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)

Brand Names: US

Colcrys [DSC];
Gloperba;
Lodoco;
Mitigare

Brand Names: Canada

EURO-Colchicine;
JAMP-Colchicine;
Myinfla;
PMS-Colchicine;
SANDOZ Colchicine

Pharmacologic Category

Antigout Agent

Dosing: Adult

Dosage guidance:

Safety: 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 (eg, hepatic/renal impairment, drug interactions).

Atherosclerotic cardiovascular disease, risk reduction

Atherosclerotic cardiovascular disease, risk reduction:

Note: Consider for use in patients with stable atherosclerotic cardiovascular disease who are already receiving other therapies to reduce risk of cardiovascular events (Ref).

Oral: 0.5 mg once daily.

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 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 calcium pyrophosphate crystal arthritis attacks annually: Limited data available: Oral: 0.6 mg twice daily (up to 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 doses lower than 0.6 mg twice daily is lacking (Ref).

Treatment : Note: Treatment should be initiated as soon as possible and within 36 hours of symptom onset; greatest response is seen when administered within 12 hours of symptom onset (Ref).

Day 1: Oral: 1.2 mg at the first sign of flare, followed in 1 hour with a single dose of 0.6 mg; do not exceed 1.8 mg/day 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 (Ref).

Patients with ≥1 tophi: Optimal duration is unclear; some experts continue colchicine therapy for 6 to 12 months (Ref).

Gout, treatment, acute flares

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). 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 48 hours after flare resolves; if symptoms do not improve after 2 to 3 days, consider switching to other anti-inflammatory agents (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 adherence to therapy 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

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 Function^a**
CrCl (mL/minute)^b	Atherosclerotic cardiovascular disease, risk reduction (Lodoco)	Gout flare, treatment^c,d	Gout flare, prophylaxis^d	Familial Mediterranean fever	Off-label indications
^aRecommendations from manufacturer's labeling and expert opinion unless otherwise specified.
^bCalculated using the Cockcroft-Gault formula.
^cUse of colchicine to treat gout flares is not recommended in patients with kidney impairment (CrCl <80 mL/minute) receiving prophylactic colchicine.
^dMany 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 2023).
30 to 80	There are no specific dose adjustments provided in the manufacturer's labeling; however, total clearance of colchicine is significantly reduced with kidney impairment; monitor closely for adverse effects.	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 2023).	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.
<30^d	*CrCl 15 to <30 mL/minute* : There are no specific dose adjustments provided in the manufacturer's labeling; however, total clearance of colchicine is significantly reduced with kidney impairment; monitor closely for adverse effects. *CrCl <15 mL/minute:* Contraindicated.	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 a flare; if flare symptoms persist after 3 days, may consider subsequent doses of no more than 0.3 mg every 3 days until flare resolves (Gaffo 2023).	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**
Atherosclerotic cardiovascular disease, risk reduction (Lodoco)	Gout flare, treatment^b,c	Gout flare, prophylaxis^c	Familial Mediterranean fever	Off-label indications
^aRecommendations from manufacturer's labeling and expert opinion unless otherwise specified.
^bUse of colchicine to treat gout flares is not recommended in patients with kidney impairment (CrCl <80 mL/minute) receiving prophylactic colchicine.
^cMany 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 2023).
Contraindicated.	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 Dialysis^a**
Atherosclerotic cardiovascular disease, risk reduction (Lodoco)	Gout flare, treatment^b,c	Gout flare, prophylaxis^c	Familial Mediterranean fever	Off-label indications
^aRecommendations from manufacturer's labeling and expert opinion unless otherwise specified.
^bUse of colchicine to treat gout flares is not recommended in patients receiving prophylactic colchicine.
^cMany 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 2023).
Contraindicated.	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.

Atherosclerotic cardiovascular disease, risk reduction (Lodoco):

Mild to moderate impairment: There are no specific dose adjustments provided in the manufacturer's labeling; however, clearance may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment; monitor closely for adverse effects.

Severe impairment: Use is contraindicated.

Familial Mediterranean fever:

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: Older Adult

Refer to adult dosing unless noted below.

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

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** **Function^a**
	Familial Mediterranean fever	Gout flare, treatment^b,c	Gout flare, prophylaxis^c
	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.

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)Diarrhea, 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

Neuromuscular & skeletal: Myalgia (21%)

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), skin rash

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: Asthenia, myasthenia (Altiparmak 2002; Todd 2012; Wilber 2004), neuropathy (Altiparmak 2002; Levy 1999; Medani 2016), numbness (Pirzada 2001), paresthesia (Pirzada 2001), peripheral neuritis (Medani 2016)

Neuromuscular & skeletal: 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)

Renal: Acute kidney injury

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.

