Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Implant, Intravitreal [preservative free]:
Ozurdex: 0.7 mg (1 ea)
Insert, Ophthalmic [preservative free]:
Dextenza: 0.4 mg (1 ea, 10 ea)
Solution, Ophthalmic, as phosphate:
Generic: 0.1% (5 mL)
Suspension, Intraocular [preservative free]:
Dexycu: 9% (0.5 mL)
Suspension, Ophthalmic:
Maxidex: 0.1% (5 mL)
Pharmacology
Mechanism of Action
Decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response.
Pharmacokinetics/Pharmacodynamics
Absorption
Ocular implant: Systemic levels negligible in majority of patients (≤50 pg/mL) ≤90 days following implant, highest systemic concentration observed: 102 pg/mL
Intracanalicular insert: Systemic levels negligible in majority of patients (≤50 pg/mL) ≤29 days following insertion, highest systemic concentration observed: 810 pg/mL
Intraocular suspension: Dexamethasone plasma concentrations ranged from 0.07 to 2.79 ng/mL on post-surgery Day 1 following a single intraocular injection at the end of cataract surgery. By post-surgery Day 15 or Day 30, very few patients had quantifiable plasma concentrations.
Onset of Action
Ocular implant: BRVO/CRVO: Improvement observed in 20% to 30% of patients within first 2 months following intravitreal injection
Duration of Action
Ocular implant: BRVO/CRVO: ~1 to 3 months (following onset of improvement)
Use: Labeled Indications
Intracanalicular (0.4 mg insert [Dextenza]): Treatment of ocular inflammation and pain following ophthalmic surgery
Intraocular (9% suspension [Dexycu]): Treatment of postoperative inflammation
Intravitreal implant (Ozurdex): Treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); treatment of noninfective uveitis affecting the posterior segment of the eye; treatment of diabetic macular edema
Ophthalmic, topical (0.1% solution, suspension, or ointment [Canadian product]): Management of steroid-responsive inflammatory conditions such as allergic conjunctivitis, iritis, or cyclitis; symptomatic treatment of corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The 0.1% ophthalmic solution is also indicated for otic use to treat steroid-responsive inflammatory conditions of the external auditory meatus.
Contraindications
Intracanalicular (0.4 mg insert): Active corneal, conjunctival, or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infections; ophthalmic fungal disease and dacryocystitis
Intraocular (9% suspension): There are no contraindications listed in the manufacturer's labeling.
Intravitreal ocular implant: Hypersensitivity to dexamethasone or any component of the formulation or product; glaucoma with cup to disc ratios of >0.8; active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases; use in patients with a posterior lens capsule that is torn or ruptured
Ophthalmic, topical (0.1% suspension, solution, or ointment [Canadian product]): Hypersensitivity to dexamethasone or any component of the formulation or product; viral disease of the cornea and conjunctiva (including epithelial herpes simplex keratitis, vaccinia, varicella); mycobacterial or fungal infection of the eye; acute, purulent untreated bacterial infections of the eye; the solution should also not be used for otic indications if perforation of a drum membrane is present
Dosage and Administration
Dosing: Adult
Ocular inflammation:
Ophthalmic, topical:
0.1% ointment [Canadian product]: Apply thin coating of ointment into conjunctival sac 3 to 4 times/day; when clinically indicated, may reduce application frequency gradually to once daily.
0.1% solution: Instill 1 to 2 drops into conjunctival sac every hour during the day and every other hour during the night; gradually reduce dose to 1 drop every 4 hours, then to 3 to 4 times/day.
0.1% suspension: Instill 1 to 2 drops into conjunctival sac up to 4 to 6 times/day; may use hourly in severe disease; taper prior to discontinuation.
Ocular postoperative inflammation (9% suspension): Intraocular: Inject 0.005 mL (517 mcg) into the posterior chamber at the end of ocular surgery.
Ocular postoperative inflammation and pain (0.4 mg insert): Intracanalicular: Place single 0.4 mg insert into the lower lacrimal canaliculus.
Otic inflammation: Otic: 0.1% ophthalmic solution, topical: Initial: Instill 3 to 4 drops into the aural canal 2 to 3 times a day; reduce dose gradually once a favorable response is obtained. Alternately, may pack the aural canal with a gauze wick saturated with the solution; remove from the ear after 12 to 24 hours. Repeat as necessary.
