(kee toe role' ak)

Brand Name(s): Toradol^®¶; also available generically

IMPORTANT WARNING:

Ketorolac injection is used for the short-term relief of moderately severe pain in people who are at least 17 years of age. Ketorolac injection should not be used for longer than 5 days, for mild pain, or for pain from chronic (long-term) conditions. You will receive your first doses of ketorolac by intravenous (into a vein) or intramuscular (into a muscle) injection in a hospital or medical office. After that, your doctor may choose to continue your treatment with oral ketorolac. You must stop taking oral ketorolac and using ketorolac injection on the fifth day after you received your first dose of ketorolac injection. Talk to your doctor if you still have pain after 5 days or if your pain is not controlled with this medication. Ketorolac may cause serious side effects.

People who are treated with nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as ketorolac may have a higher risk of having a heart attack or a stroke than people who are not treated with these medications. These events may happen without warning and may cause death. This risk may be higher for people who are treated with NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke or 'ministroke;' and if you have or have ever had high blood pressure. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

Receiving ketorolac injection increases the risk that you will experience severe or uncontrolled bleeding. Tell your doctor if you have or have ever had a bleeding or clotting problem. Your doctor will probably not give you ketorolac injection.

If you are having surgery, including dental surgery, tell the doctor or dentist that you are using ketorolac injection. If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not use ketorolac injection right before or right after the surgery.

NSAIDs such as ketorolac may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, smoke cigarettes, or drink alcohol while using ketorolac injection. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; or oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Deltasone). Do not take aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) while you are using ketorolac. Also tell your doctor if you have or have ever had ulcers, holes, or bleeding in your stomach or intestine, or a disease that causes inflammation of the bowels such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum). If you experience any of the following symptoms, stop using ketorolac injection and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Ketorolac may cause kidney failure. Tell your doctor if you have kidney or liver disease, if you have had severe vomiting or diarrhea or think you may be dehydrated, and if you are taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); or diuretics ('water pills'). If you experience any of the following symptoms, stop using ketorolac injection and call your doctor: unexplained weight gain; swelling of the hands, arms, feet, ankles, or lower legs; confusion; or seizures.

Some people have severe allergic reactions to ketorolac injection. Tell your doctor if you are allergic to ketorolac, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn), any other medications, or any of the ingredients in ketorolac injection. Also tell your doctor if you have or have ever had asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose). If you experience any of the following symptoms, stop using ketorolac injection and call your doctor right away: rash; fever; peeling or blistering skin; hives; itching; swelling of the eyes, face, throat, tongue, lips; difficulty breathing or swallowing; or hoarseness.

You should not receive ketorolac injection during labor or while you are giving birth.

Do not breast-feed while you are using ketorolac injection.

Tell your doctor if you are 65 years of age or older or if you weigh less than 110 lb (50 kg). Your doctor will need to prescribe a lower dose of medication. If you are an older adult, you should know that ketorolac injection is not as safe as other medications that can be used to treat your condition. Your doctor may choose to prescribe a different medication that is safer for use in older adults.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to ketorolac injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) each time you receive a dose of ketorolac injection . Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

WHY is this medicine prescribed?

Ketorolac is used to relieve moderately severe pain in adults, usually after surgery. Ketorolac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ketorolac injection comes as a solution (liquid) to inject intramuscularly (into a muscle) or intravenously (into a vein). It is usually given every 6 hours on a schedule or as needed for pain by a healthcare provider in a hospital or medical office.

What SPECIAL PRECAUTIONS should I follow?

Before using ketorolac injection,

• tell your doctor if you are taking probenecid (Probalan) or pentoxifylline (Pentoxil, Trental). Your doctor will probably tell you not to use ketorolac injection if you are taking either of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: alprazolam (Niravam, Xanax); angiotensin II receptor antagonists such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor), telmisartan (Micardis), or valsartan (Diovan, in Exforge); lithium (Lithobid); medications for seizures such as carbamazepine (Equetro, Tegretol) or phenytoin (Dilantin); methotrexate (Otrexup, Rheumatrex, Trexall); muscle relaxants; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax, others), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), and sertraline (Zoloft); or thiothixene (Navane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had any medical condition, especially the conditions mentioned in the IMPORTANT WARNING section.

• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Ketorolac injection may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take ketorolac injection around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking ketorolac injection, call your doctor.

• you should know that your blood pressure may increase during treatment with ketorolac injection. Your doctor will probably monitor your blood pressure during your treatment.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Ketorolac injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• drowsiness
• diarrhea
• constipation
• gas
• sores in the mouth
• sweating
• ringing in the ears
• pain at injection site
• small red or purple dots on the skin

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using ketorolac injection and call your doctor immediately:

• yellowing of the skin or eyes
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• nausea
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• pale skin
• fast heartbeat

Ketorolac injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• stomach pain
• bloody, black, or tarry stools
• vomit that is bloody or looks like coffee grounds
• drowsiness
• hives
• rash
• itching
• difficulty swallowing
• difficulty breathing, slowed breathing or fast, shallow breathing
• coma (loss of consciousness for a period of time)

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about ketorolac injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2021.