Fluorometholone

This is not a complete list of Fluorometholonedrug interactions. Ask your doctor or pharmacist for more information.

Take fluorometholone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Fluorometholone dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Fluorometholone is available in the following doses:

• Fluorometholone Ophthalmic 0.1% Ophthalmic Ointment
• Fluorometholone Ophthalmic 0.1% Ophthalmic Suspension
• Fluorometholone Ophthalmic 0.25% Ophthalmic Suspension
• Fluorometholone Ophthalmic Compounding Powder
• Fluorometholone-sulfacetamide Sodium Ophth 0.1%-10% Ophthalmic Suspension

Fluorometholone is available in the following forms:

• Ophthalmic Suspension

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

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

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

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

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

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

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

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

Specific Populations

Category C.b c d e f h

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

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

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

Storage

Ophthalmic

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

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

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

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.

Applies to fluorometholone ophthalmic: compounding powder, ophthalmic ointment, ophthalmic suspension

Ocular

Common (1% to 10%): Increased intraocular pressure
Very rare (less than 0.01%): Corneal calcification (in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas)
Frequency not reported: Eye irritation, conjunctival/ocular hyperemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid edema, blurred vision, eye discharge, eye pruritus, increased lacrimation, eye edema/eye swelling, mydriasis, cataract (including subcapsular), ulcerative keratitis, ocular infection (including bacterial, fungal, and viral infections), visual field defect, punctate keratitis, acute anterior uveitis, perforation of the globe, conjunctivitis, corneal ulcers, loss of accommodation, ptosis, ocular irritation, blurry vision[Ref]

Gastrointestinal

Frequency not reported: Dysgeusia[Ref]

Endocrine

Rare (less than 0.1%): Systemic hypercorticoidism[Ref]

Dermatologic

Frequency not reported: Rash[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Nervous system

Frequency not reported: Taste perversion[Ref]

General

The most commonly reported side effect was increased intraocular pressure.[Ref]

Some side effects of fluorometholone ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available

Fluorometholone 0.1%/0.25% suspension and ointment: Safety and efficacy have not been established in patients younger than 2 years.

Fluorometholone acetate: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.