GABITRIL (tiagabine hydrochloride) Tablets Overview
GABITRIL is available in four dosage strengths:
2 mg, 4 mg, 12 mg, and 16 mg.
GABITRIL is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
Postmarketing reports have shown that GABITRIL use has been associated with new onset seizures and status epilepticus in patients without epilepsy.
Safety and effectiveness of GABITRIL have not been established for any indication other than as adjunctive therapy for partial seizures.
In nonepileptic patients who develop seizures while on GABITRIL treatment, GABITRIL should be discontinued and patients should be evaluated for an underlying seizure disorder.
Antiepileptic drugs (AEDs), including GABITRIL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
GABITRIL should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.
In clinical trials, 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 thinking abnormal/difficulty with concentration or attention.
Full Prescribing Information for GABITRIL.
For more information, call Cephalon at 1-800-896-5855.
