Generic Name and Formulations:
Colchicine 0.6mg; caps.
West-Ward Pharmaceutical Corp.
Indications for MITIGARE:
Prophylaxis of gout flares.
Limitations Of use:
Not studied for acute treatment of gout flares during prophylaxis. Not for treating pain from other causes.
0.6mg once or twice daily; max 1.2mg/day.
Renal or hepatic impairment with concomitant CYP3A4 and P-gp dual inhibitors (life-threatening toxicity possible). Concurrent renal and hepatic impairment.
Monitor for toxicity; if present, consider temporary interruption or discontinuation. Renal or hepatic impairment. Elderly. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Avoid concomitant CYP3A4 inhibitors (eg, clarithromycin, ketoconazole, grapefruit juice, erythromycin, verapamil) and/or P-gp inhibitors (eg, clarithromycin, ketoconazole, cyclosporine); if unavoidable, reduce daily dose and monitor for colchicine toxicity. Concomitant statins, fibrates may potentiate myopathy and rhabdomyolysis.
Diarrhea, nausea, vomiting, abdominal pain; blood dyscrasias (myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia), neuromuscular toxicity, rhabdomyolysis, overdosage (may be fatal).
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