Generic
Ketorolac Tromethamine
216 brands available in the market
At a glance
Ketorolac Tromethamine is a potent analgesic used for short-term management of moderate to severe acute pain, particularly postoperative pain requiring opioid-level analgesia.
Description
Ketorolac Tromethamine is an NSAID of the pyrrolo-pyrrole group that inhibits prostaglandin synthesis by decreasing cyclooxygenase enzyme activity, acting as a peripherally acting analgesic. It is highly protein bound, largely metabolized in the liver, and excreted in urine. Its biological activity is associated with the S-form.
Indications
- Short-term management of moderate to severe acute postoperative pain
- Acute pain requiring opioid-level analgesia
Therapeutic class
NSAIDs
Pharmacological class
Non-steroidal Anti-inflammatory Drug (NSAID)
Pharmacology
Ketorolac Tromethamine is a potent NSAID analgesic that inhibits prostaglandin synthesis by blocking the cyclooxygenase enzyme system. It demonstrates minimal anti-inflammatory effect at its analgesic dose.
Mechanism of action
Inhibits prostaglandin synthesis by decreasing cyclooxygenase enzyme activity, providing pain relief.
Dosage
Tablet (Adult):
- 10 mg every 4-6 hours
- Short-term use only (up to 7 days)
- Maximum daily dose: 40 mg
Injection (Adult):
- Under 65 years: IM 60 mg single/30 mg q6hr; IV 30 mg single/30 mg q6hr
- Over 65 years or renal impairment or <50 kg: IM 30 mg/15 mg q6hr; IV 15 mg/15 mg q6hr
- Maximum daily dose: 120 mg (under 65) / 60 mg (over 65)
Children (2-16 years):
- Single dose: IM 1 mg/kg (max 30 mg); IV 0.5 mg/kg (max 15 mg)
- Multiple dose: 0.5 mg/kg IV/IM q6hr; max 5 days
Renal Impairment:
- Moderate: Use 50% of recommended dose; not to exceed 60 mg/day
- Severe: Contraindicated
Administration
- Tablets should be taken with water, with or without food
- IV bolus must be given over no less than 15 seconds
- IM injection should be given slowly and deeply into the muscle
- Always begin with parenteral therapy; oral administration only as continuation of IV/IM dosing
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose.
Side effects
>10%:
- Headache (17%)
- Somnolence/Insomnia (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 BUN (3%), Constipation (<3%)
- Increased serum creatinine (2%), Hypertension (4%)
<1%: Abnormal thinking, Anaphylaxis, Blurred vision, Bronchospasm, Cholestatic jaundice, Depression, Hepatitis, Hyperkalemia, Hyponatremia, Hypotension, Liver failure, Melena, Peptic ulcer, Rash, Urinary retention, etc.
Potentially Fatal: Anaphylaxis, Severe skin reactions, MI, Stroke, GI bleeding.
Precautions & warnings
- Use with caution in elderly patients
- Use with caution in patients weighing <50 kg
- Use with caution in hepatic dysfunction, heart failure
- Use with caution if predisposition to reduced blood volume or renal blood flow
- Monitor renal function closely in mild renal impairment
- Lactation: Drug excreted in breast milk with multiple doses; contraindicated
- May cause premature closure of ductus arteriosus in third trimester of pregnancy
Contraindications
- Hypersensitivity to aspirin or other NSAIDs
- Asthma
- Hypovolemia or dehydration
- Do not use postoperatively in patients with high risk of hemorrhage
- History of peptic ulcer or coagulation disorders
- Nasal polyps, angioedema, bronchospasm
- Moderate to severe renal impairment
- GI bleeding, cerebrovascular bleeding
- As prophylactic analgesic before surgery
- Pregnancy (especially third trimester), lactation
Drug interactions
- May reduce effects of antihypertensives such as ACE inhibitors or AIIA
- Increased risk of renal toxicity with ACE inhibitors, diuretics
- Increased adverse effects with aspirin or other NSAIDs
- Hallucinations may occur with fluoxetine, thiothixene, alprazolam
- Increased risk of GI bleeding with warfarin (potentially fatal)
- May increase toxicity of methotrexate (MTX) and lithium
- Increased plasma concentrations with probenecid
Food interactions
No food interactions found
Use in pregnancy
Pregnancy Category: C; D in third trimester (may cause premature closure of ductus arteriosus)
Should be avoided during pregnancy, especially in the third trimester.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Contraindicated during lactation (drug excreted in breast milk with multiple doses).
Pediatric use
Under 2 years: Safety and efficacy not established; 2-16 years: Doses are established.
Geriatric use
Elderly patients should start with reduced doses (over 65 years: IM 30 mg/15 mg q6hr, IV 15 mg/15 mg q6hr)
Renal / hepatic impairment
- Renal Impairment: Severe: Contraindicated; Moderate: Use 50% of dose, not to exceed 60 mg/day
- Hepatic Impairment: Use with caution
Overdose effects
Overdose symptoms include drowsiness, nausea, vomiting, and epigastric pain. No specific antidote; symptomatic treatment is recommended.
Storage conditions
Store in a dry place away from light and heat; keep out of reach of children.
Chemical structure
Ketorolac Tromethamine