Details for: ACULAR
Company: ALLERGAN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02248722 | ACULAR LS | KETOROLAC TROMETHAMINE | 0.4 % | SOLUTION | OPHTHALMIC |
| 01968300 | ACULAR LIQ 0.5% | 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
ACULAR® 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.
ACULAR LS® eye drops are used to manage eye pain and other symptoms that may occur after vision correction surgery. It may reduce eye pain, burning, stinging, sensitivity to light and the feeling that something is in your eye.
What it does
ACULAR® and ACULAR LS® belong 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
- you are allergic to ketorolac tromethamine or any of the other ingredients (see “What are the ingredients in ACULAR® and ACULAR LS®”, above)
What the medicinal ingredient is
Ketorolac tromethamine
What the non-medicinal ingredients are
ACULAR®: Benzalkonium chloride 0.01% w/v as the preservative, sodium chloride, edetate disodium, octoxynol 40, purified water, and sodium hydroxide and/or hydrochloric acid solution to adjust the pH to 7.4.
ACULAR LS®: Benzalkonium chloride 0.006% w/v as the preservative, edetate disodium, octoxynol 40, purified water, sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust the pH to 7.4.
What dosage form it comes in
ACULAR® ophthalmic solution 0.5%, w/v
ACULAR LS® ophthalmic solution 0.4%, w/v
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use ACULAR® or ACULAR LS®. 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. ACULAR® and ACULAR LS® are not recommended during pregnancy.
- breast-feeding, or are planning to be breast-feeding. ACULAR® and ACULAR LS® are 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 ACULAR® may cause bleeding in the eyes when associated with eye surgery.
Other warnings you should know about:
ACULAR® and ACULAR LS® 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.
Proper use of this medication
How to use ACULAR® or ACULAR LS®:
Remove your contact lenses before using ACULAR® or ACULAR LS®. You may re-insert them 15 minutes after taking ACULAR®
or ACULAR LS®.
ACULAR® and ACULAR LS® both contain benzalkonium chloride, which may discolour soft contact lenses.
Always use ACULAR® and ACULAR LS® exactly as your doctor has instructed you.
If you use ACULAR® or ACULAR LS® with another eye drop, leave at least five minutes between putting in ACULAR® or ACULAR LS® 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.
ACULAR® and ACULAR LS® 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 ACULAR® and ACULAR LS® properly:
- Wash your hands. Tilt your head back and look at the ceiling.
- Gently pull down the lower eyelid to create a small pocket.
- Turn the bottle upside down and squeeze it gently to release one drop into each eye that needs treatment.
- Let go of the lower lid and close your eye for 30 seconds.
If a drop misses your eye, try again.
Usual Dose
ACULAR®
Instill 1 or 2 drops in your affected eye 3 or 4 times daily or as directed by your doctor.
ACULAR LS®
Instill 1 drop in your affected eye 4 times daily for up to 4 days.
Overdose
If ingested accidentally, drink a lot of fluids.
Missed Dose
If you forget to apply ACULAR® or ACULAR LS® at your normal time, simply apply them 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 ACULAR® or ACULAR LS®. If you experience any side effects not listed here, contact your healthcare professional.
Common with ACULAR®:
- 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)
Common with ACULAR LS®:
- Eye pain
Uncommom with ACULAR LS®:
- Headache
| Symptom / effect | Talk to your healthcare professional Only if severe |
Talk to your healthcare professional 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
ACULAR® and ACULAR LS® should be stored in the original container at room temperature (25ºC). DISCARD unused solution 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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
- 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.
This leaflet was prepared by Allergan Inc.
Last revised: August 28, 2018
© 2018 Allergan Inc., Markham, ON L6G 0B5.
® Marks owned by Allergan Inc. All rights reserved.