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Pericarditis / Coronary Inflammation Pregnancy: The SPC gives no pericarditis-specific pregnancy statement; section 4.4 lists 'Pregnant or lactating women' among the groups in which caution is advised, and section 4.6 states that animal studies denote reproductive toxicity. Its detailed guidance is written for the other two indications: in FMF, use may be considered if clinically needed after weighing the risks; in gout and gout prophylaxis, use 'in this patient population and in women of childbearing potential not using effective contraception, should be avoided', with effective contraception during and for at least three months after therapy, and male patients advised not to father a child during and for at least 6 months after therapy. Fertility: rare cases of reversible oligospermia and azoospermia are known from the literature. 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.' Because no pericarditis-specific wording exists, obtain specialist advice before using colchicine for pericarditis in pregnancy or breastfeeding.

Colchicine (Pericarditis / Post-MI Inflammation)

Brand names: Colchicine Zurich

Used in: Gout

Colchicine is an anti-inflammatory used for acute gout, for flare prophylaxis when starting urate-lowering therapy, and in pericarditis.

Adult dose

Dose: SCOPE - ACUTE AND RECURRENT PERICARDITIS ONLY. Adults: 500 micrograms (2 ml) per day for patients weighing 70 kg or less, or in patients with intolerance to higher doses; 500 micrograms (2 ml) twice daily for patients with a body weight over 70 kg. Treatment duration is 3 months in acute pericarditis and 6 months in recurrent pericarditis. This is the pericarditis regimen only: the SPC carries NO regimen for post-myocardial-infarction or post-pericardiotomy inflammation, and none for secondary cardiovascular prevention, so no dose is given for those uses and the pericarditis figures above must not be transferred to them.
Route: Oral only - SPC section 4.2: 'Colchicine is for oral use only.' The product quoted is a 250 micrograms/ml oral solution, supplied with a 5 ml graduated oral syringe (0.1 ml graduations) and a press-in bottle adapter; the SPC writes every pericarditis dose as '500 micrograms (2 ml)'.
Frequency: Once daily in adults weighing 70 kg or less and in those intolerant of higher doses; twice daily in adults over 70 kg.
Max: 500 micrograms (2 ml) twice daily - the highest pericarditis dose stated anywhere in SPC section 4.2 (adults over 70 kg). Lower ceilings apply in organ impairment: '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', and the same 500 micrograms per day applies in mild and moderate hepatic impairment. Colchicine is contraindicated in severe renal and in severe hepatic impairment.
The previously fetched product (Colchicine 500 microgram Tablets) carried posology only for gout and Familial Mediterranean Fever, so this page had no source. The product now in the bundle, Colchicine 250 micrograms/ml oral solution, carries a licensed UK posology for 'Acute and Recurrent Pericarditis' under its own heading in section 4.2, which is this page's lead indication - so the dose above is the page's primary indication, taken from the product's own section 4.2, not inferred from any other indication. PARTIAL COVERAGE, STATED IN THE DOSE FIELD: the page title also names post-MI inflammation; that use is not in this SPC and remains unsourced. NOT REPRODUCED HERE: the same section 4.2 also gives gout and Familial Mediterranean Fever regimens with quite different daily doses, durations and titration - they are different indications and must never be shown or used as a pericarditis dose. NARROW THERAPEUTIC WINDOW, section 4.4 verbatim: 'Colchicine is potentially toxic, so it is important not to exceed the dose prescribed by a medical specialist with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur.' CYP3A4 / P-gp: '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 250 micrograms/ml strength is fixed by the product name, so the millilitre volumes above are only valid for this presentation.

Paediatric dose

Dose: Not for paediatric use in this indication. SPC section 4.2, directly under 'Acute and Recurrent Pericarditis': 'Paediatric population Colchicine should not be used in children and adolescents.'
Route: Not applicable - there is no paediatric pericarditis regimen in this SPC.
The same SPC does give paediatric starting doses, but ONLY for Familial Mediterranean Fever and only 'under the supervision of a medical specialist with the necessary knowledge and experience'. FMF is a different indication from this cardiology page, so those figures are deliberately not reproduced here and must never be used as a pericarditis dose. Section 4.8 also records: 'No long-term safety data are available in paediatric patients.' Verify any paediatric use against a children's formulary and specialist advice.

Dose adjustments

Renal

SPC section 4.2, verbatim: '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 and the starting dose should be reduced by 50% (e.g. <= 1,000 micrograms/day) in Familial Mediterranean Fever. 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 (see section 4.4). For severe renal impairment, see section 4.3 contraindications.'

Hepatic

SPC section 4.2, verbatim: '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 and the starting dose should be reduced by 50% (e.g. <= 1,000 micrograms/day) in Familial Mediterranean Fever. 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 (see section 4.4). For severe hepatic impairment, see section 4.3 contraindications.'

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.

