FML Ophthalmic Ointment

FML® (fluorometholone ophthalmic ointment) 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: phenylmercuric acetate (0.0008%). Inactives: mineral oil; petrolatum (and) lanolin alcohol; and white petrolatum.

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

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.

FML® (fluorometholone ophthalmic ointment) 0.1% is supplied in a collapsible aluminum tube with a black low density polyethylene screw cap in the following size: 3.5 g in 3.5 g tube – NDC 0023-0316-04

Storage: Store at 15°-25°C (59°-77°F). Avoid exposure to temperatures above 40°C (104°F).

Revised: 02/2013

© 2013 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
Made in the U.S.A.

71091US13

ALLERGAN

NDC 0023-0316-04
Rx only

FML®
(fluorometholone
ophthalmic
ointment) 0.1%

sterile

3.5 g

Applies to fluorometholone ophthalmic: ophthalmic ointment, ophthalmic suspension

Along with its needed effects, fluorometholone ophthalmic (the active ingredient contained in FML S.O.P.) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluorometholone ophthalmic:

• Bigger, dilated, or enlarged pupils (black part of the eye)
• blurred vision or other change in vision
• burning, dry, or itching eyes
• decreased vision
• delayed wound healing
• discharge from eye
• headache
• increased sensitivity of the eyes to light
• nausea or vomiting
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• tearing

Some side effects of fluorometholone ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning and stinging sensation when medicine is applied
• drooping upper eyelids
• feeling of having something in the eye