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Colchicine

Medically reviewed on March 25, 2018

Pronunciation

(KOL chi seen)

Dosage Forms

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

Capsule, Oral:

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

Generic: 0.6 mg

Tablet, Oral:

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

Generic: 0.6 mg

Brand Names: U.S.

  • Colcrys
  • Mitigare

Pharmacologic Category

  • Antigout Agent

Pharmacology

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.

Distribution

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

Vd: 5 to 8 L/kg

Metabolism

Hepatic via CYP3A4; 3 metabolites (2 primary, 1 minor)

Excretion

Urine (40% to 65% as unchanged drug); enterohepatic recirculation and biliary excretion also possible

Onset of Action

Oral: Pain relief: ~18 to 24 hours

Time to Peak

Serum: Oral: 0.5 to 3 hours

Half-Life Elimination

27 to 31 hours (multiple oral doses; young, healthy volunteers)

Protein Binding

~39%

Special Populations: Renal Function Impairment

Patients with ESRD had 75% lower clearance and prolonged elimination half-life.

Special Populations: Hepatic Function Impairment

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

Special Populations: Elderly

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

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. Note: Mitigare is only approved for prophylaxis of gout flares.

Off Label Uses

Behçet syndrome

Data from controlled trials indicate that colchicine as monotherapy has benefits over placebo for treatment of arthritis in patients with Behçet syndrome. Other benefits such as reduction in genital ulceration and erythema nodosum were limited to women. Oral ulcerations and folliculitis were not improved. Cyclosporine was superior to colchicine for treatment of ocular manifestations, dermal lesions, and aphthous ulcers. Based on the reviewed information, colchicine alone may be useful for patients with milder disease without ocular involvement; however, more aggressive treatment with alternative or combination therapy may be necessary for more severe disease.

Based on the European League Against Rheumatism (EULAR) guidelines for the management of Behçet syndrome, colchicine is recommended as the first-line agent for the treatment of patients with Behçet syndrome with acute arthritis and for the prevention of recurrent mucocutaneous lesions, especially when the lesion is erythema nodosum or genital ulcer [EULAR [Hatemi 2018]].

Calcium pyrophosphate (CPP) crystal arthritis ("pseudogout")

Data from a randomized, double-blind, placebo-controlled trial demonstrated efficacy in the treatment of chronic CPP crystal arthritis [Das 2002]; use of colchicine in the prophylaxis and treatment of acute CPP crystal arthritis is limited to noncontrolled trials [Alvarellos 1986] and extrapolation of data in patients with gout.

Based on EULAR guidelines for the treatment of CPP deposition, colchicine is recommended for the prophylaxis and treatment of acute and chronic CPP crystal arthritis [EULAR [Zhang 2011]].

Epidermolysis bullosa acquisita

Data from a limited number of patients in a small number of case reports and case series suggest that colchicine may be beneficial for the treatment of epidermolysis bullosa acquisita [Arora 2005], [Cunningham 1996], [Gurcan 2011], [Iranzo 2014], [Kim 2011], [Megahed 1994], [Tanaka 2009]. Additional data may be necessary to further define the role of colchicine in this condition.

Pericarditis, acute (adults)

Data from a double-blind, placebo-controlled, multicenter trial and an earlier open-label study by the same investigative group and conducted in Italy indicate that the addition of colchicine to aspirin or ibuprofen significantly reduces the incidence of symptoms at 72 hours and the risk of recurrence.

Based on American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines for the management of ST-segment elevation myocardial infarction (STEMI), Brazilian Society of Cardiology guidelines for the management of myocarditis and pericarditis, and European Society of Cardiology (ESC) guidelines for the management of pericardial diseases, colchicine is an effective and recommended treatment option in the management of patients with pericarditis after STEMI and idiopathic or viral acute pericarditis.

Pericarditis, recurrent (adults)

Evidence from controlled trials and a meta-analysis support the use of colchicine as an adjunct to aspirin or NSAIDs to prevent and treat recurrence of pericarditis. Colchicine reduces the risk of recurrent pericarditis, with a number needed to treat (NNT) ranging from 3 to 5 to prevent 1 recurrence. Adding colchicine also resolved pericarditis symptoms more quickly. Additional studies are needed to further evaluate the benefits of colchicine regimens without loading doses.

Based on Brazilian Society of Cardiology guidelines for the management of myocarditis and pericarditis and ESC guidelines for the management of pericardial diseases, the use of colchicine in combination with aspirin/NSAIDs is effective and recommended to prevent and treat recurrent pericarditis.