Diabetic macular edema (pseudophakic or phakic patients scheduled for cataract surgery) or macular edema (following BRVO or CRVO): Ocular implant: Intravitreal injection: 0.7 mg implant injected in affected eye
Noninfective uveitis: Ocular implant: Intravitreal injection: 0.7 mg implant injected in affected eye
Dosing: Geriatric
Refer to adult dosing. Solution/suspension: Use cautiously in the elderly in the smallest possible dose.
Dosing: Pediatric
Ocular inflammation: Infants, Children, and Adolescents:
Solution 0.1%: Ophthalmic: Limited data available: Instill 1 to 2 drops into conjunctival sac every hour during the day and every other hour during the night; gradually reduce dose to every 3 to 4 hours, then to 3 to 4 times/day (Cassidy 2001)
Suspension 0.1%: Ophthalmic: Instill 1 to 2 drops into conjunctival sac up to 4 to 6 times per day in mild disease; may use hourly in severe disease; taper prior to discontinuation as inflammation subsides. Twice daily dosing has been shown to control inflammation in children ≤10 years receiving dexamethasone after strabismus surgery while resulting in less of an increase in IOP compared to administration 4 times daily (Lam 2005; Ng 2000).
Administration
Ophthalmic, topical:
Ophthalmic 0.1% ointment [Canadian product]: Gently pull down under eye to form pocket between eyeball and lower eyelid, then apply ointment into pocket; patient should look down prior to closing eye. Do not touch tip of dropper to eye(s) or any other surface.
Ophthalmic 0.1% solution or suspension: Remove soft contact lenses prior to using solutions containing benzalkonium chloride. Do not touch tip of container to eye. Shake suspension well prior to use.
Ophthalmic 0.1% solution may also be administered otically. Prior to use, clean the aural canal thoroughly and sponge dry.
Intracanalicular 0.4 mg insert: Prior to insertion, may dilate punctum with ophthalmic dilator, if necessary. Insert in the lower lacrimal punctum into the canaliculus. Do not insert if canaliculus is perforated. Insert must be hydrated after fully inserted (if hydration occurs prior to full insertion, discard product and use new insert); 1 to 2 drops of balanced salt solution may be instilled into the punctum to aid in insert hydration. Refer to manufacturer's prescribing information for additional administration instructions.
Intraocular 9% suspension: Preparation and administration of the dose must occur in a sterile surgical setting. Administer the dose into the posterior chamber inferiorly behind the iris at the end of ocular surgery. Refer to manufacturer's prescribing information for details related to preparation and administration technique.
Intravitreal ophthalmic implant: Administer under controlled aseptic conditions (eg, sterile gloves, sterile drape, sterile eyelid speculum). Administer adequate anesthesia and a broad-spectrum bactericidal to the periocular skin, eyelid, and ocular surfaces prior to injection. Refer to manufacturer's prescribing information for administration technique. If administration is required in the second eye, a new applicator should be used and the sterile field, syringe, gloves, drapes, and eyelid speculum should be changed.
Storage
Intracanalicular 0.4 mg insert: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light; keep in foil laminate pouch prior to use; do not use if foil pouch is damaged or broken.
Intraocular 9% suspension: Store at 20°C to 25°C (68°F to 77°F).
Ocular implant: Store at 15°C to 30°C (59°F to 86°F).
Ophthalmic, topical:
0.1% ointment [Canadian product]: Store at room temperature.
0.1% solution: Store at 15°C to 30°C (59°F to 86°F).
0.1% suspension: Store upright at 8°C to 27°C (46°F to 80°F).
