Important Safety Information
- Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given colchicine capsules.
- Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine capsules out of the reach of children.
- Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia have been reported with colchicine used in therapeutic doses.
- Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
- Drug interaction with dual P-gp and CYP3A4 inhibitors: Co-administration of colchicine with dual P-gp and CYP3A4 inhibitors has resulted in life-threatening interactions and death.
- Neuromuscular toxicity and rhabdomyolysis may occur with chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (including those with normal renal and hepatic function) are at increased risk. Consider temporary interruption or discontinuation of colchicine capsules.
- The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting and abdominal pain.
- Please see full Prescribing Information. You can also refer to the Medication Guide.