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Ketorolac (Systemic)

Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: CN103
Chemical Name: (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid compd. with 2-Amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
Molecular Formula: C15H13O3•C4H11NO3
CAS Number: 74103-07-4

Medically reviewed by Drugs.com on Nov 9, 2020. Written by ASHP.

Warning

Special Alerts:

[Posted 10/15/2020]

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.

For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.

For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels, available at: [Web]. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.

BACKGROUND:

NSAIDs

  • are a class of medicines available by prescription and OTC. They are some of the most commonly used medicines for pain and fever.

  • are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu.

  • work by blocking the production of certain chemicals in the body that cause inflammation.

  • are available alone and combined with other medicines. Examples of NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib.

Common side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

RECOMMENDATION:

Consumers/Patients

  • If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.

  • Many OTC medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels, available at: [Web], to find out if the medicines contain NSAIDs.

  • Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them.

  • Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. Talk to your pharmacist or health care professional for help deciding which might be best.

Health Care Professionals

  • FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. FDA is warning that use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

  • These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.

  • Oligohydramnios is often, but not always, reversible with treatment discontinuation.

  • Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.

  • If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus.

  • The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.

  • Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice.

For more information visit the FDA website at: [Web] and [Web].

Warning

    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
  • Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may occur early in treatment and may increase with duration of use. (See Cardiovascular Thrombotic Effects under Cautions.)

  • Contraindicated in the setting of CABG surgery.

    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.

Introduction

Prototypical NSAIA; pyrrolizine carboxylic acid derivative; structurally related to tolmetin and indomethacin.

Uses for Ketorolac (Systemic)

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

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.)

Ketorolac (Systemic) 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

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

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

Hepatic Impairment

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

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.

Cautions for Ketorolac (Systemic)

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Peptic ulcer disease, recent GI bleeding or perforation, or history of peptic ulcer disease or GI bleeding.

  • Advanced renal impairment or risk of renal failure secondary to volume depletion.

  • Labor and delivery.

  • Nursing women.

  • Known hypersensitivity to ketorolac or any ingredient in the formulation.

  • History of asthma, urticaria, or other sensitivity reactions precipitated by aspirin or other NSAIAs.

  • Use as a prophylactic analgesic before major surgery; intraoperative use when hemostasis is critical.

  • In the setting of CABG surgery.

  • Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis; high risk of bleeding.

  • Concomitant use with aspirin or NSAIAs.

  • Neuraxial (epidural or intrathecal) administration.

  • Concomitant use with probenecid.

Warnings/Precautions

Warnings

Duration of Therapy

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

Only single doses of parenteral ketorolac are recommended in pediatric patients.

Cardiovascular Thrombotic Effects

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.

Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.

Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.

Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.

In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.

In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.

Increased 1-year mortality rate observed in patients receiving NSAIAs following MI; absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.

Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs. FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.

Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease. Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia. Contraindicated in the setting of CABG surgery.

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, those in poor general health, and those receiving >90 mg of parenteral ketorolac tromethamine daily. (See Contraindications under Cautions.)

Hematologic Effects

May inhibit platelet aggregation and prolong bleeding time. Use with caution and careful monitoring in patients with coagulation disorders. (See Contraindications under Cautions.)

Hematomas and other signs of wound bleeding reported in patients receiving the drug perioperatively; undertake postoperative administration with caution when hemostasis is critical. (See Contraindications under Cautions.)

Increased risk of intramuscular hematoma following IM administration in patients receiving anticoagulants.

Administer with caution in patients receiving therapeutic doses of anticoagulants (e.g., heparin, warfarin). Concurrent use with prophylactic low-dose heparin (2500–5000 units every 12 hours), warfarin, or dextrans not studied extensively, but also may be associated with increased risk of bleeding. Administer with caution when the potential benefits justify the possible risks. (See Specific Drugs under Interactions.)

Increased risk of bleeding following tonsillectomy in pediatric patients. Consider the increased risk when using ketorolac in pediatric patients undergoing tonsillectomy.

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy. Interstitial nephritis and nephrotic syndrome reported in patients receiving ketorolac.

Potential for overt renal decompensation. Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure; in patients with volume depletion; in geriatric patients; and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment and also Contraindications under Cautions, and Renal Impairment under Dosage and Administration.)

