Treatment of Gout Flares (Colcrys and Generic Tablets Only)

• PO (Adults ): 1.2 mg initially, then 0.6 mg 1 hr later (maximum dose of 1.8 mg in 1 hr); Concomitant use of strong CYP3A4 inhibitors in patients with normal renal and hepatic function (atazanavir, clarithromycin, darunavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, tipranavir/ritonavir): 0.6 mg initially, then 0.3 mg 1 hr later (do not repeat treatment course for ≥3 days); Concomitant use of moderate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil): 1.2 mg as single dose (do not repeat for ≥3 days); Concomitant use of strong P-gp inhibitors (cyclosporine, ranolazine) in patients with normal renal and hepatic function: 0.6 mg as single dose (do not repeat for ≥3 days).

Renal Impairment

• PO (Adults ): CCr <30 mL/min: 1.2 mg initially, then 0.6 mg 1 hr later; do not repeat treatment course for ≥2 wk; Dialysis: 0.6 mg as single dose; do not repeat treatment course for ≥2 wk.

Prevention of Gout Flares (Gloperba, Mitigare, and Generic Capsules Only)

• PO (Adults ): 0.6 mg once or twice daily; Concomitant use of strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, tipranavir/ritonavir) or strong P-gp inhibitors (cyclosporine, ranolazine) in patients with normal renal and hepatic function: if original dose was 0.6 mg twice daily, ↓ to 0.3 mg once daily; if original dose was 0.6 mg once daily, ↓ to 0.3 mg every other day; Concomitant use of moderate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil): if original dose was 0.6 mg twice daily, ↓ to 0.3 mg twice daily or 0.6 mg once daily; if original dose was 0.6 mg once daily, ↓ to 0.3 mg once daily.

Renal Impairment

• PO (Adults ): CCr <30 mL/min: 0.3 mg once daily; Dialysis: 0.3 mg twice weekly.

Familial Mediterranean Fever (Colcrys and Generic Tablets Only)

• PO (Adults and Children >12 yr): 1.2–2.4 mg/day (in 1–2 divided doses); may ↑ or ↓ dose in 0.3-mg/day increments based on safety and efficacy; Concomitant use of strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, tipranavir/ritonavir) or strong P-gp inhibitors (cyclosporine, ranolazine) in patients with normal renal and hepatic function: Do not exceed 0.6 mg/day (may be given as 0.3 mg twice daily); Concomitant use of moderate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil): Do not exceed 1.2 mg/day (may be given as 0.6 mg twice daily).
• PO (Children 6–12 yr): 0.9–1.8 mg/day (in 1–2 divided doses).
• PO (Children 4–6 yr): 0.3–1.8 mg/day (in 1–2 divided doses).

Renal Impairment

• PO (Adults ): CCr 30–50 mL/min: dose ↓ may be necessary; CCr <30 mL/min or dialysis: 0.3 mg/day.

Reduction in Risk of MI, Stroke, Coronary Revascularization, and Cardiovascular Death

• PO (Adults ): 0.5 mg once daily.