Details for: ACUVAIL
Company: ALLERGAN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02369362 | ACUVAIL | KETOROLAC TROMETHAMINE | 0.45 % / W/V | 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
ACUVAIL® is used for treatment of pain and inflammation (swelling and redness) following cataract eye surgery.
What it does
ACUVAIL® is a non-steroidal anti-inflammatory drug (NSAIDs). It works by reducing the release of substances called prostaglandins that cause inflammation, and pain.
When it should not be used
- you are allergic (hypersensitive) to ketorolac tromethamine or any of the other ingredients (see “What are the ingredients in ACUVAIL®”, above)
- your are allergic to other nonsteroidal antiiflammatory medicines such as acetylsalicylic acid, difusinal, fenoprofen, flurbiprofen, ketoprofen, indomethacin, mefanaimc acid, piroxicam, sulindac, tiaprofenic acid or tolmetin.
What the medicinal ingredient is
ketorolac tromethamine
What the non-medicinal ingredients are
carboxymethylcellulose sodium, sodium citrate, sodium chloride; purified water with hydrochloric acid and/or sodium hydroxide to adjust pH.
What dosage form it comes in
Ophthalmic solution 0.45%, w/v in a single‐use vial
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use ACUVAIL®. Talk about any health conditions or problems you may have, including if you:
- have any allergies to acetylsalicylic acid or to any of the other non-steroidal anti-inflammatory drugs (NSAIDs) or have asthma after using NSAIDs
- bruise easily, or if you have bleeding problems, or if you are taking blood thinning medication. ACUVAIL® may cause bleeding in the eyes with eye surgery
- have medical conditions such diabetes mellitus, dry eye syndrome, rheumatoid arthritis or problems with your cornea (the front part of your eye)
- have had recent eye surgery or are planning for eye surgery
- are pregnant or intend to become pregnant
- are breast-feeding or intend to breast-feed
Other warnings you should know about:
While using ACUVAIL® talk to your healthcare professional if you are not getting relief, your symptoms worsen or new eye problems develop.
Do not use ACUVAIL® more that two weeks unless advised by your doctor. There is risk of corneal problems if you use ophthalmic non-steroidal anti-inflammatory drugs such as ACUVAIL® beyond 14 days after the surgery.
Use ACUVAIL® single-use vial immediately after opening and discard the remaining product immediately after use. Do not allow the tip of the vial to touch the eyes or surrounding surfaces to avoid injury and contamination of the eye drops.
ACUVAIL® eye drop may slow or delay healing of the eyes.
Driving and Using Machines: ACUVAIL® may cause blurred vision. Do not drive or use heavy machinery until your vision clears.
Contact Lenses: Do not use ACUVAIL® drops with your contact lenses in. If your healthcare professional recommends contact lenses use, remove them before using ACUVAIL® drops. Wait at least 15 minutes after using ACUVAIL® before putting your contact lenses back in.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- blood thinning medication such as warfarin.
Proper use of this medication
Follow the following steps to help you use ACUVAIL® properly:
- Wash your hands well with soap and water before you start.
- Tilt your head back or lie down.
- Gently pull down the lower eyelid to create a small “pocket” between the eyelid and your eye. The drop will go in here.
- Do not touch your eye or eyelid, surrounding areas or other surfaces with the tip of the unit‐dose vial.
- Hold the unit‐dose vial, tip pointing down, While looking up, gently squeeze the vial to release one drop into each eye that needs treatment.
- Let go of the lower lid, and close your eye for 30 seconds, longer is better (up do 5 minutes). Try not to blink or squeeze your eyelids.
- Use ACUVAIL® single‐use vials immediately after opening. Discard the remaining content immediately after use.
If you are using more than 1 eye drop medication, wait 5 minutes before applying the other eye drop.
Do not allow the tip of the vial to touch the eyes or eyes lids, eyelashes, fingers, counter surface or anything else. Contact with any surface can contaminate the product which may infect your eyes later on.
If you wear contact lenses: Do not use ACUVAIL® with your contact lenses in. Remove your contact lenses. After using ACUVAIL®, wait 15 minutes before putting your contact lenses back in.
Usual adult dose (18 years of age and older):
Patient dosingOne day before your cataract surgery, apply one drop of ACUVAIL® to the affected eye twice daily. Continue to apply one drop to the affected eye twice daily on the day of cataract surgery and for as long as your doctor told you. This maybe up to two weeks after cataract surgery.
Dosing on the day of cataract surgery by healthcare professionalAdminister one drop two hours before surgery, then approximately every twenty minutes for a total of three drops. Before discharge administer one additional drop.
Overdose
If you accidentally swallow ACUVAIL® eye drops, drink fluids to dilute and contact your local poison centre or doctor.
Missed Dose
If you miss a dose of ACUVAIL®, use the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.
Side effects and what to do about them
These are not all the possible side effects you may feel when using ACUVAIL®. If you experience any side effects not listed here, contact your healthcare professional.
The most common side effects with treatment of ACUVAIL® include eye pain, abnormal sensation in the eye, increased fluid pressure inside the eye(s), and pupil disorder.
| 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 |
|---|---|---|---|
Ulcerative keratitis [open sores and swelling of
the cornea (clear window in the front of the eye)]:
|
✔ | ||
Corneal perforation (hole in the cornea):
|
✔ |
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 room temperature (15 - 30°C). Store the vials in the pouch. Protect from light.
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/health-canada/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
- 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: September 11, 2018
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