What is the recommended maintenance dose of colchicine for gout prophylaxis?

Maintenance Dose of Colchicine for Gout Prophylaxis

For gout flare prophylaxis, the recommended maintenance dose of colchicine is 0.6 mg once or twice daily (maximum 1.2 mg/day), continued for at least 6 months after initiating urate-lowering therapy. 1, 2

Standard Prophylaxis Dosing

• The FDA-approved maintenance dose is 0.6 mg once or twice daily for prophylaxis of gout flares in adults and adolescents older than 16 years. 2
• The maximum recommended daily dose for prophylaxis is 1.2 mg/day. 2
• Prophylaxis should be initiated with or just prior to starting urate-lowering therapy (allopurinol, febuxostat, pegloticase). 1, 3

Duration of Prophylaxis

Continue prophylaxis based on the following algorithm: 1, 3

• Minimum duration: At least 6 months after starting urate-lowering therapy 4, 1
• If no tophi present: Continue for 3 months after achieving target serum urate (<6 mg/dL) 1, 3
• If tophi are present: Continue for 6 months after achieving target serum urate 1, 3

Dose Adjustments for Renal Impairment

Renal function significantly impacts colchicine dosing due to narrow therapeutic window: 4

• Mild renal impairment (eGFR 60-89 mL/min/1.73 m²): No dose adjustment needed; standard 0.6 mg daily is appropriate 5
• Moderate renal impairment (eGFR 30-59 mL/min/1.73 m²): Reduce to 0.48-0.5 mg daily (using oral solution or available 0.5 mg tablets where available) 5
• Severe renal impairment (eGFR 15-29 mL/min/1.73 m²): Reduce to 0.3 mg daily 5
• eGFR <30 mL/min: Colchicine should be avoided; consider alternative prophylaxis with low-dose NSAIDs or corticosteroids 4, 3

Critical caveat: Simply splitting the 0.6 mg tablet to 0.3 mg daily or dosing every-other-day in moderate renal impairment results in subtherapeutic levels 20-70% of the time, exposing patients to breakthrough flares. 5

Dose Adjustments for Drug Interactions

Colchicine is metabolized by CYP3A4 and is a P-glycoprotein substrate, creating significant interaction risks: 2, 6

Strong CYP3A4/P-gp Inhibitors (CONTRAINDICATED in renal/hepatic impairment)

If coadministered with strong inhibitors (clarithromycin, ketoconazole, ritonavir, cyclosporine, itraconazole), reduce prophylaxis dose: 2, 6

• Original dose 0.6 mg twice daily: Reduce to 0.3 mg once daily 2
• Original dose 0.6 mg once daily: Reduce to 0.3 mg once daily or 0.6 mg every other day 2
• Maximum daily dose: 0.6 mg (may be given as 0.3 mg twice daily) 2

Moderate CYP3A4/P-gp Inhibitors

For verapamil ER or diltiazem ER: Dose reduction of 33-50% is recommended 6

No Dose Adjustment Needed

Azithromycin does not require colchicine dose adjustment 6

Alternative Prophylaxis When Colchicine is Contraindicated

If colchicine is not tolerated or contraindicated, use the following alternatives: 4, 7

• Low-dose NSAIDs with proton pump inhibitor (if not contraindicated by renal function or cardiovascular disease) 4, 7
• Low-dose prednisone ≤10 mg/day 7

Monitoring and Safety Considerations

Patients on colchicine prophylaxis require monitoring for: 4

• Neurotoxicity and myotoxicity, especially in patients with renal impairment or concurrent statin therapy 4
• Drug interaction screening before initiating colchicine, particularly for CYP3A4/P-gp inhibitors 3
• Hepatic disease is a relative contraindication requiring dose reduction 7

Common pitfall: Co-prescribing colchicine with strong P-glycoprotein/CYP3A4 inhibitors without dose adjustment has resulted in fatal colchicine toxicity. 2, 6 Always screen medication lists before prescribing.