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Physicians should ensure that patients are suitable candidates for treatment with colchicine capsules and remain alert for signs and symptoms of toxic reactions associated with increased colchicine exposure due to drug interactions.

Information about Colchicine.

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

Before using this medicationtell your doctor or pharmacist your medical historyespecially ofkidney problemsliver problemssuch as cirrhosis

Advise patients that muscle pain or weaknesstingling or numbness in fingers or toes may occur with colchicine capsules alone or when it is used with certain other drugsPatients developing any of these signs or symptoms must discontinue colchicine capsules and seek medical evaluation immediately.

Published studies demonstrated that colchicine was negative for mutagenicity in the bacterial reverse mutation assayHoweverin vitro chromosomal aberration assays demonstrated the formation of micronuclei following colchicine treatmentBecause published studies demonstrated that colchicine induces aneuploidy through the process of mitotic nondisjunction without structural DNA changescolchicine is not considered clastogenicalthough micronuclei are formed.

The most common side effects of colchicine capsules include abdominal paindiarrheanauseaand vomiting.

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