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Anti-Gout Agent Pregnancy: Contraindicated in pregnancy, in breast-feeding, and in women of childbearing potential unless using effective contraceptive measures (section 4.3). Animal studies denote reproductive toxicity. When used for acute gout or gout prophylaxis, there are limited data in pregnancy - use should be avoided as a precautionary measure and considered only if NSAIDs and glucocorticoids are not applicable; female patients must use effective contraception during and for at least three months after stopping colchicine, and male patients should not father a child during and for at least six months after stopping. Colchicine/metabolites are found in breastfed infants of treated women and colchicine should not be used in breast-feeding women with gout.

Colchicine

Brand names: Colcrys, Colchicine (generic)

Colchicine is an anti-inflammatory alkaloid used for acute gout flares and their prophylaxis, and for other conditions such as pericarditis and familial Mediterranean fever; this page concerns its use in older patients.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Treatment of an acute gout attack: 1 mg (2 x 500 microgram tablets) to start, followed by 500 micrograms (1 tablet) after 1 hour. No further tablets should be taken for 12 hours. After 12 hours, treatment can resume if necessary with a maximum dose of 500 micrograms (1 tablet) every 8 hours until symptoms are relieved.
Route: Oral - tablets swallowed whole with a glass of water (an oral dispersion may be prepared per section 6.6 where oral tablet administration is not possible, including via nasogastric or PEG tube)
Frequency: 1 mg, then 500 micrograms 1 hour later, then no further doses for 12 hours, then up to 500 micrograms every 8 hours until symptoms are relieved
Max: 6 mg (12 x 500 microgram tablets) in total as a course of treatment; the course should end when symptoms are relieved or when a total of 6 mg has been taken, and another course should not be started for at least three days (72 hours)
NO ELDERLY-SPECIFIC DOSE is stated in section 4.2 of this SPC; section 4.4 states only that caution is advised in elderly and debilitated patients (and in liver or renal impairment, cardiovascular disease, gastrointestinal disorders, and abnormalities in blood counts). Because renal impairment is common in older people, apply the renal dose reduction below. STOP IMMEDIATELY if diarrhoea or vomiting occurs - these may be the first signs of intoxication; colchicine has a narrow therapeutic window and administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain or diarrhoea occur. PROPHYLAXIS OF GOUT ATTACK during initiation of allopurinol or uricosuric therapy: 0.5-1 mg per day, taken in the evening; treatment duration should be decided after assessing flare frequency, gout duration, and the presence and size of tophi. FAMILIAL MEDITERRANEAN FEVER (adults): 1 to 3 mg (2 to 6 tablets) per day, as a single dose, or divided twice daily if above 1 mg per day; increase stepwise to a maximum of 3 mg per day in patients who do not respond, monitoring closely; in impaired renal or liver function the starting dose should be reduced by 50% (e.g. 1 mg per day or less). CYP3A4 / P-GLYCOPROTEIN INHIBITORS: if a patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or a P-glycoprotein inhibitor, the maximum recommended oral colchicine dose should be reduced and the patient carefully monitored for adverse effects. HEPATIC IMPAIRMENT: use with caution in mild/moderate hepatic impairment - the dose is 0.5 mg per day, with careful monitoring; severe hepatic impairment is contraindicated. MONITORING: periodic checks of the blood picture are essential; check blood counts immediately if petechiae occur, and stop colchicine and investigate fully if fever, stomatitis, sore throat, prolonged bleeding, bruising or skin disorders develop. Long-term use may be associated with vitamin B12 deficiency. PAEDIATRIC: this product should not be used in children and adolescents for gout; for familial Mediterranean fever the SPC gives age-based (not per-kg) starting doses to be prescribed only under specialist supervision - verify against a children's formulary.

