Details for: KETOROLAC
Company: AA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02245821 | KETOROLAC | KETOROLAC TROMETHAMINE | 0.5 % | SOLUTION | OPHTHALMIC |
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
KETOROLAC eye drops are used to prevent and treat inflammation in your eyes after having cataracts removed. A cataract is the clouding of the lens of the eye.
What it does
KETOROLAC belongs to a family of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). These drugs reduce certain substances (called prostaglandins). When prostaglandin levels are reduced, the intensity of pain, and inflammation is reduced as well.
When it should not be used
Do not use KETOROLAC if:
- you are allergic to ketorolac tromethamine or any of the other ingredients (see “What are the ingredients in KETOROLAC”, above)
What the medicinal ingredient is
Medicinal ingredients: Ketorolac tromethamine
What the non-medicinal ingredients are
Non-medicinal ingredients: Benzalkonium chloride 0.01% w/v as the preservative, edetate disodium, octoxynol 40, sodium chloride, sodium hydroxide or hydrochloric acid solution to adjust pH, and water for injection.
What dosage form it comes in
KETOROLAC (ketorolac tromethamine) ophthalmic solution 0.5% w/v
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use KETOROLAC. Talk about any health conditions or problems you may have, including if you:
- are allergic to acetylsalicylic acid (e.g. Aspirin®) or to any of the other non-steroidal anti-inflammatory drugs (NSAID).
- have a past medical history of asthma.
- are pregnant or are planning to become pregnant. KETOROLAC is not recommended during pregnancy.
- breast-feeding, or are planning to be breast-feeding. KETOROLAC is not recommended for nursing mothers.
- have had recent eye surgery or are planning for eye surgery.
- have medical conditions such diabetes mellitus, dry eye syndrome, rheumatoid arthritis or any issues with your cornea (the front part of your eye).
- have bleeding problems, as KETOROLAC may cause bleeding in the eyes when associated with eye surgery.
Other warnings you should know about:
KETOROLAC may cause blurred vision. Do not drive or use heavy machinery until your vision clears.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals,
natural supplements or alternative medicines.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Proper use of this medication
How to use KETOROLAC:
Remove your contact lenses before using KETOROLAC. You may re-insert them 15 minutes after taking
KETOROLAC
KETOROLAC contains benzalkonium chloride, which may discolour soft contact lenses.
Always use KETOROLAC exactly as your doctor has instructed you.
If you use KETOROLAC with another eye drop, leave at least five minutes between putting in KETOROLAC and
then the other drops.
To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and
close the bottle immediately after you have used it.
KETOROLAC should only be applied to the eye.
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
Follow the following steps to help you use KETOROLAC properly:
- Before using the medication for the first time, be sure the sealing tape on the bottle is unbroken (Fig.1).
- To open the bottle, unscrew the cap by turning as indicated by the arrow (Fig.2).
- Wash your hands. Tilt your head back and look at the ceiling. With clean hands, gently pull your lower eyelid
down slightly to create a small pocket between your eyelid and your eye (Fig.3).
- Turn the bottle upside down and squeeze it gently to release one drop into each eye that needs treatment (Fig. 4).
DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
If a drop misses your eye, try again. - Let go of the lower lid, and close your eye for 30 seconds. Do not blink.
Immediately after applying the eye drops, wash your hands to remove any medicine that may be on them. - Repeat steps 2, 3 and 4 with the other eye if instructed to do so by your doctor.
- Replace the cap by turning until it is firmly touching the bottle. Do not over tighten the cap.
Usual Dose
Instill 1 or 2 drops in your affected eye 3 or 4 times daily or as directed by your doctor.
Overdose
If ingested accidentally, drink a lot of fluids.
Missed Dose
If you forget to apply KETOROLAC at your normal time, simply apply it as soon as you remember, and then go back to your regular routine. Do not take two doses to make up for the one that you missed.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking KETOROLAC. If you experience any side effects
not listed here, contact your healthcare professional.
Common with KETOROLAC:
- Irritation of the eye (stinging, burning, redness)
- Itchy and/or swollen eye
- Blurred vision after instillation of the eye drops
- Eye pain
- Conjunctivitis (pink eye)
| 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 |
|---|---|---|---|
| Rare | |||
| delay wound healing in those with serious eye conditions including corneal thinning, erosion, perforation or ulceration, and cause these conditions to worsen and may affect sight | ✔ | ||
| bronchospasm (shortness of breath) and worsen asthma symptoms | ✔ | ||
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
Store at 15ºC to 30ºC. Protect from light. Discard 28 days after opening.
Keep out of reach and sight of children.
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/medeffect-canada/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 KETOROLAC:
- 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 (https://www.canada.ca/en/health-canada.html); Find the Patient Medication Information on the manufacturer’s website (https://www.aapharma.ca/en/) or by calling 1-877-998-9097.
This leaflet was prepared by AA Pharma Inc.
Last revised: May 10, 2019