Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Gouty Arthritis
Treatment to relieve pain in attacks of acute gouty arthritis. Used as a second-line agent in patients who have not responded to or who cannot tolerate other recommended therapy (i.e., NSAIAs, corticosteroids).
Prophylactic treatment of recurrent gouty arthritis. Has no effect on plasma concentrations or urinary excretion of uric acid; use concomitantly with allopurinol or a uricosuric agent (e.g., probenecid, sulfinpyrazone) to decrease serum urate concentrations. Colchicine/probenecid fixed-dosage preparation has limited usefulness for prophylactic therapy because colchicine present exceeds the amount required by most patients.
Perioperatively, used for prevention of an attack that may be precipitated by any surgical procedure.
Familial Mediterranean Fever
Chronic prophylactic therapy to reduce frequency and severity of episodic attacks of painful serositis in patients with familial Mediterranean fever†.
Not curative; manifestations return to pretreatment levels following discontinuance.
Chronic prophylactic therapy appears to prevent amyloidosis (manifested by nephropathy) when there is no evidence of it at initiation of therapy; appears to be effective for preventing amyloidosis regardless of whether patients continue to experience episodic attacks of serositis during chronic prophylactic therapy with the drug. May prevent deterioration during proteinuric phase of the disease (when amyloid involvement is minimal).
Generally of limited value in altering the effects of amyloid deposits when clinical amyloidosis is evident, particularly when proteinuria has progressed to nephrosis, although a beneficial effect (e.g., restoration of serum albumin concentrations toward normal, slight improvement in renal function) may be evident in some patients.
Primary Biliary Cirrhosis
Has also been used for the treatment of primary biliary cirrhosis†.
Regulations Governing Colchicine Injection
On February 8, 2008, FDA announced that it would take enforcement action (e.g., seizure, injunction, other judicial proceeding) against all firms, including compounding pharmacies, attempting to manufacture, ship, or deliver colchicine injection because of potentially serious health risks associated with use of the injection. (See Serious Adverse Effects Related to Colchicine Injection under Cautions and see Preparations.)
Dosage and Administration
General
Gouty Arthritis
Administer prophylactic doses of colchicine before initiation of allopurinol or uricosurics because sudden changes in serum urate concentrations may precipitate acute gout attacks.
May discontinue colchicine and use urate-lowering agents alone after serum urate concentration is reduced to the desired level, and acute gout attacks have not occurred for 3–6 months (some clinicians suggest 1–12 months).
For subsequent acute attacks, patients should become familiar with dosage that provides relief without causing diarrhea.
Administration
Administer orally. Has been administered IV; parenteral preparation no longer available in the US. (See Serious Adverse Effects Related to Colchicine Injection under Cautions.)
Oral Administration
Initiate therapy for acute gouty arthritis at the first sign of an impending attack; initiation in later stages may not completely abate the attack.
Dosage
Pediatric Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Familial Mediterranean Fever
Chronic Prophylactic Therapy
Oral
Children <5 years of age: 0.5 mg daily has been used.†
Children 5–10 years of age: 1 mg daily has been used.†
Children >10 years of age: 1.5 mg daily has been used.†
Adults
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Gouty Arthritis
Treatment to Relieve Pain in Acute Attacks
Oral
Initially, 0.6–1.2 mg, followed by 0.6 mg every hour or 1.2 mg every 2 hours.
Alternatively, 0.6–1.2 mg initially, then 0.6 mg every 2–3 hours may be sufficient. Some clinicians recommend 0.6 mg 2 or 3 times daily.
Continue course of therapy until pain is relieved, GI distress or diarrhea occurs, or maximum recommended dosage is attained.
Total amount usually required is 4–8 mg per course.
Allow at least 3 days to elapse between oral courses of therapy to avoid toxicity from drug accumulation.
When ACTH is used for acute attacks, administer at least 1 mg of colchicine daily during ACTH administration and for several days after ACTH is discontinued.
Prophylactic Therapy
Administer prophylactic doses before initiation of allopurinol or uricosurics. (See General under Dosage and Administration.)
Oral
For ≤1 attack per year, usually 0.6 mg daily 3 or 4 times each week.
For >1 attack per year, usually 0.5–0.6 mg daily (no longer commercially available in US as single-entity 0.5-mg preparation; available in 0.5-mg tablet strength only in fixed combination with probenecid); 1–1.8 mg daily may be required.
Colchicine/Probenecid Fixed-Combination Therapy
Oral
Fixed-dosage preparation has limited usefulness for prophylactic therapy because colchicine present exceeds the amount required by most patients.
Manufacturer recommends initial dosage of colchicine 0.5 mg in fixed combination with probenecid 500 mg (1 tablet) daily for 1 week, then 1 tablet twice daily. If gouty arthritis is not controlled or if 24-hour uric acid excretion is ≤700 mg, increase daily dosage by 1 tablet every 4 weeks as tolerated (generally not exceeding 4 tablets [colchicine 2 mg and probenecid 2 g] daily).
If acute attacks have been absent ≥6 months and serum urate concentrations are controlled, manufacturer recommends reducing dosage by 1 tablet every 6 months as long as serum urate concentrations remain controlled.
Perioperative Prophylaxis
Oral
0.6 mg 3 times daily for 3 days before and 3 days after surgery.
Familial Mediterranean Fever
Chronic Prophylactic Therapy
Oral
1–2 mg daily in divided doses.†
Reduce to 0.6 mg daily in patients who develop intolerable adverse GI effects at higher dosages.†
Intermittent Use to Abort an Impending Acute Attack
Oral
Initially, 0.6 mg when attack is first suspected, then 0.6 mg hourly for 3 doses, then 0.6 mg every 2 hours for 2 doses; may continue with 0.6 mg every 12 hours for 2 additional days.†
Relief may occur after the first 4 or 5 doses, and subsequent doses may not be necessary.†
Prescribing Limits
Adults
Gouty Arthritis
Treatment to Relieve Pain in Acute Attacks
Oral
Maximum 8 mg per treatment course. (See Overdosage-related Mortality under Cautions.)
Special Populations
Hepatic Impairment
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Renal impairment with Clcr >50 mL/minute: 0.6 mg twice daily recommended by some clinicians.
If Clcr 35–50 mL/minute: 0.6 mg daily recommended by some clinicians.
If Clcr 10–34 mL/minute: 0.6 mg every 2–3 days recommended by some clinicians.
If Clcr <10 mL/minute: Avoid use of colchicine.
Prophylactic Treatment of Recurrent Gouty Arthritis
Oral
Do not exceed 0.6 mg daily in patients with Scr ≥1.6 mg/dL or Clcr ≤50 mL/minute; 0.6 mg every other day may be adequate. Generally do not administer to patients undergoing hemodialysis.
Colchicine in fixed combination with probenecid: Fixed-dosage preparation has limited usefulness for prophylactic therapy because colchicine present exceeds the amount required by most patients. Probenecid dosage requirements may be increased in patients with mild renal impairment (Clcr ≥50 mL/minute); not recommended in patients with Clcr <50 mL/minute.
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
For prophylactic therapy of recurrent gouty arthritis in patients with reduced muscle mass (e.g., geriatric or debilitated patients), initial dosage of 0.5 mg (no longer commercially available in US) orally once daily (unless Clcr >50 mL/minute) has been recommended.
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