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ketorolac (Rx)Brand and Other Names:Toradol

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 10mg

injectable solution

  • 15mg/mL
  • 30mg/mL
more...

Moderately Severe Acute Pain

Short-term (≤5 days) management of moderately severe acute pain that requires analgesia at opioid level; not indicated for minor or chronic painful conditions

IV: 30 mg as single dose or 30 mg q6hr; not to exceed 120 mg/day

IM: 60 mg as single dose or 30 mg q6hr; not to exceed 120 mg/day

PO: 20 mg once after IV or IM therapy, THEN 10 mg q4-6hr; not to exceed 40 mg/day

Dosing Considerations

Always begin with parenteral therapy; oral administration indicated only as continuation of IV/IM dosing, if necessary

Duration of therapy should not exceed 5 days

Dosage beyond maximum or labeled doses will not provide better efficacy but will increase risk of serious adverse events

Decrease daily dose in patients >65 years, <50 kg, or with moderately elevated serum creatinine

Dosing Modifications

Renal impairment

  • Severe: Contraindicated
  • Moderate (moderately elevated serum creatinine): Use 50% of recommended dosage; not to exceed 60 mg/day IM/IV

Hepatic impairment

  • Not studied; use caution; discontinue if symptoms of liver toxicity develop

Dosage Forms & Strengths

tablet

  • 10mg

injectable solution

  • 15mg/mL
  • 30mg/mL
more...

Moderately Severe Acute Pain (Off-label)

<2 years

  • Safety and efficacy not established

2-16 years

  • Single dose: 0.5 mg/kg IV/IM once; not to exceed 15 mg 
  • Multiple dose: 0.5 mg/kg IV/IM q6hr; not to exceed 5 days

>16 years, <50 kg

  • IV: 15 mg as single dose or 15 mg q6hr; not to exceed 60 mg/day
  • IM: 30 mg as single dose or 15 mg q6hr; not to exceed 60 mg/day
  • PO: 10 mg once after IV/IM therapy, THEN 10 mg q4-6hr; not to exceed 40 mg/day

>16 years, >50 kg

  • IV: 30 mg as single dose or 30 mg q6hr; not to exceed 120 mg/day
  • IM: 60 mg as single dose or 30 mg q6hr; not to exceed 120 mg/day
  • PO: 20 mg once after IV/IM therapy, THEN 10 mg q4-6hr; not to exceed 40 mg/day

Dosing Considerations

Not approved for use in pediatric patients

Duration of therapy should not exceed 5 days

Moderately Severe Acute Pain

Short-term (≤5 days) management of moderately severe acute pain that requires analgesia at opioid level; not indicated for minor or chronic painful conditions

IV: 15 mg as single dose or 15 mg q6hr; not to exceed 60 mg/day

IM: 30 mg as single dose or 15 mg q6hr; not to exceed 60 mg/day

PO: 10 mg once after IV or IM therapy, THEN 10 mg q4-6hr; not to exceed 40 mg/day

Dosing Considerations

Long-term use should be avoided because of asymptomatic, pathologic gastrointestinal (GI) conditions; duration of therapy should not exceed 5 days

Dosage adjustment required for patients >65 years or <50 kg (see Black Box Warnings)

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Interactions

Interaction Checker

ketorolac and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
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            Adverse Effects

            >10%

            Headache (17%)

            Somnolence (3-14%)

            Dyspepsia (12-13%)

            GI pain (12-13%)

            Nausea (12-13%)

            1-10%

            Diarrhea (3-9%)

            Dizziness (3-9%)

            Pruritus (3-9%)

            Edema (1-3%)

            Increased blood urea nitrogen (BUN) (3%)

            Constipation (<3%)

            Purpura (<3%)

            Increased serum creatinine (2%)

            Drowsiness (6%)

            Hypertension (4%)

            <1%

            Abnormal thinking

            Anaphylaxis

            Blurred vision

            Bronchospasm

            Cholestatic jaundice

            Depression

            Difficulty in concentration

            Dysgeusia

            Euphoria

            Hemolytic-uremic syndrome

            Hepatitis

            Hyperkalemia

            Hyponatremia

            Hypotension

            Increased liver function test values

            Insomnia

            Laryngeal/lingual edema

            Liver failure

            Melena

            Nervousness

            Oliguria

            Pallor

            Peptic ulcer

            Rash

            Rectal bleeding

            Stomatitis

            Urinary frequency

            Urinary retention

            Vasodilation

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            Warnings

            Black Box Warnings

            Cardiovascular risk

            • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery
            • Patients treated with NSAIDs following heart attack reported to be more likely to die in first yearof heart attack compared to patients not treated with NSAIDs after first heart attack

            Gastrointestinal risk

            • NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
            • GI adverse events may occur at any time during use and without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Additional Warnings

