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)

Uses

Pain

Consider potential benefits and risks of ketorolac therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Short-term (i.e., up to 5 days) management of moderately severe, acute pain that requires analgesia at opiate level in adults; mainly used in the postoperative setting.

Management of moderately severe, acute pain in children 2–16 years of age (single IV or IM dose); studies usually have evaluated pain in the postoperative setting (e.g., pain following tonsillectomy). Limited data available to support administration of >1 parenteral dose in pediatric patients.

Parenteral ketorolac has been used concomitantly with opiate agonist analgesics (e.g., meperidine, morphine) for the management of moderate to severe postoperative pain without apparent adverse drug interactions. Combined use can result in reduced opiate analgesic requirements. (See Syringe Compatibility under Stability.)

Dosage and Administration

General

  • Current principles of pain management indicate that analgesics, including ketorolac, should be administered at regularly scheduled intervals, although the drug also has been administered on an as-needed basis (i.e., withholding subsequent doses until pain returns).
  • Consider potential benefits and risks of ketorolac therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Administer IV, IM, or orally in adults; administer IV or IM in children 2–16 years of age.

Initiate therapy in adults with parenteral (IV or IM) ketorolac; oral formulation is used as continuation therapy, as required. Administer IV or IM as a single dose or every 6 hours; administer orally every 4–6 hours.

In children 2–16 years of age, administer as a single IV or IM dose.

Switch patients to alternate analgesic therapy as soon as clinically possible.

Oral Administration

Manufacturer makes no specific recommendations regarding administration with meals; high-fat meal may decrease rate but not extent of absorption and reduce peak plasma concentrations.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Rate of Administration

Administer over ≥15 seconds.

IM Administration

Administer IM slowly and deeply into the muscle.

For drug compatibility information, see Compatibility under Stability.

Dosage

Available as ketorolac tromethamine; dosage expressed in terms of the salt.

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

For breakthrough pain, supplement with low doses of opiate analgesics (unless contraindicated) as needed rather than higher or more frequent doses of ketorolac.

Pediatric Patients

Pain

Single Dose
IV

Children 2–16 years of age: One dose of 0.5 mg/kg (maximum 15 mg).

IM

Children 2–16 years of age: One dose of 1 mg/kg (maximum 30 mg).

Adults

Pain

Oral

When switching from parenteral to oral therapy, the first oral dose is 20 mg, followed by 10 mg every 4–6 hours (maximum 40 mg in a 24-hour period).

Weight <50 kg: When switching from parenteral to oral therapy, 10 mg every 4–6 hours (maximum 40 mg in a 24-hour period).

Single Dose
IV

30 mg.

Weight <50 kg: 15 mg.

IM

60 mg.

Weight <50 kg: 30 mg.

Multiple Dose
IV or IM

30 mg every 6 hours.

Weight <50 kg: 15 mg every 6 hours.

Prescribing Limits

Pediatric Patients

Pain

Only a single parenteral dose is recommended.

Single Dose
IV

15 mg.

IM

30 mg.

Adults

Pain

Total combined duration of parenteral and oral therapy should not exceed 5 days.

Oral

All adults: Maximum 40 mg in a 24-hour period.

Multiple Dose
IV or IM

Maximum 120 mg in a 24-hour period.

Weight <50 kg: Maximum 60 mg in a 24-hour period.

Special Populations

Dosage in Hepatic Impairment

Need for dosage adjustment not fully established; evidence in patients with cirrhosis suggests that dosage adjustment may not be necessary.

Dosage in Renal Impairment

Pain

Safety not established in patients with Scr >5 mg/dL and/or those undergoing dialysis.

Oral

When switching from parenteral to oral therapy, 10 mg every 4–6 hours (maximum 40 mg in a 24-hour period).

Single Dose
IV

15 mg.

IM

30 mg.

Multiple Dose
IV or IM

15 mg every 6 hours. Maximum 60 mg in a 24-hour period.

Geriatric Patients

Dosage recommendations are the same as those for patients with moderately increased Scr or for those weighing <50 kg.

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