dexamethasone intraocular (Rx)

>10%

Increased intraocular pressure (5-15%)

Corneal edema (5-15%)

Iritis (5-15%)

1-10%

Corneal endothelial cell loss (1-5%)

Blepharitis (1-5%)

Eye pain (1-5%)

Cystoid macular edema (1-5%)

Dry eye (1-5%)

Ocular inflammation (1-5%)

Posterior capsule opacification (1-5%)

Blurred vision (1-5%)

Reduced visual acuity (1-5%)

Vitreous floaters (1-5%)

Foreign body sensation (1-5%)

Photophobia (1-5%)

Vitreous detachment (1-5%)

Contraindications

None

Cautions

Prolonged use of corticosteroids may result in glaucoma, with damage to the optic nerve and defects in visual acuity and visual fields; use with caution if glaucoma present

Corticosteroids may delay healing after cataract surgery and increase incidence of bleb formation; perforations reported with use of corticosteroids in diseases causing corneal or scleral thinning

May exacerbate infection; not recommended if active viral diseases of the cornea and conjunctiva present (eg, epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial eye infection, or ocular fungal disease; caution with history of herpes simplex; prolonged use may suppress host response to infection and increases risk of secondary ocular infections

Use in phakic individuals may promote the development of posterior subcapsular cataracts

Pregnancy

There are no available data regarding use in pregnant women

Topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice and malformations of abdominal wall/intestines and kidneys in rabbits at doses 7 and 5 times higher than the injected recommended human ophthalmic dose, respectively

Lactation

Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects

There is no information regarding the presence of intraocular dexamethasone in human milk, the effects on breastfed infants, or the effects on milk production to inform about risk to an infant during lactation

The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

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

Corticosteroids have been shown to suppress inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells

Absorption

Plasma concentrations

• Study 1, postsurgery Day 1: 0.09-0.86 ng/mL (342-mg dose); 0.07-1.16 ng/mL (517-mcg dose)
• Study 2, postsurgery Day 1: 0.349-2.79 ng/mL (517-mcg dose)
• Few patients had quantifiable plasma concentrations at the final time point of sampling (Day 15 or Day 30)

Intraocular Preparation

Each kit is for a single administration and contains drugs (0.5-mL vial), 1-mL syringe, sterile syringe guide, sterile syringe ring, sterile 18-ga needle (1.5-in), and sterile 25-ga bent cannula (8-mm)

See full prescribing information for complete, detailed instructions with diagrams for sterile field preparation

Dexamethasone vial must be vigorously shaken in sideways motion for a minimum of 30 seconds

The suspended drug material must be used immediately after shaking

Intraocular Administration

Administer single dose intraocularly in posterior chamber of the eye at the end of surgery

If the sphere of administered drug after intraocular injection appears to be >2 mm in diameter, remove excess drug material by irrigation and aspiration in the sterile surgical setting

Storage

Store at 20-25°C (68-77°F)