Dexamethasone ophthalmic

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Dexamethasone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with dexamethasone ophthalmic.

(deks a METH a sone)

• Dexamethasone Sod Phosphate
• Dexamethasone Sodium Phosphate

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

Implant, Intravitreal [preservative free]:

Ozurdex: 0.7 mg (1 ea)

Solution, Ophthalmic, as phosphate:

Generic: 0.1% (5 mL)

Suspension, Ophthalmic:

Maxidex: 0.1% (5 mL)

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

Ocular implant: BRVO/CRVO: Improvement observed in 20% to 30% of patients within first 2 months following intravitreal injection

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).

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.

Applies to dexamethasone ophthalmic: intraocular implant

Along with its needed effects, dexamethasone ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking dexamethasone ophthalmic:

• Bloody eye
• blurred vision
• change in vision
• eye pain
• loss of vision
• redness of the white part of the eye or inside of the eyelid

• Blindness
• decreased vision
• gradual loss of vision
• headache
• nausea
• seeing a veil or curtain across part of your vision
• seeing flashes or sparks of light
• seeing floating spots before the eyes
• vomiting

Applies to dexamethasone ophthalmic: intraocular implant, ophthalmic ointment, ophthalmic solution, ophthalmic suspension

General

The most commonly reported side effects were cataract, elevation of intraocular pressure, and conjunctival hemorrhage.[Ref]

Ocular

Very common (10% or more): Cataract (up to 68%), elevation of intraocular pressure (28%), conjunctival hemorrhage (22%)
Common (1% to 10%): Eye pain, conjunctival hyperemia, ocular hypertension, reduced visual acuity, conjunctivitis, vitreous floaters, conjunctival edema, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, keratitis, anterior chamber inflammation, retinal tear, eyelid ptosis, vitreous detachment, keratoconjunctivitis sicca, corneal staining, photophobia, blurred vision, eye pruritus, increased lacrimation
Rare (less than 0.1%): Burning, stinging
Frequency not reported: Glaucoma with optic nerve damage, visual acuity and visual field defects, subcapsular cataract formation, secondary ocular infection and perforation of the globe
Postmarketing experience: Complication of device insertion (implant misplacement), device dislocation with or without corneal edema, endophthalmitis, hypotony of the eye (associated with vitreous leakage due to injection), retinal detachment[Ref]

Cardiovascular

Very common (10% or more): Hypertension (13%)[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dysgeusia, migraine
Frequency not reported: Dizziness[Ref]

Respiratory

Common (1% to 10%): Bronchitis[Ref]

Some side effects of dexamethasone ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.