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Colchicine: Drug information

Colchicine: Drug information
(For additional information see "Colchicine: Patient drug information" and see "Colchicine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
Colchicine: COVID-19 Updated December 2021

Most recent update(s): The National Institutes of Health COVID-19 Treatment Guidelines recommend against colchicine use for treatment of COVID-19 in hospitalized patients. In nonhospitalized patients, the NIH guidelines recommend against the use of colchicine for the treatment of COVID-19, except in a clinical trial.

As part of our response to the evolving COVID-19 pandemic, published literature and guidelines from major health organizations are continuously monitored for potential content updates. At this time, only investigational medications with data determined to be of relatively high quality and/or consistently showing positive clinical outcomes to support dosing recommendations will be included in the monograph, outside of this Special Alert field.

Further information may be found at:

ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=covid&term=colchicine&cntry=&state=&city=&dist=

IDSA: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/

NIH: https://www.covid19treatmentguidelines.nih.gov/

Brand Names: US
  • Colcrys;
  • Gloperba [DSC];
  • Mitigare
Brand Names: Canada
  • EURO-Colchicine;
  • JAMP-Colchicine;
  • Myinfla;
  • PMS-Colchicine;
  • SANDOZ Colchicine
Pharmacologic Category
  • Antigout Agent
Dosing: Adult

Note: Colchicine has a narrow therapeutic index; drug accumulation can be associated with severe, including fatal, consequences. Monitor for signs/symptoms of colchicine toxicity and factors contributing to accumulation, such as hepatic/renal impairment or drug interactions.

Behçet syndrome

Behçet syndrome (off-label use):

Note: For treatment and/or prevention of recurrence in patients with arthritis, cutaneous lesions, and/or mucocutaneous ulcers.

Oral: 1 to 2 mg/day (or 1.2 to 1.8 mg/day) in 2 to 3 divided doses (Ref).

Calcium pyrophosphate crystal arthritis

Calcium pyrophosphate (CPP) crystal arthritis ("pseudogout") (off-label use):

Note: Due to limited data, experts often approach treatment and prophylaxis of these patients the same as patients with gout (Ref):

Prophylaxis: Patients with ≥3 CPP crystal arthritis attacks annually: Limited data available: Oral: 0.6 mg twice daily (maximum: 1.2 mg/day) (Ref). In patients with GI intolerance, some experts give 0.6 mg once daily or 0.6 mg every other day; however, evidence for a decrease in incidence of acute CPP crystal arthritis flare with doses lower than 0.6 mg twice daily is lacking (Ref).

Treatment : Note: Treatment should be initiated within 24 hours of onset (Ref). Limited data available; dosing based on expert opinion:

Day 1: Oral: 1.2 mg at the first sign of flare, followed in 1 hour with a single dose of 0.6 mg or 0.6 mg 3 times daily on the first day of flare; maximum total dose: 1.8 mg on day 1 of flare (Ref)

Day 2 and thereafter: Oral: 0.6 mg twice daily until flare resolves (Ref)

Familial Mediterranean fever

Familial Mediterranean fever (FMF):

Note: For prevention of attacks, and prevention of development and progression of amyloidosis.

Initial: Oral: 1 to 1.5 mg/day (or 1.2 to 1.8 mg/day) in a single daily dose; if single daily doses are not tolerated, give in divided doses. May consider a lower initial dose of 0.5 mg (or 0.6 mg) with subsequent dose escalation to improve tolerance (Ref). Note: Consider a higher initial dose (eg, up to 2 mg/day) in patients with greater disease activity and renal amyloidosis (but preserved renal function); in patients with secondary (AA) amyloidosis, daily doses >1.5 mg have been associated with prevention of disease progression and a reduction in protein excretion (Ref).

Titration: Oral: Increase the dose in 0.5 mg (or 0.6 mg) increments as clinically indicated (Ref); upwards titration is recommended in patients with attacks more frequent than every 3 months and/or with persistently elevated inflammatory markers. In general, a 3-month period of steady colchicine dosing is advised before judging response, although a more rapid titration schedule may be considered based on frequency of attacks (Ref).

Maximum: Oral: 3 mg/day (Ref)

Gout, prophylaxis during initiation of urate-lowering therapy

Gout, prophylaxis during initiation of urate-lowering therapy:

Oral: 0.6 mg once or twice daily (maximum: 1.2 mg/day). In patients with GI intolerance, some experts give 0.6 mg every other day (Ref).

Duration of prophylaxis:

Patients without tophi: 3 to 6 months after achieving target serum uric acid levels with urate-lowering therapy (Ref) or for the first 3 to 6 months of urate-lowering therapy (Ref).

