Colchicine Dosage

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Usual Adult Dose for Acute Gout

Oral:

Initial: Gout Flare: 1.2 mg orally at the first sign of the flare followed by 0.6 mg one hour later.
Maximum: Gout Flare: 1.8 mg orally over a one hour period

Coadministration 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.

Coadministration with moderate CYP450 3A4 inhibitors:
1.2 mg orally for one dose only. Dose to be repeated no earlier than 3 days.

Coadministration with P-glycoprotein inhibitors:
0.6 mg orally for one dose only. Dose to be repeated no earlier than 3 days.

Usual Adult Dose for Familial Mediterranean Fever

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

The dose should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day.

Coadministration with strong CYP450 3A4 inhibitors: 0.6 mg orally daily, may be given as 0.3 mg twice a day.

Coadministration with moderate CYP450 3A4 inhibitors: 1.2 mg orally daily, may be given as 0.6 mg twice a day.

Coadministration with P-glycoprotein inhibitors: 0.6 mg orally daily, may be given as 0.3 mg twice a day.

Usual Adult Dose for Gout - Prophylaxis

(Unlabeled use):
Oral:
0.5 to 0.6 mg orally once a day for 3 to 4 days a week (less than 1 attack/year).
0.5 to 0.6 mg orally once a day (greater than 1 attack/year).
Severe cases may require 1 to 1.8 mg/day.

Usual Adult Dose for Biliary Cirrhosis

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Sarcoidosis

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Pseudogout - Prophylaxis

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Fibromatosis

(Unlabeled use):
Initial: 0.6 to 1.2 mg orally once a day each day for the first 1 to 2 weeks.
Maintenance: 0.6 to 1.2 mg orally once a day 1 to 2 times per week is often used to prevent recurrence of fibromatosis.

Usual Adult Dose for Aphthous Stomatitis - Recurrent

(Unlabeled use):
0.5 to 0.6 mg orally daily. The dose may be titrated upward while the patient is observed for signs of toxicity.

Usual Adult Dose for Behcet's Disease

(Unlabeled use):
0.5 to 1.5 mg orally once a day.

Study (n=116)
Dosage adjusted to body weight:
less than 50 Kg: 1 mg daily
50 to 59 Kg: 1 mg and 1.5 mg on alternate days
60 to 75 Kg: 1.5 mg daily
76 to 84 Kg: 1.5 and 2 mg on alternate days
greater than or equal to 85 Kg: 2 mg daily

Usual Adult Dose for Constipation - Chronic

(Unlabeled use):
Study (n=16)
0.6 mg orally three times daily for 4 weeks

Usual Adult Dose for Sweet's Syndrome

(Unlabeled use):
0.6 mg orally twice daily.

Usual Pediatric Dose for Familial Mediterranean Fever

Oral:

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

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

Over 12 years: 1.2 to 2.4 mg daily, administered in 1 or 2 divided doses.

The dose should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day.

Renal Dose Adjustments

Gout Flares:

Mild (CrCl 50 to 80 mL/min) to moderate (CrCl 30 to 50 mL/min) renal impairment: No dose adjustment required, but patients should be monitored closely for adverse effects.

Severe (CrCl less than 30 mL/min) renal 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.

Familial Mediterranean Fever:

Mild (CrCl 50 to 80 mL/min) to moderate (CrCl 30 to 50 mL/min) renal impairment: No dose adjustment required, but patients should be monitored closely for adverse effects. Dose reduction may be necessary.

Severe (CrCl less than 30 mL/min) renal impairment: Dosage should be started at 0.3 mg/day; any increase in dose should be done with adequate monitoring of the patient for adverse effects.

In patients with renal impairment who are taking protease inhibitors for the treatment of HIV-1 infection, the FDA has recommended against the coadministration of colchicine.

Liver Dose Adjustments

Gout Flares:

Mild to moderate hepatic impairment: No dose adjustment required, 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.

Familial Mediterranean Fever:

Mild to moderate hepatic impairment: No dose adjustment required, but patients should be monitored closely for adverse effects. Dose reduction may be necessary.

Severe hepatic impairment: Dose reduction should be considered.

In patients with hepatic impairment who are taking protease inhibitors for the treatment of HIV-1 infection, the FDA has recommended against the coadministration of colchicine.

Dose Adjustments

Dose selection in geriatric patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or renal function, and of concomitant disease or other drug therapy.

FDA has issued new dosing recommendations for colchicine based on several clinical studies that uncovered the risk of serious interactions when colchicine is taken along with protease inhibitors for the treatment of HIV-1 infection:
1) Patients with hepatic or renal impairment: For the prevention or treatment of gout flares, or for FMF, FDA has recommended against the coadministration of colchicine with protease inhibitors.
2) For acute gout flares in patients taking protease inhibitors: Recommended dosing is 0.6 mg as 1 dose, followed by 0.3 mg 1 hour later. This dose should be repeated no earlier than 3 days. For patients taking fosamprenavir without ritonavir, the suggested dose is 1.2 mg as 1 dose. This dose should be repeated no earlier than 3 days.
3) For prophylaxis of gout flares in patients taking protease inhibitors: FDA recommends that if the original colchicine regimen was 0.6 mg 2 times a day, the regimen should be adjusted to 0.3 mg once a day. If the original colchicine regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once every other day. For patients taking fosamprenavir without ritonavir, the FDA recommends that if the original colchicine regimen was 0.6 mg 2 times a day, the regimen should be adjusted to 0.3 mg 2 times a day or 0.6 mg once a day. However, if the original colchicine regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once a day.
4) Familial Mediterranean fever (FMF) in patients taking protease inhibitors: FDA recommends a maximum daily dose of colchicine of 0.6 mg (may be given as 0.3 mg 2 times a day). For patients taking fosamprenavir without ritonavir, the maximum daily dose of colchicine is recommended to be no more than 1.2 mg (may be given as 0.6 mg 2 times a day).

Precautions

The current FDA-approved dose for gout flare is substantially lower than what has been historically used clinically. Doses higher than 1.8 mg over a 1 hour period for gout flare are not proven more effective and are not recommended.

Patients with renal or liver impairment should not be given colchicine in conjunction with P-gp or strong CYP450 3A4 inhibitors. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses.

Safety and effectiveness have not been established in pediatric patients less than 4 years of age.

Dialysis

Gout Flares: The recommended dose for patients undergoing dialysis should be reduced to a single dose of 0.6 mg. For these patients, a treatment course should not be repeated more than once every 2 weeks.

Familial Mediterranean Fever: The total recommended starting dose should be 0.3 mg/day. Dosing may be increased with close monitoring. Any increase in dose should be done with adequate monitoring of the patient for adverse effects.

Other Comments

Colchicine may be given without regard to meals.

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