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Colcrys Generic Name & Formulations
Legal Class
Rx
General Description
Colchicine 0.6mg; tabs.
Pharmacological Class
Antiinflammatory.
How Supplied
Tabs—30, 60, 100, 1000
Manufacturer
Generic Availability
YES
Mechanism of Action
The mechanism by which colchicine exerts its beneficial effect in patients with FMF has not been fully understood; however, it may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Colchicine also disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules and consequently prevents the activation, degranulation and migration of neutrophils thought to mediate some gout symptoms.
Colcrys Indications
Indications
Prophylaxis and treatment of acute gout flares. Familial Mediterranean fever (FMF).
Colcrys Dosage and Administration
Adult
Gout prophylaxis: >16yrs: 0.6mg once or twice daily; max 1.2mg/day. Gout treatment: 1.2mg at first sign of gout flare, then 0.6mg 1 hour later; max 1.8mg over a 1 hour period; may be given during prophylaxis at max 1.2mg at first sign of flare, then 0.6mg 1 hour later, wait 12 hours, then resume prophylactic dose. FMF: Usual range: 1.2mg–2.4mg daily; may give in 1–2 divided doses. May increase/decrease dose (depending on tolerability) in increments of 0.3mg/day to max daily dose. For all: concomitant CYP3A4 and/or P-glycoprotein inhibitors, severe renal or hepatic impairment: reduce dose (see full labeling).
Children
FMF: <4yrs: not recommended. Give as a single or divided dose twice daily. 4–6yrs: 0.3mg–1.8mg daily; 6–12yrs: 0.9mg–1.8mg daily. May increase/decrease dose (depending on tolerability) in increments of 0.3mg/day to max daily dose. Concomitant CYP3A4 and/or P-glycoprotein inhibitors, severe renal or hepatic impairment: reduce dose (see full labeling).
Colcrys Contraindications
Contraindications
Renal or hepatic impairment with concomitant P-glycoprotein or strong CYP3A4 inhibitors (includes all protease inhibitors except fosamprenavir); life-threatening toxicity possible.
Colcrys Boxed Warnings
Not Applicable
Colcrys Warnings/Precautions
Warnings/Precautions
Monitor for toxicity; if present, consider temporary interruption or discontinuation. Renal or hepatic impairment. Elderly. Pregnancy. Nursing mothers.
Colcrys Pharmacokinetics
Elimination
Renal. Half-life: 26.6–31.2 hours.
Colcrys Interactions
Interactions
See Contraindications. Potentiated by concomitant CYP3A4 inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, grapefruit juice) and/or P-glycoprotein inhibitors (eg, cyclosporine, ranolazine). Concomitant statins, gemfibrozil, fibrates, digoxin may potentiate myopathy and rhabdomyolysis.
Colcrys Adverse Reactions
Adverse Reactions
GI upset, abdominal pain, pharyngolaryngeal pain; blood dyscrasias, neuromuscular toxicity, rhabdomyolysis, overdosage (may be fatal).
Colcrys Clinical Trials
See Literature
Colcrys Note
Not Applicable
Colcrys Patient Counseling
See Literature
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