Patients with ≥1 tophi: Optimal duration is unclear; some experts continue colchicine therapy for 6 to 12 months after achieving target serum uric acid levels with urate-lowering therapy and resolution of tophi, unless it is clear that tophi will not resolve despite persistent normal urate levels (Ref).

Gout, treatment

Gout, treatment (acute flares):

Day 1: Oral: 1.2 mg at the first sign of flare, followed by 0.6 mg after 1 hour (Ref); maximum total dose: 1.8 mg/day on day 1 (Ref). Initiate as soon as possible, ideally within 12 to 24 hours of flare onset (Ref); consider alternative agents if >36 hours since flare onset (Ref). Note: In patients who were already receiving prophylactic colchicine at the time of their flare, some experts give the higher 1.8 mg/day dosing regimen on day 1 of the flare, in place of the usual prophylactic dose (Ref).

Day 2 and thereafter: Oral: 0.6 mg once or twice daily until flare resolves (Ref). Some experts continue for 2 to 3 days after flare resolves (Ref). Note: In patients who were already receiving prophylaxis at the time of their flare, some experts give 0.6 mg twice daily (total dose: 1.2 mg/day) from day 2 until ~48 hours after flare resolution, and then resume the previous prophylactic dose (Ref).

Note: Historically, higher dose regimens have been given for gout flares; however, high-dose regimens have not been proven more effective than low-dose regimens and low-dose regimens have a better safety profile (Ref).

Pericarditis, acute or recurrent

Pericarditis, acute or recurrent (off-label use):

Loading dose: Loading doses are not necessary; avoiding loading doses may improve patient compliance and reduce adverse effects (Ref). If a decision to use a loading dose is made, the following is recommended:

Patients ≥70 kg: Oral: 1 mg (or 1.2 mg) every 12 hours on day 1, followed by maintenance dosing (Ref).

Patients <70 kg or unable to tolerate higher dosing regimen: Oral: 0.5 mg (or 0.6 mg) every 12 hours on day 1, followed by maintenance dosing (Ref).

Maintenance dosing:

Patients ≥70 kg: Oral: 0.5 mg (or 0.6 mg) twice daily (Ref)

Patients <70 kg or unable to tolerate higher dosing regimen: Oral: 0.5 mg (or 0.6 mg) once daily (Ref)

Duration of therapy:

Initial treatment (first occurrence): 3 months (Ref)

Recurrence treatment (first recurrence or multiple recurrences): 6 months (Ref)

Concomitant therapy: Use in combination with aspirin or a nonsteroidal anti-inflammatory drug (NSAID); may also add a corticosteroid for refractory cases. Alternatively, colchicine may be used with a corticosteroid alone if aspirin or an NSAID is contraindicated (Ref).

Postpericardiotomy syndrome, prevention

Postpericardiotomy syndrome, prevention (off-label use):

Note: Initiate preventive therapy preoperatively (48 to 72 hours prior to surgery (Ref)) or postoperatively (24 to 72 hours after surgery (Ref)).

Patients ≥70 kg: Oral: 0.5 mg (or 0.6 mg) twice daily for 1 month

Patients <70 kg: Oral: 0.5 mg (or 0.6 mg) once daily for 1 month

Stable ischemic heart disease, prevention of atherosclerotic cardiovascular events

Stable ischemic heart disease, prevention of atherosclerotic cardiovascular events (adjunctive therapy) (off-label use in the United States; labeled use for ER tablet [Canadian product]):

Note: Consider for use in stable patients already receiving other secondary preventative drug therapies.

Oral: 0.5 mg (or 0.6 mg) once daily (Ref).

Sweet syndrome

Sweet syndrome (acute febrile neutrophilic dermatosis) (alternative agent ) (off-label use):

Oral: Dosage range studied: 1 to 1.5 mg/day (1.2 to 1.8 mg/day) in 1 to 3 divided doses; the mean duration of therapy in one case series was reported as 15 days (range: 10 to 21 days) (Ref).

Vasculitis, idiopathic cutaneous small-vessel

Vasculitis, idiopathic cutaneous small-vessel (alternative agent) (off-label use):

Note: Consider for use in patients who do not respond adequately to initial therapy with corticosteroids (Ref).

Oral: Usual dose studied: 0.6 mg twice daily (Callen 1985; Callen 1987); if no response after 1 to 2 weeks, may consider increasing to 0.6 mg 3 times daily (Ref); continue therapy for 2 to 3 months after lesions heal and no new lesions develop, then taper and discontinue therapy over several weeks (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Kidney impairment is a significant risk factor for the development of colchicine-induced myotoxicity, even with short-term use (eg, 4 to 7 days) (Ref).

