Colchicine 500 mcgm

Colchicine 500 mcgm

Dosing & Uses
Adult

Dosage Forms & Strengths

tablet

  • 0.6 mg

capsule

  • 0.6 mg

Gout

Treatment of acute gout flares (Colcrys): 1.2 mg PO at first sign of flare, then 0.6 mg 1 hr later; not to exceed 1.8 mg in 1-hr period

Prophylaxis (Colcrys, Mitigare): 0.6 mg PO once daily or q12hr; not to exceed 1.2 mg/day; after gout flare, wait 12 hr to continue prophylaxis

Familial Mediterranean Fever

Colcrys: 1.2-2.4 mg/day PO in single daily dose or divided q12hr; increased in 0.3 mg/day increments as necessary to control disease; decreased in 0.3 mg/day increments if intolerable side effects develop; not to exceed 2.4 mg/day

Dosage Modifications

Renal impairment (gout)

  • Mild (CrCl 50-80 mL/min) and moderate (CrCl 30-50 mL/min): Dosage adjustment not necessary; monitor patients for adverse effects
  • Severe (CrCl <30 mL/min): Dosage adjustment not necessary; do not repeat more frequently than every 2 weeks
  • Hemodialysis: 0.6 mg once; do not repeat more frequently than every 2 weeks

Renal impairment (familial Mediterranean fever)

  • Mild (CrCl 50-80 mL/min) and moderate (CrCl 30-50 mL/min): Monitor patients for adverse effects; dosage adjustment may be required
  • Severe (CrCl <30 mL/min): 0.3 mg/day initially; dosage increases should be done with adequate monitoring for adverse effects
  • Hemodialysis: 0.3 mg PO once; dosage increases should be done with adequate monitoring for adverse effects

Hepatic impairment (gout)

  • Mild to moderate: Dosage adjustment not necessary; monitor patients for adverse effects
  • Severe: Dosage adjustment not necessary; do not repeat more frequently than every 2 weeks; consider alternative therapy if repeated courses are required

Hepatic impairment (familial Mediterranean fever)

  • Mild to moderate: Monitor patients for adverse effects
  • Severe: Consider dosage reduction; do not repeat more frequently than every 2 weeks

Strong CYP3A4 inhibitors

  • Treatment of acute gout flares: 0.6 mg, then 0.3 mg 1 hour later; to be repeated no earlier than 3 days later
  • Prophylaxis of acute gout flares: If the original colchicine regimen was 0.6 mg BID, decrease dose to 0.3 mg qDay; if the original colchicine regimen was 0.6 mg qDay, decrease dose to 0.3 mg once every other day
  • Familial Mediterranean fever (FMF): Not to exceed 0.6 mg/day; 0.6 mg can be given as 0.3 mg q12hr

Moderate CYP3A4 inhibitors

  • Gout: 1.2 mg PO once; to be repeated no earlier than 3 days later
  • FMF: Not to exceed 1.2 mg/day; 0.6 mg can be given as 0.6 mg q12hr

P-gp inhibitors

  • Gout: 0.6 mg PO once; to be repeated no earlier than 3 days later
  • FMF: Not to exceed 0.6 mg/day; 0.6 mg can be given as 0.3 mg q12hr

Administration

Dosing regimens must be individualized to indication

Administered PO, without regard to meals

Post-STEMI Pericarditis (Off-label)

Treatment of pericarditis after ST-elevation myocardial infarction (STEMI)

0.6 mg PO q12hr

Behcet Syndrome (Orphan)

Orphan sponsor

  • AR Scientific, Inc, 1100 Orthodox Street, Philadelphia, PA 19124

Pediatric

Dosage Forms & Strengths
tablet

  • 0.6 mg
capsule

  • 0.6 mg
Gout
<16 years

  • Not recommended
>16 years

  • Treatment of acute gout flares (Colcrys): 1.2 mg PO at first sign of flare, then 0.6 mg 1 hr later; not to exceed 1.8 mg in 1-hr period
  • Prophylaxis (Colcrys, Mitigare): 0.6 mg PO once daily or q12hr; not to exceed 1.2 mg/day; after gout flare, wait 12 hr to continue prophylaxis
Familial Mediterranean Fever
<4 years: Safety and efficacy not established
4-6 years: 0.3-1.8 mg/day PO in single daily dose or divided q12hr
6-12 years: 0.9-1.8 mg/day PO in single daily dose or divided q12hr
>12 years: 1.2-2.4 mg/day PO in single daily dose or divided q12hr
Dosing considerations

  • Increased or decreased in 0.3 mg/day increments as necessary; not to exceed maximum recommended daily dose
References