nderlying maternal disease and maternal useof concomitant medications.
8.2 Lactation
Risk Summary
Colchicine is present in human milk (see Data). Adverse events in breastfed infants have not been reportedin the published literature after administration of colchicine to lactating women. There are no data on theeffects of colchicine on milk production. The developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for GLOPERBA and any potential adverse effects on thebreastfed infant from GLOPERBA or from the underlying maternal condition.
Data
Limited published data from case reports and a small lactation study demonstrate that colchicine is presentin breastmilk. A systematic review of literature reported no adverse effects in 149 breastfed children andadvised to reconsider breastfeeding if the infant has diarrhea. In a prospective observational cohort study,no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants.
8.3 Females and Males of Reproductive Potential
Infertility
Case reports and epidemiology studies in human male subjects on colchicine therapy indicate that infertilityfrom colchicine is rare and may be reversible.
8.4 Pediatric Use
Gout is rare in pediatric patients; safety and effectiveness of GLOPERBA in pediatric patients has not beenestablished.
8.5 Geriatric Use
Because of the increased incidence of decreased renal function in the elderly population, and the higherincidence of other co-morbid conditions in the elderly population requiring the use of other medications,reducing the dosage of colchicine when elderly patients are treated with colchicine should be carefullyconsidered [see Clinical Pharmacology (12.3)].
8.6 Renal Impairment
No dedicated pharmacokinetic study has been conducted using GLOPERBA in patients with varyingdegrees of renal impairment. Colchicine is known to be excreted in urine in humans and the presence ofsevere renal impairment has been associated with colchicine toxicity. Urinary clearance of colchicine andits metabolites may be decreased in patients with impaired renal function. Dose reduction or alternativesshould be considered for the prophylaxis of gout flares in patients with severe renal impairment. Colchicineis not effectively removed by hemodialysis. Patients who are undergoing hemodialysis should be monitoredcarefully for colchicine toxicity.
8.7 Hepatic Impairment
No dedicated pharmacokinetic study using GLOPERBA has been conducted in patients with varyingdegrees of hepatic impairment. Colchicine is known to be metabolized in humans and the presence ofsevere hepatic impairment has been associated with colchicine toxicity. Hepatic clearance of colchicinemay be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment.
Dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severehepatic impairment.
10 OVERDOSAGE
The dose of colchicine that would induce significant toxicity for an individual is unknown. Fatalities haveoccurred after ingestion of a dose as low as 7 mg over a four-day period, while other patients have survivedafter ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who
ingested less than 0.5 mg/kg survived and tended to have milder adverse reactions such as gastrointestinalsymptoms, whereas |