Altered kidney function: Oral:

Colchicine Dosage Adjustments in Altered Kidney Functiona

CrCl (mL/minute)b

Gout flare, treatmentc,d

Gout flare, prophylaxisd

Familial Mediterranean fever

Off-label indications

a Recommendations from manufacturer's labeling and expert opinion unless otherwise specified.

b Calculated using the Cockcroft-Gault formula.

c Use of colchicine to treat gout flares is not recommended in patients with kidney impairment (CrCl <80 mL/minute) receiving prophylactic colchicine.

d Many experts recommend avoiding colchicine for the treatment and prophylaxis of gout flares in severe kidney impairment (Bardin 2017; El-Zawawy 2010; EULAR [Richette 2017]; Gaffo 2021).

30 to 80

No dosage adjustment necessary.

No dosage adjustment necessary.

Alternatively, some experts limit the dose to 0.6 mg daily in patients with CrCl 30 to 60 mL/minute (Perez-Ruiz 2020).

No specific dosage adjustments are recommended; however, use of a reduced dose should be considered.

No specific dose adjustments recommended; consider risks/benefits of utilizing the usual indication-specific dose versus a reduced dose.

<30d

Consider alternate therapy (preferred). If alternate therapy is not available/tolerated, the following adjustment is recommended:

1.2 mg at the first sign of flare, followed in 1 hour with a single dose of 0.6 mg; repeat treatment should not occur for at least 14 days.

Alternatively, some experts recommend a single dose of 0.3 mg at the first sign of flare only; repeat treatment should not occur for at least 3 to 7 days (Gaffo 2021).

Consider alternate therapy (preferred). If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.3 mg once daily (or 0.6 mg every other day); titrate only if necessary and with extreme caution.

Maximum: 0.6 mg/day (expert opinion).

Initial: 0.3 mg once daily; titrate in 0.3 mg increments (refer to adult dosing for titration frequency). Risk of toxicity is high; monitor closely (Ozen 2016).

Maximum: 1.5 mg/day (expert opinion).

No specific dose adjustments recommended; consider risks/benefits of utilizing the usual indication-specific dose versus a reduced dose.

Hemodialysis, intermittent (thrice weekly): Minimally dialyzed (≤10%) (Ref): Oral:

Colchicine Dosage Adjustment in Hemodialysis (Intermittent [Thrice Weekly])a

Gout flare, treatmentb,c

Gout flare, prophylaxisc

Familial Mediterranean fever

Off-label indications

a Recommendations from manufacturer's labeling and expert opinion unless otherwise specified.

b Use of colchicine to treat gout flares is not recommended in patients with kidney impairment (CrCl <80 mL/minute) receiving prophylactic colchicine.

c Many experts recommend avoiding colchicine for the treatment and prophylaxis of gout flares in severe kidney impairment (Bardin 2017; El-Zawawy 2010; EULAR [Richette 2017]; Gaffo 2021).

Consider alternate therapy (preferred). If alternate therapy is not available/tolerated, the following adjustment is recommended:

A single dose of 0.6 mg at the first sign of flare; repeat treatment should not occur for at least 14 days.

Alternatively, some experts recommend a single dose of 0.3 mg at the first sign of flare; repeat treatment should not occur for at least 3 to 7 days (expert opinion).

Consider alternate therapy (preferred). If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.3 mg twice weekly.

Initial: 0.3 mg once daily; titrate in 0.3 mg increments (refer to adult dosing for titration frequency). Risk of toxicity is high; monitor closely (Ozen 2016).

Maximum: 1.5 mg/day (Solak 2014; expert opinion).

No specific dose adjustments recommended; consider risks/benefits of utilizing the usual indication-specific dose versus a reduced dose.

Peritoneal dialysis: Oral:

Colchicine Dosage Adjustments in Peritoneal Dialysisa

Gout flare, treatmentb,c

Gout flare, prophylaxisc

Familial Mediterranean fever

Off-label indications

a Recommendations from manufacturer's labeling and expert opinion unless otherwise specified.

b Use of colchicine to treat gout flares is not recommended in patients receiving prophylactic colchicine.

c Many experts recommend avoiding colchicine for the treatment and prophylaxis of gout flares in severe kidney impairment (Bardin 2017; El-Zawawy 2010; EULAR [Richette 2017]; Gaffo 2021).

Consider alternate therapy (preferred). If alternate therapy is not available/tolerated, the following adjustment is recommended:

A single dose of 0.6 mg at the first sign of flare; repeat treatment should not occur for at least 14 days.

Alternatively, some experts recommend a single dose of 0.3 mg at the first sign of flare; repeat treatment should not occur for at least 3 to 7 days (expert opinion).

Consider alternate therapy (preferred). If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.3 mg twice weekly.

Initial: 0.3 mg once daily; titrate in 0.3 mg increments (refer to adult dosing for titration frequency). Risk of toxicity is high; monitor closely (Ozen 2016).

