fluorometholone (Rx)

Frequency Not Defined

Glaucoma

Cataract

Potentiate super infection

Slow wound healing

Hypercorticoidism (rare)

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)

Visual field defect

Postmarketing Reports

Dysgeusia

Contraindications

Hypersensitivity to any component of the formulation

Herpes simplex keratitis, ocular fungal or mycobacterial infections; ocular viral disease

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; consider checking intraocular pressure frequently

Topical ophthalmic corticosteroids may slow corneal wound healing; in those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids

Fungal infections of cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use

Use in the treatment of herpes simplex infection requires great caution

May aid in establishment of secondary ocular infections from pathogens due to suppression of host response

Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication

May mask infection or enhance existing infection

May exacerbate severity of viral infections; use caution in patients with history of herpes simplex

Contact lenses should be removed during instillation of fluorometholone acetate ophthalmic suspension but may be reinserted 15 minutes after instillation

Patients should be advised that their vision may be temporarily blurred following dosing with fluorometholone acetate ophthalmic suspension; care should be exercised in operating machinery or driving a motor vehicle

Pregnancy Category: C

Lactation: Excretion in milk unknown; not recommended

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.

Mechanism of Action

Synthetic fluorinated corticosteroid; inhibits inflammatory response including edema, leukocyte migration, capillary dilation, and scar formation

Pharmacokinetics

Absorption aqueous humor, & systemic absorption occurs