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FDA Approves Oral Solution of Colchicine to Prevent Gout Flare

Michele B. Kaufman, PharmD, BCGP  |  April 9, 2025

Tablet/Capsule (mg)Oral Solution Dosage (mL)
0.3 mg2.5 mL
0.6 mg5 mL
1.2 mg10 mL

Colchicine oral solution is available as a slightly hazy, red liquid with a cherry odor in a 150 mL bottle. It should be stored at room temperature and with the child-resistant cap in place. The safety, adverse reactions, contraindications, warnings and precautions, drug interactions, etc. for colchicine in an oral solution are the same as for the solid oral forms of colchicine.

Colchicine is listed in the 2024 updated National Institute for Occupational Safety and Health’s Hazardous Drugs in Healthcare Settings as 2A, indicating it may have adverse developmental and/or reproductive effects. The agent is not known to be a human carcinogen.7

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Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. Scilex Holding Company announces FDA final approval to precision dosing for Gloperba label [news release]. Scilex Holding Company. 2024 Aug 29.
  2. New drug application approval letter: Gloperba (colchicine) oral solution. U.S. Food & Drug Administration. 2019 Jan 30.
  3. Highlights of prescribing information: Gloperba (colchicine) oral solution. U.S. Food & Drug Administration. 2019 Jan 7.
  4. Supplemental approval letter: Gloperba (colchicine) oral solution. U.S. Food & Drug Administration. 2024 Jul 28.
  5. Ursani M. Understanding gout symptoms and treatment. American College of Rheumatology. 2023 Apr 27.
  6. Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the U.S. general population: The National Health and Nutrition Examination Survey 2007–2008. Arthritis Rheum. 2011 Oct;63(10):3136–3141.
  7. NIOSH list of hazardous drugs in healthcare settings, 2024. U.S. Center for Disease Control and Prevention. 2024.

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Filed under:AnalgesicsConditionsDrug UpdatesGout and Crystalline Arthritis

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