Maximum: 1.5 mg/day (Solak 2014; expert opinion).

No specific dose adjustments recommended; consider risks/benefits of utilizing the usual indication-specific dose versus a reduced dose.

Dosing: Hepatic Impairment: Adult

Concurrent use of colchicine and P-gp or strong CYP3A4 inhibitors is contraindicated in hepatic impairment. Fatal toxicity has been reported. Treatment of gout flare with colchicine is not recommended in patients with hepatic impairment receiving prophylactic colchicine.

FMF:

Mild to moderate impairment: Use caution; monitor closely for adverse effects.

Severe impairment: There is no specific dosage adjustment provided in the manufacturer's labeling; dosage adjustment should be considered.

Gout prophylaxis:

Mild to moderate impairment:

Tablet (eg, Colcrys): Dosage adjustment not required; monitor closely for adverse effects.

Capsule (eg, Mitigare) and oral solution (eg, Gloperba): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Severe impairment: There is no specific dosage adjustment provided in the manufacturer's labeling; dosage adjustment should be considered.

Hepatic impairment with concomitant renal impairment: Capsule (eg, Mitigare) and oral solution (eg, Gloperba): Use is contraindicated.

Gout flare treatment: Note: Treatment of gout flares is not recommended in patients with hepatic impairment who are receiving colchicine for prophylaxis.

Mild to moderate impairment: Dosage adjustment not required; monitor closely for adverse effects.

Severe impairment: Dosage reduction not required but may be considered; treatment course should not be repeated more frequently than every 14 days.

Dosing: Pediatric

(For additional information see "Colchicine: Pediatric drug information")

Familial Mediterranean Fever

Familial Mediterranean Fever (FMF): Colcrys:

Children 4 to 6 years: Oral: 0.3 to 1.8 mg/day in 1 to 2 divided doses; titrate by increasing or decreasing dose in 0.3 mg/day increments based on efficacy or adverse effects; maximum dose: 2.4 mg/day; some guidelines recommend a lower maximum daily dose (2 mg/day) (Ref).

Children >6 to 12 years: Oral: 0.9 to 1.8 mg/day in 1 to 2 divided doses; titrate by increasing or decreasing dose in 0.3 mg/day increments based on efficacy or adverse effects; maximum dose: 2.4 mg/day; some guidelines recommend a lower maximum daily dose (2 mg/day) (Ref).

Children >12 years and Adolescents: Oral: 1.2 to 2.4 mg/day in 1 to 2 divided doses; titrate by increasing or decreasing dose in 0.3 mg/day increments based on efficacy or adverse effects; maximum dose: 2.4 mg/day; some guidelines recommend a lower maximum daily dose (2 mg/day) (Ref).

Gout

Gout: Colcrys: Adolescents >16 years:

Flare treatment: Initial: Oral: 1.2 mg at the first sign of flare, followed in 1 hour with a single dose of 0.6 mg (maximum dose: 1.8 mg over 1 hour). Patients receiving prophylaxis treatment may receive treatment dosing; wait 12 hours before resuming prophylactic dose; wait at least 3 days before repeating treatment dose.

Prophylaxis: Oral: 0.6 mg once or twice daily; maximum daily dose: 1.2 mg/day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Note: Kidney impairment has been shown to be a significant risk factor for the development of colchicine-induced myotoxicity in adults, even with short-term use (eg, 4 to 7 days) (Ref).

Altered kidney function: Oral: Colcrys:

Colchicine Dosage Adjustments in Altered Kidney Functiona

Familial Mediterranean fever

Gout flare, treatmentb,c

Gout flare, prophylaxisc

Children ≥4 years and Adolescents

Adolescents >16 years

Adolescents >16 years

aRecommendations from manufacturer's labeling.

bIn patients receiving prophylactic colchicine who have kidney impairment (CrCl <80 mL/minute), treatment with colchicine for gout flares is not recommended.

cBased on adult experience, many experts recommend avoiding colchicine for the treatment and prophylaxis of gout flares in severe kidney impairment (Bardin 2017; EULAR [Richette 2017]).

Mild to moderate impairment

(CrCl 30 to 80 mL/minute)

There are no specific dosing recommendations in the manufacturer's labeling. Monitor closely for adverse effects; dose reduction may be necessary.

No dosage adjustment necessary; monitor closely for adverse effects.

No dosage adjustment necessary; monitor closely for adverse effects.

Severe impairment

(CrCl <30 mL/minute)c

Initial dose: 0.3 mg/day; use caution if titrating dose; monitor closely for adverse effects.

Consider alternate therapy.

Treatment course should not be repeated more frequently than every 14 days. There are no specific dosage adjustments recommended by the manufacturer's labeling; however, based on adult recommendations, dosage adjustment may be necessary.

