 10mL, and 15mL