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Ketorolac Tromethamine Solution for injection

It is used to treat moderate to severe pain for up to 5 days

Generic Name: ketorolac

Brand Names: Acuvail, Toradol, Acular, Ketorolac Tromethamine, Sprix

There is an FDA Alert for this drug. Click here to view it.

    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.)

  • 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.

What is this medicine?

KETOROLAC (kee toe ROLE ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to treat moderate to severe pain for up to 5 days. It is commonly used after surgery. This medicine should not be used for more than 5 days.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • asthma, especially aspirin-sensitive asthma
  • bleeding problems
  • kidney disease
  • stomach bleed, ulcer, or other problem
  • taking aspirin, other NSAID, or probenecid
  • an unusual or allergic reaction to ketorolac, tromethamine, aspirin, other NSAIDs, other medicines, foods, dyes or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • aspirin and aspirin-like medicines
  • cidofovir
  • methotrexate
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • pentoxifylline
  • probenecid

This medicine may also interact with the following medications:

  • alcohol
  • alendronate
  • alprazolam
  • carbamazepine
  • diuretics
  • flavocoxid
  • fluoxetine
  • ginkgo
  • lithium
  • medicines for blood pressure like enalapril
  • medicines that affect platelets like pentoxifylline
  • medicines that treat or prevent blood clots like heparin, warfarin
  • muscle relaxants
  • pemetrexed
  • phenytoin
  • thiothixene

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.

Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

Last Updated: May 07, 2009
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