Consider alternate therapy. If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.3 mg/day; titrate only if necessary and use extreme caution; monitor for adverse effects.

Hemodialysis, intermittent

Nondialyzable: Initial dose: 0.3 mg/day; use caution if dose titrated; dosing can be increased with close monitoring for adverse effects.

Nondialyzable; consider alternate therapy. If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.6 mg as a single dose; wait at least 14 days to repeat.

Nondialyzable; consider alternate therapy. If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.3 mg twice weekly; monitor closely for adverse effects.

Peritoneal dialysis

Nondialyzable: Initial dose: 0.3 mg/day; use caution if dose titrated; dosing can be increased with close monitoring for adverse effects.

Nondialyzable; consider alternate therapy. If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.6 mg as a single dose; wait at least 14 days to repeat.

Nondialyzable; consider alternate therapy. If alternate therapy is not available/tolerated, the following adjustment is recommended:

0.3 mg twice weekly; monitor closely for adverse effects.

Dosing: Hepatic Impairment: Pediatric

Concurrent use of colchicine and P-gp or strong CYP3A4 inhibitors is contraindicated in hepatic impairment. Fatal toxicity has been reported.

FMF: Children ≥4 years and Adolescents: Colcrys: Oral

Mild to moderate impairment: Use caution; monitor closely for adverse effects.

Severe impairment: There are no specific dosage adjustments provided in the manufacturer's labeling; dosage adjustment should be considered.

Gout prophylaxis: Adolescents >16 years: Colcrys: Oral:

Mild to moderate impairment: No adjustment is necessary; however, monitor closely for adverse effects.

Severe impairment: There are no specific dosage adjustments provided in the manufacturer's labeling; dosage adjustment should be considered.

Gout flare treatment: Note: Treatment of gout flares is not recommended in patients with hepatic impairment who are receiving colchicine for prophylaxis. Adolescents >16 years: Colcrys: Oral:

Mild to moderate impairment: No adjustment is necessary; however, monitor closely for adverse effects.

Severe impairment: No adjustment is necessary; however, treatment course should not be repeated more frequently than every 14 days. Alternative therapy should be considered in patients requiring repeat courses.

Dosing: Older Adult

Use caution.

Gout: Reduce prophylactic daily dose by 50% in individuals ≥70 years (Ref).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Mitigare: 0.6 mg [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10)]

Generic: 0.6 mg

Solution, Oral:

Gloperba: 0.6 mg/5 mL (150 mL [DSC]) [contains benzyl alcohol, fd&c red #40 (allura red ac dye), propylene glycol; cherry flavor]

Tablet, Oral:

Colcrys: 0.6 mg [scored; contains fd&c blue #2 (indigo carmine,indigotine), fd&c red #40 (allura red ac dye)]

Generic: 0.6 mg

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 0.6 mg

Tablet Extended Release 24 Hour, Oral:

Myinfla: 0.5 mg [contains fd&c blue #1 (brilliant blue)]

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Colcrys:https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf#page=25

Gloperba:https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210942s000lbl.pdf#page=11

Mitigare:https://www.fda.gov/media/89939/download

Administration: Adult

Oral: Administer with water and maintain adequate fluid intake. May be administered without regard to meals.

Administration: Pediatric

Oral: Administer without regard to meals and maintain adequate fluid intake.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Use: Labeled Indications

Familial Mediterranean fever (tablet [eg, Colcrys] only): Treatment of familial Mediterranean fever in adults and children 4 years and older.

Gout flares: Prophylaxis and treatment of acute gout flares when taken at the first sign of a flare.

Limitations of use: Gloperba and Mitigare are only approved for prophylaxis of gout flares; use for acute treatment during gout flares has not been studied.

Stable ischemic heart disease, prevention of atherosclerotic cardiovascular events (ER tablet [Canadian product]): Reduction of atherosclerotic cardiovascular events in adults with existing ischemic heart disease, in combination with other drug therapies (eg, low-density lipoprotein cholesterol lowering and antithrombotic agents).

Use: Off-Label: Adult

Behçet syndrome; Calcium pyrophosphate (CPP) crystal arthritis ("pseudogout"); Pericarditis, acute; Pericarditis, recurrent; Postpericardiotomy syndrome, prevention; Stable ischemic heart disease, prevention of atherosclerotic cardiovascular events; Sweet syndrome (acute febrile neutrophilic dermatosis); Vasculitis, idiopathic cutaneous small-vessel

Medication Safety Issues
Sound-alike/look-alike issues:

Colchicine may be confused with Cortrosyn

Adverse Reactions (Significant): Considerations
Gastrointestinal effects

Gastrointestinal effects, including nausea, vomiting, and diarrhea, are the most common side effects associated with colchicine therapy (Ref). Symptoms generally resolve quickly after dose reduction or treatment discontinuation (Ref).