            • Major surgery: Contraindicated for prophylactic analgesic
            • CABG: Contraindicated for treatment of perioperative pain in the setting of CABG surgery
            • Labor and delivery: Contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions
            • Breastfeeding women: Contraindicated because of potential adverse effects of prostaglandin-inhibiting drugs on neonates
            • Use with other NSAIDs: Contraindicated in patients currently receiving aspirin or other NSAIDs, because of a cumulative risk of inducing serious NSAID-related adverse effects
            • Renal risk: Contraindicated with advanced renal impairment and in patients at risk for renal failure due to volume depletion
            • Gastrointestinal: Contraindicated with active peptic ulcer disease, recent GI bleeding or perforation, or history of peptic ulcer disease or GI bleeding
            • Bleeding risk: Inhibits platelet function; contraindicated with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and high risk of bleeding
            • Demonstrated hypersensitivity: Contraindicated with previously demonstrated hypersensitivity to ketorolac or allergic manifestations to aspirin or other NSAIDs
            • Injectable: Contraindicated for intrathecal or epidural administration, due to its alcohol content.
            • Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred, and appropriate counteractive measures must be available when administering the first dose of ketorolac injection

            Contraindications

            Duration of therapy >5 days

            Not for chronic or minor pain

            Demonstrated hypersensitivity to ketorolac or allergic manifestations to aspirin or other NSAIDs; appropriate counteractive measures must be available when first ketorolac injection is given

            Major surgery: Contraindicated for prophylactic analgesia; contraindicated for treatment of perioperative pain in setting of CABG surgery

            OB/GYN: Contraindicated during labor and delivery because it may adversely affect fetal circulation and inhibit uterine contractions; contraindicated in breastfeeding women because of potential adverse effects of prostaglandin-inhibiting drugs on neonates

            Renal: Contraindicated with advanced renal impairment and in patients at risk for renal failure due to volume depletion

            GI: Contraindicated with previous or currently active peptic ulcer disease, previous or current GI bleeding or perforation

            Bleeding risk: Because of inhibition of platelet function; contraindicated with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and high risk of bleeding

            Use with other NSAIDs: Contraindicated in patients currently receiving aspirin or other NSAIDs, because of a cumulative risk of inducing serious NSAID-related adverse effects

            Contraindicated for intrathecal or epidural administration because of alcohol content

            Cautions

            Use with caution in perioperative setting, tonsillectomy in children (may interfere with hemostasis), gastric perforation, hepatic/renal impairment, history of hepatic/renal disease, concomitant anticoagulant therapy, hypertension (may cause new onset of hypertension or worsening of existing hypertension)

            PO therapy should be used only as continuation after initial parenteral therapy

            Limited data supporting safe use of multiple-dose parenteral treatment in children

            Potential risk of cardiovascular damage

            Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers

            Risk of severe skin reactions

            May cause drowsiness, blurred vision, and dizziness; may impair ability to operate heavy machinery

            May increase risk of hyperkalemia, especially in renal disease, patients with diabetes, the elderly, and when used concomitantly with other agents capable of inducing hyperkalemia

            Not for use in patients with aspirin-sensitive asthma (severe bronchospasm may occur

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            Pregnancy & Lactation

            Pregnancy category: C; D in third trimester (may cause premature closure of ductus arteriosus)

            Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls

            Lactation: Drug excreted in breast milk with multiple doses; use contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclo-oxygenase (COX) isoenzymes, COX-1 and COX-2

            May inhibit chemotaxis, alter lymphocyte activity, decrease proinflammatory cytokine activity, and inhibit neutrophil aggregation; these effects may contribute to anti-inflammatory activity

            Absorption

            Bioavailability: 80-100%

            Onset: IM, 10 min; PO, 30-60 min

            Duration: 4-6 hr (analgesia)

            Peak serum time: 1-3 min (IV); 30-60 min (IM); ~1 hr (PO)

            Peak plasma concentration: Varies with dose and route

            Distribution

            Protein bound: >99%

            Vd: ~13 L

            Metabolism

            Metabolized in liver

            Metabolites: p-hydroxyketorolac, unidentified polar metabolites

            Elimination

            Half-life: 2-6 hr

            Dialyzable: Yes, with unknown effect

            Excretion: Urine (91%), feces (6%)

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            Administration

            IV Incompatibilities

            Additive: Hydroxyzine, meperidine, morphine, promethazine

            Syringe: Haloperidol, hydroxyzine, nalbuphine, prochlorperazine, promethazine, thiethylperazine

            Y-site: Azithromycin, fenoldopam

            IV Compatibilities

            Solution: D5/NS, D5W, Ringer solution, LR, NS

            Syringe: Hydromorphone, sufentanil

            Y-site: Cisatracurium, dexmedetomidine, fentanyl, hydromorphone, methadone, morphine sulfate, remifentanil, sufentanil

            IV/IM Administration

            IM: Inject slowly and deeply into muscle

            IV: Inject over ≥15 seconds

            60 mg/2 mL preparation for IM administration only

            Storage

            Store at controlled room temperature

            Protect from light

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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