Adult Dosing
Gout flares
- Initial: 1.2 mg PO, followed by 0.6 mg PO 1 hr later
- Max: 1.8 mg in 1 hrs
Familial Mediterranean fever (FMF)
- 1.2-2.4 mg PO divided qd-bid
- May increase/decrease by 0.3 mg/day based on safety and efficacy
Note:
- Refer to package insert for dose adjustment when administered with P-gp or moderate-strong CYP3A4 inhibitor
Pediatric Dosing
Gout flares
- Safety and efficacy in pediatric patients have not been established
Familial Mediterranean fever (FMF)
- Children 4-6 yrs: 0.3-1.8 mg/day PO divided qd-bid
- Children 6-12 yrs: 0.9-1.8 mg/day PO divided qd-bid
- Adolescents >12 yrs: 1.2-2.4 mg/day PO divided qd-bid
Note:
- Refer package insert for dose adjustment when administered with P-gp or moderate-strong CYP3A4 inhibitor
[Outline]
Renal Dose Adjustment (Based on CrCl)
Gout flares
- Mild (50-80 mL/min)-moderate (30-50 mL/min) renal impairment: Closely monitor for adverse events, no dose adjustments
- Severe renal impairment (<30 mL/min): No dose adjustments, but do not repeat more than once q2 wks
- Hemodialysis: 0.6 mg/attack, but do not repeat more than once q2 wks
FMF
- Mild (50-80 mL/min)-moderate (30-50 mL/min) renal impairment: Reduce dose, exact dose adjustments not defined; caution advised
- Severe renal impairment (<30 mL/min)-hemodialysis: Start with 0.3 mg/day, may increase with adequate monitoring for adverse events
Hepatic Dose Adjustment
Gout flares
- Mild-moderate hepatic impairment: Closely monitor for adverse events, no dose adjustments
- Severe hepatic impairment: No dose adjustments, but do not repeat more than once q2 wks
FMF
- Mild-moderate hepatic impairment: Closely monitor for adverse events, no dose adjustments
- Sever hepatic impairment: Reduce the dose, exact dose adjustments not defined
See Supplemental Patient Information
- Accidental and intentional overdose resulting in to fatalities have been reported in adults and children who have ingested colchicine. Keep out of reach of children
- Colchicine used in therapeutic doses can cause myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia
- Colchicine is a P-gp and CYP3A4 substrate. It can cause life-threatening and fatal drug interactions when given with P-gp and strong CYP3A4 inhibitors. Interrupt or reduce the dose of colchicine if treatment with a P-gp or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function
- Neuromuscular toxicity and rhabdomyolysis have been reported with chronic colchicine treatment in therapeutic doses. Patients with renal dysfunction and elderly patients are at increased risk. Symptoms generally resolve within 1 week to several months after the discontinuation of colchicine
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Elderly patients
- Myelosuppression
Supplemental Patient Information
- Patients should be cautioned that colchicine is not an analgesic medication and should not be used to treat pain from other causes
Pregnancy Category:C
Breastfeeding: Limited data indicates long term prophylactic maternal doses of colchicine up to 1.5 mg daily results in infant receiving less than 10% of the maternal dosage. No adverse events in breastfed infants have been reported. The infant dose can be minimized by avoiding breastfeeding 6-8 hrs after a dose, as highest milk levels occur at this time. No report available with higher maternal dosages. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 March 2011). As per manufacturer's data there are no published reports of adverse effects in breast-feeding infants of mothers taking colchicine. Colchicine can affect gastrointestinal cell renewal and permeability, hence manufacturer advises caution.
Pricing data from www.DrugStore.com in U.S.A.
- Colcrys 0.6 MG TABS [Bottle] (AR SCIENTIFIC)
30 mg = $169.99
90 mg = $499.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Colcrys 0.6 MG Oral Tablet
Ingredient(s): Colchicine
Imprint: AR;374
Color(s): Purple
Shape: Oval
Size (mm): 8.00
Score: 2
Inactive Ingredient(s): N/A
Drug Label Author:
AR Scientific Inc.
DEA Schedule:
Non-Scheduled
4 yrs
