Usual Adult Dose for Pain

The combined duration of use of parenteral, oral, and nasal ketorolac should not exceed 5 days; the oral formulation is only to be used as continuation to IV or IM therapy.

NASAL SPRAY:

• Weight 50 kg or more: 31.5 mg every 6 to 8 hours (1 spray in each nostril)
• Weight less than 50 kg: 15.75 mg every 6 to 8 hours (1 spray in 1 nostril)
• Maximum dose; weight less than 50 kg: 63 mg
• Maximum dose; weight: 50 kg or more: 126 mg

IM or IV:
Single-Dose Treatment:

• Weight 50 kg or more: 60 mg IM or 30 mg IV once
• Weight less than 50 kg: 30 mg IM or 15 mg IV once

Multiple-Dose Treatment:

• Weight 50 kg or more: 30 mg IM/IV every 6 hours as needed; maximum dose: 120 mg/day
• Weight less than 50 kg: 15 mg IM/IV every 6 hours as needed; maximum dose: 60 mg/day

ORAL:

• Continuation therapy (should not be given as an initial dose): :

Weight 50 kg or more: 20 mg orally once followed by 10 mg every 4 to 6 hours as needed
Weight less than 50 kg: 10 mg orally once followed by 10 mg every 4 to 6 hours as needed
Maximum dose: 40 mg/day

Maximum Combined Duration of Treatment: 5 days

Comments:

• Nasal spray is not an inhaled product; do not inhale when administering.
• Do not increase the dose or frequency for breakthrough pain; consider supplementing with low dose opioids as needed, if appropriate.
• Use minimum effective dose, and switch to alternative analgesics as soon as possible.

Use: For the short-term (5 days or less) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

Usual Geriatric Dose for Pain

The combined duration of use of parenteral, oral, and nasal ketorolac should not exceed 5 days; the oral formulation is only to be used as continuation to IV or IM therapy.

NASAL SPRAY:

• Dose: 15.75 mg every 6 to 8 hours (one spray in 1 nostril)
• Maximum dose: 4 doses per day (63 mg)

IM/IV:

• Single-Dose Treatment: 30 mg IM or 15 mg IV
• Multiple-Dose Treatment: 15 mg IM/IV every 6 hours as needed; maximum dose: 60 mg/day

ORAL formulation (should not be given as an initial dose):

• Continuation therapy: 10 mg orally once followed by 10 mg every 4 to 6 hours as needed maximum dose: 40 mg/day

Maximum Combined Duration of Treatment: 5 days

Comments:

• Nasal spray is not an inhaled product; do not inhale when administering.
• Do not increase the dose or frequency for breakthrough pain; consider supplementing with low dose opioids as needed, if appropriate.
• Use minimum effective dose and switch to alternative analgesics as soon as possible

Use: For the short-term (5 days or less) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

Usual Pediatric Dose for Pain

The combined duration of use of parenteral, oral, and nasal ketorolac should not exceed 5 days; the oral formulation is only to be used as continuation to IV or IM therapy.

Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions.

Age: 17 years or older:
IM/IV:
Single-Dose Treatment:

• Weight 50 kg or more: 60 mg IM or 30 mg IV
• Weight less than 50 kg: 30 mg IM or 15 mg IV

Multiple-Dose Treatment:

• Weight 50 kg or more: 30 mg IM/IV every 6 hours as needed; maximum dose: 120 mg/day
• Weight less than 50 kg: 15 mg IM/IV every 6 hours as needed; maximum dose: 60 mg/day

ORAL

• Continuation therapy (should not be given as an initial dose):
• Weight 50 kg or more: 20 mg orally once followed by 10 mg every 4 to 6 hours as needed
• Weight less than 50 kg: 10 mg orally once followed by 10 mg every 4 to 6 hours as needed

Maximum dose: 40 mg/day

Age: Greater than 17 years:
Intranasal:
Ketorolac nasal spray is not for use in pediatric patients less than 2 years of age. The safety and effectiveness of ketorolac in pediatric patients 17 years of age and younger have not been established.

• Weight 50 kg or more: 31.5 mg every 6 to 8 hours (1 spray in each nostril)
• Weight less than 50 kg: 15.75 mg every 6 to 8 hours (1 spray in 1 nostril)
• Maximum dose; weight less than 50 kg: 63 mg
• Maximum dose; weight: 50 kg or more: 126 mg

Maximum Combined Duration of Treatment: 5 days

Comments:

• Nasal spray is not an inhaled product; do not inhale when administering.
• Do not increase the dose or frequency for breakthrough pain; consider supplementing with low dose opioids as needed, if appropriate.
• Use minimum effective dose and switch to alternative analgesics as soon as possible
• This drug is not indicated for use in pediatric patients. Safety and efficacy have not been established in patients younger than 17 years. Do not use in patients younger than 2 years of age.

Use: For the short-term (5 days or less) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

Renal Dose Adjustments

Advanced renal disease or at risk for renal failure due to volume depletion: Contraindicated
Mild to moderate renal impairment:

• Intranasal: 15.75 mg every 6 to 8 hours (one spray in 1 nostril); Maximum dose: 63 mg/day
• Parenteral: Single-Dose Treatment: 30 mg IM or 15 mg IV; Multiple-Dose Treatment: 15 mg IM/IV every 6 hours as needed; Maximum dose: 60 mg/day
• Oral, as continuation therapy: 10 mg orally once followed by 10 mg every 4 to 6 hours as needed; Maximum dose: 40 mg/day

Liver Dose Adjustments

Use with caution; if signs/symptoms of liver dysfunction develop or an abnormal liver test is obtained, evaluate for hepatotoxicity

• Discontinue therapy for clinical signs/symptoms of liver disease or the presence of a systemic manifestation (eosinophilia, rash, etc.)

