dexamethasone ophthalmic (Rx)

Frequency Not Defined

Cataract

Ocular hypertension

Open-angle glaucoma, optic nerve damage, and defects in visual acuity and field of vision (after prolonged use)

<1%

• Transient ocular stinging, burning, local irritation, ocular discharge, ocular discomfort or pain, foreign body sensation, hyperemia, abnormal vision/blurring, pruritus, lid margin crusting, sticky sensation, increased fibrin, dry eye, conjunctival edema, corneal staining, keratitis, tearing, edema, irritation, corneal ulcer, browache, eyelid erythema, corneal edema, infiltrate, corneal erosion, mydriasis, ptosis, epithelial punctate keratitis, and possible corneal or scleral malacia, [posterior subcapsular cataracts] (prolonged use)

Postmarketing Reports

Cushing’s syndrome and adrenal suppression (after use in excess of listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors)

Contraindications

Hypersensitivity

Glaucoma, epithelial defect

Viral diseases including epithelial herpes simplex keratitis, acute infectious stages of vaccinia, varicella, and other diseases of cornea & conjunctiva

Mycobacterial infection of eye, fungal diseases

Cautions

Avoid prolonged treatment, if possible, because of the ocular side effects of glaucoma, secondary infection (herpes simplex), cataract formations, etc

May mask infection or enhance existing infection

Reduce to lowest dose, use suspension last, wait 5min between gtts if using multiple drugs

Contact lenses should not be worn during treatment of ophthalmic infections

Perforations may occur in diseases that cause thinning of the cornea or sclera

The possibility of persistent fungal infections of cornea should be considered after prolonged corticosteroid dosing

The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with aid of magnification, such as slit-lamp biomicroscopy and, where appropriate, fluorescein staining; if signs and symptoms fail to improve after 2 days, the patient should be re-evaluated

Pregnancy

There are no adequate or well-controlled studies in pregnant women; should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus

However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation

Animal studies

• Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose In mice, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate
• In rabbits, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, and palate

Lactation

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects

Unknown whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk

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

Inhibits the inflammatory response to mechanical, chemical, or immunologic agents

Corticosteroids inhibit edema, fibrin deposition, capillary dilatation, and migration of leukocytes and phagocytes in the acute inflammatory response

Ophthalmic Administration

Suspension: Shake well before using

Instill 1-2 gtt in conjunctival sac(s)

Storage

Store upright at 8-25°C (46-77°F)