AK-Dex ophthalmic

Name: AK-Dex ophthalmic

What is AK-Dex (dexamethasone ophthalmic)?

Dexamethasone ophthalmic is in a class of drugs called corticosteroids. It inhibits processes in the body that cause inflammation. Therefore, the swelling and pain of inflammatory conditions is decreased.

Dexamethasone ophthalmic is used to treat eye inflammation caused by infections, injury, surgery, or other conditions.

Dexamethasone ophthalmic may also be used for purposes other than those listed in this medication guide.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What should I avoid while using AK-Dex (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.

For Healthcare Professionals

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 AK-Dex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Cyclitis

Suspension: Instill one or two drops topically in the conjunctival sac(s).

Comments:
-In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation decreases.
-In mild disease, drops may be used up to four to six times a day, being tapered to discontinuation as the inflammation decreases.

Ointment: Apply a one-half to one inch ribbon of ointment into the conjunctival sac(s) up to four times a day

Comments:
-When improvement is observed, use may be reduced gradually to once a day application for several days.
-Ointment may be used in conjunction with suspension.

Uses:
-Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (including allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivities, corneal injury from chemical or thermal burns, or penetration of foreign bodies)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dexamethasone ophthalmic Pregnancy Warnings

Animal studies have shown teratogenic effects following topical ophthalmic administration. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects from topically applied corticosteroids. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Corticosteroids should not be used extensively on pregnant patients, in large amounts or for extended periods of time.

Dexamethasone ophthalmic Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes; however, it is not known whether intravitreal administration could result in sufficient systemic absorption to produce detectable quantities in human milk. Comments: The effects in the nursing infant are unknown.

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