Effects of Grapefruit and Seville Orange Juices on the Pharmacokinetic Properties of Colchicine in Healthy Subjects

Clinical Therapeutics

Volumn 34, Issue 10, 2012, Pages 2161-2173

  Wason, Suman ^a,b   DiGiacinto, Jennifer L ^c   Davis, Matthew W ^a,b  

^a URL Pharma Inc   (United States)

^b Mutual Pharmaceutical Company Inc   (United States)

^c Salamandra LLC   (United States)

Author keywords

Colchicine; Drug interaction; Grapefruit juice; Pharmacokinetics; Seville orange juice

Indexed keywords

COLCHICINE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG BLOOD LEVEL; DYSPEPSIA; FEMALE; FEVER; FOOD DRUG INTERACTION; GRAPEFRUIT JUICE; HEADACHE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; ORANGE JUICE; PAIN; PHASE 1 CLINICAL TRIAL; SINGLE DRUG DOSE; SOUR ORANGE;

ADOLESCENT; ADULT; BEVERAGES; CITRUS; CITRUS PARADISI; COLCHICINE; DRUG LABELING; FEMALE; FOOD-DRUG INTERACTIONS; GOUT SUPPRESSANTS; HUMANS; MALE; MIDDLE AGED; TIME FACTORS; YOUNG ADULT;

EID: 84867366942     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.08.007     Document Type: Article

References (38)

