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colchicine (Rx)Brand and Other Names:Colcrys, Mitigare

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 0.6mg

capsule

  • 0.6mg
more...

Gout

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

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

Familial Mediterranean Fever

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

Dosage Modifications

Renal impairment (gout)

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

Renal impairment (familial Mediterranean fever)

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

Hepatic impairment (gout)

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

Hepatic impairment (familial Mediterranean fever)

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

Strong CYP3A4 inhibitors

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

Moderate CYP3A4 inhibitors

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

P-gp inhibitors

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

Administration

Dosing regimens must be individualized to indication

Administered PO, without regard to meals

Post-STEMI Pericarditis (Off-label)

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

0.6 mg PO q12hr

Behcet Syndrome (Orphan)

Orphan sponsor

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

Dosage Forms & Strengths

tablet

  • 0.6mg

capsule

  • 0.6mg
more...

Gout

<16 years

  • Not recommended

>16 years

  • Treatment of acute gout flares (Colcrys): 1.2 mg PO at first sign of flare, then 0.6 mg 1 hr later; not to exceed 1.8 mg in 1-hr period
  • Prophylaxis (Colcrys, Mitigare): 0.6 mg PO once daily or q12hr; not to exceed 1.2 mg/day; after gout flare, wait 12 hr to continue prophylaxis

Familial Mediterranean Fever

<4 years: Safety and efficacy not established

4-6 years: 0.3-1.8 mg/day PO in single daily dose or divided q12hr

6-12 years: 0.9-1.8 mg/day PO in single daily dose or divided q12hr

>12 years: 1.2-2.4 mg/day PO in single daily dose or divided q12hr

Dosing considerations

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

Interaction Checker

colchicine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Gastrointestinal (GI) effects (eg, diarrhea, nausea, cramping, abdominal pain, vomiting) (26-77%)

            1-10%

            Fatigue (1-4%)

            Gout (0-4%)

            Pharyngolaryngeal pain (2-3%)

            Headache (1-2%)

            Postmarketing Reports

            Disseminated intravascular coagulation

            Cellular injury (eg, to kidney, vasculature, liver, central nervous system)

            Myelosuppression

            Neurologic: Sensory motor neuropathy

            Dermatologic: Alopecia, purpura, maculopapular rash, rash

            GI: Lactose intolerance, abdominal cramping, abdominal pain, vomiting, diarrhea, nausea

            Hematologic: Thrombocytopenia, leukopenia, granulocytopenia, pancytopenia, aplastic anemia

            Hepatobiliary: Elevated liver transaminases

            Musculoskeletal: Myotonia, muscle weakness, myopathy, elevated creatine phosphokinase, muscle pain, rhabdomyolysis

            Reproductive: Azoospermia, oligospermia

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            Warnings

            Contraindications

            Coadministration with P-gp or strong CY3A4 inhibitors in patients with hepatic or renal impairment; life-threatening and fatal colchicine toxicity has been reported with therapeutic dosages

            Hypersensitivity

            Cautions

            Long term use is established for FMF, but safety and efficacy of repeat treatment in gout flares has not been evaluated

            Not to be used to treat pain from other causes; drug is not analgesic

            Must be kept out of reach of children; fatal overdoses have been reported

            Blood dyscrasias (eg, leukopenia, myelosuppression, thrombocytopenia, pancytopenia, granulocytopenia, aplastic anemia) have been reported at therapeutic dosages

            Coadministration with P-gp and strong CYP3A4 inhibitors may warrant dosage reduction or interruption of therapy

            Rhabdomyolysis and neuromuscular toxicity have been reported with long-term treatment at therapeutic dosages; increased risk with renal dysfunction, elderly patients, concomitant therapy with myotoxic drugs; symptoms generally resolve within 1 week to few months upon discontinuance

            Acute gout: Dosages >1.8 mg/day provide no additional efficacy

            Dose reduction recommended in patients who develop gastrointestinal symptoms including anorexia, diarrhea, vomiting, or nausea due to the therapy

            Clearance is decreased in renal and hepatic impairment; monitor for toxicity and adjust dose if necessary

            Use with caution in the elderly; consider adjusting dose

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug enters breast milk; use with caution (American Academy of Pediatrics Committee states that drug is "compatible" with nursing)

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Gout: Disruption of cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules; this prevents activation, degranulation, and migration of neutrophils thought to mediate some gout symptoms

            FMF: Mechanism not established; may interfere with intracellular assembly of inflammasome complex present in neutrophils and monocytes, which mediates activation of interleukin-1β

            Absorption

            Bioavailability: 45%

            Onset: 18-24 hr

            Time to peak effect: 48-72 hr

            Peak plasma concentration: 6.2-6.8 ng/mL

            Distribution

            Protein bound: 34-44%

            Vd: 5-8 L/kg

            Metabolism

            Metabolized by P-gp and CYP3A4

            Metabolites: Demethylated to 2 primary metabolites and 1 minor metabolite

            Elimination

            Half-life: 26.6-31.2 hr

            Dialyzable: No (hemodialysis)

            Excretion: Feces, urine (65%)

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            Administration

            IV formulation currently not commercially available in United States

            IV Incompatibilities

            Dextrose or IV solutions with preservatives

            IV Administration

            Over 2-5 minutes, administer into tubing of NS-flowing IV line into large vein

            Avoid extravasation

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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