Postpericardiotomy syndrome (prevention)

Data from 2 major randomized controlled trials have demonstrated significant reductions in the incidence of postpericardiotomy syndrome with colchicine compared to placebo. Some regimens appear to be associated with higher risk of gastrointestinal adverse events. Further trials are needed to establish the optimal dosage regimen.

Postpericardiotomy syndrome (treatment)

Clinical experience suggests the utility of colchicine as adjunctive therapy in the treatment of postpericardiotomy syndrome [Hoit 2018].

The ESC guidelines for the management of pericardial diseases recognize the lack of human data, but support the use of colchicine for the treatment of postpericardiotomy syndrome; however, it is not recommended for postoperative effusions in the absence of systemic inflammation [ESC [Adler 2015]].

Sweet syndrome (acute febrile neutrophilic dermatosis)

Data from a limited number of patients in a small number of case reports and case series suggest that colchicine may be beneficial for the treatment of Sweet syndrome (acute febrile neutrophilic dermatosis) [Maillard 1999], [Nestor 2017], [Suehisa 1981], [Suehisa 1983]. Additional data may be necessary to further define the role of colchicine in this condition.

Contraindications

Concomitant use of a P-glycoprotein (P-gp) or strong CYP3A4 inhibitor in presence of renal or hepatic impairment

Mitigare: Patients with both renal and hepatic impairment.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to colchicine; serious gastrointestinal, hepatic, renal, and cardiac disease

Dosing: Adult

Note: In the United States, only the 0.6 mg tablets (eg, Colcrys) and capsules (eg, Mitigare) are available. In Canada, only the 0.6 mg tablets are available. For many uses, the dosage range studied is based on the internationally available dosage forms (0.5 mg or 1 mg tablets). In countries where the 0.5 mg tablets are not available, the 0.6 mg tablets are used empirically.

Due to gastrointestinal adverse effects associated with colchicine use, consider initiating therapy at a low dose, increasing gradually, and administering daily doses toward the high end of the dosage range in 2 to 3 divided doses rather than a single daily dose.

Indication-specific dosing:

Behçet syndrome (off-label use): Treatment and/or prevention of recurrence in patients with arthritis, cutaneous lesions, and/or mucocutaneous ulcers: Oral: 1 to 2 mg/day in divided doses (Aktulga 1980, Dalvi 2012, Davatchi 2009, EULAR [Hatemi 2018]). Consider using the lower end of the dosage range for patients <50 kg (Yurdakul 2001).

Calcium pyrophosphate (CPP) crystal arthritis ("pseudogout") (off-label use): Due to limited data, experts often approach treatment and prophylaxis of these patients the same as patients with gout (Becker 2018a, EULAR [Zhang 2011]). Refer to Gout indications.

Epidermolysis bullosa acquisita (off-label use): Note: Colchicine has been used as monotherapy or in combination with other agents (eg, dapsone or corticosteroids) depending on disease severity (Gürcan 2011); consider avoiding use of colchicine in patients with comorbid inflammatory bowel disease (Cunningham 1996).

Initial: Oral: 0.5 mg once daily (Cunningham 1996)

Titration: Oral: Increase by 0.5 mg/day in weekly intervals until diarrhea develops; continue the daily dosage that did not produce diarrhea in 1 to 3 divided doses (reported dosage range: 0.5 to 2 mg/day) (Arora 2005, Cunningham 1996, Gürcan 2011, Kim 2011, Megahed 1994, Tanaka 2009).

Familial Mediterranean fever (FMF): Prevention of attacks, and prevention of development and progression of amyloidosis: Oral:

Note: Administration of single daily doses is associated with increased compliance, whereas divided doses are associated with improved tolerance (Polat 2016).

Patients without preexisting complications (eg, renal amyloidosis) and with lesser disease activity: 1 to 1.5 mg/day in single or divided doses. May consider a lower initial dose (0.5 mg) with subsequent dose escalation to improve tolerance (EULAR [Ozen 2016]).

Patients with preexisting complications (eg, renal amyloidosis) or greater disease activity: Consider a higher initial dose (eg, up to 2 mg/day); in patients with AA amyloidosis, daily doses >1.5 mg have been associated with prevention of disease progression (Livneh 1992) and a reduction in protein excretion (Zemer 1992).

Titration: Increase the dose in 0.5 mg increments as clinically indicated (EULAR [Ozen 2016]); 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 (Hentgen 2013).

Maximum: 3 mg/day (Hentgen 2013, EULAR [Ozen 2016])

Gout, prophylaxis: Oral: 0.6 mg once or twice daily (maximum: 1.2 mg/day). In patients with severe GI intolerance, some experts consider giving 0.6 mg every other day (Becker 2018c).