Drug Interactions
CYP3A4 Inhibitors (Strong): May increase the serum concentration of DexAMETHasone (Ophthalmic). Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Monitor therapy
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
Intraocular implant/injection:
>10%:
Cardiovascular: Hypertension (implant: 13%)
Ophthalmic: Cataract (implant: 5% to 68%; incidence increases in patients requiring a second injection), increased intraocular pressure (6% to 28%), conjunctival hemorrhage (implant: 22% to 23%), corneal edema (injection: 5% to 15%; implant: ≤1%), iritis (5% to 15%)
1% to 10%:
Cardiovascular: Aneurysm (implant: 3%; retinal)
Central nervous system: Foreign body sensation of eye (≤5%), headache (implant: 1% to 4%)
Ophthalmic: Anterior chamber inflammation (implant: 2% to 10%), decreased visual acuity (1% to 9%), eye pain (≤8%), conjunctival hyperemia (implant: ≤7%), conjunctivitis (implant: ≤6%), corneal erosion (≤5%), xerophthalmia (≤5%), conjunctival edema (implant: 5%), ocular hypertension (implant: 5%), blepharitis (injection: 1% to 5%), blurred vision (injection: 1% to 5%), cystoid macular edema (1% to 5%), ophthalmic inflammation (injection: 1% to 5%), photophobia (injection: 1% to 5%), secondary cataract (injection: 1% to 5%), vitreous detachment (1% to 5%), vitreous opacity (1% to 5%), retinal hole without detachment (implant: 2%), blepharoptosis (implant: ≤2%), keratitis (implant: ≤2%)
Respiratory: Bronchitis (implant: 5%)
Frequency not defined: Ophthalmic: Glaucoma (injection)
Ophthalmic solution/suspension:
Frequency not defined:
Central nervous system: Dizziness, headache
Hypersensitivity: Hypersensitivity reaction
Ophthalmic: Burning sensation of eyes, cataract, decreased visual acuity, eye perforation, glaucoma (with optic nerve damage), inadvertent filtering bleb, secondary ocular infection, stinging of eyes, visual field defect
<1% postmarketing, and/or case reports (all routes): Blurred vision, conjunctivitis, crusting of eyelid, endophthalmitis, eye pain, eye pruritus, foreign body sensation of eye, hypotony of eye (associated with vitreous leakage from injection), increased lacrimation, keratitis, mydriasis, ocular hyperemia, photophobia, retinal detachment, xerophthalmia
Warnings/Precautions
Concerns related to adverse effects:
- Immunosuppression: Prolonged use may increase the hazard of secondary ocular infections. May mask infection or enhance existing infection. The possibility of persistent corneal fungal infection should be considered after prolonged use. Corticosteroids should not be used to treat ocular herpes simplex; use caution in patients with a history of ocular herpes simplex; reactivation of viral infection may occur.
- Ocular effects: Avoid prolonged use, which may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Hypotony of the eyes have also been reported with the implant, some of which were serious. Monitor intraocular pressure if topical ophthalmic products are used for 10 days or longer.
Disease-related concerns:
- Ocular disease: Perforations may occur in diseases which cause thinning of the cornea or sclera.
Special populations:
- Contact lens wearers: Some topical ophthalmic products may contain benzalkonium chloride which may be absorbed by contact lenses; contact lens should not be worn during treatment of ophthalmic infections.
Dosage form specific issues:
- Intravitreal implant: Endophthalmitis, ocular inflammation, intraocular pressure elevations and retinal detachments may occur with intravitreal injection. Intraocular pressure elevations peak ~8 weeks following injection; prolonged monitoring of intraocular pressure may be required. A risk of implant migration into the anterior chamber may be present if the posterior capsule of the lens is absent or torn. Temporary blurring may occur following intravitreal injections; patients should not drive until this resolves. Administer adequate anesthesia and a broad-spectrum microbicide prior to procedure.
- Sulfite sensitivity: Some products may contain sulfites, which may cause allergic reactions in susceptible individuals.
Monitoring Parameters
Intracanalicular 0.4 mg insert: Intraocular pressure
Intraocular 9% suspension: Intraocular pressure
Ophthalmic 0.1% solution/suspension, topical: Intraocular pressure (with use >10 days)
Ophthalmic implant (intravitreal injection): Following injection, monitor for increased intraocular pressure and endophthalmitis; check for perfusion of optic nerve head immediately after injection, tonometry within 30 minutes, biomicroscopy between 2 to 7 days after injection.
Pregnancy
Pregnancy Considerations
Information related to the use of the intravitreal implant during pregnancy is limited (Concillado 2016; Hodzic-Hadzibegovic 2017). Following use of the intraocular suspension, systemic exposure is below the limit of quantification after 15 days.
If ophthalmic drops (eg, dexamethasone 0.1% solution) are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).
Patient Education
What is this drug used for?
- It is used to treat eye swelling.
- It is used to treat eye irritation.
- It is used to treat ear swelling.
Frequently reported side effects of this drug
- Foreign body sensation in eye
- Dry eyes
- Blurred vision
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe ear irritation
- Eye redness
- Sensitivity to lights
- Floater in the eye
- Severe eye irritation
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
