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Ketorolac Tromethamine Injection USP by Fresenius Kabi
How does this medication work? What will it do for me?
Ketorolac belongs to the group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term treatment (5 to 7 days) of acute pain associated with injuries, dental problems or procedures, and after surgery or giving birth. The injectable form of this medication is used for no longer than 2 days to treat moderate-to-severe pain following surgery. Ketorolac reduces a substance in the body that leads to inflammation and pain.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each mL of ketorolac tromethamine injection contains 30 mg of ketorolac tromethamine. Nonmedicinal ingredients: alcohol USP, citric acid, sodium chloride for isotonicity, sodium hydroxide and/or hydrochloric acid for pH adjustment, and sterile water for injection.
How should I use this medication?
The usual adult dose of ketorolac when taken by mouth is 10 mg every 4 to 6 hours as required for pain. Taking more than 40 mg daily is not recommended. Take this medication with meals or a snack to reduce stomach upset. After you have taken the medication, remain sitting or standing upright for 15 to 30 minutes to further reduce acid from the stomach irritating the throat.
The medication should be used for a maximum of 5 days for treatment of pain after surgery and for a maximum of 7 days when treating pain due to an injury. The lowest dose required to control the pain should be used. Ketorolac usually starts to work within an hour, but for some people, it may take up to a day to start working. If you don’t notice improvement in your pain, contact your doctor. This medication should be used for the shortest time period possible.
Ketorolac is also available for use in the hospital as an injectable medication. The usual recommended dose is 10 mg to 30 mg injected into a muscle for no more than 2 days.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not use this medication if you:
- are allergic to ketorolac or any ingredients of this medication
- are allergic to ASA or other anti-inflammatory medications (e.g., ibuprofen, naproxen, diclofenac) or have had allergic symptoms (e.g., runny nose, nasal polyps, asthma, itchy skin rash) caused by these medications
- are currently taking other NSAIDs (e.g., ibuprofen, naproxen, diclofenac)
- are in the third trimester of pregnancy
- are in labour or delivery
- are breast-feeding
- are scheduled for surgery in the immediate future or have just had surgery
- are taking probenecid
- are taking oxpentifylline
- have a stomach or intestinal ulcer or a history of recurring ulcers
- have an inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease)
- have bleeding disorders or bleeding in the brain
- have just had coronary artery bypass graft (CABG) surgery
- have severe, uncontrolled heart failure
- have high levels of potassium in the blood
- have severely reduced liver function or liver disease
- have reduced kidney function or are at risk of kidney failure
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- bruising at place of injection
- burning or pain at place of injection
- feeling of being generally unwell
- increased skin sensitivity to sunlight
- loss of appetite
- stomach upset
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blurred vision
- hearing problems
- high blood pressure
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, painful or difficult urination)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- skin rash or itching
- small, red spots on skin
- swelling of the lower legs, ankles, or feet
- vomiting or persistent indigestion, nausea, stomach pain, or diarrhea
Stop taking the medication and seek immediate medical attention if any of the following occur:
- chest pain
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
- signs of meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
- signs of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the face, mouth, throat, or tongue)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
October 30, 2020
Health Canada has issued new restrictions concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Allergic reactions: If you have had a reaction to acetylsalicylic acid (ASA) or other NSAIDs (e.g., ibuprofen, ketoprofen, diclofenac) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing, you should not take this medication. Get immediate medical attention if you experience symptoms of a severe allergic reaction (e.g., hives, difficulty breathing, wheezing, or swelling of the face, tongue, or throat).
Bladder symptoms: This medication can cause bladder symptoms such as frequent or painful urination and blood in urine. If you develop these symptoms, stop taking this medication and contact your doctor immediately.
