Fluorometholone

FML

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Fluorometholone ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Fluorometholone ballicule

What it isTopical glucocorticoid agonist; corticosteroid-responsive ocular inflammation.

Why this oneLimited corneal penetration tends to raise intraocular pressure less than prednisolone acetate but also limits potency.

What limits itProlonged use can still cause glaucoma and cataract; monitor pressure and reassess if deeper inflammation persists.

Fluorometholone molecular structure (skeletal formula) — Molecular structure: Fluorometholone

FDA-approved for

corticosteroid-responsive ocular inflammation

FDA label

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FDA dosing	Population	Start	Target	Max
Steroid-responsive ocular inflammation	Ophthalmic	1 drop into conjunctival sac 2–4×/day	1 drop 2–4×/day	1 drop q4h during initial 24–48 h

Renal Undefined

Hepatic Undefined

Instructions

Shake well before use
In chronic conditions, taper by gradually decreasing frequency; do not discontinue prematurely

Available strengths

susp 0.1, 0.25 %
drops 1 mg/mL

Contraindications

Most viral corneal/conjunctival diseases (epithelial herpes simplex keratitis/dendritic keratitis, vaccinia, varicella)
Mycobacterial infection of the eye
Fungal diseases of ocular structures

Cautions

Elevated intraocular pressure / glaucoma, optic nerve damage
Posterior subcapsular cataract formation
Delayed wound healing; risk of globe perforation where cornea/sclera thinned
Secondary ocular infection (bacterial, fungal, viral)

Adverse reactions

Elevated IOP
Posterior subcapsular cataract
Delayed wound healing
Transient burning/stinging
Blurred vision

Pregnancy Embryocidal and teratogenic in rabbits at low multiples of the ocular dose; use only if potential benefit justifies risk.

Lactation Undefined

Cost

Fluorometholone (FML)

Strength		#/mo	generic $/unit	CostPlus
0.1 %	susp	per unit		not offered
0.25 %	susp	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Fluorometholone is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entryLong generic

NO BOXED WARNINGS

Principal riskSteroid-induced glaucoma and cataract on prolonged use

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger0 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryC

Defining liabilityLocal irritation, sensitization or administration-site injury; negligible systemic toxicity at usual use.

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