PREGNANCY ADN BREASTFEEDING SAFETY: There are no adequate studies of colchicine in pregnant women. Colchicine crosses the placenta, and animal studies suggest that colchicine is harmful to the developing fetus; however, their are no reports that contain miscarriage, still births, or harmful effects to the fetus when pregnant women used colchicine for treating FMF. Nevertheless, colchicine should only be used during pregnancy if the benefit justifies the risk to the fetus.
Colchicine is excreted into human milk and may cause adverse effects in the infant.
STORAGE: Colchicine should be stored between 20 and 25 C (68-77 F)
The recommended dose of colchicine for acute gout is:
- 1.2 mg at the first sign of symptoms followed by 0.6 mg one hour later.
- The maximum dose over a one hour period is 1.8 mg.
- In clinical trials 1.8 mg of colchicine administered over 1 hour was as effective as 4.8 mg administered over 6 hours, and patients experienced fewer side effects.
- The recommended dose for preventing flares of gout in individuals older than 16 years of age is 0.6 mg once or twice daily.
The recommended doses of colchicine for FMF are:
- Children 4-6 years old: 0.3 to 1.8 mg daily
- Children 6-12 years old: 0.6 to 1.8 mg daily
- Adults and adolescents older than 12 years: 1.2 to 2.4 mg daily
Total daily doses may be administered in two divided doses. Doses should be increased by 0.3 mg daily as tolerated until symptoms are controlled or maximum daily doses are reached. Doses should be decreased by 0.3 mg daily if side effects occur.
DRUG CLASS AND MECHANSIM: Colchicine is an oral drug used for treating acute gout and familial Mediterranean fever (FMF). In acute gout there is severe inflammation in response to the presence of uric acid crystals that form in bony joints. This causes severe pain, redness, and swelling of the affected joint(s). Colchicine is useful in suppressing inflammation caused by gout. The exact mechanism of action of colchicine is not known. It may involve reduction in crystallization of uric acid leading to a reduction in the inflammatory response. Colchicine is not an analgesic (pain killer), but it reduces pain caused by gout. The FDA approved colchicine in September 1977 without clinical studies. In July 2009 the FDA approved colchicine for gout flares and FMF.
Medically reviewed by Eni Williams, PharmD, PhD
Reference: Colcrys FDA Prescribing Information
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