COLGOUT

What it is

COLGOUT contains 500 micrograms of colchicine per tablet. The tablets are round, off-white coloured biconvex uncoated tablets.

Approved indications

— Relief of pain in acute gout. COLGOUT should not be used unless NSAIDs are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. Colchicine is not an analgesic and does not provide relief from other types of pain.

Dosing overview

For acute gout flares in adults, the dose is 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 of 1.5 mg over a one hour period. Do not repeat the course within 3 days. If gastrointestinal side effects occur, discontinue immediately. The elderly, even those with normal renal and hepatic function, may be more susceptible to cumulative toxicity with colchicine, and careful attention to dosage is recommended. 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. In patients with creatinine clearance of 50 mL per minute or less, dosage should be reduced by half, and colchicine should not be used at all if creatinine clearance is 10 mL per minute or less.

Key safety warnings

Colchicine has a narrow therapeutic index where the separation between therapeutic and toxic doses is not well defined, and 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. Treatment should be discontinued immediately when gastrointestinal symptoms (abdominal pain, diarrhoea, nausea or vomiting) occur. The most common side effects are gastrointestinal (nausea, vomiting, abdominal pain, diarrhoea), particularly in patients with peptic ulcer or spastic colon, occurring approximately 8 to 12 hours after oral administration in 80 per cent of patients, especially when maximal doses are used. Colchicine has been associated with several clinically significant haematological conditions including anaemia, leukopenia, neutropenia, thrombocytopenia and aplastic anaemia, typically related to overdosage but also related to long-term therapy.

Contraindications

Colchicine is contraindicated in patients with combined hepatic and renal disease; renal or hepatic impairment who are taking a P-glycoprotein inhibitor or strong CYP3A4 inhibitor; severe renal or hepatic impairment; serious cardiac or gastrointestinal disorders; blood dyscrasias; hypersensitivity to colchicine or any 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

No information regarding PBS listing, item count, restriction type, or ex-manufacturer price is available in the provided documents.

Regulatory history

COLGOUT colchicine 0.5 mg tablets were first listed on the ARTG on 21 October 1991. The current product information for PHARMACOR COLCHICINE was first approved on 22 March 2021.