Patient Medication Information: uses, side effects, how to take - Clobivis
What CLOBIVIS is used for:
CLOBIVIS is used to treat pain and inflammation in the eye after cataract surgery.
How CLOBIVIS works:
CLOBIVIS is a medication that works by reducing pain and inflammation of the eye.
The ingredients in CLOBIVIS are:
Medicinal ingredient: clobetasol propionate
Non-medicinal ingredients: boric acid, citric acid, edetate disodium, glycerin, lecithin, methylcellulose, poloxamer, polyvinyl alcohol, sodium chloride, sodium citrate and water for injection
Preservative: Benzalkonium chloride
CLOBIVIS comes in the following dosage forms:
As an ophthalmic suspension containing 0.05% clobetasol.
Do not use CLOBIVIS if:
- you are allergic to clobetasol propionate or to any of the non-medicinal ingredients in CLOBIVIS.
- you are allergic to any part of the container.
- you have an eye infection.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLOBIVIS. Talk about any health conditions or problems you may have, including if you:
- have ever had an eye infection.
- have a condition called glaucoma or have increased pressure in your eye.
- have a condition called diabetes mellitus.
- have any other kind of eye disease.
Other warnings you should know about:
Bacterial Eye Infections: Using CLOBIVIS can suppress your immune system and make you more likely to get eye infections including those caused by bacteria. It may also mask or enhance infections. Contact your healthcare professional if you get any symptoms of an eye infection. These include redness in the eye, itching or irritation, pain or soreness, watery eyes, swelling, discharge from eye, blurry vision and sensitivity to light.
Viral Infections: Tell your healthcare professional before you take CLOBIVIS if you have ever had a herpes infection of the eye. Your healthcare professional will be very careful when prescribing CLOBIVS to you. This is because CLOBIVIS can make eye infections caused by viruses, including herpes, last longer and even make them worse.
Fungal Infections: Fungal infections in the cornea (the clear front part of your eye) can happen more easily when taking CLOBIVIS. Contact your healthcare professional if you get any symptoms of an eye infection while you are taking CLOBIVIS. These include: redness, itching, irritation or pain in the eye, watery eyes, eye swelling, discharge from eye, blurry or decreased vision, sensitivity to light, swollen eyelids.
Glaucoma:
Talk to your healthcare professional before you use CLOBIVIS if you have an eye condition called glaucoma. Your healthcare professional will be very careful when prescribing CLOBIVS to you.
If you have glaucoma, your healthcare professional will monitor the pressure inside your eye while you are taking CLOBIVIS. If you have diabetes, you have a higher chance of getting glaucoma. Taking CLOBIVIS for long periods of time can cause glaucoma with damage to the optic nerve and vision problems.
Contact lenses: You must not put CLOBIVIS in your eyes while you are wearing contact lenses. If you wear contact lenses, remove the lenses before applying CLOBIVIS. Wait 15 minutes before you put your contact lenses back in.
Driving and using machines:
Do not drive or use machines until your healthcare professional tells you it is safe.
Pregnancy:
Before you use CLOBIVIS, talk to your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. There is no information on the use of CLOBIVIS in pregnant women. CLOBIVIS should only be used in a pregnant woman following a careful risk-benefit assessment by the prescribing health care professional.
Breastfeeding:
Before you use CLOBIVIS, talk to your healthcare professional if you are breastfeeding or planning to breastfeed. It is not known if CLOBIVIS passes into breastmilk.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to use CLOBIVIS:
- Do not use CLOBIVIS if the vial is cracked or damaged in any way.
- Always use CLOBIVIS exactly as your healthcare professional has told you. Ask your healthcare professional if you are not sure.
- To help prevent infections and eye injury never let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle right after you have used it.
- If you are using any other eye drops, wait at least 5 minutes after using them before using CLOBIVIS. If you apply CLOBIVIS first, wait 5 minutes before applying any other medicine to your eyes.
- If you wear contact lenses, remove the lenses before applying CLOBIVIS. Wait 15 minutes before you put your contact lenses back in.
To apply CLOBIVIS:
- 1. Wash your hands.
- 2. Twist off the cap, being careful not to touch the dropper tip.
- 3. Tilt your head back and look upward. Gently pull down the lower eyelid of the eye that was operated on to create a small pocket.
- 4.
Turn the bottle upside down and squeeze it gently to release one drop into the eye
pocket. If a drop misses your eye, try again.
- 5. Close your eyes for a few seconds after applying CLOBIVIS, so that it spreads across your eye. Do not squeeze your eyelids shut.
- 6. Place the cap back on the bottle and keep the bottle tightly closed when not in use.
Usual dose:
Apply one drop of CLOBIVIS in each eye twice daily starting the day after cataract surgery for
14 days.
Overdose:
If you think you, or a person you are caring for, have taken too much CLOBIVIS, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you forget to use CLOBIVIS, skip that dose and continue with the next dose as planned. Never take a double dose to make up for a missed dose.
Possible side effects from using CLOBIVIS:
These are not all the possible side effects you may have when taking CLOBIVIS. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- change in your sense of taste
- eye inflammation including redness, swelling and watery eyes
- eye pain
- feeling like something is in your eye
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Rare | |||
| Allergic Reaction: difficulty breathing, difficulty swallowing, fever, hives, itchy skin, loss of consciousness, rash, swelling of your tongue, throat or face. | ✔ | ||
| Anterior chamber inflammation (inflammation of the middle layer of the eye): pain, redness, light sensitivity and blurred vision. | ✔ | ||
| Cataracts formation (cloudy areas that form in the lens of | ✔ | ||
| your eye): blurry vision, cloudy vision, colours look faded, things look hazy or foggy, trouble seeing at night, light sensitivity, double vision in one eye, halos around lights. | |||
| Cystoid macular edema (swelling in the centre or the retina): blurry vision, distorted vision, colour distortion, dark or empty spot in the centre of your view, light sensitivity, trouble seeing fine detail. | ✔ | ||
| Delayed Healing: wound from surgery does not get better over time, blebs or blisters in the eye form. | ✔ | ||
| Eye infection: redness, itching, irritation or pain in the eye, watery eyes, eye swelling, discharge from eye, blurry or decreased vision, sensitivity to light, swollen eyelids. | ✔ | ||
| Glaucoma (eye disease with damage to the optic nerve): gradual loss of peripheral vision, trouble seeing in low light, hazy vision, severe eye pain, seeing halos around lights. | ✔ | ||
| Intraocular pressure increased (increase in pressure inside the eye): sometimes no symptoms or symptoms may include eye pain, headaches, blurred vision, loss of side vision, red eyes and halos around eyes. | ✔ | ||
| Photophobia (extreme sensitivity to light): light sensitivity, eye pain, aversion to light headaches. | ✔ | ||
| Thinning of the cornea (clear front window of the eye) or sclera (white outer wall of the eye): blurry vision, distorted vision, vision that becomes progressively worse, light sensitivity, trouble seeing at night, discomfort or mild pain in the eye, bluish tint on the white of the eye. | ✔ | ||
| Vitreous detachment (gel inside eye pulls away from retina): sudden increase in floaters, shadows or darks spots in your vision, flashes of light, reduced vision, sudden vision loss. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store upright at 15°C to 25°C. Do not freeze. Discard 28 days after opening.
Keep out of reach and sight of children.
Do not use if tamper-evident ring seal is broken.
If you want more information about CLOBIVIS:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.