Ozurdex

What is Ozurdex?

• Ozurdex (Dexamethasone) is a corticosteroid used for the treatment of macular edema, non-infectious uveitis and diabetic macular edema.

Dexamethasone

Dexamethasone2

What are the uses of this medicine?

OZURDEX® (dexamethasone intravitreal implant) is used:

• for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
• for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
• for the treatment of diabetic macular edema.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• 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.
• glaucoma, who have cup to disc ratios of greater than 0.8.
• whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber.
• with known hypersensitivity to any components of this product.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Ozurdex.

Is this medicine FDA approved?

• Initial U.S. Approval: 1958

How should this medicine be used?

Recommended dosage: ophthalmic intravitreal injection of intravitreal implant containing dexamethasone 0.7 mg.

Administration:

• The intravitreal injection procedure should be carried out under controlled aseptic conditions.
• Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis.
• Each applicator can only be used for the treatment of a single eye.
• If the contralateral eye requires treatment, a new applicator must be used, and the sterile field, syringe, gloves, drapes, and eyelid speculum should be changed before OZURDEX® is administered to the other eye.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system.

This medicine is available in fallowing brand namesː

• OZURDEX

What side effects can this medication cause?

The most common side effects of this medicine include:

• cataract
• increased intraocular pressure
• conjunctival hemorrhage

What special precautions should I follow?

• Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection.
• Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.
• Inform patients that they may experience temporary visual blurring after receiving an intravitreal injection. Advise patients not to drive or use machines until this has been resolved.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with OZURDEX® in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness of OZURDEX® in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DEXAMETHASONE

Inactive ingredients: none

Who manufactures and distributes this medicine?

Distributed by: Allergan USA, Inc. Madison, NJ

What should I know about storage and disposal of this medication?

• Store at 15oC to 30oC (59oF to 86oF).

• Dailymed label info on Ozurdex
• FDA Ozurdex

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