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warnings and cautions
WARNINGS AND PRECAUTIONS General In rare instances severe allergic reactions and anaphylaxis have been reported with the use of colchicine. Most of these rare allergic reactions have been reported to occur within several hours after readministration following prior usage of the drug. The appearance of hypersensitivity reactions requires cessation of therapy with colchicine. Both accidental and intentional overdoses with colchicine in children and adults have been reported [See OVERDOSE (10)]. Keep Colchicine Tablets out of the reach of children. Renal Impairment Colchicine is significantly excreted in urine in healthy subjects. Clearance of Colchicine is decreased in patients with impaired renal function. Consideration should be given to the reduction of the dosage in patients with renal impairment. Patients with any degree of renal dysfunction, who are treated with Colchicine, should be monitored closely for adverse effects of Colchicine. Hepatic Impairment The clearance of Colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment, compared to healthy subjects. Consideration should be given to the reduction of the dosage in patients with hepatic impairment. All patients with hepatic impairment should be monitored closely for adverse effects of Colchicine.
ADVERSE REACTIONS The most frequent adverse effects of oral colchicine in therapeutic doses are those involving the gastrointestinal tract with diarrhea, nausea, vomiting, and abdominal pain often being the first signs of toxicity and the first indication that the colchicine dose may need to be reduced or therapy stopped. Larger doses may cause profuse diarrhea, gastrointestinal hemorrhage, skin rashes, renal and hepatic damage. Bone marrow suppression with agranulocytosis, thrombocytopenia, and aplastic anemia have rarely occurred with prolonged treatment, as have peripheral neuropathy, myopathy, rashes, and alopecia. Side effects due to Colchicine appear to be a function of dosage. The possibility of increased colchicine toxicity in the presence of renal or hepatic dysfunction should be considered.