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Fluorometholone

Class: Corticosteroids
ATC Class: S01CA07
VA Class: OP300
Chemical Name: 9-fluoro-11ß,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione
Molecular Formula: C24H31FO5
CAS Number: 426-13-1
Brands: Flarex, Fluor-Op, FML, FML-S, Tobraflex

Introduction

A synthetic fluorinated corticosteroid; structurally related to progesterone.a

Uses for Fluorometholone

Ophthalmic Inflammation

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. b c e g

Treatment of chronic anterior uveitisd f and corneal injury from burns or penetration of foreign bodies.d f g

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;d f g used in fixed combination with sulfacetamide sodium or tobramycin when such combination therapy is indicated.d f If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.g (See Infections under Cautions.)

Fluorometholone Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment or suspension.b c d e f g

Not for injection.b d f

Shake suspension vigorously prior to use.b d e f

Avoid contamination of the preparation container.a b c d e f

Do not administer suspensions containing benzalkonium chloride while wearing soft contact lenses.b e (See Advice to Patients.)

Dosage

Available as fluorometholone and fluorometholone acetate, alone or in fixed combination with anti-infectives; dosage of fluorometholone acetate expressed in terms of the salt.b c d e f

Pediatric Patients

Ophthalmic Inflammation
Ophthalmic

Fluorometholone 0.1% suspension: In children ≥2 years of age, instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.e During initial 24–48 hours, dosage may be increased to 1 drop every 4 hours.e

Fluorometholone 0.25% suspension: In children ≥2 years of age, instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.h

Fluorometholone 0.1% ointment: In children ≥2 years of age, apply ribbon of ointment (approximately 1.3 cm in length) into the conjunctival sac of the affected eye(s) 1–3 times daily.c May be applied every 4 hours during initial 24–48 hours of therapy.c

If improvement does not occur after 2 days, reevaluate the patient.c e h

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a c e h

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a c e h

Bacterial Ophthalmic Infections
Ophthalmic

Fluorometholone and sulfacetamide sodium ophthalmic suspension: In children ≥2 years of age, instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.d

Fluorometholone acetate and tobramycin ophthalmic suspension: In children ≥2 years of age, instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4–6 hours.f During initial 24–48 hours, dosage may be increased to 1 or 2 drops every 2 hours.f

If improvement does not occur after 2 days, reevaluate the patient.d

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a d f

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a d

Adults

Ophthalmic Inflammation
Ophthalmic

Fluorometholone 0.1% suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.e During initial 24–48 hours, dosage may be increased to 1 drop every 4 hours.e

Fluorometholone 0.25% suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 2–4 times daily.h

Fluorometholone 0.1% ointment: Apply ribbon of ointment (approximately 1.3 cm in length) into the conjunctival sac of the affected eye(s) 1–3 times daily.c May be applied every 4 hours during initial 24–48 hours of therapy.c

Fluorometholone acetate 0.1% suspension: Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) 4 times daily.b During initial 24–48 hours, dosage may be increased to 2 drops every 2 hours.b

If improvement does not occur after 2 days, reevaluate the patient.c e h

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a c e h

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a c e h

Bacterial Ophthalmic Infections
Ophthalmic

Fluorometholone and sulfacetamide sodium ophthalmic suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily.d

Fluorometholone acetate and tobramycin ophthalmic suspension: Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) every 4–6 hours.f During initial 24–48 hours, dosage may be increased to 1 or 2 drops every 2 hours.f

If improvement does not occur after 2 days, reevaluate the patient.d

Duration of therapy depends on the type and severity of the disease and response to therapy.a Do not discontinue prematurely.a d f

In chronic conditions, gradually taper the dosage when the drug is discontinued to avoid exacerbation of the disease.a d

Special Populations

No special population dosage recommendations at this time.a b c d e f h

Cautions for Fluorometholone

Contraindications

  • Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).b c d e f g h

  • Mycobacterial infection of the eye.b c d e f g h

  • Fungal disease of ocular structures.b c d e f g h

  • Acute, purulent, untreated infections of the eye.b g

  • Known hypersensitivity to fluorometholone, other corticosteroids, or any ingredient in the formulation.b c d e f g h

Warnings/Precautions

Warnings

Ocular Effects

Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.b c d e f g h Use with caution in glaucoma because IOP may increase.b c d e f g h

Average time until IOP increase occurs is longer with fluorometholone than with ophthalmic dexamethasone.b c d e f h

If used for ≥10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.c d e f g h

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.b c d e f g h

Use of high-dose corticosteroids may delay healing.b c e g Use after cataract surgery may delay healing and increase incidence of bleb formation.c d e g h

Infections

See Contraindications under Cautions.