Mechanism: Dose-related; related to the pharmacologic action. May be due to binding to tubulin (Ref) or an increase in prostaglandins, intestinal secretion, and gastrointestinal motility (Ref).

Onset: Rapid; generally occurs within 24 hours of treatment initiation, dose adjustments, or drug interaction (Ref).

Risk factors:

• Higher doses (Ref)

• Kidney impairment (Ref)

• Hepatic impairment (Ref)

• Concomitant use of P-gp inhibitors or CYP3A4 inhibitors (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Diarrhea (23%) (table 1), nausea (Slobodnick 2018), vomiting (Slobodnick 2018)

Colchicine: Adverse Reaction: Diarrhea

Drug (Colchicine)

Placebo

Indication

Number of Patients (Colchicine)

Number of Patients (Placebo)

23%

14%

Gout flare

74

59

1% to 10%: Respiratory: Pharyngolaryngeal pain (3%)

<1%:

Hematologic & oncologic: Disseminated intravascular coagulation

Neuromuscular & skeletal: Neuromuscular disease (toxic)

Postmarketing:

Dermatologic: Alopecia (Levy 1999; Medani 2016), maculopapular rash (Medani 2016)

Gastrointestinal: Abdominal cramps, abdominal pain, dysgeusia (Syed 2016), lactose intolerance

Genitourinary: Azoospermia, oligospermia

Hematologic & oncologic: Aplastic anemia (Leung 2015; Todd 2012), bone marrow depression (Leung 2015; Todd 2012), granulocytopenia (Leung 2015), leukopenia (Leung 2015; Todd 2012), pancytopenia (Leung 2015; Levy 1999; Todd 2012), purpuric disease (Medani 2016), thrombocytopenia (Leung 2015; Todd 2012)

Hepatic: Hepatotoxicity (Abbott 2017)

Nervous system: Myasthenia (Altiparmak 2002; Todd 2012; Wilber 2004), neuropathy (Altiparmak 2002; Levy 1999; Medani 2016), peripheral neuritis (Medani 2016)

Neuromuscular & skeletal: Myalgia (Wilber 2004), myopathy (Altiparmak 2002; Levy 1999; Medani 2016; Wilber 2004), myotonia (Wilber 2004), rhabdomyolysis (risk factors include renal dysfunction, inappropriate use/dose, potential drug interactions) (Medani 2016; Wilber 2004)

Contraindications

Tablet (eg, Colcrys): Concomitant use of a P-glycoprotein (P-gp) inhibitor or strong CYP3A4 inhibitor in presence of renal or hepatic impairment.

Gloperba, Mitigare: Concomitant use of drugs that inhibit both P-gp and CYP3A4 in presence of renal or hepatic impairment; patients with both renal and hepatic impairment.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to colchicine; serious GI, hepatic, renal, and cardiac disease; existing blood dyscrasias.

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Clearance is decreased in hepatic impairment; monitor closely for adverse effects/toxicity. Dosage adjustments may be considered depending on degree of impairment or indication, and may be affected by the use of concurrent medication (CYP3A4 or P-gp inhibitors). Concurrent use of P-gp or strong CYP3A4 inhibitors is contraindicated in hepatic impairment. Fatal toxicity has been reported.

• Renal impairment: Clearance is decreased in renal impairment; monitor closely for adverse effects/toxicity. Dosage adjustments may be required depending on degree of impairment or indication, and may be affected by the use of concurrent medication (CYP3A4 or P-gp inhibitors). Concurrent use of P-gp or strong CYP3A4 inhibitors is contraindicated in renal impairment. Fatal toxicity has been reported.

Special populations:

• Older adult: Use with caution in elderly patients; consider dosage adjustments.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP 1997; CDC 1982); some data suggest that benzoate displaces bilirubin from protein-binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: Colchicine is not an analgesic and should not be used to treat pain from other causes.

• Fatal overdose: Accidental and intentional fatal overdoses have been reported. Dosage associated with fatal toxicity is variable (eg, wide dosage range).

