Comparing the pharmacokinetics of doxylamine/pyridoxine delayed-release combination in nonpregnant women of reproductive age and women in the first trimester of pregnancy.

MedStar author(s):
Citation: Journal of Clinical Pharmacology. 53(3):334-8, 2013 Mar.PMID: 23444286Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Antiemetics/pk [Pharmacokinetics] | *Doxylamine/pk [Pharmacokinetics] | *Pregnancy/me [Metabolism] | *Pyridoxine/pk [Pharmacokinetics] | Adolescent | Adult | Antiemetics/ad [Administration & Dosage] | Antiemetics/bl [Blood] | Delayed-Action Preparations/ad [Administration & Dosage] | Delayed-Action Preparations/pk [Pharmacokinetics] | Double-Blind Method | Doxylamine/ad [Administration & Dosage] | Doxylamine/bl [Blood] | Drug Combinations | Female | Humans | Middle Aged | Pregnancy Trimester, First/me [Metabolism] | Pyridoxine/ad [Administration & Dosage] | Pyridoxine/bl [Blood] | Young AdultLocal holdings: Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0091-2700
Name of journal: Journal of clinical pharmacologyAbstract: Although Diclectin (doxylamine/pyridoxine delayed-released combination) is widely used in Canada, its pharmacokinetics (PK) during pregnancy has never been described. The objective of this study was to compare the PK of doxylamine/pyridoxine delayed-released combination in pregnant versus nonpregnant women. The apparent clearances (CL) of doxylamine and pyridoxal 5'-phosphate (PLP; the active metabolite of vitamin B(6) ) during the first-trimester pregnancy in women who participated in a Diclectin randomized trial were compared with those of healthy, adult, nonpregnant women who participated in a voluntary PK trial. Eighteen nonpregnant women were compared with 50 pregnant women who were treated with Diclectin. There was no difference in the apparent CL of doxylamine in women in their first trimester of pregnancy when compared with nonpregnant women on day 4 (median = 196.7 vs 249.5 mL/h/kg, respectively, P = .065), day 8 (median = 248.4 vs 249.5 mL/h/kg, respectively, P = .82), and day 15 (median = 200.9 vs 249.5 mL/h/kg, respectively, P = .55). No difference was found in the apparent CL of PLP on day 15 (median = 342.3 vs 314.7 mL/h/kg, respectively, P = .92). There was no pregnancy-induced effect in the apparent CL of either doxylamine or PLP in women during the first trimester of pregnancy despite the existence of morning sickness. The Author(s) 2013.All authors: Caritis S, Clark S, Hankins G, Koren G, Matok I, Miodovnik M, Umans JDigital Object Identifier: Date added to catalog: 2013-09-17
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article Available 23444286

Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2006

Although Diclectin (doxylamine/pyridoxine delayed-released combination) is widely used in Canada, its pharmacokinetics (PK) during pregnancy has never been described. The objective of this study was to compare the PK of doxylamine/pyridoxine delayed-released combination in pregnant versus nonpregnant women. The apparent clearances (CL) of doxylamine and pyridoxal 5'-phosphate (PLP; the active metabolite of vitamin B(6) ) during the first-trimester pregnancy in women who participated in a Diclectin randomized trial were compared with those of healthy, adult, nonpregnant women who participated in a voluntary PK trial. Eighteen nonpregnant women were compared with 50 pregnant women who were treated with Diclectin. There was no difference in the apparent CL of doxylamine in women in their first trimester of pregnancy when compared with nonpregnant women on day 4 (median = 196.7 vs 249.5 mL/h/kg, respectively, P = .065), day 8 (median = 248.4 vs 249.5 mL/h/kg, respectively, P = .82), and day 15 (median = 200.9 vs 249.5 mL/h/kg, respectively, P = .55). No difference was found in the apparent CL of PLP on day 15 (median = 342.3 vs 314.7 mL/h/kg, respectively, P = .92). There was no pregnancy-induced effect in the apparent CL of either doxylamine or PLP in women during the first trimester of pregnancy despite the existence of morning sickness. The Author(s) 2013.

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