Fml

• If you have an allergy to fluorometholone or any other part of FML (fluorometholone eye ointment).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a bacterial eye infection.
• If you have any of these health problems: A fungal, TB (tuberculosis), or viral infection of the eye.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take FML with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

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.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.

FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

FML® suspension 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.

FML® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

General

The initial prescription and renewal of the medication order beyond 20 milliliters of FML® suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

Information for Patients

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

The preservative in FML® suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling FML® suspension to insert soft contact lenses.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Pregnancy

Teratogenic effects. Pregnancy 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.

Nursing Mothers

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically‑administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in infants below the age of two years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Applies to fluorometholone ophthalmic: compounding powder, ophthalmic ointment, ophthalmic suspension

Ocular

Common (1% to 10%): Increased intraocular pressure
Very rare (less than 0.01%): Corneal calcification (in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas)
Frequency not reported: Eye irritation, conjunctival/ocular hyperemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid edema, blurred vision, eye discharge, eye pruritus, increased lacrimation, eye edema/eye swelling, mydriasis, cataract (including subcapsular), ulcerative keratitis, ocular infection (including bacterial, fungal, and viral infections), visual field defect, punctate keratitis, acute anterior uveitis, perforation of the globe, conjunctivitis, corneal ulcers, loss of accommodation, ptosis, ocular irritation, blurry vision[Ref]

Gastrointestinal

Frequency not reported: Dysgeusia[Ref]

Endocrine

Rare (less than 0.1%): Systemic hypercorticoidism[Ref]

Dermatologic

Frequency not reported: Rash[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Nervous system

Frequency not reported: Taste perversion[Ref]

General

The most commonly reported side effect was increased intraocular pressure.[Ref]

Some side effects of FML may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.