Details for: APO-KETOROLAC
Company: APOTEX INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02229080 | APO-KETOROLAC | KETOROLAC TROMETHAMINE | 10 MG | TABLET | ORAL |
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
Your health care provider has prescribed APO-KETOROLAC tablets for you for one or more of the following medical conditions:
- for short-term use as pain relief after surgery, after labour or after injury causing muscle or joint pain (not to exceed 5 days for postsurgical patients or 7 days for patients with musculoskeletal pain)
What it does
APO-KETOROLAC (ketorolac tromethamine), as a
non-steroidal antiinflammatory drug (NSAID), can
reduce the chemicals produced by your body which
cause pain and swelling.
APO-KETOROLAC, as a non-steroidal antiinflammatory drug (NSAID), does NOT cure your
illness or prevent it from getting worse.
APO-KETOROLAC only can relieve pain and reduce
swelling as long as you continue to take it.
When it should not be used
DO NOT TAKE APO-KETOROLAC if you have any of the following medical conditions:
- have had or are planning to have heart bypass surgery
- have severe, uncontrolled heart failure
- have bleeding in the brain or other bleeding disorders
- are at 28 weeks of pregnancy or more
- are in labour and delivery
- are breastfeeding or planning to breastfeed
- are allergic to ASA (Acetylsalicylic Acid), other NSAIDs (Non-steroidal Anti-Inflammatory Drugs), APO-KETOROLAC or its ingredients
- have active ulcer or bleeding from the stomach or gut
- have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
- have liver or kidney disease
- have high potassium in the blood
- are currently using probenecid or oxpentifylline
- are having central nervous system injection e.g. epidural, brain or spinal administration
- are going into have any major surgery
- are using other NSAIDs
Patients who took a drug in the same class as
APO-KETOROLAC after a type of heart surgery
(coronary artery bypass grafting (CABG)) were
more likely to have heart attacks, strokes, blood
clots in the leg(s) or lung(s), and infections or
other complications than those who did NOT take
that drug.
APO-KETOROLAC should NOT be used in
patients under 18 years of age since the safety
and effectiveness have NOT been established.
What the medicinal ingredient is
ketorolac tromethamine
What the non-medicinal ingredients are
APO-KETOROLAC tablets: carnauba wax, croscarmellose sodium, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
What dosage form it comes in
APO-KETOROLAC is available as: tablets (10 mg).
Warnings and precautions
Serious Warnings and Precautions
If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than APO-KETOROLAC:
- Heart Attack or Angina
- Stroke or Mini-stroke
- Loss of Vision
- Current Pregnancy (less than 28 weeks)
- Congestive Heart Failure
Before taking this medication, tell your health care provider if you have any of the following:
- High blood pressure
- High cholesterol
- Diabetes mellitus or on a low sugar diet
- Thickening or hardening of your artery walls (Atherosclerosis)
- Poor circulation to your extremities
- Smoker or ex-smoker
- Kidney disease or urine problems
- Previous ulcer or bleeding from the stomach or gut
- Previous bleeding in the brain
- Bleeding problems
- Liver, biliary, pancreatic or renal problems
- Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
- Family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
- Family history of allergy to sulfonamide drugs (if applicable)
- Any other medical problem
Also, before taking this medication, tell your health
care provider if you are planning to get pregnant.
While taking this medication:
- tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery;
- do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop stomach problems;
- fertility may be decreased. The use of APO-KETOROLAC is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping APO-KETOROLAC should be considered.
Interactions with this medication
Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):
- Acetylsalicylic Acid (ASA) or other NSAIDs
- e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen)
- Antacids
- Antidepressants
- Selective Serotonin Reuptake Inhibitors (SSRIs)
- e.g. citalopram, fluoxetine, paroxetine, sertraline
- Blood pressure medications
- ACE (angiotensin converting enzyme) inhibitors
- e.g. enalapril, lisinopril, perindopril, ramipril
- ARBs (angiotensin II receptor blockers)
- e.g. candesartan, irbesartan, losartan, valsartan
- Blood thinners
- e.g. warfarin, ASA, clopidogrel
- Corticosteroids (including glucocorticoids)
- e.g. prednisone
- Cyclosporin
- Digoxin
- Diuretics
- e.g. furosemide, hydrochlorothiazide
- Lithium
- Methotrexate
- Morphine
- Oxpentifylline
- Probenacid
Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking APO-KETOROLAC. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both APO-KETOROLAC and ASA than if you took APO-KETOROLAC alone.
