Generic Name and Formulations:
Colchicine 0.6mg; tabs.
Takeda Pharmaceuticals USA, Inc.
Indications for COLCRYS:
Prophylaxis and treatment of acute gout flares. Familial Mediterranean fever (FMF).
Gout prophylaxis: >16yrs: 0.6mg once or twice daily; max 1.2mg/day. Gout treatment: 1.2mg at first sign of gout flare, then 0.6mg 1 hour later; max 1.8mg over a 1 hour period; may be given during prophylaxis at max 1.2mg at first sign of flare, then 0.6mg 1 hour later, wait 12 hours, then resume prophylactic dose. FMF: Usual range: 1.2mg–2.4mg daily; may give in 1–2 divided doses. May increase/decrease dose (depending on tolerability) in increments of 0.3mg/day to max daily dose. For all: concomitant CYP3A4 and/or P-glycoprotein inhibitors, severe renal or hepatic impairment: reduce dose (see literature).
FMF: <4yrs: not recommended. Give as a single or divided dose twice daily. 4–6yrs: 0.3mg–1.8mg daily; 6–12yrs: 0.9mg–1.8mg daily. May increase/decrease dose (depending on tolerability) in increments of 0.3mg/day to max daily dose. Concomitant CYP3A4 and/or P-glycoprotein inhibitors, severe renal or hepatic impairment: reduce dose (see literature).
Renal or hepatic impairment with concomitant strong CYP3A4 or P-glycoprotein inhibitors (life-threatening toxicity possible).
Monitor for toxicity; if present, consider temporary interruption or discontinuation. Renal or hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Potentiated by concomitant CYP3A4 inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, grapefruit juice) and/or P-glycoprotein inhibitors (eg, cyclosporine, ranolazine). Concomitant statins, gemfibrozil, fibrates, digoxin may potentiate myopathy and rhabdomyolysis.
GI upset, abdominal pain, pharyngolaryngeal pain; blood dyscrasias (myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia), neuromuscular toxicity, rhabdomyolysis, overdosage (may be fatal).
Tabs—30, 60, 100, 250, 500, 1000