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Anti-Inflammatory — NLRP3 Inflammasome Inhibitor (Cardiovascular Indication) Pregnancy: §4.6 gives indication-specific advice and does not address pericarditis separately. Pregnancy: 'Animal studies denote reproductive toxicity.' For FMF, a moderate amount of data indicate no malformative or feto/neonatal toxicity. For acute gout or gout prophylaxis, data in pregnant women are limited and 'As a precautionary measure, use of colchicine in this patient population and in women of childbearing potential not using effective contraception, should be avoided and may only be considered if other treatment options, including NSAIDs and glucocorticoids, are not applicable'; female patients 'have to use effective contraception during and for at least three months following termination of colchicine therapy'. Breast-feeding: 'Colchicine/metabolites is/are found in breastfed newborns/infants of treated women. There is insufficient information on the effects of colchicine in newborns/infants. Colchicine should not be used in breast-feeding women with gout.' Fertility: colchicine may negatively influence spermatogenesis; rare reversible oligospermia and azoospermia are reported; for gout indications 'Male patients should not father a child during and for at least 6 months following termination of colchicine therapy.' §4.4 also lists pregnant or lactating women among those needing caution.

Colchicine (Cardiovascular Anti-Inflammatory)

Brand names: Colchicine 500 mcg, Zynreva (low-dose MR — US only)

Colchicine is an anti-inflammatory alkaloid which, beyond gout and pericarditis, has been studied at low dose for secondary prevention in chronic coronary and post-myocardial-infarction disease, though UK cardiovascular use remains off-label.

Adult dose

Dose: Acute or recurrent pericarditis (adults): 500 micrograms once daily for patients weighing ≤70 kg or with intolerance to higher doses; 500 micrograms twice daily for patients weighing >70 kg.
Route: Oral — 'Colchicine is for oral use only.' In the 250 micrograms/mL oral solution used as the source, 500 micrograms = 2 mL. Indication scope: acute and recurrent pericarditis, the only cardiovascular indication in this SPC.
Frequency: Once daily (≤70 kg or intolerant of higher doses) or twice daily (>70 kg). 'Treatment duration is 6 months in recurrent pericarditis and 3 months in acute pericarditis.'
Max: Maximum 500 micrograms twice daily (1,000 micrograms/day) in pericarditis — the highest pericarditis dose given anywhere in the SPC dosage table (adults >70 kg); no higher pericarditis dose appears. Caution: the SPC's two explicitly labelled 'Maximum dose' figures — 6,000 micrograms (24 mL) per course and 3,000 micrograms/day (12 mL/day) — belong to acute gout and to familial Mediterranean fever respectively and must NOT be applied to pericarditis.
Verbatim SPC §4.2 (Acute and Recurrent Pericarditis, Adults): 'The recommended dose is 500 micrograms/day (2 ml/day) for patients weighing ≤ 70 kg or in patients with intolerance to higher doses. The recommended dose is 500 micrograms (2 ml) twice daily for patients with a body weight of >70 kg.' SCOPE — post-MI / chronic coronary disease secondary prevention (the low-dose cardiovascular anti-inflammatory use) is NOT a licensed indication in this SPC and NO dose for it appears anywhere in the bundle; the SPC's indications are gout (acute attack and prophylaxis), acute and recurrent pericarditis, and familial Mediterranean fever. Do not read the pericarditis dose above as a post-MI secondary-prevention dose. FORMULATION NOTE: microgram amounts are the drug quantity and are formulation-independent; the mL volumes quoted are specific to the 250 micrograms/mL oral solution that this SPC covers (tablet products will differ in volume, not in microgram dose). INTERACTING DRUGS: 'If a patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or with a P-glycoprotein inhibitor, the maximum recommended dosage of oral colchicine should be reduced and should be carefully monitored for adverse effects of colchicine' — the SPC gives no numeric reduced dose for this scenario. NARROW THERAPEUTIC WINDOW (§4.4): 'Colchicine is potentially toxic, so it is important not to exceed the dose prescribed... Colchicine has a narrow therapeutic window.' PAEDIATRICS: for pericarditis (as for gout) the SPC states 'Colchicine should not be used in children and adolescents' and the dosage table records 'Not suitable for paediatric use' — hence paedDose is null. The SPC does carry age-banded paediatric starting doses, but only for familial Mediterranean fever under specialist supervision (500 micrograms/day under 5 years; 1,000 micrograms/day 5‑10 years; 1,500 micrograms/day over 10 years; maximum 2,000 micrograms/day); those are a different indication, are age-banded rather than per-kg, and must not be used for any cardiovascular indication.