Lodoco: Hypersensitivity to colchicine or any component of the formulation; concomitant use of P-gp inhibitors or strong CYP3A4 inhibitors; patients with renal failure (CrCl <15 mL/minute) and severe hepatic impairment; preexisting blood dyscrasias.

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

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

Warnings/Precautions

Concerns related to adverse effects:

• Blood dyscrasias: Can cause myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia, which can be life-threatening or fatal.

• Neuromuscular toxicity: Can cause neuromuscular toxicity and rhabdomyolysis. If a patient develops signs of neuromuscular toxicity, discontinue therapy, investigate other causes, and treat appropriately.

Disease-related concerns:

• Hepatic impairment: Clearance is decreased in hepatic impairment; may increase risk of 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).

• Renal impairment: Clearance is decreased in renal impairment; may increase risk of 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).

Special populations:

• Older adult: Use with caution in older adults; 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:

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

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) [contains benzyl alcohol, fd&c red #40 (allura red ac dye), propylene glycol; cherry flavor]

Tablet, Oral:

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

Lodoco: 0.5 mg

Generic: 0.6 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Capsules (Colchicine Oral)

0.6 mg (per each): $6.68 - $7.50

Capsules (Mitigare Oral)

0.6 mg (per each): $7.58

Solution (Gloperba Oral)

0.6 mg/5 mL (per mL): $3.01

Tablets (Colchicine Oral)

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

Tablets (Lodoco Oral)

0.5 mg (per each): $19.80

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.

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)]

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, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

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

Use: Labeled Indications

Atherosclerotic cardiovascular disease, risk reduction (ER tablet [Canadian product]; Lodoco [US product]): To reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

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.

Use: Off-Label: Adult

Behçet syndrome; Calcium pyrophosphate crystal arthritis ("pseudogout"); Pericarditis, acute; Pericarditis, recurrent; Postpericardiotomy syndrome, prevention; 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

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 Inducers (Strong): May decrease the serum concentration of Colchicine. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Colchicine. Management: Avoidance, dose reduction, or increased monitoring for colchicine toxicity may be needed and will depend on brand, indication for colchicine use, renal/hepatic function, and use of a P-gp inhibitor. See full monograph for details. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Colchicine. Management: This combination is often contraindicated, but combined use may be permitted with dose adjustment and monitoring. Recommendations vary based on brand, indication, use of P-gp inhibitors, and hepatic/renal function. See interaction monograph for details Risk D: Consider therapy modification

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

Elacestrant: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). 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). HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Colchicine. Risk C: Monitor therapy

Hormonal Contraceptives: Colchicine may enhance the adverse/toxic effect of Hormonal Contraceptives. Risk C: Monitor therapy

Itraconazole: May increase the serum concentration of Colchicine. Management: Colchicine is contraindicated during and for 2 weeks after itraconazole in patients with impaired renal or hepatic function. In those with normal renal and hepatic function, reduce colchicine dose as directed. See interaction monograph for details. Risk D: Consider therapy modification

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 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: This combination is often contraindicated, but combined use may be permitted with dose adjustment and monitoring. Recommendations vary based on brand, indication, use of CYP3A4 inhibitors, and hepatic/renal function. See interaction monograph for details. Risk D: Consider therapy modification

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

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

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

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; signs/symptoms of colchicine toxicity (early signs include nausea, vomiting, diarrhea, and abdominal pain), particularly in patients with increased risk of accumulation (renal or hepatic impairment, concomitant use of P-gp inhibitors or CYP3A4 inhibitors, chronic therapy).

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 (Adult Data Unless Noted)

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

V_d: 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 (Adult Data Unless Noted)

