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Medication Safety Issues
International issues:
Flarex® may be confused with Flurets® which is a brand name for sodium fluoride in Australia
Flarex® may be confused with Fluarix® which is a brand name for influenza virus vaccine in the U.S. and in numerous international markets
Flarex® may be confused with Fluorex® which is a brand name for sodium fluoride in France
Fluor-Op® may be confused with Fluoron® which is a brand name for fluorine in Canada
Pronunciation
(flure oh METH oh lone)
U.S. Brand Names
Generic Available
Yes: Suspension (as base)
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of steroid-responsive inflammatory conditions of the eye
Pregnancy Risk Factor
C
Pregnancy Considerations
The extent of systemic absorption is not known. Use with caution in pregnant women.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to fluorometholone or any component of the formulation; viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis, vaccinia, and varicella); mycobacterial or fungal infections of the eye; untreated eye infections which may be masked/enhanced by a steroid
Warnings/Precautions
Concerns related to adverse effects:
• Exacerbation of viral infections: May exacerbate severity of viral infections. Use caution in patients with history of herpes simplex. Re-evaluate after 2 days if symptoms have not improved.
• Ocular effects: Prolonged use may result in glaucoma and injury to the optic nerve and lead to or mask secondary ocular infections (eg, bacterial, viral, fungal). Visual defects in acuity and field of vision may occur. Posterior subcapsular cataracts may form after long-term use. Use with caution in presence of glaucoma (steroids increase intraocular pressure). Perforation may occur with topical steroids in diseases which thin the cornea or sclera. Steroid use may delay healing after cataract surgery. Intraocular pressure should be monitored if this product is used >10 days.
Special populations:
• Contact lens wearers: Some products contain benzalkonium chloride which may be adsorbed by contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.
• Pediatrics: Safety and efficacy have not been established in children <2 years of age.
Adverse Reactions
Frequency not defined.
Gastrointestinal: Taste perversion
Ocular: Anterior uveitis, bleb formation increased, blurred vision, burning, cataract formation, conjunctival hyperemia, conjunctivitis, corneal ulcers, delayed wound healing, glaucoma, glaucoma with optic nerve damage, intraocular pressure increased, irritation, keratitis, mydriasis, perforation of the globe, ptosis, secondary ocular infection (bacterial, fungal, viral), stinging, visual acuity and field defects
Miscellaneous: Allergic reaction, systemic hypercorticoidism (rare)
Drug Interactions
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy
Storage
Suspension:
Flarex®, FML®: Store at room temperature of 2°C to 25°C (36°F to 77°F); do not freeze.
FML® Forte: Store at ?25°C (77°F); do not freeze.
Ointment: FML®: Store at ?25°C (77°F).
Mechanism of Action
Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability
Pharmacodynamics/Kinetics
Absorption: Into aqueous humor with slight systemic absorption
Dosage
Ophthalmic:
Children >2 years and Adults: Re-evaluate therapy if improvement is not seen within 2 days; use care not to discontinue prematurely; in chronic conditions, gradually decrease dosing frequency prior to discontinuing treatment
Ointment (FML®): Apply small amount (?1/2 inch ribbon) to conjunctival sac 1-3 times/day; may increase application to every 4 hours during the initial 24-48 hours
Suspension:
FML®: Instill 1 drop into conjunctival sac 2-4 times/day; may instill 1 drop every 4 hours during initial 24-48 hours
FML® Forte: Instill 1 drop into conjunctival sac 2-4 times/day
Adults: Suspension (Flarex®): Instill 1-2 drops into conjunctival sac 4 times/day; may increase application to 2 drops every 2 hours during initial 24-48 hours. Consult prescriber if no improvement after 14 days.
Administration: Other
Contact lenses should be removed before instillation. Shake suspension well before use.
Monitoring Parameters
Intraocular pressure in patients with glaucoma or when used for ?10 days; presence of secondary infections (including the development of fungal infections and exacerbation of viral infections)
Patient Education
For ophthalmic use only. Apply prescribed amount as often as directed. Wash hands before using. Wipe away excess from skin around eye. Do not use any other eye preparation for at least 10 minutes. Do not touch tip of applicator to eye or any other surface. Do not share medication with anyone else. May cause sensitivity to bright light (dark glasses may help); temporary stinging or blurred vision may occur. Do not wear contacts during administration and for 15 minutes after. Inform prescriber if you experience eye pain, redness, burning, watering, dryness, double vision, puffiness around eye, vision changes, or other adverse eye response; worsening of condition or lack of improvement. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.
Ointment: Gently squeeze the tube to apply to inside of lower lid. Close eye for 1-2 minutes and roll eyeball in all directions.
Suspension: Shake well before using. Tilt head back and look upward. Gently pull down lower lid and put drop(s) in inner corner of eye. Close eye and roll eyeball in all directions. Do not blink for 30 seconds. Apply gentle pressure to inner corner of eye for 30 seconds.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Monitor intraocular pressure in patients with glaucoma or when used for ?10 days; monitor for presence of secondary infections (including the development of fungal infections and exacerbation of viral infections). Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Ointment, ophthalmic, as base:
FML®: 0.1% (3.5 g)
Suspension, ophthalmic, as base: 0.1% (5 mL, 10 mL, 15 mL)
FML®: 0.1% (5 mL, 10 mL, 15 mL) [contains benzalkonium chloride]
FML® Forte: 0.25% (2 mL, 5 mL, 10 mL, 15 mL) [contains benzalkonium chloride]
Suspension, ophthalmic, as acetate:
Flarex®: 0.1% (5 mL) [contains benzalkonium chloride]
Pricing: U.S. (www.drugstore.com)
Ointment (FML S.O.P.)
0.1% (3.5): $42.79
Suspension (Flarex)
0.1% (5): $40.99
Suspension (FML Forte)
0.25% (5): $27.80
0.25% (10): $44.92
0.25% (15): $60.98
Suspension (FML Liquifilm)
0.1% (5): $38.52
0.1% (10): $55.63
0.1% (15): $75.97
International Brand Names
Lexi-Comp.com
Last full review/revision February 2009
Content last modified February 2009
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