Usual Adult Dose for Acute Gout

Initial: 1.2 mg orally at first sign of gout flare followed by 0.6 mg 1 hour later
Maximum dose: 1.8 mg orally over a 1 hour period; higher doses have not been found to be more effective

Comments:

• Dose adjustments may be required based on renal function, hepatic function, and use of concomitant medications.
• The safety and effectiveness of repeat treatment in gout flares has not been evaluated.

Use: For the treatment of acute gout flares when taken at the first sign of a flare.

Usual Adult Dose for Familial Mediterranean Fever

Usual dose: 1.2 mg to 2.4 mg orally daily, administered in 1 or 2 divided doses

• Dose increases should be made in increments of 0.3 mg/day as needed and tolerated to control disease; if intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day

Maximum dose: 2.4 mg/day

Comments:

• Dose adjustments may be required based on renal function, hepatic function, and use of concomitant medications.

Use: For the treatment of familial Mediterranean fever.

Usual Adult Dose for Gout - Prophylaxis

0.6 mg orally once or twice a day
Maximum dose: 1.2 mg/day

Comments:

• Dose adjustments may be required based on renal function, hepatic function, and use of concomitant medications.
• The safety and effectiveness for the acute treatment of gout flares during prophylaxis has not been studied.

Use: For the prophylaxis of gout flares.

Usual Geriatric Dose for Acute Gout

Use caution; dose selection should reflect the greater frequency of decreased renal function, concomitant disease, and/or concomitant drug therapy.

Usual Geriatric Dose for Familial Mediterranean Fever

Use caution; dose selection should reflect the greater frequency of decreased renal function, concomitant disease, and/or concomitant drug therapy.

Usual Geriatric Dose for Gout - Prophylaxis

Use caution; dose selection should reflect the greater frequency of decreased renal function, concomitant disease, and/or concomitant drug therapy.

Usual Pediatric Dose for Familial Mediterranean Fever

Age: 4 to 6 years: 0.3 to 1.8 mg orally daily, administered in 1 or 2 divided doses

Age: 6 to 12 years: 0.9 to 1.8 mg orally daily, administered in 1 or 2 divided doses

Age: Older than 12 years: 1.2 to 2.4 mg orally daily, administered in 1 or 2 divided doses

• Dose increases should be made in increments of 0.3 mg/day as needed and tolerated to control disease; if intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day

Maximum dose: 2.4 mg/day

Comments:

• Dose adjustments may be required based on renal function, hepatic function, and use of concomitant medications.

Use: For the treatment of familial Mediterranean fever in pediatric patients 4 years of age and older.

Renal Dose Adjustments

Patients with renal impairment should not take colchicine in conjunction with drugs that inhibit both P-glycoprotein (P-gp) and CYP450 3A4.

Gout Flares:
Mild to moderate renal impairment (CrCl 30 to 80 mL/min): Use caution; no adjustment recommended, but dose reduction may be necessary; monitor closely for adverse effects
Severe renal impairment (CrCl less than 30 mL/min):

• Dose reduction should be considered
• Treatment course should be repeated no more than once every 2 weeks
• For patients requiring repeated courses, consideration should be given to alternate therapy.

Gout Prophylaxis:
Severe renal impairment: Dose reductions or alternatives should be considered

Familial Mediterranean Fever (FMF):
Mild to moderate renal impairment (CrCl 30 to 80 mL/min): Use caution; no adjustment recommended, but dose reduction may be necessary; monitor closely for adverse effects
Severe renal impairment (CrCl less than 30 mL/min):

• Initial dose: 0.3 mg/day; dose increases should be done with adequate monitoring for adverse effects.

Liver Dose Adjustments

Patients with hepatic impairment should not take colchicine in conjunction with drugs that inhibit both P-glycoprotein (P-gp) and CYP450 3A4.

Gout Flares:
Mild to moderate hepatic impairment: Use caution; no dose adjustment recommended, but patients should be monitored closely for adverse effects.
Severe hepatic impairment:

• No dose adjustment required, but a treatment course should not be repeated more than once every 2 weeks.
• For patients requiring repeated courses, consideration should be given to alternate therapy.