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.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AR) Argentina: Colchicina houde | Colchicina phoenix | Colchicine houde | Xuric;
(AT) Austria: Colchicin tiofarma | Colchicina | Colctab;
(AU) Australia: Colcine | Colgout | Lengout;
(BD) Bangladesh: Colimax | Kolchin;
(BE) Belgium: Colchicine houde;
(BF) Burkina Faso: Colchicine opocalcium;
(BG) Bulgaria: Colchicin | Colchicine ecopharm | Colchicum dispert | Licocin;
(BR) Brazil: Cixin | Cocichimil | Colchicina | Colchin | Colchis | Colcitrat | Colzuric | Coxym | Goltrite | Reugot;
(CH) Switzerland: Colchicin Streuli | Colchicine houde | Colctab;
(CL) Chile: Colchicina;
(CO) Colombia: Colchicina | Colchimedio;
(CZ) Czech Republic: Colchicum dispert;
(DE) Germany: Colchicin tiofarma | Colchicin ysat;
(DO) Dominican Republic: Colchicina | Colchimedio;
(EC) Ecuador: Artrichine | Colchimedio;
(EE) Estonia: Colchicin tiofarma | Colchicin ysat | Colchicina seid | Colchicine mylan | Colchicum dispert;
(EG) Egypt: Colmediten;
(ES) Spain: Colchicine houde;
(FI) Finland: Colchicin | Colrefuz;
(FR) France: Colchicine Opocalium;
(GB) United Kingdom: Colchicine kent;
(GR) Greece: Colchicina Lirca | Colchicina/med line | Colchicine seid | Colchicine/farmasyn;
(HK) Hong Kong: Colchily | Colcina | Colgout | Cp-Colchi | Kolcine;
(HU) Hungary: Colchicum dispert;
(ID) Indonesia: Ar gout | Colcitine | Frigout | Kolchisina | Pyricin | Recolfar;
(IN) India: Colchicindon | Coljoy | Goutnil | Zycolchin;
(IT) Italy: Colchicina Lirca;
(JO) Jordan: Colmediten;
(JP) Japan: Colchicine alfresa | Colchicine hachi | Colchicine mitsubishi | Colchicine nakano | Colchicine s.s. seiyaku | Colchicine sawai | Colchicine shionogi;
(KE) Kenya: Goutnil | Kolzine;
(KR) Korea, Republic of: Colchin | Colchine | Colchinine;
(KW) Kuwait: Colmediten;
(LB) Lebanon: Colchicine benta | Colchicine seid | Colmediten;
(LT) Lithuania: Colchicin | Colchicina Lirca | Colchicum dispert;
(LU) Luxembourg: Colchicine opocalcium;
(LV) Latvia: Colchicin | Colchicin ysat | Colchicina | Colchicina Lirca | Colchicina seid | Colchicine mylan | Colchicine opocalcium | Colchicum dispert;
(MA) Morocco: Colchicine houde;
(MX) Mexico: Colchicina | Colchicina gi | Colchiquim | Sixol | Ticolcin;
(MY) Malaysia: Colchimil | Goutnil | Goutnor | Tolchicine;
(NL) Netherlands: Colchicine A | Colchicine Actavis | Colchicine mylan;
(NO) Norway: Colchicine abbott | Colchicine Actavis | Colchicine opocalcium | Colchicine ria | Colchicine rph | Colchicine tiofarma | Colchicum dispert | Colrefuz | Kolkicin tiofarma | Kolkisin aurora medical | Kolkisin naf;
(NZ) New Zealand: Colgout;
(PE) Peru: Articol | Colchicina | Colchisol | Gotecina;
(PH) Philippines: Beragout | Cocilone | Goutless | Goutnil | Goutrelief | Goutsaph | Lesirheu | Rhea colchicine | Vonwelt colchicine;
(PL) Poland: Colchican | Colchicin | Colchicine genoptim | Colchicum dispert;
(PY) Paraguay: Colchicina millet | Colchicina quimfa;
(QA) Qatar: Colmediten;
(RO) Romania: Colchicina;
(RU) Russian Federation: Colchicin | Colchicum dispert;
(SA) Saudi Arabia: Colmediten | Pms colchicine;
(SE) Sweden: Colchimex | Colrefuz | Kolkicin | Kolkicin ebb | Kolkicin Medartuum | Kolkicin tiofarma;
(SG) Singapore: Colcitex;
(SI) Slovenia: Colchican | Colchicina seid | Colchicum dispert;
(TH) Thailand: Chicine | Colchily | Colchimex | Colcine | Colcitex | Colmed | Colstarcine | Gocine | Goticine | Goutichine | Koji | M colchicine | Pipchicine | Prochic | Remecine | Tolchicine | Zoric;
(TN) Tunisia: Colchicina Lirca | Colchicine houde | Colchicine opocalcium;
(TR) Turkey: Colchicum dispert | Kolsin;
(TW) Taiwan: Cocine | Cofoncin | Colcin | Colcine | Colicine | Conicine | Suyuni;
(UA) Ukraine: Colchicin | Colchicina Lirca | Colgout;
(UY) Uruguay: Colchicina;
(VN) Viet Nam: Dochicin;
(ZA) South Africa: Choldix | Cinited | Cinwol | Colchicine houde | Colcine

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Colchicine: Drug information