Ketorolac Tromethamine

Do not use any ketorolac products (including this nasal spray, tablets, or injection) for more than a total of 5 days. Do not use this medication for minor or long-term painful conditions.

This drug may rarely 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 ulcers, bleeding).

This drug may also increase your risk of serious bleeding in other parts of your body. Do not use this medication if you have bleeding or blood clotting problems, or are at high risk for bleeding.

Nonsteroidal anti-inflammatory drugs (including ketorolac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater in older adults or 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). Talk to your doctor about the benefits and risks of using this drug.

Do not use this drug 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.

Stop using ketorolac and get medical help right away if you notice any of the following rare but serious side effects: bloody or black/tarry stools, stomach/abdominal pain, vomit that looks like coffee grounds, unusual or easy bruising/bleeding, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, trouble speaking.

Read the Medication Guide provided by your pharmacist before you start using ketorolac and each time you get a refill. Also read and follow the product instructions for how to properly prime and use this nasal spray. If you have any questions, ask your doctor or pharmacist.

Spray this medication in your nose as directed by your doctor, usually every 6 to 8 hours. Your doctor may adjust your dosage so that you spray the medication in only one nostril instead of both nostrils. The dosage is based on your medical condition, age, weight, and response to treatment.

To reduce your risk of stomach bleeding and other side effects, use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medicine may not work as well.

Drink plenty of fluids during treatment with this medication. This will help reduce the risk of kidney problems.

Avoid getting this medication in your eyes. If this occurs, rinse your eyes with water or saline and call your doctor if eye irritation lasts.

Tell your doctor if your condition does not improve or if it worsens.

See also Warning section.

Mild and temporary irritation/discomfort in the nose may occur. Upset stomach, nausea, dizziness, or drowsiness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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: headache that is severe or doesn't go away, signs of kidney problems (such as change in the amount of urine), hearing changes (such as ringing in the ears), mental/mood changes, unexplained stiff neck, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

This drug may rarely cause serious (possibly fatal) liver disease. Stop using ketorolac and get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

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: fever, swollen lymph nodes, 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.

See also Warning section.

Before using ketorolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin; or to other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as EDTA), 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), growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, swelling of the hands/ankles/feet (edema).

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. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

Daily use of alcohol and tobacco, especially when combined with this medication, may increase your risk for stomach bleeding. Limit alcohol and stop smoking.

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 at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

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

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), cidofovir, probenecid, corticosteroids (such as prednisone), "water pills" (diuretics such as furosemide).

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, pentoxifylline, among others.

Do not use this medication with other forms of ketorolac, high doses of aspirin, or other NSAIDs.

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 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, stomach pain, drowsiness.

Do not share this medication with others.

Lab and/or medical tests (including blood pressure, kidney function) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you are using this medication on a regular schedule (not just "as needed") and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Refrigerate unopened bottles. Do not freeze. Store the opened bottle in use at room temperature, away from light and direct sunlight. Since this medication does not contain preservatives, throw away the bottle 24 hours after you first use it, even if there is still some medication left in it. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.