Bleeding: Ketorolac may cause the platelets in the blood to not stick together very well. This can make it difficult to stop cuts from bleeding. If you have a condition where your blood does not clot easily, or if you are taking medications to prevent your blood from clotting, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Blood pressure: Like other NSAIDs, ketorolac can cause increased blood pressure, which may contribute to other heart conditions. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Drowsiness and dizziness: This medication can cause drowsiness or dizziness. Do not drive or operate machinery until you are sure that this medication does not affect your ability to do these safely.
Fertility: As with other NSAIDs, this medication may make it more difficult for a couple to conceive if the woman is taking ketorolac. Stopping the medication allows the body’s chemistry to return to normal which often resolves this issue.
Heart conditions: This medication can cause fluid retention, which will make symptoms of certain heart conditions worse. If you have heart failure, high blood pressure, or other medical conditions that increase your risk of fluid retention (e.g., kidney problems), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Heart problems: Like other NSAID medications, ketorolac may increase the risk of heart attacks, strokes, and blood clots. If you have any risk factors for heart problems, such as high blood pressure, high cholesterol, diabetes, peripheral arterial disease, heart failure, or coronary artery disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infection: This medication may mask signs of infection such as fever or muscle aches. If you notice other symptoms of infection (e.g., painful or frequent urination, sore throat, cough), contact your doctor.
Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. This medication can also affect kidney function. You have a higher risk of developing kidney problems if you are a senior, take diuretics (water pills; e.g., hydrochlorothiazide, furosemide), or already have kidney disease, liver disease, or heart failure. Your doctor may monitor your kidney function with blood tests if you take this medication.
Liver function: This medication may affect your liver function or cause liver problems. If you experience symptoms of liver problems (e.g., nausea, vomiting, feeling tired, yellowing of the skin or eyes), contact your doctor immediately. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced liver function or have active liver disease should not take this medication.
Long-term use: Long-term use of ketorolac (beyond 5 to 7 days for the tablets, or 2 days for the injection) is not recommended, as the risk of side effects increases with the length of treatment.
Potassium levels: Ketorolac may cause high blood potassium levels. If you are a senior, have diabetes or kidney failure, or are taking beta-blockers (e.g., metoprolol, atenolol), angiotensin converting enzyme (ACE) inhibitors (e.g., ramipril, enalapril), or some diuretics (e.g., triamterene, amiloride), you are more at risk of high blood potassium. Because extremely high blood potassium levels can contribute to other conditions, such as heart problems, your doctor will monitor your potassium level with blood tests while you are taking this medication.
Ulcers and bleeding in the stomach and intestines: This medication may cause stomach ulcers and bleeding from the stomach. These complications can occur at any time and are sometimes severe.
If you have had a stomach or intestinal ulcer, diverticulosis, Crohn’s disease, or ulcerative colitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms of an ulcer or other stomach problems (e.g., stomach or abdominal pain, black stools, bloody or coffee-ground-like vomit, weakness) contact your doctor immediately or get immediate medical attention.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. It must not be used during the last 3 months of pregnancy as it may cause heart and kidney problems for the developing baby and cause prolonged labour with excessive bleeding during delivery.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking ketorolac, it may affect your baby. Breast-feeding is not recommended while you are taking ketorolac.
Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.
Seniors: Seniors have a higher risk of side effects with this medication. If you are a senior, your doctor will closely monitor you for side effects and may prescribe a lower dose than usually recommended.
What other drugs could interact with this medication?
There may be an interaction between ketorolac and any of the following:
- acetylsalicylic acid (ASA)
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
- beta-blockers (e.g., atenolol, metoprolol)
- bisphosphonates (e.g., alendronate, etidronate)
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- diuretics (water pills; e.g., spironolactone, furosemide, hydrochlorothiazide)
- herbal products that affect blood clotting (e.g., cat’s claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- other non-steroidal anti-inflammatory medications (NSAIDs; e.g., naproxen, diclofenac, ibuprofen)
- omega-3 fatty acids
- potassium supplements
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, citalopram, escitalopram)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
- sodium phosphates
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- vitamin E
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Ketorolac-Tromethamine-Injection-USP-by-Fresenius-Kabi