fluorometholone (Flarex, FML, FML Forte)

Dosing and uses of Flarex, FML (fluorometholone)

• Adult
• Pediatric

 

Adult dosage forms and strengths

ophthalmic suspension

• 0.1%
• 0.25%

 

Inflammatory Eye Conditions

Instill 1-2 gtt in affected eye(s) QID; may use q2hr during first 24-48 hr

Use lowest dose possible

<2 years: Safety & efficacy not established

 

Other Indications & Uses

Ocular corticosteroid, antiinflammatory agent

Effective in iritis, keratitis, conjunctivitis, and many ocular inflammatory diseases; bacterial and viral infections require concomitant antibacterial and antiviral coverage respectively

 

Pediatric dosage forms and strengths

ophthalmic suspension

• 0.1%
• 0.25%

 

Inflammatory Eye Conditions

Instill 1-2 gtt in affected eye(s) QID; may use q2hr during first 24-48 hr

Use lowest dose possible

<2 years: Safety & efficacy not established

 

Flarex, FML (fluorometholone) adverse (side) effects

Frequency not defined

Glaucoma

Cataract

Potentiate super infection

Slow wound healing

Rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin

Other adverse effects include: allergic reactions; foreign body sensation; erythema of eyelid; eyelid edema/eye swelling; eye discharge; eye pain; eye pruritus; lacrimation increased; rash; taste perversion; visual disturbance (blurry vision); and visual field defect

 

Warnings

Contraindications

Hypersensitivity to any component of the formulation

Absolute: herpes simplex keratitis, ocular fungal disease, ocular tuberculosis, ocular viral disease

Relative: cataracts, glaucoma, ophthalmic infection

 

Cautions

Monitor closely with diabetes mellitus

Prolonged use of corticosteroids may increase IOP in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation

 

Pregnancy and lactation

Pregnancy category: C

Lactation: excretion in milk unknown; use with caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Flarex, FML (fluorometholone)

Absorption: following topical instillation of corticosteroids into the conjunctival sac, the drugs are absorbed into the aqueous humor, & systemic absorption occurs

 

Mechanism of action

Synthetic fluorinated corticosteroid