Colchicine

DRUG INFORMATION

  ADULT
    - Gout Flares: Prophylaxis of Gout Flares: 0.6 mg once or twice daily in adults and
      adolescents older than 16 years of age ( 2.1 ).
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29
    - Treatment of Gout Flares: 1.2 mg (two tablets) at the first sign of a gout flare
      followed by 0.6 mg (one tablet) one hour later ( 2.1 ).
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29
    - Increase or decrease the dose as indicated and as tolerated in increments of 0.3
      mg/day, not to exceed the maximum recommended daily dose ( 2.2 ).
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and efficacy of colchicine in children of all ages with FMF has been
      evaluated in uncontrolled studies. There does not appear to be an adverse effect
      on growth in children with FMF treated long-term with colchicine. Safety and
      effectiveness of colchicine in pediatric patients with gout has not been
      established.
      Source: US FDA label for colchicine (Colchicine), section 'pediatric use',
      retrieved 2026-08-29
    - 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.
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29
    - Gout Flares: Prophylaxis of Gout Flares: 0.6 mg once or twice daily in adults and
      adolescents older than 16 years of age ( 2.1 ).
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a
      day 0.3 mg once a day 0.6 mg once a day 0.3 mg once every other day Treatment of
      gout flares with colchicine tablets are not recommended in patients receiving
      prophylactic dose of colchicine tablets and CYP3A4 inhibitors.
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29
    - For the prophylaxis of gout flares in patients undergoing dialysis, the starting
      doses should be 0.3 mg given twice a week with close monitoring [see Clinical
      Pharmacology ( 12.3 ), Use in Specific Populations ( 8.6 )] .
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29
    - For patients undergoing dialysis, the total recommended dose for the treatment of
      gout flares should be reduced to a single dose of 0.6 mg (one tablet).
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Maximum daily dose of 1.2 mg to 2.4 mg Maximum daily dose of 0.6 mg (may be given
      as 0.3 mg twice a day) Table 2 Colchicine Tablets Dose Adjustment for
      Coadministration with Protease Inhibitors Protease Inhibitor Clinical Comment
      w/Colchicine -Prophylaxis of Gout Flares w/Colchicine -Treatment of Gout Flares
      w/Colchicine -Treatment of FMF Atazanavir sulfate (Reyataz) Patients with renal or
      hepatic impairment should not be given colchicine with Reyataz.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for colchicine (Colchicine),
      section 'dosage and administration', retrieved 2026-08-29
    - Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a
      day 0.3 mg once a day 0.6 mg once a day 0.3 mg once every other day Darunavir
      (Prezista) Patients with renal or hepatic impairment should not be given
      colchicine with Prezista/ ritonavir.
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29
    - Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a
      day 0.3 mg once a day 0.6 mg once a day 0.3 mg once every other day Fosamprenavir
      (Lexiva) with Ritonavir Patients with renal or hepatic impairment should not be
      given colchicine with Lexiva/ritonavir.
      Source: US FDA label for colchicine (Colchicine), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available data from published literature on colchicine use in
      pregnancy over several decades have not identified any drug associated risks for
      major birth defects, miscarriage, or adverse maternal or fetal outcomes (see
      Data).
      Source: US FDA label for colchicine (Colchicine), section 'pregnancy', retrieved
      2026-08-29
    - Although animal reproductive and developmental studies were not conducted with
      colchicine, published animal reproduction and development studies indicate that
      colchicine causes embryofetal toxicity, teratogenicity and altered postnatal
      development at exposures within or above the clinical therapeutic range.
      Source: US FDA label for colchicine (Colchicine), section 'pregnancy', retrieved
      2026-08-29
    - The estimated background risk of major birth defects and miscarriage for the
      indicated population is unknown.
      Source: US FDA label for colchicine (Colchicine), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Infertility Case reports and epidemiology studies in human male subjects on
      colchicine therapy indicated that infertility from colchicine is rare and may be
      reversible.
      Source: US FDA label for colchicine (Colchicine), section 'nursing mothers',
      retrieved 2026-08-29
    - A case report indicated that azoospermia was reversed when therapy was stopped.
      Source: US FDA label for colchicine (Colchicine), section 'nursing mothers',
      retrieved 2026-08-29
    - Case reports and epidemiology studies in female subjects on colchicine therapy
      have not established a clear relationship between colchicine use and female
      infertility.
      Source: US FDA label for colchicine (Colchicine), section 'nursing mothers',
      retrieved 2026-08-29