fluorometholone
Drug Details
- Generic Name
- fluorometholone
- Brand Names
- FML FORTE, fluorometholone ophthalmic suspension, FML, FLUOROMETHOLONE
- Application Number
- NDA019216
- Sponsor
- Allergan, Inc.
- NDC Codes
- 6
- Dosage Forms
- SUSPENSION/ DROPS, SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- FLUOROMETHOLONE
Indications and Usage
INDICATIONS AND USAGE FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients.