Classes
DEA Class; Rx
Common Brand Names; Toradol
NSAIDs
Description
Pyrrolo-pyrrole NSAID; for the short-term relief of pain; max of 5 consecutive days regardless of dosage form(s) used.
Indications
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
For the short-term treatment of acute moderate pain or moderately severe pain that requires analgesia at the opioid level.
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
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%)
Warnings
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)
Heart Failure(HF) risk
Pregnancy and Lactation
Pregnancy category: C; D in third trimester (may cause premature closure of ductus arteriosus)
Lactation: Drug excreted in breast milk with multiple doses; use contraindicated
Maximum Dosage
Total systemic therapy should not exceed 5 days.
Weighing 50 kg or more: 30 mg IV or 60 mg IM as a single dose; 120 mg/day IV/IM as multiple-dose treatment; 40 mg/day PO; 126 mg/day intranasally; ophthalmic dosage is indication and product specific.
Weighing less than 50 kg: 15 mg IV or 30 mg IM as a single dose; 60 mg/day IV/IM as multiple-dose treatment; 40 mg/day PO; 63 mg/day intranasally; ophthalmic dosage is indication and product specific.
15 mg IV or 30 mg IM as a single dose; 60 mg/day IV/IM as multiple-dose treatment; 40 mg/day PO; 63 mg/day intranasally; ophthalmic dosage is indication and product specific.
17 years weighing 50 kg or more: 30 mg IV or 60 mg IM as a single dose; 120 mg/day IV/IM as multiple-dose treatment; 40 mg/day PO; ophthalmic dosage is indication and product specific; safety and efficacy have not been established for intranasal use; .
17 years weighing less than 50 kg: 15 mg IV or 30 mg IM as a single dose; 60 mg/day IV/IM as multiple-dose treatment; 40 mg/day PO; ophthalmic dosage is indication and product specific; safety and efficacy have not been established for intranasal use.
13 to 16 years: Safety and efficacy have not been established for systemic therapy; however, doses up to 0.5 mg/kg/dose IV (Max: 15 mg/dose) or 1 mg/kg/dose IM (Max: 30 mg/dose) as a single dose and up to 0.5 mg/kg/dose IV/IM (Max: 30 mg/dose) or 0.25 mg/kg/dose PO (Max: 10 mg/dose) every 6 hours as multiple-dose treatment have been used off-label; ophthalmic dosage is indication and product specific.
2 to 12 years: Safety and efficacy have not been established for systemic therapy; however, doses up to 0.5 mg/kg/dose IV (Max: 15 mg/dose) or 1 mg/kg/dose IM (Max: 30 mg/dose) as a single dose and up to 0.5 mg/kg/dose IV/IM (Max: 30 mg/dose) or 0.25 mg/kg/dose PO (Max: 10 mg/dose) every 6 hours as multiple-dose treatment have been used off-label; ophthalmic dosage is indication and product specific.
1 year: Safety and efficacy have not been established; however, doses up to 0.5 mg/kg/dose IV or 1 mg/kg/dose IM as a single dose and up to 0.5 mg/kg/dose IV/IM (Max: 30 mg/dose) or 0.25 mg/kg/dose PO (Max: 10 mg/dose) every 6 hours as multiple-dose treatment have been used off-label.
6 to 11 months: Safety and efficacy have not been established; however, doses up to 0.5 mg/kg/dose IV or 1 mg/kg/dose IM as a single dose and up to 0.5 mg/kg/dose IV/IM every 6 hours as multiple-dose treatment have been used off-label.
1 to 5 months: Safety and efficacy have not been established; however, doses up to 0.5 mg/kg/dose IV every 6 hours as multiple-dose treatment have been used off-label.
Safety and efficacy have not been established; however, doses up to 0.5 mg/kg/dose IV every 6 hours as multiple-dose treatment have been used off-label.
How supplied
tablet
10mg
Injectable solution
15mg/mL
30mg/mL
Prefilled syringe
15mg/mL
30mg/mL
60mg/2mL