Duration of prophylaxis:

Patients without tophi: 3 to 6 months after achieving target serum uric acid levels (ACR [Khanna 2012], Becker 2018c, EULAR [Richette 2017])

Patients with ≥1 tophi: Optimal duration is unclear; some experts continue colchicine therapy for 6 months after achieving target serum uric acid levels and resolution of tophi (ACR [Khanna 2012], Becker 2018c).

Gout, treatment (acute flares): Oral:

Note: Treatment should be initiated at the first sign of flare and/or within 12 hours (EULAR [Richette 2017] to 36 hours of the onset of flare (ACR [Khanna 2012]). Combination therapy with NSAIDs or glucocorticoids may be considered in patients with severe and/or polyarticular gout (ACR [Khanna 2012], EULAR [Richette 2017]).

Low-dose regimens (preferred):

Day 1: 1.2 mg at the first sign of flare, followed in 1 hour with a single dose of 0.6 mg (maximum: 1.8 mg within 1 hour) (ACP [Qaseem 2017], EULAR [Richette 2017], Terkeltaub 2010) or 0.6 mg 3 times daily on the first day of flare (maximum total dose: 1.8 mg on day 1) (Becker 2018b). Note: In patients who were already receiving prophylactic colchicine, the manufacturer and the American College of Rheumatology (ACR) recommend resuming prophylaxis dosing 12 hours after the initial treatment dosing (ACR [Khanna 2012]); this approach may result in higher doses being administered on day 1.

Day 2 and thereafter: 0.6 mg once or twice daily until flare resolves (ACP [Qaseem 2017], ACR [Khanna 2012], Becker 2018b, EULAR [Richette 2017]).

High-dose regimens: Note: Historically, high-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 (EULAR [Richette 2017], Terkeltaub 2010, Wechalekar 2014).

Pericarditis, acute or recurrent (treatment) (off-label use): Patients with acute idiopathic or viral pericarditis: Oral:

Loading dose: Loading doses are not necessary; avoiding loading doses may improve patient compliance and reduce adverse effects (Adler 2018, ESC [Adler 2015], Imazio 2018). If a decision to use a loading dose is made, the following is recommended:

Patients ≥70 kg: 0.5 to 1 mg every 12 hours on day 1, followed by maintenance dosing (Imazio 2005, Imazio 2011).

Patients <70 kg or unable to tolerate higher dosing regimen: 0.5 mg every 12 hours on day 1, followed by maintenance dosing (Imazio 2005, Imazio 2011).

Maintenance dosing:

Patients >70 kg: 0.5 mg twice daily (Imazio 2013, Imazio 2014a)

Patients ≤70 kg or unable to tolerate higher dosing regimen: 0.5 mg once daily (Imazio 2013, Imazio 2014a)

Duration of therapy:

Initial treatment (first occurrence): 3 months (Imazio 2013)

Recurrence treatment (first recurrence or multiple recurrences): 6 months (Imazio 2014a)

Concomitant therapy: Colchicine is adjunctive therapy to be used in combination with aspirin or an NSAID; aspirin or NSAID therapy should be continued until resolution of symptoms and then tapered gradually over several weeks. Concurrent gastroduodenal prophylaxis with a proton pump inhibitor is recommended and should be provided. In patients with contraindications to NSAIDs/aspirin, glucocorticoid therapy has been used for initial acute pericarditis; however, glucocorticoid use should be avoided in patients with recurrent pericarditis (Adler 2018, ESC [Adler 2015], Imazio 2018) Coadministration with corticosteroids (prednisone) is reserved for refractory cases (ESC [Adler 2015]).

Postpericardiotomy syndrome (off-label use): Oral:

Prevention: Note: May consider initiating preventive therapy preoperatively (48 to 72 hours prior to surgery [Imazio 2014b]) or postoperatively (24 to 72 hours after surgery [Hoit 2018, Imazio 2010]). However, preoperative administration was associated with increased risk of gastrointestinal adverse effects (Imazio 2014b).

Patients ≥70 kg: 0.5 mg twice daily for 1 month

Patients <70 kg: 0.5 mg once daily for 1 month

Treatment: Limited data exist; however, most experts recommend the routine use of colchicine as adjunctive therapy (at doses used for prevention) with aspirin or an NSAID, with the exception of treatment of asymptomatic postoperative pericardial effusions, as use is not recommended due to lack of efficacy (ESC [Adler 2015], Hoit 2018).

