U.S. Brand Names:
Eflone® [DSC]; Flarex®; Fluor-Op® [DSC]; FML®; FML® Forte
Generic Available:
Yes: Suspension (as base)
Canadian Brand Names:
Flarex®; FML®; FML Forte®; PMS-Fluorometholone
Use:
Treatment of steroid-responsive inflammatory conditions of the eye
Pregnancy Risk Factor:
C
Pregnancy Implications:
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:
Not recommended in children <2 years of age; prolonged use may result in glaucoma, elevated intraocular pressure, or other ocular damage; 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; may delay healing following cataract surgery; some products contain sulfites
Adverse Reactions:
Ocular: Anterior uveitis, burning upon application, cataract formation, conjunctival hyperemia, conjunctivitis, corneal ulcers, glaucoma with optic nerve damage, perforation of the globe, secondary ocular infection (bacterial, fungal, viral), intraocular pressure elevation, visual acuity and field defects, keratitis, mydriasis, stinging upon application, delayed wound healing
Miscellaneous: Systemic hypercorticoidism (rare) and taste perversion have also been reported
Overdosage/Toxicology:
When consumed in high doses over prolonged periods, systemic hypercorticism and adrenal suppression may occur. In those cases, discontinuation of the corticosteroid should be done judiciously.
Drug Interactions:
No data reported
Stability:
Store at room temperature
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:
Children >2 years and Adults: Ophthalmic: 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: Apply small amount (~1/2 inch ribbon) to conjunctival sac every 4 hours in severe cases; 1-3 times/day in mild to moderate cases
Solution: Instill 1-2 drops into conjunctival sac every hour during day, every 2 hours at night until favorable response is obtained, then use 1 drop every 4 hours; for mild to moderate inflammation, instill 1-2 drops into conjunctival sac 2-4 times/day
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.
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.
Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.
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
Dosage Forms:
[DSC] = Discontinued product
Ointment, ophthalmic, as base (FML®): 0.1% (3.5 g)
Suspension, ophthalmic, as base: (5 mL, 10 mL, 15 mL)
Fluor-Op®: 0.1% (5 mL, 10 mL, 15 mL) [contains benzalkonium chloride and polyvinyl alcohol] [DSC]
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:
Eflone®: 0.1% (5 mL, 10 mL) [DSC]
Flarex®: 0.1% (5 mL, 10 mL) [contains benzalkonium chloride]
International Brand Names:
Aflarex® (CL, CO, EC); Cortisdin® (ES); Efflumidex® (CZ, DE, HR, HU); Flarex® (AR, AU, CA, CZ, IL, IT, NL, NZ, PL, SI, TH, TR, ZA); Florate® (BR); Fluaton® (IT); Flucon® (AU, BE, CZ, FR, HK, HU, LU, NZ, PL, TH, ZA); Fluforte® (CL); Flumetholon® (HK, ID, JP); Flumetol® (CZ, IT, RO); Flumex® (BR, CO); Flu Oph® (TH); Fluoro-Ophtal® (DE); Fluoropos® (CZ, DE); Flurolon® (DK); Flurop® (PT); FML® (AR, AU, CA, CH, ES, GB, HK, IE, IL, NZ, SG, TH, TR); FML Forte® (CA); FML Liquifilm® (AR, BE, CH, FI, LU, NL, PT); Isopto Flucon® (DE, ES); PMS-Fluorometholone (CA)
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