Epistatus
Epistatus is a medicine used to stop long-lasting epileptic seizures in infants, young children, children, and adolescents aged 3 months to under 18 years.
Form
liuos suuonteloon
Strength
7.5 mg
Active Ingredient
Midazolam maleate
Manufacturer
SERB S.A.
How to Use
Dosage
The dose depends on the child's age: 3-6 months (in hospital) 2.5 mg (0.25 ml), >6 months to <1 year 2.5 mg (0.25 ml), 1-5 years 5 mg (0.5 ml), 5-10 years 7.5 mg (0.75 ml), 10-18 years 10 mg (1 ml).
Method
Epistatus is given into the mouth. Slowly squirt the solution onto the inner side of the cheek, between the gum and the cheek. The full dose is usually given in two parts, one half to one cheek lining and the other half to the other side.
Important
Do not give more than one dose without a doctor's instruction.
Possible Side Effects
COMMON
- •Drowsiness or loss of consciousness
- •Muscle spasms and tremors (uncontrolled muscle shaking)
- •Reduced attention
- •Headache
- •Dizziness
- •Nausea and vomiting
- •Tiredness
RARE
- •Severe breathing difficulties, such as slow or shallow breathing or blue lips. In very rare cases, breathing may stop.
- •Cardiac arrest; very rare. Symptoms include loss of consciousness and no pulse.
- •Swelling of the face, lips, tongue, or throat, making swallowing or breathing difficult; or pale skin, weak and rapid pulse, or feeling like losing consciousness. This could be a severe allergic reaction.
- •Agitation
- •Hallucinations (seeing or hearing things that are not real)
- •Temporary memory loss
- •Rash, hives (itchy rash), itching
- •Aggression
- •Difficulty with muscle coordination
- •Violence
- •Seizures (convulsions)
- •Restlessness
- •Low blood pressure
- •Slow heart rate
- •Redness of face and neck (flushing)
- •Shortness of breath
- •Constipation
- •Dry mouth
- •Hiccups
- •Rage
- •Confusion
- •Anger
- •Euphoria (excessive happiness or excitement)
- •Thrombosis (blood clot, blood clotting that forms a blockage inside a blood vessel)
- •Laryngospasm (tightening of the vocal cords, causing breathing difficulties and noisy breathing)
Important Warnings
- Do not give this medicine if the patient is allergic to midazolam, other benzodiazepines (like diazepam or nitrazepam), or any other ingredient in this medicine.
- Do not give this medicine if the patient has myasthenia gravis (a disease causing muscle weakness).
- Do not give this medicine if the patient has severe breathing difficulties (Epistatus can make breathing worse).
- Do not give this medicine if the patient has sleep apnea syndrome (which causes repeated breathing pauses during sleep).
- Do not give this medicine if the patient has severe liver problems.
Show 6 more warnings
- This medicine can cause temporary memory loss, so patients might not remember what happened after taking it. Parents or caregivers should carefully monitor patients after administration.
- Babies aged 3-6 months must be treated in a hospital where monitoring and resuscitation equipment are available.
- Using this medicine with strong pain relievers (opioids) can be life-threatening, increasing the risk of severe drowsiness, breathing problems, and coma.
- Do not drink alcohol during Epistatus treatment. Alcohol can increase the sedative effect and make the patient very drowsy.
- Do not drink grapefruit juice during Epistatus treatment, as it can increase the sedative effect.
- This medicine greatly affects the ability to drive or operate machinery. Do not drive or operate machines until fully recovered.