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|Ketorolac Tablets

Ketorolac

Ketorolac is used for:

The short-term (up to 5 days) treatment of moderate to severe pain (usually after surgery), alone or in combination with other medicines.

Ketorolac is an NSAID. It reduces inflammation by preventing certain chemicals (prostaglandins) from being produced by the injured tissue.

Do NOT use Ketorolac if:

• you are allergic to any ingredient in Ketorolac
• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin or an NSAID (eg, ibuprofen, naproxen, celecoxib)
• you are taking an aminoglycoside (eg, gentamicin), heparin, methotrexate, probenecid, tacrolimus, aspirin, or another NSAID (eg, ibuprofen, celecoxib)
• you are breast-feeding, in labor or delivery, or you are scheduled to have surgery
• you have a history of ulcers or severe stomach problems (eg, bleeding, perforation)
• you have severe kidney problems (including risk for kidney failure), or you have or are at risk for bleeding problems (eg, stroke, hemorrhage)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ketorolac:

Some medical conditions may interact with Ketorolac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant or planning to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have asthma, nasal polyps, kidney problems, dehydration, liver disease or other liver problems, heart failure or other heart problems, high blood pressure, stomach or intestinal problems (eg, ulcer, bleeding), or a blood-clotting disorder
• if you drink more than 3 alcohol-containing drinks a day

Some MEDICINES MAY INTERACT with Ketorolac. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aspirin, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or NSAIDs (eg, ibuprofen, celecoxib) because side effects, such as increased risk of intestinal bleeding, may occur
• Anticoagulants (eg, warfarin) or cyclosporine because the actions and side effects of Ketorolac and these medicines may be increased
• Aminoglycosides (eg, gentamicin), heparin, lithium, or methotrexate because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ketorolac may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ketorolac:

Use Ketorolac as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ketorolac comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Ketorolac refilled.
• Ketorolac may be taken with food if it upsets your stomach. Taking it with food may not decrease the risk of stomach or bowel problems (such as bleeding or ulcers) that may occur while taking Ketorolac. Talk with your doctor or pharmacist if you experience persistent stomach upset.
• Do not use this medication for more than 5 days. Ketorolac is not for the treatment of mild to moderate or chronic pain (eg, headache).
• Discard any unused tablets. Do not share Ketorolac with anyone.
• If you miss a dose of Ketorolac and you are using it regularly, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ketorolac.

Important safety information:

• Ketorolac may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ketorolac. Using Ketorolac alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Ketorolac is an NSAID. NSAIDs have been associated with serious, possibly fatal, heart and blood vessel risks such as heart attack and stroke. This risk increases with long-term use of NSAIDs or if you have heart problems. NSAIDs should not be used right before or after bypass heart surgery. Additionally, NSAIDs can cause serious, possibly fatal stomach ulcers and bleeding, which can occur without warning signs. The following factors increase the risk of serious stomach problems in patients being treated with NSAIDs: history of stomach bleeding or ulcer disease, long-term use of NSAIDs, smoking, use of alcohol, poor health, older age, use of certain medicines such as anticoagulants (eg, warfarin) or corticosteroids (eg, prednisone) while taking an NSAID. To reduce your risk of serious side effects, take Ketorolac exactly as instructed, at the lowest dose possible, and for the shortest time needed.
• Do not take other anti-inflammatory medicines while you are taking Ketorolac. This includes any medicine that contains aspirin, ibuprofen, naproxen, and many prescription medicines. If you have questions about which medicines are anti-inflammatory agents, ask your doctor or pharmacist. If you are taking aspirin, prescribed by your doctor for reasons such as heart attack or stroke prevention (usually 81 to 325 mg per day), talk with your doctor before using Ketorolac.
• If you drink more than 3 alcohol-containing drinks a day, do not take Ketorolac without first discussing it with your doctor.
• Additional monitoring of your dose or condition may be needed if you are taking amphetamines (eg, dextroamphetamine), bisphosphonates (eg, alendronate), or diuretics or "water pills" (eg, hydrochlorothiazide).
• LAB TESTS may be required to monitor therapy or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Ketorolac with caution in the ELDERLY because they may be more sensitive to its effects.
• Ketorolac is not recommended for use in CHILDREN younger than 16 years of age. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ketorolac during pregnancy. Ketorolac is excreted in breast milk. Do not breast-feed while taking Ketorolac.

Possible side effects of Ketorolac:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; indigestion; mouth sores; nausea; purple patches under the skin; stomach fullness; stomach pain; sweating; swelling; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; dark urine or pale stools; fainting; fluid retention; hallucinations; meningitis; persistent stomach/abdominal pain; pounding in the chest; psychosis; rectal bleeding; seizures; severe and continuing nausea; shortness of breath; stomach perforation; tightness in chest; tremors; ulcers; unusual bleeding or bruising; unusual fatigue; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blood in stools; difficulty breathing; stomach pain.

Store Ketorolac at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketorolac out of the reach of children and away from pets.

General information:

• If you have any questions about Ketorolac, please talk with your doctor, pharmacist, or other health care provider.
• Ketorolac is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ketorolac. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.