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Gabitril

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Gabitril

OVERDOSE

Human Overdose Experience

Human experience of acute overdose with GABITRIL (tiagabine hydrochloride) is limited. Eleven patients in clinical trials took single doses of GABITRIL (tiagabine hydrochloride) up to 800 mg. All patients fully recovered, usually within one day. The most common symptoms reported after overdose included somnolence, impaired consciousness, agitation, confusion, speech difficulty, hostility, depression, weakness, and myoclonus. One patient who ingested a single dose of 400 mg experienced generalized tonic-clonic status epilepticus, which responded to intravenous phenobarbital.

From post-marketing experience, there have been no reports of fatal overdoses involving GABITRIL (tiagabine hydrochloride) alone (doses up to 720 mg), although a number of patients required intubation and ventilatory support as part of the management of their status epilepticus. Overdoses involving multiple drugs, including GABITRIL (tiagabine hydrochloride) , have resulted in fatal outcomes. Symptoms most often accompanying GABITRIL (tiagabine hydrochloride) overdose, alone or in combination with other drugs, have included: seizures including status epilepticus in patients with and without underlying seizure disorders, nonconvulsive status epilepticus, coma, ataxia, confusion, somnolence, drowsiness, impaired speech, agitation, lethargy, myoclonus, spike wave stupor, tremors, disorientation, vomiting, hostility, and temporary paralysis. Respiratory depression was seen in a number of patients, including children, in the context of seizures.

Management of Overdose

There is no specific antidote for overdose with GABITRIL (tiagabine hydrochloride) . If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of clinical status of the patient. Since tiagabine is mostly metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial. A Certified Poison Control Center should be consulted for up to date information on the management of overdose with GABITRIL (tiagabine hydrochloride) .

CONTRAINDICATIONS

GABITRIL (tiagabine hydrochloride) is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Last reviewed on RxList: 11/5/2010
This monograph has been modified to include the generic and brand name in many instances.

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