COLCINE

What it is

COLCINE contains 500 microgram of colchicine per tablet. The tablets are round, off white coloured biconvex, uncoated tablets embossed "C5" on one upper side and plain on the bottom face.

Approved indications

— Relief of pain in acute gout.

Dosing overview

Adults should take 1 mg (2 tablets) at the first sign of the flare followed by 0.5 mg (1 tablet) one hour later, with a maximum recommended dose for treatment of gout flares of 1.5 mg over a one hour period. Do not repeat the course within 3 days. If gastrointestinal side effects occur, discontinue immediately. If the patient's creatinine clearance is 50 mL per minute or less, dosage should be reduced by half, and colchicine should not be used at all if the patient's creatinine clearance is 10 mL per minute or less. In elderly patients who are small and slight (less than 50 kg) and those with renal or hepatic impairment, a maximum cumulative dose of 1.5 mg over three days should be observed.

Key safety warnings

Colchicine has a narrow therapeutic index and the separation between therapeutic and toxic doses is not well defined. Colchicine can be fatal in overdose. There have been cases of fatality when colchicine was taken for a therapeutic purpose with doses as small as 6 or 7 mg. The elderly, even those with normal renal and hepatic function, may be more susceptible to cumulative toxicity with colchicine. As the elderly are more likely to have age-related renal function impairment, caution and careful attention to dosage is recommended. The leukopenic and thrombocytopenic effects of colchicine may result in an increased incidence of microbial infection, delayed healing and gingival bleeding. The most common side effects are gastrointestinal (including nausea, vomiting, abdominal pain and diarrhoea), particularly in the presence of peptic ulcer or spastic colon.

Contraindications

Colchicine is contraindicated in patients with combined hepatic and renal disease; renal or hepatic impairment who are taking a P-glycoprotein inhibitor or a strong CYP3A4 inhibitor; severe renal or hepatic impairment; serious cardiac or gastrointestinal disorders; blood dyscrasias; hypersensitivity to colchicine or any listed ingredients; children under 2 years of age; and patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

PBS listing

The 500 microgram tablet is listed on the PBS as 1 item with unrestricted access at an ex-manufacturer price of A$3.28.

Regulatory history

COLCINE colchicine 500 microgram tablets were first listed on the ARTG on 22 March 2021.