Gout Prophylaxis:
Severe hepatic impairment: Dose reductions or alternatives should be considered

Familial Mediterranean Fever (FMF):
Mild to moderate hepatic impairment: Use caution, no adjustment recommended, but dose reduction may be necessary; monitor closely for adverse effects
Severe hepatic impairment: Dose reduction should be considered

Dose Adjustments

Colchicine Toxicity: Temporary interruption or discontinuation will be necessary

• Gastrointestinal tract adverse effects (e.g. cramping, nausea, diarrhea, abdominal pain, vomiting) often present within 24 hours of initiating therapy: GI adverse effects occur in up to 20% of patients given therapeutic doses; severe GI events should be considered dose-limiting as they may signal more significant toxicity.

CYP450 3A4 and P-glycoprotein (P-gp) Inhibitors:

• Concomitant use in patients with renal or hepatic impairment is contraindicated
• Concomitant use of strong or moderate CYP450 3A4 or P-gp inhibitors in patients with normal renal and hepatic function will require colchicine dose adjustments as increased colchicine concentrations are likely.

Gout Flares:

• Concomitant use with Strong CYP450 3A4 inhibitors: 0.6 mg orally followed by 0.3 mg one hour later; dose to be repeated no earlier than 3 days
• Concomitant use with Moderate CYP450 3A4 inhibitors: 1.2 mg orally for one dose; dose to be repeated no earlier than 3 days.
• Concomitant use with P-gp inhibitors: 0.6 mg orally for one dose; dose to be repeated no earlier than 3 days.

Familial Mediterranean Fever (FMF):

• Concomitant use with Strong CYP450 3A4 inhibitors: Maximum dose: 0.6 mg/day
• Concomitant use with Moderate CYP450 3A4 inhibitors: Maximum dose: 1.2 mg/day
• Concomitant use with P-gp inhibitors: Maximum dose: 0.6 mg/day

Precautions

Safety and efficacy in the treatment of gout have not been established in patients younger than 18 years.

Safety and efficacy of colchicine in children of all ages with familial Mediterranean fever (FMF) has been evaluated in uncontrolled studies.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Not dialyzable

• Gout Flare: 0.6 mg orally once; a treatment course should not be repeated more than once every 2 weeks
• Gout Prophylaxis: Dose reduction or alternatives should be considered
• Familial Mediterranean fever (FMF): Initial dose: 0.3 mg orally once a day; dose increases should be done with adequate monitoring for adverse effects

Peritoneal dialysis: Not dialyzable

Other Comments

Administration advice:

• Take orally, with or without food
• If a dose is missed, do not double the next dose

Storage requirements:

• Protect from light

General:

• This drug is not an analgesic medication and should not be used to treat pain from other causes.
• For the treatment of gout, the initial response occurs in about 12 to 24 hours; peak response is expected within 48 to 72 hours.
• This drug has a narrow therapeutic window; patients should be monitored for closely for toxicity.

Monitoring:

• Monitor for drug toxicity, especially among geriatric and debilitated patients, patients with renal or hepatic impairment, and those with cardiac, renal, hepatic, or gastrointestinal disease.
• Monitor for hematologic toxicities; for patients developing signs or symptoms of blood cell dyscrasias, a full hematologic investigation should be conducted.
• Monitor renal function in patients at-risk for renal impairment

Patient advice:

• Instruct patients on proper use and inform patients that fatal overdose, both accidental and intentional, have occurred; this drug should be kept out of the reach of children.
• Inform patients that there are a number of potentially serious drug interactions; grapefruit, grapefruit juice, and some herbal products should be avoided; patients should check with their healthcare provider before starting any new medications including short-term medications such as antibiotics.
• Inform patients that bone marrow depression and neuromuscular toxicity may occur; patients should seek medical attention promptly for unusual bleeding or bruising, increased infections, weakness or fatigue, muscle pain or weakness, or numbness or tingling in fingers or toes.
• Inform patients that gastrointestinal adverse events occur, but if these events are severe or persistent, they should be reported promptly to their healthcare provider.

Frequently asked questions

• Can Colchicine be used to treat COVID-19 (coronavirus)?