Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans
The highest known dose of pregabalin received in the clinical development program in which there was no fatal outcome was 15,000 mg in 1 patient. The types of adverse events experienced by patients who received an overdose were not clinically different from other patients receiving recommended doses of pregabalin.
In post-marketing experience, fatal outcomes in cases in which pregabalin has been taken in combination with other medications have been reported with a pregabalin overdose as low as 800 mg in a day. In none of these cases has pregabalin been established as the cause of death or in pregabalin monotherapy. The lowest fatal dose with pregabalin alone has not yet been identified.
The most commonly reported adverse events observed when pregabalin was taken in overdose (dose range from 800 mg/day up to 11,500 mg as a single dose) included affective disorder, somnolence, confusional state, depression, agitation, and restlessness. Seizures were also reported.
Treatment or Management of Overdose
There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted 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 the clinical status of the patient. A Certified Poison Control Center should be contacted for up-to-date information on the management of overdose with pregabalin.
Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment.