Description
Ethosuximide 250 Mg / 5 ML Syrup
1. Clinical information
1.1 Therapeutic indications
– Pyknoleptic absences as well as complex and atypical absences.
Myoclonic-astatic petite goods and myoclonic compatibility (impulsive petite goods) of adolescents if other medicinal products are not effective and / or not tolerated.
1.2 Posology and method of administration
Drug quantities information
Adults, elderly patients and children over 6 years old: Treatment is started at a daily dose of 500 mg.
Depending on the patient’s tolerance, the dose is max. Every five to seven days. Seizures are 250 mg until controlled with a daily dose of 1000-1500 mg. In an individual case, a daily dose of 2000 mg taken in several single doses may be required.
The therapeutic plasma level of ethosuximide is normally between 40 and 100 µg / ml. However, the dose depends on the clinical response of the patient. The half-life of ethosuximide in plasma is more than 24 hours, so the daily dose can be taken as a single dose, provided the medicinal product is well tolerated. However, higher daily doses should be taken in 2 or 3 single doses.
The probability of dose-dependent adverse effects can be reduced by careful dosing (small initial dose at the start of treatment, gradual increasing the dose) and taking the medicinal product during or after meals.
Anti-epileptic treatments are basically long-term treatments. A specialist (neurologist, neuropediatrist) must decide on the individual initiation, duration and discontinuation of ethosuximide.
In general, reducing the dose and discontinuation of the medicinal product should not be considered before the patient is free of compliance for 2-3 years.
The medicinal product should be cut gradually over a period of one to two years. Children may be allowed to exceed the dose per kilogram of body weight rather than adjusting the doses for their age, but EEC findings should be maintained.
Special populations
Hemodialysis patients
Etosuximide can be dialyzed. Hemodialysis patients therefore require an additional dose or a modified dosage regimen. During a four-hour dialysis period, 39% to 52% of the dose taken is subtracted.
Children-
Children under 2 years old:
Treatment is started at a daily dose of 125 mg (2.5 ml). Doses are gradually increased in small increments every few days until checked.
Children from 2 to 6 years old:
Treatment is started at a daily dose of 250 mg (5 ml). Doses are gradually increased in small increments every few days until checked.
The optimum daily dose for most children is 20 mg / kg. The maximum daily dose is 1000 mg.
Data from clinical studies on the use of ethosuximide in children and adolescents are described in section 5.1.
Method of Application
Ethosuximide Aristo is for oral use.
The solution can be taken during or after meals.
The package includes a 10 ml graduated oral syringe (0.5 ml steps) and an adapter for the oral syringe. A single dose of oral solution is drawn into the oral syringe to the required level and transferred to a glass of water or mixed with milk pudding. Alternatively, the oral solution can be administered directly into the mouth. Then the patient should drink half a glass of water.











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