Details for: OZURDEX
Company: ALLERGAN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02363445 | OZURDEX | DEXAMETHASONE | 0.7 MG | IMPLANT | INTRAVITREAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
OZURDEX® is used to treat:
- a condition called macular edema that is caused by a blockage of veins in the eye.
- a condition called non-infectious uveitis of the posterior segment of the eye that is not caused by an eye infection.
- a condition called diabetic macular in patients who have had cataract surgery and intraocular lens implantation.
What it does
OZURDEX® works by reducing swelling of the macula. This helps to lessen or prevent more
damage to the macula. The macula is an area in the centre of the back part of the eye. It is
responsible for clear vision.
OZURDEX® also works by reducing the inflammation in the back part of the eye.
When it should not be used
Do not use OZURDEX® if:
- you are allergic to dexamethasone or any of the other ingredients in OZURDEX®
- you are allergic to other medicines like OZURDEX® , called corticosteroids
- you have an eye infection of any kind caused by bacteria, a virus or a fungus
- you have glaucoma that is at an advanced stage
- you have aphakic eyes (eyes without natural or artificial lens) along with a tear in the posterior lens capsule of your eye
- you have a condition called Anterior Chamber Intraocular Lens (ACIOL) along with a tear in the posterior lens capsule of your eye
The use of OZURDEX® in children and adolescents is not recommended.
What the medicinal ingredient is
dexamethasone
What the non-medicinal ingredients are
A polymer drug delivery system contains PLGA biodegradable polymer matrix (NOVADUR™): Resomer® RG 502, Poly (D,L-lactide-co-glycolide), 50:50 PLGA ester terminated; and Resomer® RG 502 H, Poly (D,L-lactide-co-glycolide),50:50 PLGA acid terminated.
What dosage form it comes in
As an intravitreal implant that contains 0.7 mg dexamethasone. Intravitreal means that this implant is placed into the eye through an injection.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OZURDEX® . Talk about any health conditions or problems you may have, including if:
- you have aphakic eyes (eyes without natural or artificial lens)
- you have a tear in the posterior lens capsule of your eye
- you have had a herpes simplex infection in your eye before (an ulcer on the eye that has been there a long time, or sores on the eye),
- you are taking any medication to thin the blood or any other medication
- you are pregnant or planning to become pregnant,
- you are breast feeding or planning to breast feed,
- you had recent eye surgery, or plan to have one,
The following may occur or get worse after OZURDEX® treatment:
- an infection inside or around the eye
- redness (inflammation) inside the eye
- glaucoma and/or increased pressure in the eye
- detachment of the layer in the back of the eye (retinal detachment), or
- clouding of the lens (cataract
- misplacement of implant that requires surgical intervention
- Blurred or decreased vision
- Eye pain or increased discomfort
- Worsening eye redness
- A feeling of spots in front of the eye (called ‘floaters’)
- Increased sensitivity to light
Driving and using machines:
After OZURDEX® treatment you may experience some blurred vision for a short time. Wait until you can see clearly before driving or using machines. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following medicines may interact with OZURDEX®
- Medicines used to thin your blood called blood thinners.
- Sedatives and sleep-inducing medicines called barbiturates.
- Rifampin, which is a medicine used to treat tuberculosis.
- Ketoconazole, which is a medicine used to treat fungal infections.
- Indinavir, which is a medicine used to treat HIV infection.
- Medicines used to treat seizures, like phenytoin or carbamazepine.
- Erythromycin, which is an antibiotic.
Proper use of this medication
How to take OZURDEX®?
- OZURDEX® will be given to you by a doctor, called an ophthalmologist, who has experience in giving injections into the eye.
- It will be implanted directly into your eye through an injection.
- It is not recommended that both of your eyes be injected with OZURDEX® at the same time.
- After you receive the injection, your doctor will check your eye.
- You may be given antibiotic eye drops to use before, during or after your injection to prevent eye infections.
- You may also be given a pain medicine on the day of your injection.
- You may hear a ‘click’ during the injection of OZURDEX® ; you should not move, as this is expected.
- Follow all instructions given to you by your doctor.
Usual Dose
The usual dose is one OZURDEX® implant to be given by injection into your eye. Your doctor will decide if you should receive another OZURDEX injection If you need another injection, your doctor will wait 6 months to give it to you.
Overdose
Missed Dose
If you miss your appointment to receive OZURDEX® , contact your doctor or hospital as soon as possible to reschedule your appointment.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking OZURDEX® . If you experience any side effects not listed here, contact your healthcare professional.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Common | |||
| Increased pressure in the eye x | ✘ | ||
| Glaucoma (serious eye disease where pressure in the eye is increased): blurred vision, eye redness, halos around lights, loss of vision, nausea, severe eye pain, vomiting. | ✘ | ||
| Cataracts (clouding of the lens of your eye): blurry vision, clouded vision, eye pain, fading or yellowing of colours, seeing halos and glare around lights, trouble seeing at night | ✘ | ||
| Bleeding on the surface of the eye* | ✘ | ||
| Common | |||
| Vitreous detachment (detachment of the jelly inside the eye from the light-sensitive layer at the back of the eye): seeing flashes and floaters | ✘ | ||
| Bleeding into the inside of the eye*: blurry or blocked vision, floaters | ✘ | ||
| Vision blurred, decreased or difficulty seeing clearly | ✘ | ||
| A feeling of spots in front of the eye (including ‘floaters’)* | ✘ | ||
| Abnormal feeling in the eye | ✘ | ||
| Eye pain* | ✘ | ||
| Inflammation and itchiness of the eyelid | ✘ | ||
| Migraine | ✘ | ||
| Seeing flashes of light | ✘ | ||
| Swelling on the surface of the eye* | ✘ | ||
| A feeling of looking through mist or fog* | ✘ | ||
| Difficulties in seeing clearly | ✘ | ||
| Redness of the white of the eye | ✘ | ||
| Rare | |||
| Tear in the retina: vision loss or difficulty seeing | ✘ | ||
| Anterior chamber flare (increased protein in the front of the eye due to inflammation): blurry vision | ✘ | ||
| Headache | ✘ | ||
| A severe inflammation at the back of the eye (usually due to viral infection): eye redness, pain in your eyeball, sensitive to light, and vision loss | ✘ | ✘ | |
| Severe infection and Inflammation inside the eye: eye pain, redness, visual loss | ✘ | ||
| Unknown Frequency | |||
| mplant migrated from the back to the front part of the eye: blurry vision | ✘ | ||
| Low eye pressure | ✘ | ||
*Some of these side effects could have been caused by the injection procedure or the
OZURDEX implant itself
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough
to interfere with your daily activities, talk to your healthcare professional.
How to store
Keep out of the reach and sight of children.
Store at room temperature between 15º C and 30º C. Protect from excessive heat.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about OZURDEX®
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website: www.allergan.ca, or by calling 1-800-668-6424.
Last revised: August 21, 2019
©2019 Allergan Inc., Markham, ON L6G 0B5. ®Marks owned by Allergan Inc. All rights reserved.