Correct hypovolemia before initiating ketorolac therapy.

Hypertension

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP.

Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur. (See Specific Drugs under Interactions.)

Heart Failure and Edema

Fluid retention and edema reported.

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.

NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema. (See Specific Drugs under Interactions.)

Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.

Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions (e.g., anaphylaxis, angioedema) reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations in ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue ketorolac if associated with abnormal liver function test results.

Specific Populations

Pregnancy

Category C. Avoid use in the third trimester because of possible premature closure of the ductus arteriosus. May inhibit uterine contractions during labor and delivery. (See Contraindications under Cautions.)

Lactation

Distributed into milk; contraindicated in nursing women.

Pediatric Use

Safety and efficacy of parenteral ketorolac administered as a single dose established in children 2–16 years of age. Safety and efficacy not established in children <2 years of age.

Bleeding reported following tonsillectomy. (See Hematologic Effects under Cautions.)

Geriatric Use

Geriatric patients appear to tolerate NSAIA-induced adverse effects less well than younger adults. Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.

Caution and reduced dosages advised. (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Severe hepatic reactions possible. Use with caution in patients with hepatic impairment or a history of liver disease. (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Use with caution in patients with renal impairment or a history of kidney disease; monitor closely. (See Contraindications under Cautions.)

Clearance may be decreased. Dosage adjustment necessary in patients with moderately elevated Scr. (See Renal Impairment under Dosage and Administration.)

Patients with underlying renal insufficiency are at risk of developing acute renal failure; consider risks and benefits before instituting therapy in these patients.

Common Adverse Effects

Headache, somnolence or drowsiness, dizziness, dyspepsia, nausea, GI pain, diarrhea, edema.

Interactions for Ketorolac (Systemic)

Does not induce or inhibit hepatic enzymes involved in drug metabolism; unlikely to alter its own metabolism of that or other drugs metabolized by CYP isoenzymes.

Protein-bound Drugs

Could be displaced from binding sites by, or could displace from binding sites, some other protein-bound drugs.

Drugs Affecting Hemostasis

Possible increased risk of bleeding complications; carefully monitor patients receiving therapy that affects hemostasis.

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Increased risk of renal impairment

Reduced BP response to ACE inhibitor

Monitor BP

Acetaminophen

No alteration in the protein binding of ketorolac

Angiotensin II receptor antagonists

Reduced BP response to angiotensin II receptor antagonist

Possible deterioration of renal function in individuals with renal impairment

Monitor BP

Antacids

No effect on the extent of oral ketorolac absorption

Anticonvulsants

Seizures reported in patients receiving carbamazepine or phenytoin

Phenytoin does not alter the protein binding of ketorolac

CNS agents (alprazolam, fluoxetine, thiothixene)

Hallucinations reported in patients receiving fluoxetine, thiothixene, or alprazolam

Dextrans

Possible increased risk of bleeding

Carefully monitor patients

Digoxin

No alteration in the protein binding of either drug

Diuretics (furosemide, thiazides)

Reduced natriuretic effect

Heparin

Increased risk of bleeding complications

Increased bleeding time when administered with heparin 5000 units; concurrent use with heparin 2500–5000 units sub-Q every 12 hours not studied extensively

Extreme caution advised in patients receiving therapeutic doses of heparin; carefully monitor patients

Lithium

Increased plasma lithium concentrations

Monitor for lithium toxicity

Methotrexate

Increased plasma methotrexate concentrations in patients receiving other NSAIAs; studies with ketorolac have not been undertaken

Caution advised

Nondepolarizing skeletal muscle relaxants

May potentiate the effects of the muscle relaxant resulting in apnea

NSAIAs

NSAIAs including aspirin: Potential for increased risk of GI toxicity

Aspirin: No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs

Therapeutic anti-inflammatory concentrations of salicylates (300 mcg/mL) may displace ketorolac from binding sites; ibuprofen, naproxen, or piroxicam does not alter the protein binding of ketorolac

Concomitant use contraindicated

Probenecid

Increased plasma concentrations and AUC of ketorolac

Concomitant use contraindicated

Thrombolytic agents

Possible increased risk of bleeding

Carefully monitor patients

Tolbutamide

No alteration in the protein binding of ketorolac

Warfarin

Increased risk of bleeding complications; concurrent use not studied extensively

Possible slight displacement of warfarin (but not ketorolac) from binding sites; other pharmacokinetic interactions unlikely

Extreme caution advised in patients receiving therapeutic doses of warfarin; carefully monitor patients

Ketorolac (Systemic) Pharmacokinetics

Absorption

Bioavailability

Rapidly and completely absorbed following IM administration.