Metabolism/Transport Effects

Substrate of CYP3A4 (major), P-glycoprotein/ABCB1 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Antihepaciviral Combination Products: May increase the serum concentration of Colchicine. Risk X: Avoid combination

Asciminib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Choline C 11: Colchicine may diminish the therapeutic effect of Choline C 11. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Colchicine. Management: Reduce colchicine dose as directed when using with a moderate CYP3A4 inhibitor, and increase monitoring for colchicine-related toxicity. See interaction monograph for details. Use extra caution in patients with impaired renal and/or hepatic function. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Colchicine. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a strong CYP3A4 inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. See interaction monograph for details. Risk D: Consider therapy modification

Digoxin: May enhance the adverse/toxic effect of Colchicine. Risk C: Monitor therapy

Erdafitinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Management: If coadministration with these narrow therapeutic index/sensitive P-gp substrates is unavoidable, separate erdafitinib administration by at least 6 hours before or after administration of these P-gp substrates. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fibric Acid Derivatives: May enhance the myopathic (rhabdomyolysis) effect of Colchicine. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Futibatinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Gilteritinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Grapefruit Juice: May increase the serum concentration of Colchicine. Risk X: Avoid combination

HMG-CoA Reductase Inhibitors (Statins): Colchicine may enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Colchicine may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Lasmiditan: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination

Lumacaftor and Ivacaftor: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may decrease the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Risk C: Monitor therapy

Mitapivat: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Multivitamins/Fluoride (with ADE): Colchicine may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, colchicine may decrease absorption of cyanocobalamin (vitamin B12). Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Colchicine may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, colchicine may decrease the serum concentration of Cyanocobalamin. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): Colchicine may decrease the serum concentration of Multivitamins/Minerals (with AE, No Iron). Specifically, colchicine may decrease absorption of cyanocobalamin (vitamin B12). Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Colchicine. Risk X: Avoid combination

Pacritinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a P-gp inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. See interaction monograph for details. Risk D: Consider therapy modification

Sotorasib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Management: Consider avoiding use of sotorasib and narrow therapeutic index/sensitive P-gp substrates. If combined use is unavoidable, monitor for increased toxicities of the substrate and consider a decrease in the substrate dosage. Risk D: Consider therapy modification

Tacrolimus (Systemic): May increase the serum concentration of Colchicine. Risk C: Monitor therapy

Taurursodiol: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination

Tipranavir: May increase the serum concentration of Colchicine. Management: Colchicine should not be used with tipranavir in patients with impaired renal or hepatic function. In those with normal renal and hepatic function, reduced colchicine doses (as directed) are required if used with tipranavir. Risk D: Consider therapy modification

Food Interactions

Grapefruit juice may increase colchicine serum concentrations. Management: Administer orally with water and maintain adequate fluid intake. Avoid grapefruit juice.

Reproductive Considerations

Colchicine should not be discontinued in females with familial Mediterranean fever who are planning a pregnancy (EULAR [Ozen 2016]). Conception in females with rheumatic and musculoskeletal diseases should be planned during a period of quiescent/low disease activity (ACR [Sammaritano 2020]).

Continuation of colchicine therapy is strongly recommended for use in males with rheumatic and musculoskeletal diseases who are planning to father a child (ACR [Sammaritano 2020]). Use in males may rarely be associated with reversible infertility. A temporary dose reduction or discontinuation may be needed if azoospermia or oligospermia is related to use; however, men generally do not need to discontinue colchicine prior to conception (EULAR [Ozen 2016]).

Pregnancy Considerations

Colchicine crosses the placenta.

Based on available information, an increased risk of major birth defects or pregnancy loss has not been observed following maternal use of colchicine for the treatment of rheumatic diseases, such as familial Mediterranean fever (FMF) (EULAR [Ozen 2016]; Indraratna 2018). However, untreated FMF is associated with adverse pregnancy outcomes including abortion, miscarriage, and exacerbations of FMF attacks (EULAR [Ozen 2016]).

Colchicine can be continued during pregnancy in females with rheumatic and musculoskeletal diseases (ACR [Sammaritano 2020]). Available guidelines recommend continuing colchicine during pregnancy for the treatment of conditions such as FMF when there are no acceptable alternatives and discontinuation of treatment may lead to uncontrolled disease and adverse pregnancy outcomes. Increased monitoring during pregnancy is recommended; amniocentesis is not warranted (ACR [Sammaritano 2020]; EULAR [Ozen 2016]).

Breastfeeding Considerations

Colchicine is present in breast milk.

In a study of 4 lactating women taking colchicine for familial Mediterranean fever, breast milk and maternal serum concentrations peaked at the same time. Breast milk concentrations decreased by half 6 hours after the dose (Ben-Chetrit 1996). According to the manufacturer, exclusively breastfed infants are expected to receive <10% of the weight-adjusted maternal dose; however, reported breast milk concentrations are highly variable (Ben-Chetrit 1996; Guillonneau 1995; Milunsky 1991). Adverse effects in breastfed infants have been not observed with use.

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Colchicine is considered compatible with breastfeeding and use should be continued in women with familial Mediterranean fever. Avoiding breastfeeding 2 to 4 hours after the maternal dose may decrease exposure to the breastfed infant (ACR [Sammaritano 2020]; EULAR [Ozen 2016]; WHO 2002).

Dietary Considerations

May need to supplement with vitamin B12. Avoid grapefruit juice.

