Pronunciation:

kee-toe-ROLE-ak

Brand Names:

• Toradol
• Toradol IV/IM

Dosage Forms:

• Solution
• Tablet

Warnings:

Ketorolac tromethamine oral tablets are indicated for short term use only (up to 5 days total duration, including IV/IM and oral therapy in adults) for the management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine if necessary. Not for use in pediatric patients and not indicated for minor or chronic pain. Daily doses beyond label recommendations increase the risk for serious adverse events and do not improve efficacy. The risk for serious and potentially fatal cardiovascular thrombotic events may increase with use, duration of use, and in patients with cardiovascular disease, or risk factors for cardiovascular disease. Contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. May cause peptic ulcers, gastrointestinal bleeding, or potentially fatal stomach or intestinal perforation. Contraindicated in active or history of peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of gastrointestinal bleeding. Contraindicated in patients with: advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high-risk of bleeding. Contraindicated in patients receiving concomitant aspirin or NSAIDs, or as prophylactic analgesic before any major surgery. Contraindicated in labor and delivery and in nursing mothers. Use caution in elderly patients due to high risk of gastrointestinal adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine .

Ketorolac tromethamine is indicated for short term use only (up to 5 days total duration, including IV/IM and oral therapy in adults) for the management of moderately severe acute pain that requires analgesia at the opioid level. Ketorolac tromethamine oral tablets are indicated only as continuation treatment following IV or IM dosing of ketorolac tromethamine if necessary. Not for use in pediatric patients and not indicated for minor or chronic pain. Oral daily doses beyond label recommendations increase the risk for serious adverse events and do not improve efficacy. The risk for serious and potentially fatal cardiovascular thrombotic events may increase with use, duration of use, and in patients with cardiovascular disease, or risk factors for cardiovascular disease. Contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. May cause peptic ulcers, gastrointestinal bleeding, or potentially fatal stomach or intestinal perforation. Contraindicated in active or history of peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of gastrointestinal bleeding. Contraindicated in patients with: advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high-risk of bleeding. Contraindicated in patients receiving concomitant aspirin or NSAIDs, or as prophylactic analgesic before any major surgery. Contraindicated in labor and delivery and in nursing mothers. Use caution in elderly patients due to high risk of gastrointestinal adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine. Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred. Contraindicated in patients who previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other NSAIDs. Contraindicated for intrathecal or epidural administration. Use caution in elderly patients due to high risk of gastrointestinal adverse events. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine. Doses of ketorolac tromethamine injection should not exceed 60 mg/day in these patients .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

NSAID

Chemical—

Acetic Acid (class)

Uses of This Medicine:

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac is not a narcotic and is not habit-forming. It will not cause physical or mental dependence, as narcotics can. However, ketorolac is sometimes used together with a narcotic to provide better pain relief than either medicine used alone.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the dose of ketorolac and with the length of treatment. Therefore, ketorolac should not be used for more than 5 days. Before using this medicine, you should discuss with your doctor the good that this medicine can do as well as the risks of using it.

Ketorolac is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ketorolac in children up to 16 years of age with use in other age groups.

Older adults—

Stomach or intestinal problems, swelling of the face, feet, or lower legs, or sudden decrease in the amount of urine may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of ketorolac. Also, elderly people are more likely than younger adults to get very sick if the medicine causes stomach problems. Studies in older adults have shown that ketorolac stays in the body longer than it does in younger people. Your doctor will consider this when deciding on how much ketorolac should be given for each dose and how often it should be given.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentoxifylline
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Probenecid
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulfasalazine
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Budesonide
• Bumetanide
• Cangrelor
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Cilostazol
• Citalopram
• Clomipramine
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Diazoxide
• Dibenzepin
• Digoxin
• Dipyridamole
• Dothiepin
• Doxepin
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etozolin
• Feverfew
• Fluocortolone
• Fluoxetine
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Iloprost
• Imipramine
• Indapamide
• Inotersen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Meadowsweet
• Melitracen
• Melphalan
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Nadroparin
• Nefazodone
• Nortriptyline
• Opipramol
• Paramethasone
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Piretanide
• Polythiazide
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Selexipag
• Sertraline
• Sibutramine
• Spironolactone
• Sulfinpyrazone
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tianeptine
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or
• Diabetes mellitus (sugar diabetes) or
• Edema (swelling of face, fingers, feet or lower legs caused by too much fluid in the body) or
• Kidney disease or
• Liver disease (severe) or
• Systemic lupus erythematosus (SLE)—The chance of serious side effects may be increased

• Asthma or
• Heart disease or
• High blood pressure—Ketorolac may make your condition worse.

