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Newly-Published Colchicine Safety Data Provide First Evidence-Based Dosing Guidance to Avoid Potentially Serious Interactions With Commonly Prescribed Drugs

se studies are part of our continued investigation of the pharmacokinetics of colchicine, and reflect our ongoing commitment to making the necessary research investments to advance colchicine science."

Dosing RecommendationsSeven separate drug-drug interaction (DDI) studies were conducted with single-dose Colcrys® to understand the effect of administering colchicine concomitantly with medications that are known inhibitors of CYP3A4 or P-gp. Six of the seven drugs caused significant increases in mean peak colchicine concentrations and mean peak total colchicine exposure (AUC(0-t)). Dosing recommendations are summarized as follows:DrugAcute Flare Dosing Recommendations Flare Prophylaxis Dosing RecommendationsFMF Dosing RecommendationsCyclosporine

0.6mg (1 tablet) X 1 dose

0.3mg once a day, or 0.3 mg every other day

Maximum daily dose of 0.6 mg (or 0.3mg twice a day) Clarithromycin, Ketoconazole, Ritonavir

0.6mg (1 tablet) X 1 dose, followed by 0.3mg (half tablet) 1 hour later

0.3mg once a day, or 0.3mg every other day

Maximum daily dose of 0.6mg (or 0.3mg twice a day)Diltiazem, Verapamil

1.2mg (2 tablets) X 1 dose

0.3mg twice a day (or 0.6mg once a day), or 0.3mg once a day

Maximum daily dose of 1.2mg (or 0.6mg twice a day)Azithromycin

No dose reduction required

No dose reduction required

No dose reduction requiredThe studies were among the 17 clinical trials conducted by URL Pharma that led to the FDA approval of Colcrys. URL Pharma also conducted AGREE (Acute Gout Flare Receiving Colchicine Evaluation), the first placebo-controlled comparison of low-dose and high-dose colchicine in the treatment of acute gout flares. AGREE was published in Arthritis & Rheumatism in April 2010.

About Gout and Painful Gout FlaresGout is a painful form of arthritis that affects an estimated 8 million Americans, most c

SOURCE URL Pharma, Inc.
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