Dose Adjustments

Do not exceed doses of 60 mg IV/IM per day in patients 65 years or older, in patients weighing 50 kg (110 lbs.) or less, and in patients with moderately elevated serum creatinine.

Precautions

US BOXED WARNINGS:
Oral and Parenteral Formulations:

• This drug is a NSAID indicated for the short term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level; oral therapy is indicated only for continuation treatment following IV or IM dosing. Total combined duration of use should not exceed 5 days.
• This drug is not indicated for use in pediatric patients and is not indicated for minor or chronic painful conditions; increasing the dose beyond the label recommendations will not provide better efficacy but will result in increasing the risk of developing serious adverse events.
• GASTROINTESTINAL (GI) EFFECTS: This drug can cause peptic ulcers, GI bleeding and/or perforation; these events may occur at any time during use and without warning symptoms. This drug is contraindicated in patients with active peptic ulcer disease, in patients with recent GI bleeding or perforation, and in patients with a history of peptic ulcer disease or GI bleeding; elderly patients are at greater risk for serious GI events.
• CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• RENAL EFFECTS: This drug is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
• RISK OF BLEEDING: This drug inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding.
• SURGERY: This drug is contraindicated as prophylactic analgesic before any major surgery.
• HYPERSENSITIVITY: Reactions ranging from bronchospasm to anaphylactic shock have occurred; appropriate counteractive measures must be available when administering the first dose. This drug is contraindicated in patients with previously demonstrated hypersensitivity to this drug or allergic manifestations to aspirin or other NSAIDs.
• INTRATHECAL OR EPIDURAL ADMINISTRATION: Contraindicated due to its alcohol content.
• LABOR, DELIVERY, AND NURSING: Contraindicated in labor and delivery because it may adversely affect fetal circulation and inhibit uterine contractions.
• CONCOMITANT USE WITH NSAIDS: Due to the cumulative risk of inducing serious NSAID-related side effects, this drug is contraindicated in patients currently receiving aspirin or NSAIDs.
• DOSAGE AND ADMINISTRATION: Tablets are only indicated as continuation therapy to injection, and the combined duration of use is not to exceed 5 days because of the increased risk of serious adverse events. The recommended total daily dose of tablets (maximum 40 mg/day) is significantly lower than for the injection (maximum 120 mg/day).
• SPECIAL POPULATIONS: Dosage should be adjusted for patients 65 year or older, for patients under 50 kg, and for patients with moderately elevated serum creatinine. Do not exceed a total daily injection dose of 60 mg in these patients.

NASAL SPRAY: US BOXED WARNING INCLUDE RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

CONTRAINDICATIONS:

• Hypersensitivity to this drug or any product excipients
• Active peptic ulcer disease, recent gastrointestinal (GI) bleed or perforation, or history of peptic ulcer disease or GI bleeding
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Use as prophylactic analgesia prior to any major surgery
• In the setting of coronary artery bypass graft (CABG) surgery
• Advanced renal impairment or at risk for renal failure due to volume depletion
• Labor and delivery
• Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding
• Concomitant use of aspirin, NSAID, probenecid, or pentoxifylline
• Neuraxial (epidural or intrathecal) administration due to its alcohol content

Safety and efficacy have not been established in patients younger than 17 years.

• Do not use in patients younger than 2 years of age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Intranasal Spray:

• This is not an inhaled product; do not inhale when administering
• Activate pump prior to first use; hold bottle at arm's length, press down evenly and release pump 5 times
• Blow nose gently; sit up straight or stand; tilt head slightly forward
• Insert tip into nostril pointing away from center of nose
• Hold breath and spray once into nostril; resume breathing through mouth after dosing
• If spray starts to drip, pinch nose to help retain spray
• Repeat in second nostril if indicated.
• Discard bottle 24 hours after opening

Oral:

• Tablets should not be given as an initial dose; use parenteral formulation to initiate therapy; combined duration of use should not exceed 5 days.

Parenteral:

• IV bolus should be given over no less than 15 seconds
• IM injections should be administered slowly and deeply into the muscle

Storage requirements:
Parenteral formulations: Store at controlled room temperature; protect from light

Intranasal Spray:

• Protect from light and freezing
• Refrigerate unopened bottles between 2C and 8C (36F and 46F)
• During use, store at controlled room temperature; discard within 24 hours of priming

Reconstitution/preparation techniques:
Intranasal spray bottle should be primed prior to first use; press down on the finger flange and release the pump 5 times to prime.

IV compatibility:

• This drug should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride, or hydroxyzine hydrochloride as this will result in precipitation of this drug from solution.
• Compatible with normal saline, D5W, Ringer's, Lactated Ringer's or Plasmacyte solutions

General:

• Hypovolemia should be corrected prior to administration.
• Use the lowest effective dose for the shortest time needed.
• This drug should not be used concomitantly with aspirin or any other NSAIDs; do not use nasal spray concomitantly with parenteral or oral ketorolac

Monitoring:

• Blood pressure should be monitored closely during initiation and throughout course of therapy.
• Monitor for signs/symptoms of gastrointestinal bleeding.
• Closely monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.

Patient advice:

• Because of the risk for serious complications, this drug should not be used for more than 5 days.
• Maintain adequate fluid intake during use and seek medical advice if urine output decreases significantly.
• Patients should seek medical advice for signs and symptoms of cardiovascular effects, gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
• For patients using the nasal spray, transient, mild to moderate nasal irritation or discomfort is not uncommon. Patients should be instructed to discard bottle 24 hours after priming.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.

Frequently asked questions

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