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news.URL Pharma has presented the safety and efficacy data of colchicine in patients with moderate or severe renal impairment for the prevention of gout flares.
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Colcrys is used for the prophylaxis and treatment of gout flares, besides Familial Mediterranean Fever (FMF).
In the study, ‘Colchicine Dosing Guidance for Gout Patients with Varying Degrees of Renal Impairment Based on Pharmacokinetic Data,’ 40 subjects were randomized into five groups based on creatinine clearance (CrCl) levels, a measure of kidney function.
The groups ranged from subjects with normal renal function to those with end-stage renal disease (ESRD) and each patient received a single 0.6 mg dose of colchicine.
According to the researchers, colchicine dosing for the prophylaxis of gout flares which is traditionally, one tablet (0.6 mg) once or twice a day should be reduced by half in patients with moderate or severe renal impairment.
Specifically, patients with moderate or severe renal impairment who take two tablets of colchicine (1.2 mg) per day should have their dosage reduced to one tablet (0.6 mg) per day, while those who take one tablet of colchicine (0.6 mg) per day should have their dosage reduced to half a tablet (0.3 mg) per day.
The pharmacokinetic (PK) study showed that no dosing adjustments are necessary in patients with mild renal impairment or end-stage renal disease (ESRD).