Abstract
Purpose 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 50 mg dose of LTG (stable labeled) was given intravenously and replaced 50 mg 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. Conclusion 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 390-392 |
| Number of pages | 3 |
| Journal | Seizure |
| Volume | 23 |
| Issue number | 5 |
| DOIs | |
| State | Published - Jan 1 2014 |
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Keywords
- Cyclodextrin
- Epilepsy
- Intravenous
- Lamotrigine
- Safety
Cite this
Safety of an intravenous formulation of lamotrigine. / Conway, Jeannine M; Birnbaum, Angela K; Leppik, Ilo E; Pennell, Page B.; White, James R.; Rarick, John O.; Remmel, Rory P.
In: Seizure, Vol. 23, No. 5, 01.01.2014, p. 390-392.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety of an intravenous formulation of lamotrigine
AU - Conway, Jeannine M
AU - Birnbaum, Angela K
AU - Leppik, Ilo E
AU - Pennell, Page B.
AU - White, James R.
AU - Rarick, John O.
AU - Remmel, Rory P
PY - 2014/1/1
Y1 - 2014/1/1
N2 - Purpose 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 50 mg dose of LTG (stable labeled) was given intravenously and replaced 50 mg 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. Conclusion 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.
AB - Purpose 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 50 mg dose of LTG (stable labeled) was given intravenously and replaced 50 mg 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. Conclusion 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.
KW - Cyclodextrin
KW - Epilepsy
KW - Intravenous
KW - Lamotrigine
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=84899633987&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84899633987&partnerID=8YFLogxK
U2 - 10.1016/j.seizure.2014.01.019
DO - 10.1016/j.seizure.2014.01.019
M3 - Article
C2 - 24560492
AN - SCOPUS:84899633987
VL - 23
SP - 390
EP - 392
JO - Seizure : the journal of the British Epilepsy Association
JF - Seizure : the journal of the British Epilepsy Association
SN - 1059-1311
IS - 5
ER -