GABITRIL Epilepsy

Preclinical data suggest that GABA action prevents the propagation of neural impulses that contribute to seizures
The precise mechanism by which GABITRIL exerts its antiseizure effect in humans is unknown

In both studies, patients were receiving one or more hepatic enzyme-inducing anticonvulsants at therapeutic concentrations

The mean number of concomitant anticonvulsants was two and the median number of anticonvulsants ever taken was six

BID shown to be as effective as QID dosing schedule in the dose-frequency study
GABITRIL is only indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Cephalon, Inc. does not recommend the use of GABITRIL for any other indication.
Adverse events were usually mild to moderate in intensity. The most common adverse events for GABITRIL in combination with other anticonvulsants* were: dizziness/lightheadedness,^† asthenia^†/lack of energy, somnolence, nausea, nervousness^†/irritability, tremor,^† abdominal pain and abnormal thinking/difficulty with concentration or attention^†
As with other anticonvulsants, GABITRIL should be withdrawn gradually to minimize the potential of increased seizure frequency unless safety concerns require a more rapid withdrawal
About 1% of GABITRIL-treated patients reported moderately severe to incapacitating generalized weakness that resolved after dose reduction or discontinuation
Initiate at 4 mg once daily

*	One to three concomitant hepatic enzyme-inducing anticonvulsants.
†	Dose or titration rate related.

Important Safety Update

References:
1.	GABITRIL package insert, Cephalon, Inc.
2.	Data on file, Cephalon, Inc.
3.	Uthman BM, Rowan J, Ahmann PA, et al. Tiagabine for complex partial seizures: a randomized, add-on, dose-response trial. Arch Neurol. 1998;55:56-62.
4.	Sachdeo RC, Leroy RF, Krauss GL, et al, for the Tiagabine Study Group. Tiagabine therapy for complex partial seizures: a dose-frequency study. Arch Neurol. 1998;54:595-601.