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.b c d e f g h

In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.b c d e f g h

Herpes Simplex

Use of corticosteroids in the treatment of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution; periodic slit-lamp microscopy is essential.b d c g h

General Precautions

Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 8 g of 0.1% ointment or 20 mL of 0.1 or 0.25% suspension should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).c d e h

Reevaluate patient if improvement does not occur after 2 days.c d e h

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.b c d e f g Consider possibility of fungal infection in patients with persistent corneal ulceration who have been or are receiving corticosteroid therapy.b c d e f g

Use of Fixed Combinations

When fluorometholone or fluorometholone acetate is used in fixed combination with sulfacetamide sodium or tobramycin, consider the cautions, precautions, and contraindications associated with the concomitant agent.d f

Ophthalmic Ointments

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.c g

Specific Populations

Pregnancy

Category C.b c d e f h

Lactation

Not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.b c d e f h

Caution if used in nursing women.b f Most manufacturers recommend that women discontinue nursing or the drug.c d e h

Pediatric Use

Safety and efficacy of fluorometholone alone or in fixed combination with sulfacetamide sodium or fluorometholone acetate in fixed combination with tobramycin not established in children <2 years of age.a c d e f h

Manufacturer states that safety and efficacy of fluorometholone acetate alone have not been established in children of any age.a b

Geriatric Use

No substantial differences in safety or efficacy relative to younger patients.c d e f h

Common Adverse Effects

Elevated IOP,c d e h transient stinging or burning,e g h blurred vision,e g h ocular irritation,e g h taste perversion.e h

Fluorometholone Pharmacokinetics

Absorption

Bioavailability

Corticosteroids are absorbed through the aqueous humor; because only low doses are given, little if any systemic absorption occurs.g

Stability

Storage

Ophthalmic

Ointment

<25°C. c Avoid exposure to temperatures >40°C. c

Suspension

Fluorometholone or fluorometholone acetate suspension: 2–27°C.a b Do not freeze. a b

Fluorometholone and sulfacetamide sodium suspension: Light-protected container at 15–30°C.d Do not freeze.d Do not use suspension if dark brown. d

Fluorometholone acetate and tobramycin suspension: Upright at 2–25°C.f

Compatibility

Ophthalmic

Suspension

Fluorometholone and sulfacetamide sodium suspension: Incompatible with preparations containing silver.d

Actions

  • Corticosteroids suppress the inflammatory response to mechanical, chemical, or immunologic agents.b c d e f g h

  • Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.c d e g h

Advice to Patients

  • Importance of discontinuing therapy and consulting a clinician if inflammation or pain persists for >48 hours or worsens.c d e h

  • Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chlorideb e and of delaying reinsertion of the lenses for ≥15 minutes after administration.e

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.b c d e f h

  • Importance of warning the patient not to share the drug.c d e h

  • Importance of informing a clinician if an intercurrent ocular condition (e.g., trauma, surgery, infection) develops during ophthalmic therapy.g

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.c d e f h

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d e f h

  • Importance of informing patients of other important precautionary information.b c d e f g h (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Fluorometholone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.1%

FML (with phenylmercuric acetate)

Allergan

Suspension

0.1%

Fluor-Op (with benzalkonium chloride)

Novartis

Fluorometholone Ophthalmic Suspension

Bausch & Lomb, Falcon

FML (with benzalkonium chloride)

Allergan

0.25%

FML Forte (with benzalkonium chloride)

Allergan

Fluorometholone Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1% with Sulfacetamide Sodium 10%

FML-S Liquifilm (with benzalkonium chloride and povidone)

Allergan

Fluorometholone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1%

Flarex (with benzalkonium chloride)

Alcon

Fluorometholone Acetate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.1% with Tobramycin 0.3%

Tobraflex (with benzalkonium chloride)

Alcon

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions September 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2007. McEvoy GK, ed. Fluorometholone. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: 2825.

b. Alcon Laboratories, Inc. Flarex (fluorometholone acetate) suspension prescribing information. Fort Worth , TX; 1999 Jun.

c. Allergan, Inc. FML (fluorometholone) ointment prescribing information. Irvine, CA; 2001 Nov.

d. Allergan, Inc. FML-S (fluorometholone and sulfacetamide sodium) suspension prescribing information. Irvine, CA; 2005 Feb.

e. Allergan, Inc. FML (fluorometholone) ophthalmic suspension, 0.1% prescribing information. Irvine, CA; 2003 Jun.

f. Alcon Pharmaceuticals. Tobraflex (tobramycin and fluorometholone acetate) suspension prescribing information. Fort Worth, TX; 2001 May.

g. AHFS drug information 2007. McEvoy GK,ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health Systems Pharmacists; 2007: 2813-5.

h. Allergan, Inc. FMLForte(fluorometholone) suspension prescribing information. Irvine, CA; 2004 Jun.

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