• Bleeding in the brain (history of) or
• Hemophilia or other bleeding problems—Ketorolac may increase the chance of serious bleeding

• Bleeding from the stomach or intestines (history of) or
• Colitis, stomach ulcer, or other stomach or intestinal problems (or history of)—Ketorolac may make stomach or intestinal problems worse. Also, bleeding from the stomach or intestines is more likely to occur during ketorolac treatment in people with these conditions

Proper Use of This Medicine:

For patients taking ketorolac tablets:

• To lessen stomach upset, ketorolac tablets should be taken with food (a meal or a snack) or with an antacid.
• Take this medicine with a full glass of water. Also, do not lie down for about 15 to 30 minutes after taking it. This helps to prevent irritation that may lead to trouble in swallowing.

For patients using ketorolac injection:

• Medicines given by injection are sometimes used at home. If you will be using ketorolac at home, your health care professional will teach you how the injections are to be given. You will also have a chance to practice giving injections. Be certain that you understand exactly how the medicine is to be injected.

For safe and effective use of this medicine, do not use more of it, do not use it more often, and do not use it for more than 5 days. Using too much of this medicine increases the chance of unwanted effects, especially in elderly patients.

Ketorolac should be used only when it is ordered by your doctor for treating certain kinds of pain. Because of the risk of serious side effects, do not save any leftover ketorolac for use in the future, and do not share it with other people.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For pain:
    • Adults (patients 16 years of age and older)—One 10-milligram (mg) tablet four times a day, four to six hours apart. Some people may be directed to take two tablets for the first dose only.
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
• For injection dosage form:
  • For pain:
    • Adults (patients 16 years of age and older)—15 or 30 mg, injected into a muscle or a vein four times a day, at least 6 hours apart. This amount of medicine may be contained in 1 mL or in one-half (0.5) mL of the injection, depending on the strength. Some people who do not need more than one injection may receive one dose of 60 mg, injected into a muscle.
    • Children up to 16 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Taking certain other medicines together with ketorolac may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. Therefore, do not take acetaminophen (e.g., Tylenol) together with ketorolac for more than a few days, unless otherwise directed by your medical doctor or dentist. Also, do not take any of the following medicines together with ketorolac, unless your medical doctor or dentist has directed you to do so and is following your progress:

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren®)
• Diflunisal (e.g., Dolobid®)
• Etodolac (e.g., Lodine®)
• Fenoprofen (e.g., Nalfon®)
• Floctafenine (e.g., Idarac®)
• Flurbiprofen (e.g., Ansaid®)
• Ibuprofen (e.g., Motrin®)
• Indomethacin (e.g., Indocin®)
• Ketoprofen (e.g., Orudis®)
• Meclofenamate (e.g., Meclomen®)
• Mefenamic acid (e.g., Ponstel®)
• Nabumetone (e.g., Relafen®)
• Naproxen (e.g., Naprosyn®)
• Oxaprozin (e.g., Daypro®)
• Phenylbutazone (e.g., Butazolidin®)
• Piroxicam (e.g., Feldene®)
• Sulindac (e.g., Clinoril®)
• Tenoxicam (e.g., Mobiflex®)
• Tiaprofenic acid (e.g., Surgam®)
• Tolmetin (e.g., Tolectin®)
• Zomepirac (e.g., Zomax®)

Ketorolac may cause some people to become dizzy or drowsy. If either of these side effects occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Swelling of face, fingers, lower legs, ankles, and/or feet

weight gain (unusual)

Less common

Bruising (not at place of injection)

high blood pressure

skin rash or itching

small, red spots on skin

sores, ulcers, or white spots on lips or in mouth

Rare

Abdominal or stomach pain, cramping, or burning that is severe

bleeding from the rectum or bloody or black, tarry stools

bloody or cloudy urine

blue lips and fingernails

blurred vision of other vision change

burning, red, tender, thick, scaly, or peeling skin

chest pain

convulsions

cough or hoarseness

dark urine

decrease in amount of urine that is sudden

fainting

fast, irregular, noisy, or troubled breathing

fever with severe headache, drowsiness, confusion, and stiff neck or back

fever with or without chills or sore throat

hallucinations (seeing, hearing, or feeling things that are not there)

hearing loss

hives

increase in amount of urine or urinating often

light-colored stools

loss of appetite

low blood pressure

mood changes or unusual behavior

muscle cramps or pain

nausea, heartburn, or indigestion that is severe and continues

nosebleeds

pain in lower back and/or side

pain, tenderness, or swelling in the upper stomach area

painful or difficult urination

pale skin

puffiness or swelling of the eyelids or eyes

ringing or buzzing in ears

runny nose

severe restlessness

shortness of breath

swollen or painful glands

swollen tongue

thirst that continues

tightness in the chest with or without wheezing

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain (mild or moderate)

bruising at place of injection

diarrhea

dizziness

drowsiness

headache

indigestion

nausea

Less common or rare

Bloating or gas

burning or pain at place of injection

constipation

feeling of fullness in abdominal or stomach area

increased sweating

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.