Dose adjustments

Renal

Mild and moderate renal impairment: the dose is 0.5 mg per day, with careful monitoring for adverse effects of colchicine (for familial Mediterranean fever, reduce the starting dose by 50%, e.g. 1 mg per day or less). Severe renal impairment: contraindicated. Colchicine must not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion. Contraindicated in renal impairment together with a P-glycoprotein inhibitor or a strong CYP3A4 inhibitor.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to colchicine or to any of the excipients
  • Patients with blood dyscrasias
  • Pregnancy
  • Breast-feeding
  • Women of childbearing potential unless using effective contraceptive measures
  • Severe renal impairment
  • Severe hepatic impairment
  • Patients undergoing haemodialysis, since colchicine cannot be removed by dialysis or exchange transfusion
  • Patients with renal or hepatic impairment who are taking a P-glycoprotein inhibitor or a strong CYP3A4 inhibitor

Side effects

  • Abdominal pain, nausea, vomiting and diarrhoea (common) - diarrhoea or vomiting requires immediate discontinuation as an early sign of intoxication
  • Bone marrow depression with agranulocytosis, aplastic anaemia and thrombocytopenia (frequency not known) - aplastic anaemia in particular has a high mortality rate
  • Myopathy and rhabdomyolysis (frequency not known)
  • Peripheral neuritis and neuropathy (frequency not known)
  • Hepatotoxicity and renal damage (frequency not known)
  • Vitamin B12 deficiency, alopecia, rash, gastrointestinal haemorrhage, pharyngolaryngeal pain

Interactions

  • Strong CYP3A4 inhibitors and/or P-glycoprotein inhibitors - increase colchicine exposure and may cause colchicine-induced toxicity including fatalities; reduce the colchicine dose if required in patients with normal renal and hepatic function, and avoid the combination wherever possible in renal or hepatic impairment (contraindicated in that group)
  • Macrolides (e.g. clarithromycin) - may cause clinically significant interactions leading to colchicine toxicity
  • Ciclosporin - may cause clinically significant interactions leading to colchicine toxicity
  • HIV protease inhibitors - may cause clinically significant interactions leading to colchicine toxicity
  • Calcium channel blockers - may cause clinically significant interactions leading to colchicine toxicity
  • Statins (HMG-CoA reductase inhibitors) - may cause clinically significant interactions leading to colchicine toxicity; the US label notes myopathy and rhabdomyolysis (including a fatality) when one drug is added to a stable regimen of the other
  • NOTE: the SPC section 4.5 interactions section itself was not captured in this bundle; the entries above are drawn from sections 4.3 and 4.4

Clinical monograph

How it works

It binds tubulin and inhibits microtubule polymerisation, impairing neutrophil chemotaxis, activation and the inflammatory response to urate crystals.

Prescribing in practice

  • Colchicine has a narrow therapeutic margin, and toxicity (severe diarrhoea, vomiting, myelosuppression and neuromyopathy) is more likely in older patients and in renal or hepatic impairment, so dose conservatively and reduce in impairment.
  • It interacts dangerously with strong CYP3A4 and P-glycoprotein inhibitors (such as clarithromycin, certain antifungals and ciclosporin), which can precipitate life-threatening toxicity; avoid or markedly adjust.
  • Combining with statins or fibrates increases the risk of myopathy, and gastrointestinal side effects often limit the tolerated dose.

Monitoring

Monitor renal and hepatic function and, with prolonged use, the full blood count, and review promptly if diarrhoea, vomiting or muscle symptoms develop.

Counselling the patient

  • Stop the medicine and seek advice if you develop significant diarrhoea, vomiting, unusual bruising or muscle weakness.
  • Avoid grapefruit juice and tell clinicians before starting any new medicine, especially certain antibiotics or antifungals.
  • Do not take more than prescribed, as excess is dangerous.

Evidence & guidelines

Use in acute and prophylactic gout and the importance of dose limitation in renal impairment and interacting drugs are reflected in NICE and British Society for Rheumatology gout guidance.

Reference: NICE CG177 (Gout); AGREE Trial; BSR Gout Guidelines 2017; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.