DIASTAT® AcuDial™
Indication
Diastat® AcuDial™ (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increases seizure activity.
Product Description
Diastat® AcuDial™ is indicated for the treatment of selected, refractory patients with epilepsy, on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity, for patients two years and older. Diastat ® AcuDial™ has been established through extensive research and clinical use in more than 1 million patients experiencing seizure emergencies.
Availability
- United States
- Canada
Important Safety Information
Diazepam rectal gel should only be administered by caregivers who in the opinion of the prescribing physician 1) are able to distinguish the distinct cluster of seizures (and/or the events presumed to herald their onset) from the patient’s ordinary seizure activity, 2) have been instructed and judged to be competent to administer the treatment rectally, 3) understand explicitly which seizure manifestations may or may not be treated with diazepam rectal gel, and 4) are able to monitor the clinical response and recognize when that response is such that immediate professional medical evaluation is required.
Diastat® is a Schedule IV controlled substance and it is recommended that patients be treated with diazepam rectal gel no more frequently than every five days and no more than five times per month.
In clinical trials with Diastat®, the most frequent adverse event was somnolence (23%). Less frequent adverse events reported were dizziness, headache, pain, vasodilation, diarrhea, ataxia, incoordination, asthma, rash, abdominal pain, nervousness, and rhinitis (1-5%).