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Avoid eating grapefruit or drinking grapefruit juice while taking colchicine capsulesIt can increase your chances of getting serious side effects.

Fatal overdosesboth accidental and intentionalhave been reported in adults and children who have ingested colchicineSee OVERDOSEColchicine capsules should be kept out of the reach of children.

Published reports on the pharmacokinetics of intravenous colchicine in patients with severe chronic liver diseaseas well as those with alcoholic or primary biliary cirrhosisand normal renal function suggest wide inter-patient variabilityIn some subjects with mild to moderate cirrhosisthe clearance of colchicine is significantly reduced and plasma half-life prolonged compared to healthy subjectsIn subjects with primary biliary cirrhosisno consistent trends were notedSee Hepatic ImpairmentNo pharmacokinetic data are available for patients with severe hepatic impairmentChild-Pugh C

Colchicine has a mean apparent volume of distribution in healthy young volunteers of approximately 5 to 8 L/kgColchicine binding to serum protein is about 39primarily to albuminColchicine crosses the placenta and distributes into breast milkSee Pregnancy and Nursing Mothers

Pharmacokinetic studies evaluating changes in systemic levels of colchicine when co-administered with CYP3A4 inhibitors in healthy volunteers have been conducted with colchicine capsulesWhile voriconazole 200 mg BID for 5 daysconsidered a strong CYP3A4 inhibitorand cimetidine 800 mg BID for 5 daysconsidered a weak CYP3A4 inhibitordid not cause any changes in colchicine systemic levelsfluconazole 200 mg QD for 4 days with a 400 mg loading doseconsidered a moderate CYP3A4 inhibitorincreased colchicine AUC by 40As voriconazolecimetidineand fluconazole are known as CYP3A4 inhibitors that do not inhibit P-gpthese studies show that CYP3A4 inhibition by itself may not lead to clinically significant increases in colchicine systemic levels in humansand P-gp inhibition in addition to CYP3A4 inhibition may be necessary for clinically meaningful interactions of colchicineHoweverbased on published case reports that indicate the presence of colchicine toxicity when colchicine is co-administered with strong to moderate CYP3A4 inhibitors such as clarithromycinerythromycingrapefruit juiceetcas well as the 40increase in systemic levels of colchicine observed with concomitantly administered fluconazolea moderate CYP3A4 inhibitor that is not known to inhibit P-gpin a drug-drug interaction studythe drug-drug interaction potential of colchicine with strong or moderate CYP3A4 inhibitors that do not inhibit P-gp cannot be ruled out completely.

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