Waymade-Ketorolac Tromethamine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

WAYMADE-Ketorolac Tromethamine Tablets

Your health care provider has prescribed WAYMADE-Ketorolac Tromethamine 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 post-surgical patients or 7 days for patients with musculoskeletal pain)

What it does:

WAYMADE-Ketorolac Tromethamine (ketorolac tromethamine), as a non-steroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling.

WAYMADE-Ketorolac Tromethamine, as a non-steroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. WAYMADE-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 WAYMADE-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), WAYMADE-Ketorolac Tromethamine 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 WAYMADE-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.

WAYMADE-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:

WAYMADE-Ketorolac Tromethamine tablets: microcrystalline cellulose, lactose, magnesium stearate, hydroxy-propyl-methylcellulose, titanium dioxide, polyethylene glycol, edible black printing ink.

What dosage forms it comes in:

WAYMADE-Ketorolac Tromethamine is available as: tablets (10 mg).

WARNINGS AND PRECAUTIONS

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 WAYMADE-Ketorolac Tromethamine is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping WAYMADE-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
  • Probenecid

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 WAYMADE-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 WAYMADE-Ketorolac Tromethamine and ASA than if you took WAYMADE-Ketorolac Tromethamine alone.

PROPER USE OF THIS MEDICATION

WAYMADE-Ketorolac Tromethamine Tablets

Usual dose (18-65 years of age):

Take WAYMADE-Ketorolac Tromethamine 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 WAYMADE-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.

In general, WAYMADE-Ketorolac Tromethamine 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.

WAYMADE-Ketorolac Tromethamine 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 WAYMADE-Ketorolac Tromethamine 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 15-30 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 WAYMADE-Ketorolac Tromethamine should not be taken at the same time.

Overdose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

WAYMADE-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.

WAYMADE-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 light-headed after taking WAYMADE-Ketorolac Tromethamine, do NOT drive or operate machinery.

WAYMADE-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.

This is not a complete list of side effects. If you develop any other symptoms while taking WAYMADE-Ketorolac Tromethamine, see your health care provider.

HOW TO STORE IT

Store WAYMADE-Ketorolac Tromethamine at room temperature (15-30^o 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 SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the distributor Ignite Pharma Inc., at: 1-800-840-4068 (Drug Information).

Imported and distributed by:

Ignite Pharma Inc.

King City, Ontario L7B 1C2

For Waymade PLC, UK

Last revised: March 30, 2017