Version May 2024
Ocular inflammation: Ophthalmic:
Ointment: Apply small amount (~1/2 inch ribbon) to conjunctival sac 1 to 3 times daily; may increase application to every 4 hours during the initial 24 to 48 hours
Suspension:
0.1%: Instill 1 to 2 drops into conjunctival sac 2 to 4 times daily; may instill 2 drops every 2 hours or 1 drop every 4 hours during initial 24 to 48 hours
0.25%: Instill 1 drop into conjunctival sac 2 to 4 times daily; may instill 1 drop every 4 hours during initial 24 to 48 hours
Note: Re-evaluate therapy if improvement is not seen within 2 to 14 days (product specific); use care not to discontinue prematurely; in chronic conditions, gradually decrease dosing frequency prior to discontinuing treatment
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Fluorometholone: Pediatric drug information")
Note: Reevaluate therapy if improvement not observed within 2 days. Use care not to discontinue treatment prematurely; in chronic conditions, gradually decrease dosing frequency prior to discontinuing treatment.
Ocular inflammation:
Children ≥2 years and Adolescents: Ophthalmic:
Ointment: FML 0.1%: Apply small amount (~1/2-inch ribbon) to conjunctival sac 1 to 3 times daily; may increase application to every 4 hours during the initial 24 to 48 hours or in severe cases (Ref).
Suspension:
FML Liquifilm 0.1%: Instill 1 to 2 drops into conjunctival sac 2 to 4 times daily; may instill 2 drops every 2 hours or 1 drop every 4 hours during initial 24 to 48 hours.
FML Forte 0.25%: Instill 1 drop into conjunctival sac 2 to 4 times daily; may instill 1 drop every 4 hours during initial 24 to 48 hours.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Dermatologic: Skin rash
Gastrointestinal: Dysgeusia
Hypersensitivity: Hypersensitivity reaction
Ophthalmic: Blurred vision, burning sensation of eyes, erythema of eyelid, eye discharge, eye irritation, eye pain, eye pruritus, eyelid edema, foreign body sensation of eye, glaucoma, increased intraocular pressure, increased lacrimation, optic nerve damage, secondary ocular infection, stinging of eyes, subcapsular posterior cataract, swelling of eye, visual field defect
Miscellaneous: Wound healing impairment
Hypersensitivity to fluorometholone, other corticosteroids, 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; acute purulent untreated eye infections which may be masked/enhanced by a steroid.
Concerns related to adverse effects:
• Cataracts: Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. Use following cataract surgery may delay healing or increase the incidence of bleb formation.
• Corneal thinning: Various ophthalmic disorders, as well as prolonged use of corticosteroids, may result in corneal and scleral thinning. Continued use in a patient with thinning may result in perforation.
• Glaucoma: Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma; damage to the optic nerve; and defects in visual acuity and fields of vision. Use with caution in patients with glaucoma; monitor IOP in any patient receiving treatment for ≥10 days.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection (including fungal infections). Acute purulent ocular infections may be masked or exacerbated with use. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
Disease-related concerns:
• Herpes simplex: Use caution in patients with history of herpes simplex; frequent slit lamp microscopy is recommended.
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.
Other warnings/precautions:
• Appropriate use: Patients should be re-evaluated if symptoms fail to improve after 2 to 14 days (product specific). Initial prescription and renewal of medication >20 mL (suspension) or >8 g (ointment) should be made by health care provider only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate).
• Discontinuation of therapy: In chronic conditions, withdraw therapy with gradual tapering of dose.
Increased intraocular pressure (IOP) may occur especially with prolonged use; in children, increased IOP with ophthalmic corticosteroids has been shown to be dose dependent and produce a greater IOP in children <6 years of age than older children (Lam 2005).
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 [DSC]) [contains phenylmercuric acetate]
Suspension, Ophthalmic, as acetate:
Flarex: 0.1% (5 mL)
Flarex: 0.1% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium]
Suspension, Ophthalmic, as base:
FML Forte: 0.25% (5 mL, 10 mL) [contains benzalkonium chloride, edetate (edta) disodium, polysorbate 80]
FML Liquifilm: 0.1% (5 mL, 10 mL)
Generic: 0.1% (5 mL, 10 mL)
May be product dependent
Suspension (Flarex Ophthalmic)
0.1% (per mL): $21.59
Suspension (Fluorometholone Ophthalmic)
0.1% (per mL): $18.59
Suspension (FML Forte Ophthalmic)
0.25% (per mL): $40.42
Suspension (FML Liquifilm Ophthalmic)
0.1% (per mL): $40.42
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Ophthalmic, as acetate:
Flarex: 0.1% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium]
Suspension, Ophthalmic, as base:
FML: 0.1% (5 mL, 10 mL) [contains benzalkonium chloride, disodium edta, polysorbate 80]
Generic: 0.1% (5 mL)
Ophthalmic: For topical ophthalmic use only; to avoid contamination, do not touch dropper or tube tip to eyelids or other surfaces. Remove contacts prior to administration and wait 15 minutes before reinserting. Shake suspension well before using.
Ophthalmic: Wash hands prior to use. Avoid contact of medication tube or bottle tip with skin or eye.
Suspension: Shake well before use; apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Ref). The preservative (benzalkonium chloride) may be absorbed by soft contact lenses; remove contact lenses before instillation; wait at least 15 minutes after administration of suspension before inserting soft contact lenses.
Ocular inflammation: Treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye
Flarex [US, Canada, and multiple international markets] may be confused with Fluarix brand name for influenza virus vaccine (inactivated) [US and multiple international markets] and Fluorex brand name for fluoride [France]
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Adverse events were observed in animal reproduction studies following use of ophthalmic fluorometholone. The extent of systemic absorption following topical application of the ophthalmic drops is not known. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).
Systemic corticosteroids are excreted in human milk. The extent of systemic absorption following topical application of the ophthalmic drops is not known. The manufacturer recommends that caution be exercised when administering fluorometholone to breastfeeding women.
Intraocular pressure when used for ≥10 days; signs or symptoms of infection.
Corticosteroids inhibit the inflammatory response including edema, capillary dilation, leukocyte migration, and scar formation. Fluorometholone penetrates cells readily to induce the production of lipocortins. These proteins modulate the activity of prostaglandins and leukotrienes.
Absorption: Primarily into aqueous humor (Hui 1986)
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