Pronunciation:

(KOL chi seen)

Generic Available:

Canadian Brand Names:

Use:

Use - Unlabeled/Investigational:

Pregnancy Risk Factor:

Lactation:

Contraindications:

Warnings/Precautions:

Intravenous: Use only with extreme caution; potential for serious, life-threatening complications. Should not be administered to patients with renal insufficiency, hepatobiliary obstruction, patients >70 years of age, or recent oral colchicine use. Should be reserved for hospitalized patients who are under the care of a physician experienced in the use of intravenous colchicine.

Adverse Reactions:

>10%: Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain

1% to 10%:

Dermatologic: Alopecia

Gastrointestinal: Anorexia

<1%: Rash, azoospermia, agranulocytosis, aplastic anemia, bone marrow suppression, hepatotoxicity, myopathy, peripheral neuritis

Overdosage/Toxicology:

Drug Interactions:

Cyclosporine: Concurrent use with colchicine may increase toxicity of colchicine.

CYP3A4 inhibitors: May increase the levels/effects of colchicine. Example inhibitors include azole antifungals, ciprofloxacin, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, and verapamil.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol.

Food: Cyanocobalamin (vitamin B12): Malabsorption of the substrate. May result in macrocytic anemia or neurologic dysfunction.

Herb/Nutraceutical: Vitamin B12 absorption may be decreased by colchicine.

Stability:

Compatibility:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Onset of action: Oral: Pain relief: ~12 hours if adequately dosed

Distribution: Concentrates in leukocytes, kidney, spleen, and liver; does not distribute in heart, skeletal muscle, and brain

Protein binding: 10% to 31%

Metabolism: Partially hepatic via deacetylation

Half-life elimination: 12-30 minutes; End-stage renal disease: 45 minutes

Time to peak, serum: Oral: 0.5-2 hours, declining for the next 2 hours before increasing again due to enterohepatic recycling

Excretion: Primarily feces; urine (10% to 20%)

Dosage:

Familial Mediterranean fever (unlabeled use): Prophylaxis: Oral:

Children:

5 years: 0.5 mg/day

>5 years: 1-1.5 mg/day in 2-3 divided doses

Adults: 1-2 mg daily in divided doses (occasionally reduced to 0.6 mg/day in patients with GI intolerance)

Gouty arthritis: Adults:

Prophylaxis of acute attacks: Oral: 0.6 mg twice daily; initial and/or subsequent dosage may be decreased (ie, 0.6 mg once daily) in patients at risk of toxicity or in those who are intolerant (including weakness, loose stools, or diarrhea); range: 0.6 mg every other day to 0.6 mg 3 times/day

Acute attacks:

Oral: Initial: 0.6-1.2 mg, followed by 0.6 every 1-2 hours; some clinicians recommend a maximum of 3 doses; more aggressive approaches have recommended a maximum dose of up to 6 mg. Wait at least 3 days before initiating another course of therapy

I.V.: Initial: 1-2 mg, then 0.5 mg every 6 hours until response, not to exceed total dose of 4 mg. If pain recurs, it may be necessary to administer additional daily doses. The amount of colchicine administered intravenously in an acute treatment period (generally ~1 week) should not exceed a total dose of 4 mg. Do not administer more colchicine by any route for at least 7 days after a full course of I.V. therapy.

Note: Many experts would avoid use because of potential for serious, life-threatening complications. Should not be administered to patients with renal insufficiency, hepatobiliary obstruction, patients >70 years of age, or recent oral colchicine use. Should be reserved for hospitalized patients who are under the care of a physician experienced in the use of intravenous colchicine.

Surgery: Gouty arthritis, prophylaxis of recurrent attacks: Adults: Oral: 0.6 mg/day or every other day; patients who are to undergo surgical procedures may receive 0.6 mg 3 times/day for 3 days before and 3 days after surgery

Primary biliary cirrhosis (unlabeled use): Adults: Oral: 0.6 mg twice daily

Pericarditis (unlabeled use): Adults: Oral: 0.6 mg twice daily

Elderly: Reduce maintenance/prophylactic dose by 50% in individuals >70 years

Dosing adjustment in renal impairment: Gouty arthritis, acute attacks: Oral: Specific dosing recommendations not available from the manufacturer:

Prophylaxis:

Clcr 35-49 mL/minute: 0.6 mg once daily

Clcr 10-34 mL/minute: 0.6 mg every 2-3 days

Clcr<10 mL/minute: Avoid chronic use of colchicine. Use in serious renal impairment is contraindicated by the manufacturer.

Treatment: Clcr<10 mL/minute: Use in serious renal impairment is contraindicated by the manufacturer. If a decision is made to use colchicine, decrease dose by 75%.

Peritoneal dialysis: Supplemental dose is not necessary

Dosage adjustment in hepatic impairment: Avoid in hepatobiliary dysfunction and in patients with hepatic disease.

Administration:

I.V.: Injection should be made over 2-5 minutes into tubing of free-flowing I.V. with compatible fluid. Do not administer I.M. or SubQ; severe local irritation can occur following SubQ or I.M. administration. Extravasation can cause tissue irritation.

Tablet: Administer orally with water and maintain adequate fluid intake.

Monitoring Parameters:

Test Interactions:

Dietary Considerations:

Patient Education:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

Injection, solution: 0.5 mg/mL (2 mL)

Tablet: 0.6 mg

International Brand Names: