Fluor-Op - Novartis Ophthalmics

Fluor-Op^®

(FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP) 0.1%

FLUOR-OP (fluorometholone ophthalmic suspension, USP) 0.1%, is a topical anti-inflammatory agent for ophthalmic use.

Chemical Name: 9-fluoro-11ß,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.

DESCRIPTION

Contains:

Fluorometholone 0.1%

with: polyvinyl alcohol 1.4%; benzalkonium chloride 0.004%, edetate disodium; sodium chloride; sodium phosphate monobasic, monohydrate; sodium phosphate dibasic, anhydrous; polysorbate 80; sodium hydroxide to adjust the pH, and purified water.

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 on patients' eyes treated with both dexamethasone and fluorometholone 0.1% suspensions, fluorometholone demonstrated a lower propensity to increase intraocular pressure than did dexamethasone.

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

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

Prolonged use of corticosteroids may result 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 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 untreated 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.

Corticosteroids are not effective in mustard gas keratitis and Sjögren’s keratoconjunctivitis.

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

Corticosteroid-containing preparations have also been reported to cause acute uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following use of corticosteroids.

The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS).

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

The dosing of FLUOR-OP suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

FLUOR-OP (fluorometholone ophthalmic suspension, USP) 0.1% is supplied in plastic dropper bottles in the following sizes:

5 mL…………………………………………………………………………..NDC 58768-358-05

10 mL…………………………………………………………………………NDC 58768-358-10

15 mL…………………………………………………………………………NDC 58768-358-15

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing. Shake well before using. Keep bottle tightly closed when not in use.

Rx only

Mfd. by OMJ Pharmaceuticals, Inc.,

San Germán, P.R., 00683 for:

Novartis Ophthalmics

Duluth, GA 30097

6069-B