Ketorolac Injection

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.

It is important that you use this medication properly to help reduce your risk of side effects. Your doctor may adjust your dose if you are older, have low body weight, or have kidney problems.

Nonsteroidal anti-inflammatory drugs (including ketorolac) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. Talk to your doctor about the benefits and risks of using this drug.

This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning at any time while using this drug. Older adults may be at higher risk for this effect. Do not use this medication if you have stomach/intestinal problems (such as bleeding, ulcers).

Stop using ketorolac and seek immediate medical attention if you notice any of the following rare but serious side effects: bloody or black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, slurred speech.

This drug should not be used right before or after heart bypass surgery (CABG) or before any surgery. It also should not be used during labor/delivery or in people with severe kidney problems or high risk for kidney problems. Do not use ketorolac if you are taking high doses of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). See also Drug Interactions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aliskiren, ACE Inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (such as prednisone), methotrexate, probenecid, other medications that may affect the kidneys (including cidofovir, cyclosporine, tenofovir).This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include lithium, pemetrexed, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to ketorolac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have asthma, talk with your doctor. You may be more sensitive to ketorolac injection.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• If you are 65 or older, use ketorolac injection with care. You could have more side effects.
• NSAIDs like this medicine may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when ketorolac injection is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ketorolac injection is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take ketorolac injection or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ketorolac injection. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

1 mL Fill Single-dose Fliptop Vial
25 Units/NDC 0409-3795-01

Ketorolac Tromethamine Inj., USP

30 mg/mL*

Rx only

FOR INTRAVENOUS/INTRAMUSCULAR USE.

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

See also Warning section.

Pain at the injection site, dizziness, drowsiness, headache, or upset stomach may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: fainting, fast/pounding heartbeat, hearing changes (such as ringing in the ears), mental/mood changes (such as confusion, depression), persistent/severe headache, stomach pain, sudden/unexplained weight gain, swelling of the hands or feet, vision changes (such as blurred vision), easy bruising/bleeding, signs of kidney problems (such as change in the amount of urine), signs of infection (such as fever, chills, persistent sore throat), symptoms of meningitis (such as unexplained stiff neck, fever), unusual tiredness.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Ketorolac TROMETHAMINE Syringe side effects by likelihood and severity.

Before using ketorolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, blood disorders (such as anemia), heart disease (such as previous heart attack), high blood pressure, liver disease, growths in the nose (nasal polyps), throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers), stroke, swelling of the ankles/feet/hands.

Kidney problems can sometimes occur with the use of NSAID medications, including ketorolac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medicine may cause stomach/intestinal bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of the drug, especially bleeding in the stomach/intestines or kidney problems. Using high doses for a long time may increase this risk.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

This drug passes into breast milk. Consult your doctor before breast-feeding.