Sweet syndrome (acute febrile neutrophilic dermatosis) (alternative agent) (off-label use): Oral: Dosage range studied: 1 to 1.5 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) (Maillard 1999, Suehisa 1981, Suehisa 1983).

Dosage adjustment for concomitant therapy with CYP3A4 or P-gp inhibitors: Oral: Note: Colcrys labeling recommends dosage adjustments in patients receiving CYP3A4 or P-gp inhibitors up to 14 days prior to initiation of colchicine. Treatment of gout flare with colchicine is not recommended in patients receiving prophylactic colchicine and CYP3A4 inhibitors.

Coadministration of strong CYP3A4 inhibitor (eg, atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir):

FMF: Maximum dose: 0.6 mg daily (0.3 mg twice daily)

Gout prophylaxis:

Tablet (eg, Colcrys):

If original dose is 0.6 mg twice daily, adjust dose to 0.3 mg once daily

If original dose is 0.6 mg once daily, adjust dose to 0.3 mg every other day

Capsule (eg, Mitigare): Avoid concomitant use; if coadministration is necessary, reduce daily dosage or dose frequency and monitor closely.

Gout flare treatment: Initial: 0.6 mg, followed in 1 hour by a single dose of 0.3 mg; do not repeat for at least 3 days

Coadministration of moderate CYP3A4 inhibitor (eg, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil):

FMF: Maximum dose: 1.2 mg daily (0.6 mg twice daily)

Gout prophylaxis:

Tablet (eg, Colcrys):

If original dose is 0.6 mg twice daily, adjust dose to 0.3 mg twice daily or 0.6 mg once daily

If original dose is 0.6 mg once daily, adjust dose to 0.3 mg once daily

Capsule (eg, Mitigare): Avoid concomitant use; if coadministration is necessary, reduce daily dosage or dose frequency and monitor closely.

Gout flare treatment: 1.2 mg as a single dose; do not repeat for at least 3 days

Coadministration of P-gp inhibitor (eg, cyclosporine, ranolazine):

FMF: Maximum dose: 0.6 mg daily (0.3 mg twice daily)

Gout prophylaxis:

Tablet (eg, Colcrys):

If original dose is 0.6 mg twice daily, adjust dose to 0.3 mg once daily

If original dose is 0.6 mg once daily, adjust dose to 0.3 mg every other day

Capsule (eg, Mitigare): Avoid concomitant use; if coadministration is necessary, reduce daily dosage or dose frequency and monitor closely.

Gout flare treatment: Initial: 0.6 mg as a single dose; do not repeat for at least 3 days

Dosing: Geriatric

Use caution.

Gout: Reduce prophylactic daily dose by 50% in individuals ≥70 years (Terkeltaub 2003).

Dosing: Pediatric

Familial Mediterranean fever (FMF): Oral:

Tablet (eg, Colcrys) only:

Children 4 to 6 years: 0.3 to 1.8 mg daily in 1 to 2 divided doses

Children 6 to 12 years: 0.9 to 1.8 mg daily in 1 to 2 divided doses

Adolescents >12 years: Refer to adult dosing.

Gout prophylaxis/treatment: Oral: Adolescents >16 years: Refer to adult dosing.

Dosing: Renal Impairment

Concurrent use of colchicine and P-gp or strong CYP3A4 inhibitors is contraindicated in renal impairment. Fatal toxicity has been reported. Use of colchicine to treat gout flares is not recommended in patients with renal impairment receiving prophylactic colchicine.

FMF:

CrCl 30 to 80 mL/minute: Monitor closely for adverse effects; dose reduction may be necessary.

CrCl <30 mL/minute: Initial dose: 0.3 mg daily; use caution if dose titrated; monitor for adverse effects.

Dialysis: 0.3 mg as a single dose; use caution if dose titrated; dosing can be increased with close monitoring; monitor for adverse effects. Not removed by dialysis.

Gout prophylaxis:

CrCl 30 to 80 mL/minute:

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

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

CrCl <30 mL/minute:

Tablet (eg, Colcrys): Initial dose: 0.3 mg daily; use caution if dose titrated; monitor for adverse effects.

Capsule (eg, Mitigare): There is no specific dosage adjustment provided in the manufacturer’s labeling; dosage reduction or alternative therapy should be considered

Dialysis:

Tablet (eg, Colcrys): 0.3 mg twice weekly; monitor closely for adverse effects.

Capsule (eg, Mitigare): There are no dosage adjustments provided in the manufacturer’s labeling; monitor closely.

Renal impairment with concomitant hepatic impairment: Capsule (eg, Mitigare): Use is contraindicated.

