Classes
DEA Class; Rx
Common Brand Names; Colcrys, Mitigare, Gloperba
- Antigout Agents
Description
Antigout anti-inflammatory agent
Used primary for treatment and prevention of acute gout and for familial Mediterranean fever
Concomitant renal or hepatic dysfunction and the use of P-glycoprotein or strong CYP3A4 inhibitors increase toxicity risk
Indications
Indicated for the prevention and treatment of gout flares (gouty arthritis).
Contraindications
Coadministration with P-gp or strong CY3A4 inhibitors in patients with hepatic or renal impairment
Patients with both renal and hepatic impairment
Adverse Effects
- Rash (1.5%)
- Nausea (1.3%)
- Renal failure (1.2%)
- Vomiting (1.2%)
- Amblyopia
- Arthralgias
- Blood dyscrasias
- Bronchospasm
- Cardiovascular abnormalities
- Cataracts
- Confusion
- Decrease in libido
- Dizziness
- Ecchymosis
- Electrolyte abnormalities
- Epistaxis
- Foot drop
- Hematuria
- Hepatotoxicity
- Hypotonia
- Iritis
- Kidney function abnormality
- Macular retinitis
- Malaise
- Neuritis
Warnings
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 reported in both adults and children
Blood dyscrasias (eg, leukopenia, myelosuppression, thrombocytopenia, pancytopenia, granulocytopenia, aplastic anemia) reported at therapeutic dosages
Rhabdomyolysis and neuromuscular toxicity reported with long-term treatment at therapeutic dosages; increased risk in renal dysfunction, elderly patients, and concomitant therapy with myotoxic drugs; symptoms generally resolve within 1 week to few months upon discontinuance
Pregnancy and Lactation
Available human data from published literature on colchicine use in pregnancy over several decades have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Colchicine is present in human milk
Maximum Dosage
Maximum dosages are dependent on indication for use. Do not exceed the maximum dose recommended for the indication for use.
1.8 mg PO per acute gout flare course (tablets); 1.2 mg/day PO for gout prophylaxis (tablets, capsules, oral solution); 2.4 mg/day PO for familial Mediterranean fever (tablets).
1.8 mg PO per acute gout flare course (tablets); 1.2 mg/day PO for gout prophylaxis (tablets, capsules, oral solution); 2.4 mg/day PO for familial Mediterranean fever (tablets).
2.4 mg/day PO for familial Mediterranean fever (tablets). Rare off-label use for gout prophylaxis has been described, do not exceed 1.2 mg/day PO.
4 to 12 years: 1.8 mg/day PO for familial Mediterranean fever (tablets).
4 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
colchicine
tablet
- 0.6mg (Colcrys)
capsule
- 0.6mg (Mitigare)
oral solution
- 0.6mg/5mL (Gloperba)