Proper use of this medication
APO-KETOROLAC Tablets
Usual Dose
Medical Condition | Starting Dose | Maximum Dose (per day) | Maximum Duration Of Treatment (days) |
Post- Surgical Pain or postpartum uterine cramping pain | 10 mg every 4 to 6 hours as required | Doses exceeding 40 mg per day are not recommended | 5 days |
Musculoskeletal Pain | 10 mg every 4 to 6 hours as required | Doses exceeding 40 mg per day are not recommended | 7 days |
Take APO-KETOROLAC only as directed by your
health care provider. Do NOT take more of it, do
NOT take it more often and do NOT take it for a
longer period of time than your health care
provider recommended. If possible, you should
take the lowest dose of this medication for the
shortest time period. Taking too much APO-KETOROLAC may increase your chances of
unwanted and sometimes dangerous side effects,
especially if you are elderly, have other diseases or
take other medications.
In general, APO-KETOROLAC should not be used for
more than 7 days. If a longer period is considered,
see your health care provider regularly to discuss
whether this medicine is working for you and if it is
causing you any unwanted effects.
This medication has been prescribed specifically
for you. Do NOT give it to anyone else. It may
harm them, even if their symptoms seem to be
similar to yours.
APO-KETOROLAC is NOT recommended for use
in patients under 18 years of age since safety and
effectiveness have NOT been established.
To lessen stomach upset, take APO-KETOROLAC
immediately after a meal or with food or milk.
However, the presence of food in the stomach may
delay the onset of pain relief. If stomach upset
(indigestion, nausea, vomiting, stomach pain or
diarrhea) occurs and continues, contact your doctor.
You should remain standing or sitting upright (i.e. do
not lie down) for about 15 to 30 minutes after taking
the medicine. This helps to prevent irritation that may
lead to trouble swallowing.
Missed Dose
The missed dose should be taken as soon as remembered, and then the regular dosing schedule should be continued. Two doses of APO-KETOROLAC should not be taken at the same time.
Overdose
Side effects and what to do about them
APO-KETOROLAC may cause some side effects,
especially when used for a long time or in large
doses. When these side effects occur, you may
require medical attention. Report all symptoms or side
effects to your health care provider.
APO-KETOROLAC may cause you to become drowsy
or tired. Be careful about driving or participating in
activities that require you to be alert. If you become
drowsy, dizzy or light-headed after taking APO-KETOROLAC, do NOT drive or operate machinery.
APO-KETOROLAC may cause you to become more
sensitive to sunlight. Any exposure to sunlight or
sunlamps may cause sunburn, skin blisters, skin rash,
redness, itching or discolouration, or vision changes.
If you have a reaction from the sun, check with your
health care provider.
Check with your health care provider IMMEDIATELY
if you develop chills, fever, muscle aches or pains, or
other flu-like symptoms, especially if they occur before
or together with a skin rash. These symptoms may be
the first signs of a SERIOUS ALLERGIC REACTION
to this medication.
Symptom / effect | STOP taking APO-KETOROLAC and get emergency medical attention IMMEDIATELY | STOP taking drug and seek immediate emergency medical attention |
---|---|---|
Bloody or black tarry stools | ✔ | |
Shortness of breath, wheezing, any trouble breathing or chest tightness | ✔ | |
Skin rash, hives, swelling or itching | ✔ | |
Blurred vision, or any visual disturbance | ✔ | |
Any change in the amount or colour of your urine (red or brown) | ✔ | |
Any pain or difficulty experienced while urinating | ✔ | |
Swelling of the feet, lower legs, weight gain | ✔ | |
Vomiting or persistent indigestion, nausea, stomach pain or diarrhea | ✔ | |
Yellow discolouration of the skin or eyes, with or without itchy skin | ✔ | |
Malaise, fatigue, loss of appetite | ✔ | |
Headaches, stiff neck | ✔ | |
Mental confusion, depression | ✔ | |
Dizziness, lightheadedness | ✔ | |
Hearing problems | ✔ |
This is not a complete list of side effects. If you develop any other symptoms while taking APO-KETOROLAC, see your health care provider.
How to store
Store APO-KETOROLAC at room temperature (15 °C to 30°C). Protect from light.
Do NOT keep outdated medicine or medicine no
longer needed. Any outdated or unused medicine
should be returned to your pharmacist
Keep out of sight and reach of children
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO-KETOROLAC:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada.html). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products) or by calling 1-800-667-4708
This leaflet was prepared by Apotex Inc., Toronto, Ontario,
M9L 1T9.
Last revised: February 5, 2019