From the Guidelines
Colchicine dosing should be carefully tailored to the individual patient's condition, with a recommended regimen of 1.2 mg at first onset, followed by 0.6 mg one hour later for acute gout flares, and 1.2-2.4 mg daily for familial Mediterranean fever (FMF), with dose adjustments for renal or hepatic impairment and monitoring for toxicity 1.
Indications and Dosing
- For acute gout flares, the recommended regimen is 1.2 mg at first onset, followed by 0.6 mg one hour later (total 1.8 mg for the acute attack) 1.
- For gout prophylaxis, patients typically take 0.6 mg once or twice daily.
- For FMF, adults usually require 1.2-2.4 mg daily, which can be divided into two doses, while children's dosing is based on age and weight, ranging from 0.3-1.8 mg daily 1.
Dose Adjustments and Monitoring
- Dose adjustments are necessary for patients with renal or hepatic impairment, and doses should be reduced when used with CYP3A4 or P-glycoprotein inhibitors due to increased toxicity risk.
- Monitoring should include complete blood counts, liver function tests, and renal function tests at baseline and periodically during treatment.
- Patients should be monitored for signs of toxicity including gastrointestinal symptoms (nausea, vomiting, diarrhea), muscle weakness, and neuropathy.
Mechanism of Action and Therapeutic Window
- Colchicine works by inhibiting microtubule assembly and leukocyte migration, thereby reducing inflammation associated with crystal deposition in gout and amyloidosis in FMF.
- The narrow therapeutic window of colchicine necessitates careful dosing and monitoring to prevent potentially serious toxicity while maintaining efficacy.
Special Considerations
- In patients with FMF, colchicine dose may be increased by 0.5 mg/day (or 0.6 mg/day depending on the available drug) if inflammation persists despite adherence to the advised initial dose 1.
- The development of amyloidosis can be prevented in most patients by suppressing chronic inflammatory activity with colchicine treatment.
From the FDA Drug Label
2 DOSAGE AND ADMINISTRATION
The recommended dosage of Colchicine Tablets, USP depends on the patient's age, renal function, hepatic function and use of coadministered drugs [see Dosage and Administration (2.4)] .
2.1 Gout Flares Prophylaxis of Gout Flares The recommended dosage of Colchicine Tablets, USP for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day.
Treatment of Gout Flares The recommended dose of Colchicine Tablets, USP for treatment of a gout flare is 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later.
2.2 FMF The recommended dosage of Colchicine Tablets, USP for FMF in adults is 1.2 to 2.4 mg daily.
2.3 Recommended Pediatric Dosage FMF The recommended dosage of Colchicine Tablets, USP for FMF in pediatric patients four years of age and older is based on age
The recommended dosing for patients taking colchicine (Colcrys) is as follows:
- Gout Flares Prophylaxis: 0.6 mg once or twice daily for adults and adolescents older than 16 years of age, with a maximum recommended dose of 1.2 mg/day.
- Treatment of Gout Flares: 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later.
- FMF: 1.2 to 2.4 mg daily for adults, and for pediatric patients four years of age and older, the dose is based on age. Monitoring should include:
- Renal function
- Hepatic function
- Use of coadministered drugs
- Patient's age It is also important to note that dose modification may be necessary when coadministering colchicine with certain interacting drugs, such as strong CYP3A4 or P-gp inhibitors 2.
From the Research
Recommended Dosing for Colchicine
- For patients with gout, low-dose colchicine (1.8 mg over 1 h) taken as early as possible is effective in reducing pain and is well tolerated 3.
- For long-term prevention of gout flare and cardiovascular events, low-dose colchicine (0.5 mg daily) is effective and safe 4.
- For patients with familial Mediterranean fever, colchicine is the only available drug to prevent both acute attacks and long-term complications, with dosing based on individual patient needs 5.
Monitoring for Patients Taking Colchicine
- Patients should be monitored for gastrointestinal side effects, such as diarrhea, which may occur early and are the most frequent manifestations of colchicine toxicity 5, 6.
- Patients with significant renal or hepatic impairment should be closely monitored for potential adverse effects, such as myelosuppression, myotoxicity, and serious drug-drug interactions 6.
- Patients taking colchicine should be monitored for signs of toxicity, such as multiple organ failure, which is very rarely reported as an overdosage expression 5.
Safety and Efficacy of Colchicine
- Low-dose colchicine (0.5 mg daily) is well tolerated and very safe, with mild diarrhea on initiation of therapy typically subsiding within a week 6.
- Continuous use of low-dose colchicine does not affect renal, liver, or cognitive function, and has no adverse effects on bleeding, wound healing, fertility, or pregnancy 6.
- Colchicine may be useful in preventing postcardiac injury syndrome and atrial fibrillation following cardiac surgery or percutaneous interventions, and in improving outcomes of COVID-19 infection 7.