Monitoring Parameters

CBC, renal and hepatic function tests

Reference Range

Uric acid, serum:

Uric Acid Normal Values

Age

Normal Serum Concentration

1 to 3 years

1.8 to 5 mg/dL

4 to 6 years

2.2 to 4.7 mg/dL

7 to 9 years

2 to 5 mg/dL

Males 10 to 11 years

2.3 to 5.4 mg/dL

Females 10 to 11 years

3 to 4.7 mg/dL

Males 12 to 13 years

2.7 to 6.7 mg/dL

Males 14 to 15 years

2.4 to 7.8 mg/dL

Females 12 to 15 years

3 to 5.8 mg/dL

Males 16 to 19 years

4 to 8.6 mg/dL

Females 16 to 19 years

3 to 5.9 mg/dL

Adults:

Normal values:

Males: 3.4 to 7 mg/dL or slightly more

Females: 2.4 to 6 mg/dL or slightly more

Goal in gout (with urate-lowering therapy): <6 mg/dL; <5 mg/dL in patients with severe gout (eg, tophi, frequent attacks, chronic arthropathy) (EULAR [Richette 2017]). Levels <3 mg/dL are not recommended long term (EULAR [Richette 2017]).

Mechanism of Action

Disrupts cytoskeletal functions by inhibiting β-tubulin polymerization into microtubules, preventing activation, degranulation, and migration of neutrophils associated with mediating some gout symptoms. In familial Mediterranean fever, may interfere with intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediate activation of interleukin-1β.

Pharmacokinetics

Onset of action: Oral: Pain relief: ~18 to 24 hours

Distribution: Concentrates in leukocytes, kidney, spleen, and liver; does not distribute in heart, skeletal muscle, and brain

Vd: 5 to 8 L/kg

Protein binding: ~39%

Metabolism: Hepatic via CYP3A4 and glucuronidation; 3 metabolites (2 primary, 1 minor)

Bioavailability: ~45%

Half-life elimination: 27 to 31 hours (multiple oral doses; young, healthy volunteers)

Time to peak, serum: Oral: 0.5 to 3 hours

Excretion: Urine (40% to 65% as unchanged drug); enterohepatic recirculation, biliary excretion, and p-glycoprotein efflux also possible

Pharmacokinetics: Additional Considerations

Altered kidney function: Patients with ESRD had 75% lower clearance and prolonged elimination half-life.

Hepatic function impairment: Clearance is significantly reduced and plasma half-life prolonged in patients with mild to moderate cirrhosis.

Older adult: Mean peak plasma levels and AUC were 2 times higher in elderly patients; however, this may be caused by decreased renal function.

Pricing: US

Capsules (Colchicine Oral)

0.6 mg (per each): $6.54 - $6.68

Capsules (Mitigare Oral)

0.6 mg (per each): $7.58

Tablets (Colchicine Oral)

0.6 mg (per each): $5.76 - $11.15

Tablets (Colcrys Oral)

0.6 mg (per each): $8.63

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Artrichine (EC);
  • Calchicine Houde (PY);
  • Cholchicin ”Agepha” (AT);
  • Cochic (TH);
  • Cocine (TW);
  • Colchicin Agepha (AT);
  • Colchicina Lirca (IT);
  • Colchicina Phoenix (AR);
  • Colchicine (IL);
  • Colchicine capsules (NL);
  • Colchicine Houde (AR, BE, FR, LU, PT);
  • Colchicum-Dispert (BG, DE, HU, PL, TR);
  • Colchifar (VN);
  • Colchily (TH);
  • Colchimedio (CO, CR, DO, GT, HN, NI, PA, SV);
  • Colchimex (SE);
  • Colchin (KR);
  • Colchiquim (CR, DO, GT, HN, MX, NI, PA, SV);
  • Colchis (BR);
  • Colchisol (PE);
  • Colchysat Burger (DE);
  • Colcin (TW);
  • Colcine (TH);
  • Colcitex (SG);
  • Colgout (AU, HK, NZ);
  • Colmediten (EG, KW, SA);
  • Colrefuz (DK, FI, SE);
  • Coluric (BD);
  • Cryscol (BD);
  • Degout (TW);
  • Gotine (SA);
  • Goutcolcin (VN);
  • Goutic (TH);
  • Goutichine (TH);
  • Goutnil (IN, LK, PH);
  • Goutnor (MY);
  • Kolchin (BD);
  • Kolkisin (NO);
  • L-Cisin (ID);
  • Lengout (AU);
  • Lennon-Colchicine (ZA);
  • Oripicin (VN);
  • Prochic (TH);
  • Recolfar (ID);
  • Sixol (CR, DO, GT, HN, MX, NI, PA, SV);
  • Tolchicine (TH)


For country code abbreviations (show table)
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