FML Eye Drops (fluorometholone)

FML Eye Drops general information

What is FML Eye Drops used for?

FML Eye Drops 0.1% are used to treat inflammation of the eye, including inflammation of the ocular or bulbar conjunctiva, a clear membrane that covers the outer surface of the eye or sclera (white of the eye) and the palpebral conjunctiva that lines the inside of the eyelids.  Also the cornea, which is the clear protective area at the front of the eye, and the anterior segment of the globe that includes the iris, pupil, lens, cornea and fluid filled anterior chamber.  FML Eye Drops 0.1% are used as short-term treatment to relieve symptoms of eye inflammation, including irritation, burning, redness and swelling that are caused by chemicals, heat, radiation, allergy, or foreign objects in the eye, but they should not be used for viral, fungal or bacterial eye infection and is only suitable for steroid-responsive inflammation.

How does FML Eye Drops work?

FML Eye Drops 0.1% contain fluorometholone, which is a synthetic corticosteroid hormone and is a derivative of the natural glucocorticoid cortisol, with potent anti-inflammatory properties.  Fluorometholone in FML Eye Drops 0.1% acts directly through the glucocorticoid receptor that is expressed inside most cells of the body and regulates transcription of specific genes that control the inflammatory and immune response.  The major therapeutic actions of fluorometholone are to reduce the vascular (blood vessels) and cellular inflammatory response primarily by blocking the production of inflammatory chemicals, like prostaglandins and leukotrienes, from inflammatory cells.  This action modifies the actions of cells involved in allergic and inflammatory responses, such as phagocytic migration and reduces the swelling (oedema), redness and pain associated with inflammation of the eye. 

What does FML Eye Drops contain?

FML Eye Drops contain the active ingredient fluorometholone 1 mg/mL (0.1%), a synthetic corticosteroid used to treat inflammation of the eye.  They also contain, LIQUIFILM® (polyvinyl alcohol) 1.4%, benzalkonium chloride 0.004%, disodium edetate, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, purified water and sodium hydroxide if needed to adjust pH.

Treating inflammation of the eye with FML Eye Drops

FML Eye Drops 0.1% contain fluorometholone, which is synthetic corticosteroid hormone and is a derivative of the natural glucocorticoid cortisol, with potent anti-inflammatory properties.  FML Eye Drops 0.1% are used for short-term treatment of steroid-responsive inflammation of the eye, including inflammation of the ocular or bulbar conjunctiva, a clear membrane that covers the outer surface of the eye or sclera (white of the eye) and the palpebral conjunctiva that lines the inside of the eyelids.  Also the cornea, which is the clear protective area at the front of the eye, and the anterior segment of the globe that includes the iris, pupil, lens, cornea and fluid filled anterior chamber.  Fluorometholone in FML Eye Drops 0.1% acts directly through the glucocorticoid receptor inside the cells of the eye and regulates transcription of specific genes that control the inflammatory and immune response.  The major therapeutic actions of fluorometholone are to reduce the vascular (blood vessels) and cellular inflammatory response primarily by blocking the production of inflammatory chemicals, like prostaglandins and leukotrienes, from inflammatory cells to reduce the swelling (oedema), redness and pain associated with inflammation and to modify the actions of cells involved in allergic and inflammatory responses, such as phagocytic migration.  These actions of fluorometholone in FML Eye Drops 1% help relieve symptoms of eye inflammation, including irritation, burning, redness and swelling that are caused by chemicals, heat, radiation, allergy, or foreign objects in the eye.

What are the side effects of FML Eye Drops?

The most commonly reported side effects when taking FML Eye Drops include eye irritation like burning or stinging, increased intraocular pressure (IOP) that may lead to glaucoma and optic nerve damage, delayed wound healing, cataract formation at the back of the lens (posterior subcapsular), visual disturbance (blurry vision) and allergic reactions.  Long term use of corticosteroids can lead to infection of the eye and can mask infections; also to systemic effects.

When should FML Eye Drops not be used?

You should not use FML Eye Drops if you:

• are allergic to fluorometholone or any ingredients in FML Eye Drops
• are pregnant or are breastfeeding, without discussion with your doctor
• have a bacterial, viral or fungal eye infection
• have glaucoma or are at risk of developing glaucoma
• have recently had cataract surgery as corticosteroids can delay healing

How should FML Eye Drops be applied?

You should apply your FML Eye Drops by shaking the bottle well, tilting your head back, pulling the lower eyelid to form a pouch and applying one drop into this conjunctival sac, using the dropper provided.  You should apply your FML Eye Drops 2-4 times daily or more frequently in the first 24-48 hours as required (2 drops per hour).  You should see an improvement in symptoms after 2 days but continue to use your FML Eye Drops for as long as recommended by your doctor but not for more than 10 days.  If you wear soft contact lenses these should be removed before adding FML Eye Drops into your eye, as the preservative can cause discolouration, and do not return them for at least 15 minutes.

How long should you take FML Eye Drops?

You should see an improvement in symptoms after 2 days but continue to use your FML Eye Drops for as long as recommended by your doctor but not for more than 10 days.  

Missed dose of FML Eye Drops

If you miss a dose of FML Eye Drops apply it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should FML Eye Drops be stored?

You should store your FML Eye Drops below 25°C in a cool dry place.