Dexamethasone 0.4 mg · intracanalicular insert
Steroid, Injections & Implants
Approved uses
Ocular inflammation and pain following ophthalmic surgery
One insert placed in the lower lacrimal punctum, releasing 0.4 mg dexamethasone over up to 30 days
No drop schedule and no patient adherence problem; it resorbs on its own
Ocular itching associated with allergic conjunctivitis, age 2 and over
One insert placed in the lower lacrimal punctum, releasing 0.4 mg dexamethasone over up to 30 days
Contraindications
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. Active ocular infections.
0.4 mg dexamethasone insert, supplied sterile in a foam carrier within a foil pouch; carton of 10.
Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
Warnings & Precautions
- Intraocular pressure increase: monitor.
- Bacterial infections: steroids may mask signs of infection and worsen an existing one.
- Viral infections: ocular steroids may prolong the course of, and worsen, herpes simplex keratitis.
- Fungal infections: consider fungal invasion in any persistent corneal ulcer where a steroid has been used.
- Delayed healing: corticosteroids slow corneal and scleral healing.
Common Side Effects
The most commonly reported adverse reactions were anterior chamber inflammation and elevations in intraocular pressure.
Pregnancy: No adequate or well-controlled studies in pregnant women. Systemic exposure from the insert is low.
Lactation: No data on presence in human milk; systemic levels after insertion are low.
The safety and effectiveness of DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery have been established in pediatric patients.