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Details for: KEYLIN DIETARY SUPPLEMENT

Company: JUNO PHARMACEUTICALS CORP.

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02443376KETOROLAC TROMETHAMINE INJECTION, USPKETOROLAC TROMETHAMINE30 MG / MLSOLUTIONINTRAMUSCULAR
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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 Tromethamine Injection
Your health care provider has prescribed Ketorolac Tromethamine Injection for you for one or more of the following medical conditions:

  • for short-term use in the hospital for pain relief after surgery (not to exceed 2 days)
    • What it does

    Ketorolac tromethamine, as a non-steroidal anti- inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling.
    Ketorolac tromethamine, as a non-steroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse.
    Ketorolac tromethamine only can relieve pain and reduce swelling as long as you continue to take it.

    When it should not be used

    DO NOT TAKE KETOROLAC TROMETHAMINE 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), Ketorolac Tromethamine Injection 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 ketorolac tromethamine 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.

    Ketorolac tromethamine 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

    Ketorolac Tromethamine Injection: 10% (w/v) alcohol, sodium chloride, sodium hydroxide, hydrochloric acid.

    What dosage form it comes in

    Ketorolac tromethamine is available as a solution for intramuscular injection (30 mg/mL).

    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 ketorolac tromethamine:

  • 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 ketorolac tromethamine is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping ketorolac tromethamine 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 ketorolac tromethamine. 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 ketorolac tromethamine and ASA than if you took ketorolac tromethamine alone.
    Proper use of this medication

    Ketorolac Tromethamine Injection

    Usual dose (18-65 years of age):

    Medical Condition Starting Dose Maximum Dose (per day) Maximum Duration of Treatment (days)
    Post surgical or Musculo skeletal Pain Initial dose: 10 mg to 30 mg according to pain. Subsequent doses: 10 mg to 30 mg every 4 to 6 hours as needed to control pain Doses exceeding 120 mg per day are not recommended 2 days

    Administer ketorolac tromethamine only as directed by your health care provider. Do NOT administer more of it, do NOT administer it more often and do NOT administer it for a longer period of time than your health care provider recommended. If possible, you should administer the lowest dose of this medication for the shortest time period.

    Administering too much ketorolac tromethamine may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

    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.

    Ketorolac tromethamine is NOT recommended for use in patients under 18 years of age since safety and effectiveness have NOT been established.

    Missed Dose:
    The missed dose should be administered as soon as remembered, and then the regular dosing schedule should be continued. Two doses of ketorolac tromethamine should not be administered at the same time.

    Overdose:
    In case of drug overdose contact a health care practitioner, hospital emergency department, or regional Poison Control Centre immediately even if there are no symptoms.
    Side effects and what to do about them

    Ketorolac tromethamine 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.

    Ketorolac tromethamine 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 lightheaded after taking ketorolac tromethamine, do NOT drive or operate machinery.

    Ketorolac tromethamine 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.

    Serious side effects and what to do about them
    Symptom STOP taking Ketorolac Tromethamine and get emergency medical attention IMMEDIATELY STOP taking Ketorolac Tromethamine and talk to your physician or pharmacist
    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 ketorolac tromethamine , see your health care provider.

    How to store

    Store ketorolac tromethamine at room temperature (15-30o C) away 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 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/medeffectcanada/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

    This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Juno Pharmaceuticals Corp. at: 1-855-819-0505

    This leaflet was prepared by Juno Pharmaceuticals Corp.

    Juno Pharmaceuticals Corp.
    402-2233 Argentia Rd.
    Mississauga, Ontario
    L5N 2X7

    Last Revised: September 21, 2020

    All other trade-marks are the property of their respective owners.

    Date modified: