Absence of excretion of the active moiety of bisacodyl and sodium picosulfate into human breast milk: An open-label, parallel-group, multiple-dose study in healthy lactating women

Drug Metabolism and Pharmacokinetics

Volumn 26, Issue 5, 2011, Pages 458-464

  Friedrich, Christian ^a   Richter, Erika ^a   Trommeshauser, Dirk ^a   De Kruif, Sandra ^a   Van Iersel, Thijs ^b   Mandel, Ken ^c   Gessner, Ulrika ^a  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^b Xendo Drug Development BV   (Netherlands)

^c KGM Innovation Associates Inc   (United States)

Author keywords

Bisacodyl; Breast milk; Constipation; Lactating women; Laxative; Pharmacokinetics; Sodium picosulfate

Indexed keywords

BIS(PARA HYDROXYPHENYL)PYRIDYL 2 METHANE; BISACODYL; DRUG METABOLITE; PICOSULFATE SODIUM; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ABDOMINAL SWELLING; ADULT; ARTICLE; BREAST MILK; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG ACCUMULATION; DRUG CLEARANCE; DRUG HALF LIFE; DRUG LABELING; FATIGUE; FEMALE; FLATULENCE; HEADACHE; HUMAN; HUMAN EXPERIMENT; LACTATION; LIMIT OF DETECTION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; MIGRAINE; MILK LEVEL; MULTIPLE DRUG DOSE; MYALGIA; NAUSEA; NORMAL HUMAN; OPEN STUDY; PARALLEL DESIGN; RHINOPHARYNGITIS; SCLERA DISEASE; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; URINE LEVEL; VALIDATION PROCESS;

EID: 80055085548     PISSN: 13474367     EISSN: 18800920     Source Type: Journal    
DOI: 10.2133/dmpk.DMPK-11-RG-007     Document Type: Article

References (21)

1. Longstreth, G. F., Thompson, W. G., Chey, W. D., Houghton, L. A., Mearin, F. and Spiller, R. C.: Functional bowel disorders. Gastroenterology, 130(5): 1480-1491 (2006).
2. Johanson, J. F., Sonnenberg, A. and Koch, T. R.: Clinical epidemiology of chronic constipation. J. Clin. Gastroenterol., 11: 525-536 (1989).
3. Locke, G. R., III, Pemberton, J. H. and Phillips, S. F.: AGA technical review on constipation. Gastroenterology, 119: 1766-1778 (2000).
4. Higgins, P. D. R. and Johanson, J. F.: Epidemiology of constipation in North America: a systematic review. Am. J. Gastroenterol., 99: 750-759 (2004).
5. Brandt, L. J., Prather, C. M., Quigley, E. M. M., Schiller, L. R., Schoenfeld, P. and Talley, N. J.: Systematic review on the management of chronic constipation in North America. Am. J. Gastroenterol., 100: S5-S21 (2005).
6. Drossman, D. A., Sandler, R. S. and McKee, D. C.: Bowel patterns among subjects not seeking health care. Use of a questionnaire to identify a population with bowel dysfunction. Gastroenterology, 83: 529-534 (1982).
7. Drossman, D. A., Li, Z., Andruzzi, E., Temple, R. D., Talley, N. J., Thompson, W. G., Whitehead, W. E., Janssens, J., Funch-Jensen, P., Corazziari, E., Richter, J. E. and Koch, G. G.: U.S. household survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig. Dis. Sci., 38: 1569-1580 (1993).
8. Wald, A., Scarpignato, C. and Mueller-Lissner, S. et al.: A multinational survey of prevalence and patterns of laxative use among adults with self-defined constipation. Aliment Pharmacol Ther., 28: 917-930 (2008).
9. Stewart, W. F., Liberman, J. N., Sandler, R. S., Woods, M. S., Stemhagen, A., Chee, E., Lipton, R. B. and Farup, C. E.: Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am. J. Gastroenterol., 94: 3530-3540 (1999).
10. Talley, N. J., Weaver, A. L., Zinsmeister, A. R. and Melton, L.J., 3rd: Functional constipation and outlet delay: a population-based study. Gastroenterology, 105: 781-790 (1993).
11. Everhart, J. E., Go, V. L. W. and Johannes, R. S. et al.: A longitudinal survey of self-reported bowel habits in the United States. Dig. Dis. Sci., 34: 1153-1162 (1989).
12. Ramkumar, D. and Rao, S. S. C.: Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am. J. Gastroenterol., 100: 936-971 (2005).
13. Jauch, R., Hankwitz, R. and Besche, K. et al.: Bis-(p-hydroxyphenyl)-pyridyl-2-methane: the common laxative principle of bisacodyl and sodium picosulfate. Arzneimittelforschung, 25(11): 1796-1800 (1975).
14. Kim, D. H., Hyun, S. H., Shim, S. B. and Kobashi, K.: The role of intestinal bacteria in the transformation of sodium picosulfate. Jpn. J. Pharmacol., 59(1): 1-5 (1992).
15. Roth, W. and Beschke, K.: Pharmakokinetik und laxierende Wirkung von bisacodyl nach Gabe verschiedener Zubereitungs-formen. [Pharmacokinetics and laxative effect of bisacodyl following administration of various dose forms]. Arzneimittelforschung, 38(4): 570-574 (1988).
16. Sund, R. B., Roland, M., Kristiansen, S. and Salvesen, B.: Biliary excretion of bisacodyl and picosulfate in man: studies in gallstone patients after biliary tract surgery. Acta Pharmacol. Toxicol. (Copenh), 50(1): 50-57 (1982).
17. Faber, P. and Strenge-Hesse, A.: Relevance of rhein excretion into breast milk. Pharmacology, 36 suppl 1: 212-220 (1988).
18. Perego, R., Martinelli, E., Vanoni, P. C., Bonardi, G. and Coppi, G.: On the metabolic disposition of sodium picosulfate in rats. Arzneimittelforschung, 19: 1889-1890 (1969).
19. Jauch, R., Hammer, R., Busch, U., Kopitar, Z., Ohnuma, N. and Niki, T.: Pharmacokinetics and metabolism of sodium picosulfate in the rat. Arzneimittelforschung, 27: 1045-1050 (1977).
20. Flig, E., Hermann, T. W. and Zabel, M.: Is bisacodyl absorbed at all from suppositories in man? Int. J. Pharm., 196(1): 11-20 (2000).
21. Weist, F. R.: Drug levels of a new laxative in human milk. Med. Monatsschr., 26(11): 534-535 (1972).