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Colchicine is a substrate for both CYP3A4 and the transport protein P-gpIn the presence of CYP3A4 or P-gp inhibitorsthe concentrations of colchicine in the blood increaseToxicityincluding fatal caseshave been reported during concurrent use of CYP3A4 or P-gp inhibitors such as macrolidesclarithromycin and erythromycinciclosporinketoconazoleitraconazolevoriconazoleHIV protease inhibitorscalcium channel blockersverapamil and diltiazemand disulfiramsee section 4.4

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.

There are no adequate and well-controlled studies with colchicine capsules in pregnant womenColchicine crosses the human placentaDevelopmental studies in animals were not conducted with colchicine capsuleshowever published animal reproduction and development studies with colchicine demonstrated embryofetal toxicityteratogenicityand altered postnatal development at exposures within or above the clinical therapeutic rangeColchicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Colchicine consists of pale yellow scales or powderit darkens on exposure to lightColchicine is soluble in waterfreely soluble in alcoholand slightly soluble in ether.

There were no studies of the effects of colchicine capsules on fertilityHoweverpublished nonclinical studies have demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosisPublished reproductive studies with colchicine reported abnormal sperm morphology and reduced sperm counts in malesand interference with sperm penetrationsecond meiotic divisionand normal cleavage in females.

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colchicine is soluble in water, freely soluble in alcohol and in chloroform, and slightly soluble in ether.

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