Abstracts

REPEAT AND INDIVIDUALIZED DOSING INSTRUCTIONS WITH DIAZEPAM RECTAL GEL

Abstract number : 2.273
Submission category :
Year : 2004
Submission ID : 762
Source : www.aesnet.org
Presentation date : 12/2/2004 12:00:00 AM
Published date : Dec 1, 2004, 06:00 AM

Authors :
1Anthony Marmarou, and 2John M. Pellock

Diazepam rectal gel, the only antiepilepsy medication approved by the Food and Drug Administration for the at-home treatment of breakthrough seizures by medically trained as well as nonmedically trained caretakers, has demonstrated efficacy and safety. Dosing guidelines are based on patient age and weight; few adverse events have been reported even in cases where the recommended dosage was exceeded. Because underdosing may pose a greater health risk than overdosing, a higher dose may be the better option for some patients whose age and weight falls at the upper limit of a dosage category. In some instances seizures may not resolve with the first dose of diazepam rectal gel, and repeat dosing may be beneficial. Individualized and repeat dosing represent 2 important components for providing effective seizure management. We surveyed epilepsy specialists to determine how they instruct patients regarding repeat and individualized dosing of diazepam rectal gel. Members of the International Epilepsy Consortium were surveyed to obtain information about their clinical experience with diazepam rectal gel. The survey was sent to 41 epilepsy centers and included questions about individualized and repeat dosing instructions for diazepam rectal gel. Fourteen centers responded, representing information from 34 epileptologists. Thirteen of 14 centers reported following the dosing recommendations in the diazepam rectal gel package insert, with 1 center consistently dosing higher. Of the centers that followed insert dosing recommendations, however, 43% also developed individualized dosing regimens for some patients. In total, 6 sites reported using higher doses and 5 sites lower ones, including 1 center that reported using lower doses for patients receiving chronic benzodiazepines. Fifty-eight per cent of responding centers instructed caregivers to administer a second dose of diazepam rectal gel if the first dose was ineffective; only 1 center specifically instructed caregivers not to give a repeat dose. The time period between administration of first and second doses of diazepam rectal gel varied among respondents. If seizure activity persisted, the time ranged from 10 to 30 minutes after the initial dose; the average recommended time was 15 minutes. If the first dose did not stop the seizure, 71% of centers advised seeking emergency medical attention regardless of whether a second dose was given. Four centers recommended that both a second dose be administered and that emergency medical treatment be sought as an additional precaution. The results of this survey indicate that individualized dosing of diazepam rectal gel is practiced by epilepsy specialists. Together with repeat dosing, diazepam rectal gel can provide significant contributions to effective seizure management. (Supported by Xcel Pharmaceuticals)