Ketoprofen and ketorolac: gastrointestinal risk

Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.

From:
Medicines and Healthcare products Regulatory Agency
Published
11 December 2014
Therapeutic area:
Pain management and palliation and Rheumatology

Article date: October 2007

Although epidemiological studies have suggested that is associated with a higher gastrointestinal risk than most non-steroidal anti-inflammatory drugs (NSAIDs), these studies have also raised concern about the relative gastrointestinal safety of ketorolac [footnote 1] [footnote 2] [footnote 3] [footnote 4] [footnote 5] [footnote 6] [footnote 7] [footnote 8] and ketoprofen. [5][footnote 9] [footnote 10] Prescribers are reminded of the following restrictions:

Dose

  • Ketorolac: treatment should be initiated only in hospital. Maximum duration of treatment should not exceed 7 days for tablets, or 2 days for continuous daily dosing with intravenous or intramuscular formulations
  • Ketoprofen: recommended maximum daily dose range is 100바카라 사이트“200 mg in divided doses. The balance of risks and benefits should be considered carefully before commencing treatment with 200 mg daily

Contraindications

Ketoprofen and ketorolac are contraindicated in patients with active peptic ulcer, or with any history of gastrointestinal bleeding, ulceration, or perforation.

General advice on gastrointestinal safety for all NSAIDs

  • Use the lowest dose and shortest duration of treatment necessary to control symptoms
  • Avoid use with other concomitant NSAIDs (including COX-2 selective inhibitors)
  • Consider combination therapy with protective agents (eg, misoprostol or a proton pump inhibitor) for high-risk patients (eg, elderly people and patients who need concomitant low-dose aspirin)
  • Patients with a history of any gastrointestinal toxicity, particularly those who are elderly, should report any unusual abdominal symptoms, particularly in the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, withdraw treatment immediately
  • Give NSAIDs with care to patients who have a history of gastrointestinal disease (eg, ulcerative colitis, Crohn바카라 사이트™s disease) because these conditions may be exacerbated

Interactions and gastrointestinal risk

Corticosteroids, antiplatelet agents, and selective serotonin reuptake inhibitors (SSRIs) may increase the risk of gastrointestinal ulceration or bleeding. NSAIDs may enhance the effects of anticoagulants, such as warfarin.

See also Information about dosing of ketorolac in

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Article citation: Drug Safety Update October 2007; Vol 1, Issue 3: 3.

  1. Traversa G, et al. Epidemiology 1995; 6: 49바카라 사이트“54Ìý↩

  2. Strom B, et al. JAMA 1996; 275: 376바카라 사이트“82Ìý↩

  3. Garcia-Rodriguez LA, et al. Arch Intern Med 1998: 158: 33바카라 사이트“39Ìý↩

  4. Menniti-Ippolito F, et al. Eur J Clin Pharmacol 1998; 54: 393바카라 사이트“97Ìý↩

  5. Laporte JR, et al. Drug Saf 2004; 27: 411바카라 사이트“20Ìý↩

  6. Lanas A, et al. Eur J Gastroenterol Hepatol 2003; 15: 173바카라 사이트“78Ìý↩

  7. Gallerani M, et al. J Clin Epidemiol 2004; 57: 103바카라 사이트“10Ìý↩

  8. Llorente-Melero MJ, et al. Rev Esp Enferm Dig 2002; 94: 7바카라 사이트“12Ìý↩

  9. Henry D, et al. Int J Clin Pract 2003; 135 (Suppl): 43바카라 사이트“49Ìý↩

  10. Lanas A, et al. Gut 2006; 55: 1731바카라 사이트“38Ìý↩

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Published 11 December 2014
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