dexamethasone ophthalmic insert (Rx)

1-10%

Anterior chamber inflammation including iritis and iridocyclitis (9%)

Increased intraocular pressure (IOP) (5%)

Visual acuity reduced (2%)

Eye pain (1%)

Cystoid macular edema (1%)

Corneal edema (1%)

Conjunctival hyperemia (1%)

Headache (1%)

Contraindications

Active corneal, conjunctival, or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye; dacryocystitis

Cautions

The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the 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

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity, and defects in fields of vision; caution if used in the presence of glaucoma; monitor IOP

Corticosteroids may suppress immune response and increase risk for secondary ocular infections; may also mask infection and enhance existing infection

Ocular corticosteroids may prolong viral eye infections and exacerbate severity

Consider fungal invasion with any persistent corneal ulceration while using ocular corticosteroids

Use after cataract surgery may delay healing and increase bleb formation incidence

Pregnancy

Data are not available regarding use in pregnant women

Animal data

• Topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate, and multiple visceral malformations
• In mice, topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10-13 produced embryofetal lethality and a high incidence of cleft palate; 0.75 mg/kg/day in mice is ~5x the entire dose of dexamethasone in the Dextenza product (based on body surface)
• In rabbits, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg/day, on gestational day 6, then 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis, and hypoplastic kidneys; 0.24 mg/day is ~6x the entire dose of dexamethasone in the Dextenza product (based on body surface)

Lactation

Unknown if distributed in human breast milk

Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however, systemic concentration of dexamethasone following administration of Dextenza is low

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug 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

Corticosteroid; decreases postoperative ocular pain by suppressing inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells

Absorption

Low plasma concentrations were detectable (>50 pg/mL, lower limit of quantification) in 11% of samples (21 of 189), and ranged from 0.05-0.81 ng/mL

Intracanalicular Administration

For single intracanalicular use only

Do not use if pouch damaged or opened; do not resterilize

Instructions

• Carefully remove foam carrier and transfer to a clean and dry area
• If necessary, dilate punctum with an ophthalmic dilator; do not perforate the canaliculus during dilation or insertion of dexamethasone; if perforation occurs, do not insert dexamethasone
• After drying punctal area, use blunt (nontoothed) forceps to grasp dexamethasone and insert into the lower lacrimal canaliculus; it should be placed just below the punctal opening; excessively squeezing the insert may cause deformation
• To aid hydration, instill 1-2 drops of balanced salt solution into punctum; insert hydrates quickly upon contact with moisture
• If dexamethasone begins to hydrate before fully inserted, discard product and use a new dexamethasone
• Inserts can be visualized when illuminated by a blue light source (eg, slit lamp or hand held blue light) with yellow filter

Storage

Store refrigerated, between 2-8°C (36-46°F)

Do not freeze

Protect from light; keep in package until use