US labelling (FDA)

Reference — US labelling, may differ from UK

The long-term use of colchicine is established for FMF and the prophylaxis of gout flares, but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for colchicine tablets are different for each indication and must be individualized. The recommended dosage of colchicine tablets depends on the patient’s age, renal function, hepatic function and use of coadministered drugs [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ] . Colchicine tablets are administered orally without regard to meals. Colchicine tablets are not an analgesic medication and should not be used to …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-07-01. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (section 4.3)
  • Patients with blood dyscrasias (section 4.3)
  • Patients with severe renal impairment (section 4.3)
  • Patients with severe hepatic impairment (section 4.3)
  • Section 4.4 'should not be used', and directly relevant to this page: 'Colchicine in patients with pre-existing blood dyscrasias, gastrointestinal disease, elevated aminotransferase, creatinine or troponin levels, severe liver disease, myopathy, bacterial or neoplastic pericarditis should not be used due to the risk of developing neuromuscular toxicity is increased.'
  • Section 4.2: 'Patients with any degree of renal impairment should not be given colchicine in conjunction with strong P-glycoprotein inhibitors or strong CYP3A4 inhibitors', and the same restriction applies to any degree of hepatic impairment

Side effects

  • Blood and lymphatic system: bone marrow depression with agranulocytosis, aplastic anaemia, pancytopenia, neutropenia, thrombocytopenia, leukopenia
  • Nervous system: peripheral neuritis, neuropathy
  • Gastrointestinal: abdominal pain, nausea, vomiting and diarrhoea
  • Hepatobiliary: hepatotoxicity, transaminases increased
  • Renal and urinary: renal impairment
  • Skin and subcutaneous tissue: urticaria, maculopapular rash, erythema, oedema, alopecia, rash
  • Musculoskeletal and connective tissue: myopathy, rhabdomyolysis, muscle weakness
  • Reproductive system: amenorrhoea, dysmenorrhoea, oligospermia, azoospermia
  • Respiratory: pharyngolaryngeal pain
  • Metabolism and nutrition: vitamin B12 deficiency
  • Section 4.8 presents these in a frequency table; the fetched text flattens the table columns, so no frequency band has been assigned to any individual reaction here.

Interactions

  • 'Macrolides, CYP3A4 inhibitors, ciclosporin, HIV protease inhibitors, calcium channel blockers, and statins may cause clinically significant interactions with colchicine which may lead to colchicine-induced toxicity.' (section 4.4)
  • 'Co-administration with P-gp inhibitors and/or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine-induced toxicity including fatalities.' If such a medicine is required in a patient with normal renal and hepatic function, reduce the colchicine dose and monitor carefully (sections 4.2 and 4.4)
  • 'For patients with an impaired renal or hepatic function, the combined use of colchicine and P-gp inhibitors and/or strong CYP3A4 inhibitors should be avoided whenever possible.' (section 4.4)
  • INCOMPLETE LIST: section 4.5 was not retrieved as its own section in this bundle and section 4.4 is cut off at the source-fetch limit, so the items above are not the whole interaction set. Check the current SmPC.

Monitoring

  • Full blood count - section 4.4: 'Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia). The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood count are essential. If skin abnormalities (petechiae) occur, blood counts should be checked immediately.'
  • Stop at the first sign of toxicity - 'The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur.' (section 4.4)
  • Signs of blood dyscrasia - '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.' (section 4.4)
  • Renal and hepatic function - the pericarditis dose is capped at 500 micrograms per day in mild-to-moderate impairment and colchicine is contraindicated in severe impairment (sections 4.2 and 4.3)
  • Concomitant P-gp / CYP3A4 inhibitors - reduce the dose and monitor closely for colchicine toxicity; avoid the combination altogether in renal or hepatic impairment (sections 4.2 and 4.4)
  • Vitamin B12 - 'Long-term use of colchicine may be associated with vitamin B12 deficiency.' (section 4.4)
  • Caution and closer review in liver or renal impairment, cardiovascular disease, gastrointestinal disorders, elderly and debilitated patients, patients with abnormalities in blood counts, and pregnant or lactating women (section 4.4)

Clinical monograph

How it works

It disrupts microtubule assembly, impairing neutrophil migration and the inflammatory response.

Prescribing in practice

  • It has a narrow margin — diarrhoea and gastrointestinal upset signal that the dose is too high; stop and reassess.
  • Reduce or avoid in significant renal or hepatic impairment.
  • Serious toxicity occurs with strong CYP3A4/P-glycoprotein inhibitors (e.g. clarithromycin, some antifungals); it is dangerous in overdose.

Monitoring

Review gastrointestinal symptoms, renal and hepatic function, and interacting drugs.

Counselling the patient

  • Stop and seek advice if you develop significant diarrhoea or vomiting.
  • Do not exceed the prescribed dose, and keep it away from children.

Evidence & guidelines

Used for acute gout and flare prophylaxis (NICE NG219) and as an adjunct in pericarditis.

Reference: COPE Trial (Imazio et al. Lancet 2005); COLCOT Trial (Tardif et al. NEJM 2019); LoDoCo2 Trial (Nidorf et al. NEJM 2020); ESC Pericardial Disease Guidelines 2015; SPC Colchicine; 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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