Dose adjustments

Renal

§4.2: 'In patients with mild and moderate renal impairment, the dose is 500 micrograms (2 mL oral solution) per day in gout, acute and recurrent pericarditis... The dose should be carefully monitored for adverse effects of colchicine.' 'Patients with any degree of renal impairment should not be given colchicine in conjunction with strong P-glycoprotein inhibitors or strong CYP3A4 inhibitors.' Severe renal impairment is a contraindication (§4.3).

Hepatic

§4.2: 'In patients with mild and moderate hepatic impairment, the dose is 500 micrograms (2 mL oral solution) per day in gout, acute and recurrent pericarditis... The dose should be carefully monitored for adverse effects of colchicine.' 'Patients with any degree of hepatic impairment should not be given colchicine in conjunction with strong P-glycoprotein inhibitors or strong CYP3A4 inhibitors.' Severe hepatic impairment is a contraindication (§4.3).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (§4.3)
  • Patients with blood dyscrasias (§4.3)
  • Patients with severe renal impairment (§4.3)
  • Patients with severe hepatic impairment (§4.3)
  • §4.4 'should not be used' — pre-existing blood dyscrasias, gastrointestinal disease, elevated aminotransferase, creatinine or troponin levels, severe liver disease, myopathy, or bacterial or neoplastic pericarditis, 'due to the risk of developing neuromuscular toxicity is increased' (note the direct relevance of bacterial or neoplastic pericarditis to the pericarditis indication)
  • Colchicine should not be used in children and adolescents (§4.2, gout and pericarditis)

Side effects

  • Abdominal pain, nausea, vomiting and diarrhoea (gastrointestinal disorders) — 'The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur' (§4.4)
  • Bone marrow depression with agranulocytosis, aplastic anaemia, pancytopenia, neutropenia, thrombocytopenia, leukopenia — 'The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate'
  • Peripheral neuritis, neuropathy
  • Myopathy, rhabdomyolysis, muscle weakness
  • Hepatotoxicity, transaminases increased
  • Renal impairment
  • Urticaria, maculopapular rash, erythema, oedema; alopecia, rash
  • Amenorrhoea, dysmenorrhoea, oligospermia, azoospermia
  • Pharyngolaryngeal pain
  • Vitamin B12 deficiency (associated with long-term use)

Monitoring

  • Full blood count: 'Periodic checks of the blood count are essential.' 'If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, or prolonged bleeding, treatment with colchicine should be immediately discontinued and a full haematological investigation should be conducted.' 'If skin abnormalities (petechiae) occur, blood counts should be checked immediately.' Discontinue immediately if nausea, vomiting, abdominal pain or diarrhoea occur — these may be the first signs of intoxication.
  • Long-term use may be associated with vitamin B12 deficiency.
  • Monitor carefully for colchicine toxicity whenever a P-gp inhibitor and/or strong CYP3A4 inhibitor is co-prescribed (macrolides, ciclosporin, HIV protease inhibitors, calcium channel blockers, statins) — 'may lead to colchicine-induced toxicity including fatalities'
  • in renal or hepatic impairment such combinations 'should be avoided whenever possible'.
  • Caution overall in liver or renal impairment, cardiovascular disease, gastrointestinal disorders, elderly and debilitated patients, and patients with abnormalities in blood counts.

Clinical monograph

How it works

It binds tubulin and disrupts microtubule assembly, impairing neutrophil chemotaxis and inflammasome activation, thereby dampening the vascular inflammation that contributes to atherosclerotic events.

Prescribing in practice

  • Colchicine has a narrow therapeutic margin and is dangerous in overdose, so the dose must be reduced or avoided in significant renal or hepatic impairment to prevent toxicity.
  • It is a substrate of CYP3A4 and P-glycoprotein, so combining it with strong inhibitors such as clarithromycin, ciclosporin or verapamil can precipitate serious toxicity.
  • Diarrhoea is an early warning sign of toxicity and should prompt dose review.

Monitoring

Monitor renal and hepatic function and the full blood count during longer-term use, and review for gastrointestinal symptoms, neuromyopathy and interacting drugs.

Counselling the patient

  • Stop and seek advice if you develop diarrhoea, vomiting or muscle weakness.
  • Avoid grapefruit juice and tell clinicians before starting new medicines.
  • Never exceed the prescribed dose, as overdose can be fatal.

Evidence & guidelines

The COLCOT and LoDoCo2 trials showed low-dose colchicine reduced cardiovascular events in coronary disease, but it is not currently licensed for this purpose in the UK.

Reference: COLCOT Trial (Tardif et al. NEJM 2019); LoDoCo2 Trial (Nidorf et al. NEJM 2020); MHRA SPC Colchicine; ESC ACS Guidelines 2023; 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.

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