1. Bailey D.G., Spence J.D., Edgar B., et al. Ethanol enhances the hemodynamic effects of felodipine. Clin Invest Med 1989, 12:357-362.
2. Bailey D.G., Spence J.D., Munoz C., Arnold J.M. Interaction of citrus juices with felodipine and nifedipine. Lancet 1991, 337:268-269.
3. Lown K.S., Bailey D.G., Fontana R.J., et al. Grapefruit juice increases felodipine oral availability in humans by decreasing intestinal CYP3A protein expression. J Clin Invest 1997, 99:2545-2553.
4. Seden K., Dickinson L., Khoo S., Back D. Grapefruit-drug interactions. Drugs 2010, 70:2373-2407.
5. Won C.S., Oberlies N.H., Paine M.F. Influence of dietary substances on intestinal drug metabolism and transport. Curr Drug Metab 2010, 111:778-792.
6. Hanley M.J., Cancalon P., Widmer W.W., Greenblatt D.J. The effect of grapefruit juice on drug disposition. Expert Opin Drug Metab Toxicol 2011, 7:267-286.
7. Malhotra S., Bailey D.G., Paine M.F., Watkins P.B. Seville orange juice-felodipine interaction: comparison with dilute grapefruit juice and involvement of furocoumarins. Clin Pharmacol Ther 2001, 1:14-23.
8. Scora R.W. On the history and origin of citrus. Bull Torry Bot Club 1975, 102:369-375.
9. Guo L.Q., Fukuda K., Ohta T., Yamazoe Y. Role of furanocoumarin derivatives on grapefruit juice-mediated inhibition of human CYPA activity. Drug Metab Dispos 2000, 20:766-771.
10. Zhu Y., Pandya B., Choi H.K. Prevalence of gout and hyperuricemia in the US general population. Arthritis Rheum 2011, 63:3136-3141.
11. Neogi T., Hunter D.J., Chaisson C.E., et al. Frequency and predictors of inappropriate management of recurrent gout attacks in a longitudinal study. J Rheumatol 2006, 33:104-109.
12. Hak A.E., Choi H.K. Lifestyle and gout. Curr Opin Rheumatol 2008, 20:179-186.
13. Simkin P.A., Gardner G.C. Colchicine use in cyclosporine treated transplant recipients: how little is too much?. J Rheumatol 2000, 27:1334-1337.
14. Speeg K.V., Maldonado A.L., Liaci J., Muirhead D. Effect of cyclosporine on colchicine secretion by a liver canalicular transporter studied in vivo. Hepatology 1992, 15:899-903.
15. Speeg K.V., Maldonado A.L., Liaci J., Muirhead D. Effect of cyclosporine on colchicine secretion by a kidney multidrug transporter studied in vivo. J Pharmacol Exp Ther 1992, 261:50-55.
16. Ferron G.M., Rochdi M., Jusko W.J., Scherrmann J.-M. Oral absorption characteristics and pharmacokinetics of colchicine in healthy volunteers after single and multiple doses. J Clin Pharmacol 1996, 36:874-883.
17. Niel E., Scherrmann J.-M. Colchicine today. Joint Bone Spine 2006, 73:672-693.
18. Terkeltaub R.A. Colchicine update: 2008. Semin Arthritis Rheum 2009, 38:411-419.
19. Ford E.S., Giles W.H., Dietz W.H. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA 2002, 287. 356-259.
20. Choi H.K., Mount D.B., Reginato A.M. Pathogenesis of gout. Ann Intern Med 2005, 143:499-516.
21. Primatesta P., Plana E., Rothenbacher D. Gout treatment and comorbidities: a retrospective cohort study in a large US managed care population. BMC Musculoskelet Disord 2011, 12:103.
22. Information for Healthcare Professionals: New Safety Information for Colchicine (marketed as Colcrys) US Dept of Health and Human Services, Food and Drug Administration, Accessed March 17, 2012. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm174382.htm.
23. Terkeltaub R.A., Furst D.E., DiGiacinto J.L., et al. Novel evidence-based colchicine dose-reduction algorithm to predict and prevent colchicine toxicity in the presence of cytochrome P450 3A4/P-glycoprotein inhibitors. Arthritis Rheum 2011, 63:2226-2237.
24. Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations US Dept of Health and Human Services, Food and Drug Administration, Accessed March 26, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf.
25. Dahan A., Amidon G.L. Grapefruit juice and its constituents augment colchicine intestinal absorption: potential hazardous interaction and the role of p-glycoprotein. Pharm Res 2009, 26:883-892.
26. Dahan A., Sabit H., Amidon G.L. Multiple efflux pumps are involved in the transepithelial transport of colchicine: combined effects of P-glycoprotein and multidrug resistance-associated protein 2 leads to decreased intestinal absorption throughout the entire small intestine. Drug Metab Dispos 2009, 37:2028-2036.
27. Bailey D.G. Fruit juice inhibition of uptake transport: a new type of food-drug interaction. Br J Clin Pharmacol 2010, 70:645-655.
28. Dresser G.K., Bailey D.G., Leake B.F., et al. Fruit juices inhibit organic anion transporting polypeptide-mediated drug uptake to decrease the oral availability of fexofenadine. Clin Pharmacol Ther 2002, 71:11-20.
29. Satoh H., Yamashita F., Tsujimoto M., et al. Citrus juices inhibit the function of human organic anion-transporting polypeptide OATP-B. Drug Metab Dispos 2005, 33:518-523.
30. Bailey D.G., Dresser G.K., Leake B.F., Kim R.B. Naringin is a major and selective clinical inhibitor of organic anion-transporting polypeptide 1A2 (OATP1A2) in grapefruit juice. Clin Pharmacol Ther 2007, 28:491-500.
31. Lilja J.J., Backman J.T., Laitila J., et al. Itraconazole increases but grapefruit juice greatly decreases plasma concentrations of celiprolol. Clin Pharmacol Ther 2003, 73:192-198.
32. Schwarz U.I., Seemann D., Oertel R., et al. Grapefruit juice ingestion significantly reduces talinolol bioavailability. Clin Pharmacol Ther 2005, 77:291-301.
33. Kato Y., Miyazaki T., Kano T., et al. Involvement of influx and efflux transport systems in gastrointestinal absorption of celiprolol. J Pharm Sci 2009, 98:2529-2539.
34. Tapaninen T., Neuvonen P.J., Niemi M. Grapefruit juice greatly reduces the plasma concentrations of the OATP2B1 and CYP3A4 substrate aliskiren. Clin Pharmacol Ther 2010, 88:339-342.
35. Neuhofel A.L., Wilton J.H., Victory J.M., et al. Lack of bioequivalence of ciprofloxacin when administered with calcium-fortified orange juice: a new twist to an old interaction. J Clin Pharmacol 2002, 42:461-466.
36. Reif S., Nicolson M.C., Bisset D., et al. Effect of grapefruit juice intake on etoposide bioavailability. Eur J Clin Pharmacol 2002, 58:327-331.
37. Colcrys (colchicine) tablets for oral use [prescribing information], Accessed March 14, 2012. http://www.colcrys.com/assets/pdf/COLCRYS_Full_Prescribing_Information.pdf.
38. Goldbart A., Press J., Sofer S., Kapelushnik J. Near fatal acute colchicine intoxication in a child. A case report. Eur J Pediatr 2000, 159:895-897.