Drug Notebook

FDA Alerts

    Appropriate Use
  • Indicated for short-term (≤5 days in adults) management of moderately severe acute pain that requires analgesia at opiate level. Not indicated for use in minor or chronic painful conditions.
  • A potent NSAIA; administration associated with risks. Serious NSAIA-related adverse effects can occur in patients in whom the drug is indicated, especially when the drug is used inappropriately. Increasing the dose beyond the recommended dose will not result in improved efficacy and increases the risk of serious adverse effects.

    GI Effects
  • Can cause peptic ulcers, GI bleeding, and/or perforation. Contraindicated in patients with active peptic ulcer disease, recent GI bleeding or perforation, or a history of peptic ulcer disease or GI bleeding.
  • Serious GI events can occur at any time and may not be preceded by warning signs and symptoms. Geriatric individuals are at greater risk for serious GI events. (See GI Effects under Cautions.)

    Renal Effects
  • Contraindicated in patients with advanced renal impairment and those at risk of renal failure because of volume depletion.

    Hematologic Effects
  • Inhibits platelet function. Contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis and in patients at a high risk of bleeding.
  • Contraindicated as prophylactic analgesic before major surgery; contraindicated as intraoperative analgesic during procedures where hemostasis is critical. Increased risk of bleeding in these patients.

    Cardiovascular Risk
  • Contraindicated for the treatment of pain in the setting of CABG surgery.
  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may increase with duration of use. Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk. (See Cardiovascular Effects under Cautions.)

    Sensitivity Reactions
  • Hypersensitivity reactions (e.g., bronchospasm, anaphylactic shock) reported; appropriate counteractive measures must be available when administering the first dose. Contraindicated in patients with known hypersensitivity to ketorolac, aspirin, or other NSAIAs.

    Intrathecal or Epidural Administration
  • Contraindicated for intrathecal or epidural administration because of alcohol content in parenteral formulation.

    Labor and Delivery
  • Contraindicated during labor and delivery. (See Pregnancy under Cautions.)

    Lactation
  • Contraindicated in nursing women.

    Concomitant Use with NSAIAs
  • Contraindicated in patients receiving aspirin or other NSAIAs because of cumulative risk of serious adverse effects.

    Dosage and Administration
  • Oral formulation is used as continuation therapy in adults; total combined duration of parenteral and oral therapy in adults should not exceed 5 days because of increased risk of serious adverse effects.
  • Maximum daily oral dosage (40 mg) is lower than the maximum daily parenteral dosage (120 mg).

    Special Populations
  • Adjust dosage in patients ≥65 years of age, adults weighing <50 kg, and those with moderately increased Scr. Daily parenteral dosage should not exceed 60 mg in these patients. (See Dosage and Administration.)
  • Administer only a single parenteral dose in children; maximum 30 mg IM or 15 mg IV.

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ketorolac
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(KEE toe ROLE ak)

What is the most important information I should know about ketorolac?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use ketorolac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking ketorolac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking ketorolac. Alcohol can increase the risk of stomach bleeding caused by ketorolac.

What is ketorolac?

Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac works by reducing hormones that cause inflammation and pain in the body.

Ketorolac is used short-term (5 days or less) to treat moderate to severe pain.

Ketorolac may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ketorolac?

Do not use this medication if you are allergic to ketorolac, aspirin, or other NSAIDs, or if you have: Do not take ketorolac if you are also taking pentoxifylline (Trental) or probenecid (Benemid). Do not take ketorolac with aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), or piroxicam (Feldene).

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Before taking ketorolac, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ketorolac.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking ketorolac during labor can increase the risk of bleeding during childbirth. Do not take ketorolac during pregnancy unless your doctor has told you to.

This medication can affect fertility (your ability to have children). Do not take ketorolac while you are trying to get pregnant.

Ketorolac can pass into breast milk and may harm a nursing baby. Do not take this medicine without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone younger than 18 years old.
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