title: Safety of an intravenous formulation of lamotrigine.
abstract: OBJECTIVE
  Intravenous (IV) formulations are useful when treating patients where oral administration is not possible and to study certain pharmacokinetic parameters such as bioavailability. We developed a stable-labeled IV formulation of lamotrigine (LTG) for studying pharmacokinetics in epilepsy patients.
  
  
  METHODS
  Stable-labeled IV LTG was given to 20 persons with epilepsy (6 men; 14 women) with a mean age of 34.8 years (SD 11.7). A 50mg dose of LTG (stable labeled) was given intravenously and replaced 50mg of the regular morning oral dose of LTG (unlabeled, commercially available formulation).
  
  
  RESULTS
  No significant changes in blood pressure, heart rate, or adverse events including rash were attributed to administration of a 50-mg dose of the intravenous LTG formulation.
  
  
  CONCLUSIONS
  Our results show that LTG base that is complexed with 2-hydroxypropyl-β-cyclodextrin and stable-labeled can be given safely as a tracer replacement dose.
authors.affiliation: Experimental and Clinical Pharmacology, 308 Harvard Street SE, Minneapolis, MN 55455, United States.
authors.forename: Jeannine M
authors.initials: JM
authors.lastname: Conway
authors.affiliation: Experimental and Clinical Pharmacology, 308 Harvard Street SE, Minneapolis, MN 55455, United States. Electronic address: birnb002@umn.edu.
authors.forename: Angela K
authors.initials: AK
authors.lastname: Birnbaum
authors.affiliation: Experimental and Clinical Pharmacology, 308 Harvard Street SE, Minneapolis, MN 55455, United States; Department of Neurology, 420 Delaware St. SE, University of Minnesota, Minneapolis, MN 55455, United States; MINCEP Epilepsy Care, 5775 Wayzata Boulevard, Minneapolis, MN 55416, United States.
authors.forename: Ilo E
authors.initials: IE
authors.lastname: Leppik
authors.affiliation: Department of Neurology and Division of Women's Health at Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, United States.
authors.forename: Page B
authors.initials: PB
authors.lastname: Pennell
authors.affiliation: MINCEP Epilepsy Care, 5775 Wayzata Boulevard, Minneapolis, MN 55416, United States.
authors.forename: James R
authors.initials: JR
authors.lastname: White
authors.affiliation: Experimental and Clinical Pharmacology, 308 Harvard Street SE, Minneapolis, MN 55455, United States.
authors.forename: John O
authors.initials: JO
authors.lastname: Rarick
authors.affiliation: Department of Medicinal Chemistry, 308 Harvard Street SE, University of Minnesota, Minneapolis 55455, MN, United States.
authors.forename: Rory P
authors.initials: RP
authors.lastname: Remmel
mesh_terms: D000073738:2-Hydroxypropyl-beta-cyclodextrin; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D014227:Triazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult; D047392:beta-Cyclodextrins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000927:Anticonvulsants; D014227:Triazines; D047392:beta-Cyclodextrins; D000073738:2-Hydroxypropyl-beta-cyclodextrin; D000077213:Lamotrigine
keywords: Cyclodextrin; Epilepsy; Intravenous; Lamotrigine; Safety