Brand Name

      US Brand Name

      Dexycu

      Ozurdex


      Description

      Dexamethasone intravitreal implant is used to treat an eye disease called macular edema (swelling of the back of the eye). Macular edema occurs when a blood vessel in the eye is clogged. This causes vision changes that must be treated right away. This medicine is also used to treat diabetic macular edema.

      Dexamethasone intravitreal implant is also used to treat an eye disease called uveitis (swelling in the middle part of the eye).

      Dexamethasone injection is used to treat inflammation of the eye that may occur after eye surgery.

      Dexamethasone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions.

      This medicine is to be given only by or under the supervision of your doctor.

      This product is available in the following dosage forms:

      • Suspension
      • Implant

      Before Using

      In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

      Allergies

      Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

      Pediatric

      Appropriate studies have not been performed on the relationship of age to the effects of dexamethasone implant and injection in the pediatric population. Safety and efficacy have not been established.

      Geriatric

      Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexamethasone implant and injection in the elderly.

      Breastfeeding

      There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

      Drug Interactions

      Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

      Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

      • Artemether
      • Desmopressin
      • Praziquantel
      • Rilpivirine
      • Rotavirus Vaccine, Live

      Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Abametapir
      • Aldesleukin
      • Alfentanil
      • Amiodarone
      • Apalutamide
      • Aspirin
      • Atogepant
      • Avacopan
      • Balofloxacin
      • Bemiparin
      • Benzhydrocodone
      • Besifloxacin
      • Boceprevir
      • Buprenorphine
      • Bupropion
      • Carbamazepine
      • Ceritinib
      • Cholestyramine
      • Ciprofloxacin
      • Clarithromycin
      • Cobicistat
      • Codeine
      • Conivaptan
      • Cosyntropin
      • Cyclosporine
      • Dabrafenib
      • Daclatasvir
      • Darunavir
      • Desogestrel
      • Dienogest
      • Dihydrocodeine
      • Diltiazem
      • Doxorubicin
      • Doxorubicin Hydrochloride Liposome
      • Dronedarone
      • Drospirenone
      • Efavirenz
      • Elvitegravir
      • Enoxacin
      • Enzalutamide

      Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Alcuronium
      • Aminoglutethimide
      • Aprepitant
      • Atracurium
      • Auranofin
      • Caspofungin
      • Fluindione
      • Fosaprepitant
      • Fosnetupitant
      • Gallamine
      • Hexafluorenium
      • Licorice
      • Metocurine
      • Netupitant
      • Ospemifene
      • Pancuronium
      • Rifapentine
      • Saiboku-To
      • Vecuronium

      Other Interactions

      Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

      Other Medical Problems

      The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

      • Detached retina (eye disorder) or
      • Endophthalmitis (inflammation of the eye) or
      • Glaucoma (increased pressure in the eye) or
      • Herpes infection of the eye, history of or
      • Patients with lens implanted into the eyes—Use with caution. May make these conditions worse.
      • Bacterial eye infection, acute, untreated or
      • Eye lens problems (non-intact posterior lens capsule) or
      • Fungal eye infection or
      • Glaucoma, advanced or
      • Herpes simplex eye infection or
      • Mycobacterial eye infection or
      • Vaccinia (smallpox) eye infection or
      • Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

      Proper Use

      Your eye doctor (ophthalmologist) will give you this medicine in a hospital or clinic setting. It may be given as an implant or as a shot into the eye.


      Precautions

      Your eye doctor will want to check your progress at regular visits, especially during the first few weeks after you receive this medicine.

      Serious eye problems may occur after receiving this medicine. Check with your eye doctor right away if you have a change in vision or the eye becomes red, sensitive to light, or painful. Also, tell your doctor if you feel an increased pressure in the eye.

      This medicine may cause temporary blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

      The Ozurdex® implant could move into a different part of your eye if the back part of your lens is missing or torn. Talk to your doctor if you have concerns.

      If your symptoms do not improve or if they become worse, check with your eye doctor right away.


      Side Effects

      Along with its needed effects, a medicine 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:

      More common

      • 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
      • sensitivity of the eye to light
      • swelling of the eye
      • tearing
      • throbbing pain

      Less common

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

      Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

      Less common

      • Difficulty seeing at night
      • dry eye
      • feeling of having something in the eye

      Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

      Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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