Loading…
EPISTATUS is a brand name for Midazolam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Epistatus is indicated for the treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and infants aged 3 months and above. Epistatus must only be used by parents / caregivers where the patient has been diagnosed to have epilepsy. For infants between 3-6 months of age treatment should be in…
Verbatim from this product's MHRA label. Tap a section to expand.
75 ml) Purple 10 years and above 10 mg (1 ml) Orange Carers should only administer a single dose of midazolam. If the seizure does not stop shortly after administration of midazolam, emergency medical assistance must be sought, taking into account prior instructions from the prescribing physician, or local guidelines.
The empty syringe must be given to the healthcare professional to provide information on the dose and product received by the patient. After receiving midazolam, patients should be kept under supervision by a carer who remains with the patient.
2). Special populations Renal Impairment No efficacy studies of midazolam in patients with chronic renal failure have been reported. 4). However, in the setting of treatment of an acute epileptic seizure with a single or 2 doses of midazolam, accumulation of parent drug or metabolite is unlikely to occur causing prolongation of clinically significant pharmacological effects.
Hepatic Impairment No efficacy studies of midazolam in patients with chronic hepatic impairment have been reported. Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal half-life. 4). 3). Obesity No efficacy studies of midazolam in obese patients have been reported.
. Critically Ill Patients No efficacy studies of midazolam in critically ill patients have been reported. Cardiac Insufficiency No efficacy studies of midazolam in patients with cardiac insufficiency have been reported. Paediatric population The safety and efficacy of midazolam in children aged 0 to 3 months has not been established.
No data are available. 4). Method of Administration Epistatus is for oromucosal use. It is only to be used in the mouth. Using the pre-filled oral syringe provided, administer, over a period of 2-3 seconds, approximately half of the prescribed dose to each buccal cavity (space between the gum and the cheek).
Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution. If it is particularly difficult to get the syringe into the buccal cavity, then administer the whole dose, over a period of 4-5 seconds, to one buccal cavity.
6.
Summary of the safety profile Published clinical studies show that oromucosal midazolam was administered to approximately 446 children with seizures. 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.
Tabulated list of adverse reactions The table below lists the adverse reactions reported to occur when oromucosal midazolam was administered to children in clinical studies and post marketing experiences.
The frequency of adverse reactions is classified as follows:
Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1,000 to < 1/100 Very rare: ≤ 1/10,000 Not known: cannot be estimated from the available data Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System Organ Class Frequency:
Adverse Drug Reaction Psychiatric disorders Uncommon: Hallucination*, agitation*, Very rare: Aggression*, movement disorders*, physical assault* Frequency not known: Anger*, confusional state*, hostility*, euphoric mood* Nervous system disorders Common: Sedation, somnolence, depressed levels of consciousness, respiratory depression, ataxia*, dizziness*, headache* Uncommon: Anterograde amnesia* Very rare: Seizure*, paradoxical reactions* Cardiac disorders Very rare: Bradycardia*, cardiac arrest*, hypotension*, vasodilatation* Blood and lymphatic system disorders Frequency not known: Thrombosis Respiratory, thoracic and mediastinal disorders Very rare: Apnoea*, dyspnoea* Frequency not known: laryngospasm*, respiratory arrest* Gastrointestinal disorders Common: Nausea and vomiting Very rare: Constipation*, dry mouth* Skin and subcutaneous tissue disorders Uncommon: Pruritus, rash and urticaria Not known: Angioedema** General disorders and administration site conditions Common: Fatigue* Very rare: Hiccups* Immune system disorders Not known: Anaphylactic reaction* *These adverse reactions have been reported to occur when midazolam is injected in children and/or adults, which may be of relevance to oromucosal administration.
Paediatric patients aged 3 to 6 months Given the higher metabolite to parent drug ratio in younger children, a delayed respiratory depression as a result of high active metabolite concentrations in the 3-6 months age group cannot be excluded.
Therefore, the use of Epistatus in the 3-6 month age group should be limited for use only under the supervision of a health care professional where resuscitation equipment is available and where respiratory function can be monitored and equipment for respiratory assistance, if needed, is available.
Elderly patients In elderly patients the effects of midazolam can be enhanced and the duration can be prolonged.
Respiratory insufficiency:
Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration.
Altered elimination of midazolam:
Midazolam should be used with caution in elderly patients and patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
5).
Risk from concomitant use of opioids:
Concomitant use of Epistatus and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Epistatus with opioids should be reserved for patients for whom alternative treatment options are not possible.
If a decision is made to prescribe Epistatus concomitantly with opioids, the lowest effective dose and the shortest possible duration of opioids should be used. The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
1. Myasthenia gravis. Severe respiratory insufficiency. Sleep apnoea syndrome. Severe hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Midazolam in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
**ADR identified post-marketing. Description of selected adverse reactions There have been reports of falls and fractures in benzodiazepine users. The risk of falls and fractures is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5).
Medical history of alcohol and drug abuse:
Midazolam should be avoided in patients with a medical history of alcohol or drug abuse.
Amnesia:
Midazolam may cause anterograde amnesia.
Excipients of known effect:
MALTITOL Epistatus contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. 5 mg oromucosal solution contains 148 mg ethanol in each dose. The amount per dose is equivalent to less than 4 ml beer or 2 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects. SODIUM Epistatus contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.