Fluorometholone

Pharmacologic Category

Corticosteroid, Ophthalmic

Dosing: Adult

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.

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

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: 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 (Kliegman 2007)

Suspension: FML, FML Forte: 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.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Use: Labeled Indications

Ocular inflammation: Treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye

* See Uses in AHFS Essentials for additional information.

Class and Related Monographs

Ophthalmic Corticosteroids

Administration: 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.

Administration: Pediatric

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 (Urtti 1993; Zimmerman 1982). 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.

Storage/Stability

Ointment: Store at 15°C to 25°C (59°F to 77°F); avoid temperatures >40°C (104°F).

Suspension: Store at 2°C to 25°C (36°F to 77°F) in upright position; do not freeze.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat eye swelling.

• It is used to treat eye irritation.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning

• Stinging

• Blurred vision

• Foreign body sensation in eye

• Change in taste

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Medication Safety Issues

​International issues:

Contraindications

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.

Warnings/Precautions

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.

* See Cautions in AHFS Essentials for additional information.

Warnings: Additional Pediatric Considerations

Increased 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 than older children (Lam 2005).

Pregnancy Considerations

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).

Breast-Feeding Considerations

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.

Briggs' Drugs in Pregnancy & Lactation

• Fluorometholone Ophthalmic

Adverse Reactions

Frequency not defined.

Dermatologic: Skin rash

Endocrine & metabolic: Hypercorticoidism (rare)

Gastrointestinal: Dysgeusia

Hypersensitivity: Hypersensitivity reaction

Ophthalmic: Bacterial eye infection (secondary), blurred vision, burning sensation of eyes, cataract, decreased visual acuity, erythema of eyelid, eye discharge, eye irritation, eyelid edema, eye pain, eye pruritus, foreign body sensation of eye, fungal eye infection (secondary), glaucoma, increased intraocular pressure, increased lacrimation, optic nerve damage, stinging of eyes, swelling of eye, viral eye infection (secondary), visual field defect, wound healing impairment

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Corticosteroid Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

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

Monitoring Parameters

Intraocular pressure when used for ≥10 days; signs or symptoms of infection.

Advanced Practitioners 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).

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).

Dosage Forms: US

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) [contains phenylmercuric acetate]

Suspension, Ophthalmic, as acetate:

Flarex: 0.1% (5 mL)

Flarex: 0.1% (5 mL) [contains benzalkonium chloride, edetate disodium]

Suspension, Ophthalmic, as base:

FML Forte: 0.25% (5 mL, 10 mL) [contains benzalkonium chloride, edetate disodium, polysorbate 80]

FML Liquifilm: 0.1% (5 mL, 10 mL)

Generic: 0.1% (5 mL, 10 mL, 15 mL [DSC])

Dosage Forms: Canada

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 disodium]

Suspension, Ophthalmic, as base:

FML: 0.1% (5 mL, 10 mL, 50 mL)

Generic: 0.1% (5 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• C05AA06
• D07AB06
• D07XB04
• D10AA01
• S01BA07
• S01CB05

Generic Available (US)

May be product dependent

Pricing: US

Ointment (FML Ophthalmic)

0.1% (per gram): $52.37

Suspension (Flarex Ophthalmic)

0.1% (per mL): $21.59

Suspension (Fluorometholone Ophthalmic)

0.1% (per mL): $17.05

Suspension (FML Forte Ophthalmic)

0.25% (per mL): $38.50

Suspension (FML Liquifilm Ophthalmic)

0.1% (per mL): $38.50

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.

Mechanism of Action

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.

Pharmacodynamics/Kinetics

Absorption: Primarily into aqueous humor (Hui 1986)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date

January 12, 1972

References

Flarex (fluorometholone acetate) [prescribing information]. Fort Worth, TX: Eyevance Pharmaceuticals, LLC; received February 2020.

Flarex (fluorometholone acetate) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; August 2018.

Flarex ophthalmic suspension (fluorometholone) [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc; December 2006.

FML (fluorometholone) [product monograph]. Markham, Ontario, Canada; Allergan Inc; May 2018.

FML Forte (fluorometholone) [product monograph]. Markham, Ontario, Canada; Allergan Inc; December 2015.

FML Forte ophthalmic suspension (fluorometholone) [prescribing information]. Irvine, CA: Allergan Inc; February 2013.

FML ophthalmic ointment (fluorometholone) [prescribing information]. Irvine, CA: Allergan Inc; February 2013.

FML ophthalmic suspension (fluorometholone) [prescribing information]. Irvine, CA: Allergan Inc; February 2013.

Hui HW, Robinson JR. Effect of particle dissolution rate on ocular drug bioavailability. J Pharm Sci. 1986;75(3):280-287.[PubMed 3701612]

Kliegman RM, Behrman RE, Jenson HB, et al, eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007.

Lam DS, Fan DS, Ng JS, Yu CB, Wong CY, Cheung AY. Ocular hypertensive and anti-inflammatory responses to different dosages of topical dexamethasone in children: a randomized trial. Clin Experiment Ophthalmol. 2005;33(3):252-258.[PubMed 15932528 ]

Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623.[PubMed 2903673]

Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456.[PubMed 8100087 ]

Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553.[PubMed 6704011 ]

Brand Names: International

Aflarex (CL, CO, PE, VE); Afm (BD); Efflumidex (BG, CZ, DE, HR, HU); F.M.L. (UY); Flarex (AE, AR, AT, AU, BE, BF, BG, BH, BJ, CI, CN, CY, CZ, EG, ET, GH, GM, GN, HK, HN, IQ, IR, IT, JO, KE, KR, KW, LB, LK, LR, LT, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, OM, PH, PL, PY, RU, SA, SC, SD, SL, SN, SY, TH, TN, TW, TZ, UG, VN, YE, ZM); Florate (BR); Florom (PK); Flosef (IN); Flu Oph (TH); Flu-Base (JP); Fluaton (IT); Flucon (AU, BE, CH, CZ, EG, FR, GR, HK, HU, LU, NZ, TH, TR, TW); Fluforte (CR, DO, GT, HN, NI, PA, SV); Flulon (PH); Flumelon (KR); Flumetholon (HK, JP, KR, TW); Flumetholone (KR); Flumetol (RO); Flumetol NF Ofteno (MX); Flumex (BR, CO, EC); Fluoftal (CO); Fluoropos (KR); Flurom (BD); Flurop (PT); FML (AE, AR, BB, CN, CY, EG, ES, GB, GR, HK, IE, IL, IQ, IR, JO, KW, LB, LK, LY, MY, OM, PE, PH, QA, SA, SG, SY, TH, TW, VN, YE, ZA, ZW); FML Damla (TR); FML Liquifilm (AU, CH, FI, LU, NL, NZ); Fuluson (KR); Fumelon (KR); Inomet (BD); Isopto Flucon (ES); Medoflucon (SK); Ocuflam (ID); Ocumetholone (KR); Okilon (JP); Optiflur (LK); Optilone (AE, BH, QA, SA); Rubalon (BD); Swixflur (EG); Ursnon (JP)

Last Updated 10/8/20