Rapid and almost completed absorbed following oral administration; bioavailability reported to be 80–100%.

Onset

IM administration: Onset in 10 minutes, with peak analgesia at 75–150 minutes.

Oral administration: Onset in 30–60 minutes, with peak analgesia at 1.5–4 hours.

Duration

Oral or IM administration: 6–8 hours.

Food

Food decreases rate but not extent of absorption.

Special Populations

Rate of absorption from GI tract may be decreased in patients with hepatic or renal impairment and in geriatric individuals.

Distribution

Extent

Not distributed widely. Crosses the blood-brain barrier poorly.

Crosses the placenta; distributed into milk.

Plasma Protein Binding

>99%.

Elimination

Metabolism

Metabolized in the liver by hydroxylation; also undergoes conjugation with glucuronic acid.

Elimination Route

Excreted in urine (92%) as parent drug (60%) or metabolites (40%) and in feces (6%).

Half-life

4–6 hours in adults; 3.8–6.1 hours in pediatric patients.

Special Populations

Hepatic impairment (e.g., cirrhosis) does not appear to substantially affect half-life. In patients with cirrhosis, half-life of about 4.5–5.4 hours reported.

Renal impairment: Half-life is about 9–10 hours (range: 3.2–19 hours); in patients undergoing dialysis, half-life of about 13.6 hours (range: 8–39.1 hours) reported.

Geriatric individuals: Half-life is about 5–7 hours (range: 4.3–8.6 hours).

Stability

Storage

Oral

Tablets

15–30°C.

Parenteral

Injection

15–30°C; protect from light.

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in sodium chloride 0.9%

Dextrose 5% in water

Plasma-Lyte A, pH 7.4

Ringer’s injection

Ringer’s injection, lactated

Sodium chloride 0.9%

Drug Compatibility
Syringe Compatibility1HID

Compatible

Sufentanil citrate

Incompatible

Haloperidol lactate

Hydroxyzine HCl

Meperidine HCl

Morphine Sulfate

Nalbuphine

Prochlorperazine edisylate

Promethazine HCl

Thiethylperazine maleate

Variable

Diazepam

Hydromorphone HCl

Ketorolac tromethamine 1 mg/mL tested.

Y-Site CompatibilityHID

Compatible

Dexmedetomidine HCl

Fentanyl citrate

Hetastarch in lactated electrolyte injection (Hextend)

Hydromorphone HCl

Methadone HCl

Morphine sulfate

Remifentanil HCl

Sufentanil citrate

Incompatible

Azithromycin

Fenoldopam mesylate

Actions

  • Inhibits cyclooxygenase-1 (COX-1) and COX-2.

  • Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.

  • Risk of serious cardiovascular events (e.g., MI, stroke).

  • Risk of GI bleeding and ulceration.

  • Risk of bleeding following tonsillectomy.

  • Risk of serious skin reactions. Risk of anaphylactoid and other sensitivity reactions.

  • Risk of hepatotoxicity.

  • Risk of kidney failure.

  • Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.

  • Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.

  • Importance of discontinuing ketorolac and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop. Importance of seeking immediate medical attention if an anaphylactic reaction occurs.

  • Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.

  • Risk of heart failure or edema; importance of reporting dyspnea, unexplained weight gain, or edema.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Importance of avoiding ketorolac in late pregnancy (third trimester).

  • Importance of not exceeding recommended duration of therapy.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ketorolac Tromethamine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

10 mg*

Ketorolac Tromethamine Tablets

Parenteral

Injection, for IM or IV use

15 mg/mL*

Ketorolac Tromethamine Injection

30 mg/mL*

Ketorolac Tromethamine Injection

Injection, for IM use

30 mg/mL*

Ketorolac Tromethamine Injection

AHFS DI Essentials™. © Copyright 2021, Selected Revisions November 9, 2020. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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