Details for: KETOROLAC TROMETHAMINE INJECTION, USP
Company: FRESENIUS KABI CANADA LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02244947 | KETOROLAC TROMETHAMINE INJECTION, USP | KETOROLAC TROMETHAMINE | 30 MG / ML | LIQUID | INTRAMUSCULAR |
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 Ketorolac Tromethamine Injection, USP 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 Injection, USP, as a non-steroidal antiinflammatory drug (NSAID), can reduce the chemicals produced
by your body which cause pain and swelling.
Ketorolac Tromethamine Injection, USP, as a non-steroidal antiinflammatory drug (NSAID), does NOT cure your illness or
prevent it from getting worse.
Ketorolac Tromethamine Injection, USP 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 Injection, USP 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, USP 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 Injection, USP 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 Injection, USP 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
Vials: Alcohol, citric acid, sodium chloride, sodium hydroxide,
hydrochloric acid, water for injection.
Prefilled syringes: Alcohol, sodium chloride, sodium hydroxide
and/or hydrochloric acid, water for injection.
What dosage form it comes in
Ketorolac Tromethamine Injection, USP is available as: liquid for intramuscular injection (30 mg / mL)
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 Ketorolac Tromethamine Injection, USP:
- 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 Injection, USP is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping Ketorolac Tromethamine Injection, USP should be considered.
Interactions with this medication
- 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
Ketorolac Tromethamine Injection, USP.
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 Injection, USP and ASA
than if you took Ketorolac Tromethamine Injection, USP alone.
Proper use of this medication
Usual dose (18-65 years of age)
| Medical Condition | Starting Dose | Maximum Dose (per day) | Maximum Duration of Treatment (days) |
| Post-surgical or Musculoskeletal 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 |
Take Ketorolac Tromethamine Injection, USP 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 Ketorolac Tromethamine Injection, USP 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, Ketorolac Tromethamine Injection, USP 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.
Ketorolac Tromethamine Injection, USP 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 taken as soon as remembered, and then the regular dosing schedule should be continued. Two doses of Ketorolac Tromethamine Injection, USP should not be taken at the same time.
Instructions for Use
CAUTION: Certain glass syringes may malfunction, break or clog
when connected to some needles. This syringe has a larger internal
syringe tip and an external collar (luer collar). The external collar
must remain attached to the syringe. Data show that the syringe
achieves acceptable connections with the BD Eclipse™ Needle
and the Terumo SurGuard2™ Safety Needle. However,
spontaneous disconnection of this glass syringe from needles with
leakage of drug product may occur. Assure that the needle is
securely attached before beginning the injection. Visually inspect
the glass syringe-needle connection before and during drug
administration. Do not remove the clear plastic wrap around the
external collar (see Figure 1).
- Inspect the outer packaging (blister pack) by verifying:
- blister integrity
- drug name
- drug strength
- dose volume
- route of administration
- expiration date to be sure that the drug has not expired
- sterile field applicability
- Peel open the paper (top web) of the outer packaging that displays the product information to access the syringe. Do not pop syringe through.
- Bend the plastic part of the outer packaging (thermoform) so as
to present the plunger rod for syringe removal (see Figure 2).
- Perform visual inspection on the syringe by verifying
- Absence of syringe damage
- Absence of external particles
- Absence of internal particles
- Proper drug colour
- Expiration date to be sure that the drug has not expired
- Drug name
- Drug strength
- Dose volume
- Route of administration
- Sterile field applicability
- Integrity of the plastic wrap around the external collar
NOTES:
- All steps must be done sequentially.
- Do not autoclave syringe.
- Do not use this product on a sterile field.
- Do not introduce any other fluid into the syringe at any time.
- This product is for single dose use only. Do not reuse.
Overdose
Side effects and what to do about them
Ketorolac Tromethamine Injection, USP 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 Injection, USP 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 Ketorolac Tromethamine Injection,
USP, do NOT drive or operate machinery.
Ketorolac Tromethamine Injection, USP 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 drug and get emergency medical attention IMMEDIATELY | STOP taking drug 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. For any unexpected effects while taking Ketorolac Tromethamine Injection, USP, contact your doctor or pharmacist.
How to store
Store Ketorolac Tromethamine Injection, USP between 15 °C and
30 °C, protect from light, protect from freezing.
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/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 Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp); Fresenius Kabi Canada’s website (http://www.fresenius-kabi.com/en-ca/), or by calling 1-877-821-7724.
This leaflet was prepared by:
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Last Revised: July 18, 2019
Fresenius Kabi is a registered trademark of Fresenius SE.
Simplist is a trademark of Fresenius Kabi USA LLC.