New Colchicine Product and Dosing Regimen (October 2009)

New Colchicine Product and Dosing Regimen (October 2009)

FDA has approved the first single-ingredient oral colchicine product. The drug, called Colcrys, is approved to treat acute gout flares and familial Mediterranean fever. Oral colchicine has been used to treat gout in the past, but until now it had not been approved by FDA. Colchicine has historically been given every hour for acute gout flares, either until the flare subsided or treatment had to be stopped because the patient developed gastrointestinal problems. But a dosing study conducted as part of the approval of Colcrys demonstrated that one initial dose and a single additional dose after one hour was just as effective and much less toxic. Healthcare professionals should use this lower recommended dosing regimen to treat acute gout flares. Healthcare professionals should also be aware that colchicine interacts with other drugs, including P-glycoprotein and strong CYP3A4 inhibitors such as cyclosporine and clarithromycin. This can lead to serious or even fatal colchicine toxicity, particularly if a patient has renal or hepatic impairment. And so concomitant use of colchicine and P-glycoprotein or strong CYP3A4 inhibitors is contraindicated in these patients. For patients with normal renal and hepatic function, consider interrupting colchicine therapy or reducing the dose if the patient needs treatment with a P-glycoprotein or a strong CYP3A4 inhibitor.
Video Rating: 3 / 5

Gout - information, symptoms and treatments. Googout.info health information factsheet - advice on gout and its symptoms, causes and treatment, plus prevention through diet.

New Colchicine Product and Dosing Regimen

FDA has approved the first single-ingredient oral colchicine product. The drug, called Colcrys, is approved to treat acute gout flares and familial Mediterranean fever. Oral colchicine has been used to treat gout in the past, but until now it had not been approved by FDA. Colchicine has historically been given every hour for acute gout flares, either until the flare subsided or treatment had to be stopped because the patient developed gastrointestinal problems. But a dosing study conducted as part of the approval of Colcrys demonstrated that one initial dose and a single additional dose after one hour was just as effective and much less toxic. Healthcare professionals should use this lower recommended dosing regimen to treat acute gout flares. Healthcare professionals should also be aware that colchicine interacts with other drugs, including P-glycoprotein and strong CYP3A4 inhibitors such as cyclosporine and clarithromycin. This can lead to serious or even fatal colchicine toxicity, particularly if a patient has renal or hepatic impairment. And so concomitant use of colchicine and P-glycoprotein or strong CYP3A4 inhibitors is contraindicated in these patients. For patients with normal renal and hepatic function, consider interrupting colchicine therapy or reducing the dose if the patient needs treatment with a P-glycoprotein or a strong CYP3A4 inhibitor. FDA Patient Safety News: October 2009 For more information, please see our website: www.accessdata.fda.gov
Video Rating: 1 / 5

Gout - information, symptoms and treatments. Googout.info health information factsheet - advice on gout and its symptoms, causes and treatment, plus prevention through diet.

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Orignal From: New Colchicine Product and Dosing Regimen (October 2009)