Intended for UK Healthcare Professionals.
The prescribing information link and adverse event reporting statement are found at the bottom of this page.
Intended for UK Healthcare Professionals.
The prescribing information link and adverse event reporting statement are found at the bottom of this page.
Posology and indication
The active ingredient in Epistatus® is oromucosal midazolam (as maleate).1 Epistatus® is indicated for the treatment of prolonged, acute, convulsive seizures in adults, infants, children and adolescents aged 3 months and above*. Epistatus® must only be used by parents / caregivers where the patient has been diagnosed to have epilepsy.1
*For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available
Mechanism of action
Formulation and presentation
Epistatus® is a sweetened, sugar-free, slightly viscous midazolam formulation designed for oromucosal administration.1 Epistatus® is presented in a single-unit pack for prescribing flexibility, which can be tailored to prolonged, acute, convulsive seizure frequency for individualised patient treatment.4
References:
UK-EPI-2400075
Date of Preparation: November 2024
Epistatus® is a sweetened, sugar-free, slightly viscous midazolam formulation. It is a pre-filled syringe with a smooth, rounded tip to protect the delicate oral mucosa, and a bite-resistant plastic polymer.1
Epistatus® 10 mg dose1
Portable design1
The device is housed within a tough yet lightweight outer casing that is both protective and tamper-evident1
Prescribing flexibility1,2
Single-unit pack can be tailored to prolonged, acute, convulsive seizure frequency for individualised patient treatment2
References:
UK-EPI-2400075
Date of Preparation: November 2024
Epistatus® should be used exactly as directed by the doctor or epilepsy nurse. If the instructions on this page are different from what is written in the care plan, always follow the care plan instructions.
Epistatus® is for oromucosal (“buccal”) use only, and must only be used in the mouth. It should be administered directly from the pre-filled buccal syringe into the patient’s buccal cavity (the space between the inner cheek and the gums):1
As soon as the person’s seizure starts, make a note of the time.
Place something soft under the head for protection and support. Locate the person’s Epistatus® and continue timing the seizure. If it goes on for 5 minutes or more, Epistatus® should be administered.
Check the medication for the expiry date, and do not use if the solution is not clear (e.g. cloudy or white particles present).
Unscrew the amber cap/sheath.
Pull back the cheek and insert into the space between the cheek and teeth (buccal cavity). Do not put in between teeth.
Administer medicine slowly, 2-3 seconds in each cheek, or just into one over 4-5 seconds if difficulty in accessing one buccal cavity.
Dispose of the syringe and cap safely.
Put the person into the recovery
position once the seizure has finished.
Note the time. If the person’s seizure doesn’t stop within 5 minutes of giving Epistatus®, call an ambulance.
Record what happened in the person’s care plan.
How to administer
After receiving Epistatus®, patients should be kept under supervision by a carer. If the seizure does not stop shortly after administration or the condition improves but the seizure starts again, call an ambulance, taking into account instructions from the care plan and their doctor.
A second dose of Epistatus® should not be given without medical advice.
This video is also available for patients and carers to access directly via the Epistatus® patient website, accessible here. This website has been produced by SERB Pharmaceuticals as an educational resource for patients / carers who have been prescribed Epistatus. To email your patient a copy of the Patient Website’s URL and, please here.
To download the video, please contact SERB Pharmaceuticals via Epistatus@serb.com
References:
UK-EPI-2400075
Date of Preparation: November 2024
Epistatus® patient website
The Epistatus® patient website contains useful patient resources, including general information about epilepsy along with reference information and training materials that are specific to Epistatus®. There is also a special section for children with a younger reading age. Please note that due to the presence of product-specific information, this website is only suitable for patients, and their parents or carers, who currently have a prescription for Epistatus®.
This website is produced and provided as an educational resource for patients, and their parents or carers, and carers by SERB Pharmaceuticals, and is accessible here. To email your patient a copy of the Patient Website’s URL please click here.
UK-EPI-2400075
Date of Preparation: November 2024
Established efficacy in treatment of prolonged, acute, convulsive seizures (PACS) in adult patients1,2
Data supporting the efficacy of Epistatus® oromucosal solution midazolam in the treatment of acute seizures is derived from bibliographic sources. The efficacy of oromucosal midazolam is comparable to diazepam.1
In a retrospective observational study of adults from four UK secondary-care outpatient clinics who needed emergency treatment of an epileptic seizure (mainly generalised tonic/clonic [72.6%] or focal [13.0%]):
Clinical safety profile information
The safety profile of midazolam was comparable to rectal diazepam in published clinical trials. Respiratory depression occurs at a rate of up to 5% although this is a known complication of convulsive seizures as well as being related to benzodiazepine use.1
Please consult the SmPC for the full list of adverse drug reactions before prescribing.
References:
Shankar, R. et al. (2021) ‘Oro-mucosal midazolam maleate: Use and effectiveness in adults with epilepsy in the UK’, Epilepsy Behavior, 123, p. 108242.
UK-EPI-2400075
Date of Preparation: November 2024
Epistatus® in Paediatric Care
Access
Resources
