GLOPERBA

Colchicine 0.6mg/5mL, Oral solution

Grapefruit juice

· Severity: Major

· Notes for Consumers: Do not drink grapefruit juice while taking colchicine. Grapefruit juice can increase the risk of serious side effects from colchicine. Contact your doctor immediately if you notice any of the following while taking colchicine: blood in urine; bloody, black or tarry stools; new or unusual bruises; unusual vaginal bleeding; bloody nose lasting longer than 10 minutes; nausea, vomiting or diarrhea; numbness, tingling or pain in your hands or feet; pain or burning in your stomach or throat; or trouble passing urine or change in the amount of urine.

· Notes for Professionals: Due to the risk for serious colchicine toxicity including multi-organ failure and death, patients should avoid eating grapefruit or drinking grapefruit juice while taking colchicine. Coadministration is contraindicated in patients with renal or hepatic impairment because colchicine accumulation may be greater in these populations. Grapefruit juice can inhibit colchicine's metabolism via P-glycoprotein (P-gp) and CYP3A4, resulting in increased colchicine exposure. If coadministration in patients with normal renal and hepatic function cannot be avoided, adjust the dose of colchicine by either reducing the daily dose or the dosage frequency, and carefully monitor for colchicine toxicity. Specific dosage adjustment recommendations are available for the Colcrys product for patients who have taken grapefruit juice in the past 14 days or require concurrent use: administer half of the original intended Colcrys dosage for prophylaxis of gout flares; 1.2 mg as a single dose for treatment of gout flares and do not repeat for at least 3 days; and do not exceed a maximum daily dose of 1.2 mg/day for familial Mediterranean fever.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>