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152 concomitant use of colchicine and p-glycoprotein inhibitors is contraindicated in renal or hepatic impairment.

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Use with caution in patients with mild/moderate hepatic impairmentSuch patients should be carefully monitored for adverse effects of colchicine.

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 is a substrate of the efflux transporter P-glycoproteinP-gpand the CYP3A4 metabolizing enzymeFatal drug interactions have been reported when colchicine is administered with clarithromycina dual inhibitor of CYP3A4 and P-glycoproteinToxicities have also been reported when colchicine is administered with inhibitors of CYP3A4 that may not be potent inhibitors of P-gpe.ggrapefruit juiceerythromycinverapamilor inhibitors of P-gp that may not be potent inhibitors of CYP3A4e.gcyclosporine

Limitations of useThe safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.

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 purchase tofranil pm 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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