From the Guidelines
For patients with impaired renal function, the recommended dose of colchicine for acute gout is 0.6 mg, followed by 0.3 mg one hour later, with no additional doses for at least 3 days, as supported by the 2017 American College of Physicians guideline 1. In the context of familial Mediterranean fever (FMF) with renal impairment, the starting dose should be reduced to 0.3 mg daily, with careful monitoring and potential adjustment based on response and tolerability. Patients with severe renal impairment (creatinine clearance <30 mL/min) or those on dialysis should generally avoid colchicine or use it only under close medical supervision due to increased risk of toxicity, as also cautioned in the 2016 updated EULAR evidence-based recommendations for the management of gout 1. Colchicine is primarily eliminated through hepatic metabolism and biliary excretion, but renal excretion becomes more significant in patients with kidney dysfunction, leading to drug accumulation and potential toxicity. Common side effects include gastrointestinal symptoms like diarrhea, nausea, and vomiting, which can be early signs of toxicity. Concurrent use of P-glycoprotein or CYP3A4 inhibitors (like clarithromycin or cyclosporine) should be avoided as they can further increase colchicine levels and toxicity risk in renally impaired patients. Key considerations in managing gout and FMF in patients with renal impairment include:
- Monitoring renal function and adjusting colchicine doses accordingly
- Avoiding concurrent use of certain medications that can increase colchicine toxicity
- Educating patients on the signs of toxicity and the importance of adherence to the prescribed dosing regimen
- Regularly reviewing the patient's response to treatment and adjusting the management plan as needed to minimize morbidity, mortality, and improve quality of life.
From the FDA Drug Label
For prophylaxis of gout flares in patients with mild (estimated creatinine clearance [Cl cr] 50 to 80 mL/min) to moderate (Cl cr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, the starting dose should be 0.3 mg/day and any increase in dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring. For treatment of gout flares in patients with mild (Cl cr 50 to 80 mL/min) to moderate (Cl cr 30 to 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet). For these patients, the treatment course should not be repeated more than once every two weeks. FMF: In patients with severe renal failure (Cl cr less than 30 mL/min) and end-stage renal disease requiring dialysis, Colchicine Tablets, USP may be started at the dose of 0.3 mg/day. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine.
The recommended dose of colchicine for acute gout in patients with impaired renal function is as follows:
- Mild to moderate renal impairment: No dose adjustment required, but monitor closely for adverse effects.
- Severe renal impairment: Start with 0.3 mg/day and increase with close monitoring.
- Dialysis patients: Single dose of 0.6 mg, repeated no more than once every two weeks. The recommended dose of colchicine for familial Mediterranean fever (FMF) in patients with impaired renal function is as follows:
- Mild to moderate renal impairment: Monitor closely for adverse effects.
- Severe renal impairment: Start with 0.3 mg/day and increase with close monitoring.
- Dialysis patients: Start with 0.3 mg/day and increase with close monitoring. 2 2 2
From the Research
Colchicine Dose for Acute Gout and Familial Mediterranean Fever
Overview of Colchicine Dosage
- The recommended dose of colchicine for acute gout is a low-dose regimen, which has been shown to be effective in reducing pain with minimal adverse events 3, 4, 5.
- For patients with impaired renal function, dose adjustment may be necessary to avoid toxicity 5.
Acute Gout
- Low-dose colchicine (1.8 mg over 1 hour) is effective in reducing pain and is well tolerated in patients with acute gout 3, 4, 5.
- High-dose colchicine may improve symptoms, but with an increased risk of adverse events 3, 4.
Familial Mediterranean Fever
- Colchicine is the mainstay of treatment for familial Mediterranean fever, with a dose of 0.6 mg three times daily showing a significant reduction in the number of people experiencing attacks 6.
- The efficacy and safety of interventions for reducing inflammation in familial Mediterranean fever are still being studied, with limited RCTs available 6.