Sabril (Vigabatrin Oral Solution) Drug Information: Overdosage and Contraindications

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May 27, 2012

Sabril

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Introduction

Few experiences match the drama of a convulsive seizure. A person having a severe seizure may cry out, fall to the floor unconscious, twitch or move uncontrollably, drool, or even lose bladder control. Within minutes, the attack is over, and the person regains consciousness but is exhausted and dazed. This is the image most people have when they hear the word epilepsy. However, this type of seizure -- a generalized tonic-clonic seizure -- is only one kind of epilepsy. There are many other kinds, each with a different set of symptoms.

Epilepsy was one of the first brain disorders to be described. It was mentioned in ancient Babylon more than 3,000 years ago. The strange behavior caused by some seizures has contributed through the ages to many superstitions and prejudices. The word epilepsy is derived from the Greek word for "attack." People once thought that those with epilepsy were being visited by demons or gods. However, in 400 B.C., the early...

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OVERDOSE

Signs, Symptoms, and Laboratory Findings of Overdosage

Confirmed and/or suspected vigabatrin overdoses have been reported during clinical trials and in post marketing surveillance. No vigabatrin overdoses resulted in death. When reported, the vigabatrin dose ingested ranged from 3 g to 90 g, but most were between 7.5 g and 30 g. Nearly half the cases involved multiple drug ingestions including carbamazepine, barbiturates, benzodiazepines, lamotrigine, valproic acid, acetaminophen, and/or chlorpheniramine.

Coma, unconsciousness, and/or drowsiness were described in the majority of cases of vigabatrin overdose. Other less commonly reported symptoms included vertigo, psychosis, apnea or respiratory depression, bradycardia, agitation, irritability, confusion, headache, hypotension, abnormal behavior, increased seizure activity, status epilepticus, and speech disorder. These symptoms resolved with supportive care.

Treatment or Management for Overdosage

There is no specific antidote for SABRIL (vigabatrin oral solution) overdose. Standard measures to remove unabsorbed drug should be used, including elimination by emesis or gastric lavage. Supportive measures should be employed, including monitoring of vital signs and observation of the clinical status of the patients.

In an in vitro study, activated charcoal did not significantly adsorb vigabatrin.

The effectiveness of hemodialysis in the treatment of SABRIL (vigabatrin oral solution) overdose is unknown. In isolated case reports in renal failure patients receiving therapeutic doses of vigabatrin, hemodialysis reduced vigabatrin plasma concentrations by 40% to 60%.