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Dexamethasone (Ophthalmic)

Pronunciation

Pronunciation

(deks a METH a sone)

Index Terms

  • Dexamethasone Sod Phosphate
  • Dexamethasone Sodium Phosphate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Implant, Intraocular [preservative free]:

Ozurdex: 0.7 mg (1 ea)

Solution, Ophthalmic, as phosphate:

Generic: 0.1% (5 mL)

Suspension, Ophthalmic:

Maxidex: 0.1% (5 mL)

Brand Names: U.S.

  • Maxidex
  • Ozurdex

Pharmacologic Category

  • Anti-inflammatory Agent, Ophthalmic
  • Corticosteroid, Ophthalmic
  • Corticosteroid, Otic

Pharmacology

Decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response.

Absorption

Ocular implant: Systemic levels negligible in majority of patients (≤50 pg/mL) ≤90 days following implant, highest systemic concentration observed: 102 pg/mL

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

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 ophthalmic solution is also indicated for otic use to treat steroid-responsive inflammatory conditions of the external auditory meatus.

Ophthalmic 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

Contraindications

Hypersensitivity to dexamethasone or any component of the formulation or product

Suspension/solution, ointment [Canadian product]: Viral disease of the cornea and conjunctiva (including epithelial herpes simplex keratitis, vaccinia, varicella); mycobacterial or fungal infection of the eye; the solution should also not be used for otic indications if perforation of a drum membrane is present

Canadian labeling: Additional contraindications (not in US labeling): Acute, purulent untreated ocular infections which may be masked or enhanced by the presence of the steroid

Intravitreal implant: Glaucoma with cup to disc ratios of greater than 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

Canadian labeling: Additional contraindications (not in US labeling): Anterior chamber intraocular lens (ACIOL) and rupture of posterior lens capsule; aphakic eyes with rupture of the posterior lens capsule

Dosing: Adult

Anti-inflammatory:

Ophthalmic:

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

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

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

Otic: Solution: 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: Renal Impairment

There are no dosage adjustment provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustment provided in the manufacturer’s labeling.

Administration

Ophthalmic 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 solution, 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 solution may also be administered otically. Prior to use, clean the aural canal thoroughly and sponge dry.

Ophthalmic implant (intravitreal injection): 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

Ocular implant, ophthalmic solution: Store at 15°C to 30°C (59°F to 86°F).

Ophthalmic ointment [Canadian product]: Store at room temperature.

Ophthalmic suspension: Store at 8°C to 27°C (46°F to 80°F).

Drug Interactions

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

NSAID (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

Adverse Reactions

Intravitreal implant (Ozurdex):

>10%:

Cardiovascular: Hypertension (13%)

Ophthalmic: Cataract (5% to 68%; incidence increases in patients requiring a second injection), increased intraocular pressure (25%; ≥10 mm Hg: 28%; ≥30 mm Hg: 15%), conjunctival hemorrhage (22% to 23%)

1% to 10%:

Cardiovascular: Aneurysm (3%; retinal)

Central nervous system: Headache (4%), foreign body sensation of eye (2%)

Ophthalmic: Decreased visual acuity (9%), eye pain (8%), conjunctival hyperemia (7%), conjunctivitis (6%), conjunctival edema (5%), dry eye syndrome (5%), ocular hypertension (5%), vitreous opacity (3% to 5%), vitreous detachment (4%), anterior chamber inflammation (2%), blepharoptosis (2%), corneal erosion (2%), keratitis (2%), retinal hole without detachment (2%)

Respiratory: Bronchitis (5%)

Postmarketing and/or case reports (Limited to important or life-threatening): Corneal edema, decreased intraocular pressure, endophthalmitis, retinal detachment

Ophthalmic solution/suspension: Frequency not defined: Ophthalmic: Burning sensation of eyes, cataract, decreased visual acuity, eye perforation, filtering blebs, glaucoma (with optic nerve damage), secondary ocular infection, stinging of eyes, visual field defect

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: Ophthalmic solution and suspension 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.

• Intravitreal implant (Canadian labeling): For macular edema following CRVO, no more than two consecutive injections should be used, and an interval of ~6 months should be allowed between the two injections. In patients with posterior segment uveitis, the use of a second injection is not recommended. Caution should be exercised if a second injection is considered in cases where the possible benefits are believed to outweigh the risk to the patient; ~6 months should be allowed between the two injections. Patients who experience and retain improved vision and patients who experience a deterioration in vision, which is not slowed by dexamethasone implant, should not be re-treated. Repeat doses should only be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and may benefit from re-treatment. Not recommended in patients with macular edema secondary to RVO with significant retinal ischemia. Administration to both eyes is not recommended. Use with caution in aphakic patients.

Monitoring Parameters

Ophthalmic solution/suspension: 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 2-7 days after injection.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies following use of ophthalmic dexamethasone.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience foreign body sensation, dry eyes, or blurred vision. Have patient report immediately to prescriber vision changes, eye pain, severe ear irritation, eye redness, sensitivity to light, vitreous floaters, cough that does not go away, severe dizziness, severe headache, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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