Gout flare treatment: Tablet (eg, Colcrys): Note: Treatment of gout flares is not recommended in patients with renal impairment who are receiving colchicine for prophylaxis.

CrCl 30 to 80 mL/minute: Dosage adjustment not required; monitor closely for adverse effects.

CrCl <30 mL/minute: Dosage reduction not required but may be considered; treatment course should not be repeated more frequently than every 14 days.

Dialysis: 0.6 mg as a single dose; treatment course should not be repeated more frequently than every 14 days. Not removed by dialysis.

Hemodialysis: Not dialyzable (0% to 5%); avoid chronic use of colchicine.

Dosing: Hepatic Impairment

Concurrent use of colchicine and P-glycoprotein 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): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Severe impairment: Tablet (eg, Colcrys) and Capsule (eg, Mitigare): 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): 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.

Administration

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

Dietary Considerations

May be taken without regard to meals. May need to supplement with vitamin B12. Avoid grapefruit juice.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light and moisture.

Drug Interactions

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

Ceritinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of ceritinib with a narrow therapeutic index CYP3A substrate (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus) should be avoided when possible. Monitor therapy

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

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

Cyanocobalamin: Colchicine may decrease the serum concentration of Cyanocobalamin. 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 full monograph for details. Use extra caution in patients with impaired renal and/or hepatic function. 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 full monograph for details. Consider therapy modification

Digoxin: May increase the serum concentration of Colchicine. Monitor therapy

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

Fosamprenavir: May increase the serum concentration of Colchicine. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are receiving ritonavir-boosted fosamprenavir. In those with normal renal and hepatic function, reduce colchicine dose as directed. Consider therapy modification

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

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

Grapefruit Juice: May increase the serum concentration of Colchicine. 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). Consider therapy modification

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

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

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

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

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

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-glycoprotein inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. See full monograph for details. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

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

Telaprevir: May increase the serum concentration of Colchicine. Management: Colchicine should not be used with telaprevir 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 telaprevir. Consider therapy modification

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. Consider therapy modification

Test Interactions

May cause false-positive results in urine tests for erythrocytes or hemoglobin

Adverse Reactions

Frequency not always defined.

>10%: Gastrointestinal: Gastrointestinal disease (26% to 77%), diarrhea (23% to 77%), vomiting (17%), nausea (4% to 17%)

1% to 10%:

Central nervous system: Fatigue (1% to 4%), headache (1% to 2%)

Endocrine & metabolic: Gout (4%)

Gastrointestinal: Abdominal cramps, abdominal pain

Respiratory: Pharyngolaryngeal pain (2% to 3%)

<1%, postmarketing, and/or case reports: Alopecia, aplastic anemia, azoospermia, bone marrow depression, dermatitis, disseminated intravascular coagulation, dysgeusia (Syed 2016), granulocytopenia, hepatotoxicity, hypersensitivity reaction, increased creatine phosphokinase, increased serum ALT, increased serum AST, lactose intolerance, leukopenia, maculopapular rash, myalgia, myasthenia, myopathy, myotonia, neuropathy, oligospermia, pancytopenia, peripheral neuritis, purpura, rhabdomyolysis, skin rash, thrombocytopenia, toxic neuromuscular disease

Warnings/Precautions

Concerns related to adverse effects:

• Blood dyscrasias: Myelosuppression (eg, thrombocytopenia, leukopenia, granulocytopenia, pancytopenia) and aplastic anemia have been reported in patients receiving therapeutic doses.

• Gastrointestinal symptoms: Dosage reduction is recommended in patients who develop gastrointestinal symptoms (anorexia, diarrhea, nausea, vomiting) related to drug therapy.

• Neuromuscular toxicity: Myotoxicity (including rhabdomyolysis) has been reported in patients receiving therapeutic doses; patients with renal dysfunction and elderly patients are at increased risk. Concomitant use of cyclosporine, diltiazem, verapamil, fibrates, and statins may increase the risk of myopathy. Symptoms typically resolve within 1 week to several months of colchicine discontinuation.

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in the elderly; literature suggests dosage adjustments should be considered.

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).

Monitoring Parameters

CBC, renal and hepatic function tests

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Colchicine crosses the human placenta. Use during pregnancy in the treatment of familial Mediterranean fever has not shown an increase in miscarriage, stillbirth, or teratogenic effects (limited data).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of infection, burning or numbness feeling, severe nausea, severe vomiting, severe diarrhea, severe abdominal pain, severe loss of strength and energy, bruising, bleeding, pale skin, muscle pain, muscle weakness, urinary retention, or change in amount of urine passed (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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