In August 2024, the U.S. Food & Drug Administration (FDA) approved a supplemental new drug application for Gloperba—0.6 mg of colchicine in an oral solution—as a prophylactic treatment to prevent gout flares in adults. This approval includes specific information and dosage modifications relating to special patient populations and drug interactions.1
Background
In 1961, the FDA approved colchicine tablets for the treatment of adults with pain associated with gout. Its 0.6 mg/5 mL oral solution received subsequent FDA approval on Jan. 30, 2019.2-4
Gout is the most common form of inflammatory arthritis in the U.S., affecting nearly 8.3 million individuals, and may be more prevalent in men than women.5 The condition is due to monosodium urate crystals deposition in body tissues of individuals with hyperuricemia. The risk of gout increases with advancing age, which correlates with increased uric acid levels. Gout has a 30-fold higher frequency in patients who are at least 80 years old compared with those who are 20–29 years old. The risk of gout also increases in patients with metabolic syndrome and those with obesity.
Colchicine’s effectiveness as a prophylactic treatment for gout may be due to its ability to block neutrophil-mediated inflammatory responses caused by urate crystals in synovial fluid. Colchicine disrupts the polymerization of β-tubulin into microtubules, preventing the activation, degranulation and migration of neutrophils to inflammation sites. The agent also impedes the inflammasome complex found in neutrophils and monocytes that mediate activation of interleukin (IL) 1β.3
Colchicine Dosage & Use
Unlike other colchicine formulations, a patient’s dose of Gloperba can be reduced to 0.3 mg/day. More than 70% of patients with gout have comorbid conditions, such as chronic renal failure with severe renal impairment, that may require dose adjustments.6
Additionally, more than 17% of gout patients on colchicine tablets or capsules experience severe gastrointestinal sensitivity with such side effects as diarrhea. These patients may benefit from a lower dose with colchicine in an oral solution rather than the standard dose of 0.6 mg of colchicine as a tablet or capsule.1
Colchicine in an oral solution is indicated for prophylaxis of gout flares in adults and can be given without regard to meals. It is available as a concentration of 0.12 mg/mL (0.6 mg/5 mL) for adults and children 16 years and older for once or twice daily use. Its maximum recommended daily dose is 1.2 mg.
The colchicine tablet/capsule to oral solution dose conversion is:
| Tablet/Capsule (mg) | Oral Solution Dosage (mL) |
|---|---|
| 0.3 mg | 2.5 mL |
| 0.6 mg | 5 mL |
| 1.2 mg | 10 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
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
- Scilex Holding Company announces FDA final approval to precision dosing for Gloperba label [news release]. Scilex Holding Company. 2024 Aug 29.
- New drug application approval letter: Gloperba (colchicine) oral solution. U.S. Food & Drug Administration. 2019 Jan 30.
- Highlights of prescribing information: Gloperba (colchicine) oral solution. U.S. Food & Drug Administration. 2019 Jan 7.
- Supplemental approval letter: Gloperba (colchicine) oral solution. U.S. Food & Drug Administration. 2024 Jul 28.
- Ursani M. Understanding gout symptoms and treatment. American College of Rheumatology. 2023 Apr 27.
- 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.
- NIOSH list of hazardous drugs in healthcare settings, 2024. U.S. Center for Disease Control and Prevention. 2024.
