Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764, Langenfeld, Germany
The treatment is started at a daily dose of 500 mg.
Depending on the patient’s tolerance, the dose is increased every five to seven days in increments of max. 250 mg until the seizures are controlled by 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 patient’s clinical response. The half-life of ethosuximide in plasma is more than 24 hours so that the daily dose can be taken as a single dose provided the medicinal product is well tolerated. Higher daily doses should be taken in 2 or 3 single doses, however.
The probability of dose-dependent undesirable effects can be reduced by careful dosing (small initial dose at the start of treatment, gradual increase of dose) and by taking the medicinal product during or after meals.
Anti-epileptic therapies are principally long-term therapies. A specialist (neurologist, neuropaediatrician) should decide about the start, duration and discontinuation of ethosuximide on an individual basis.
In general, reduction of the dose and discontinuation of the medicinal product should not be considered before the patient has been free from fits for 2-3 years.
The medicinal product must be discontinued by reducing the dose gradually over a period of one to two years. Children may be allowed to outgrow the dose per kg body weight instead of adjusting the dose according to their age, however, it must be ensured that the EEC findings do not deteriorate.
Ethosuximide is dialysable. Haemodialysis patients therefore require a supplementary dose or a modified dose regimen. During a dialysis period of four hours, 39% to 52% of the dose taken is removed.
Children under 2 years:
The treatment is started at a daily dose of 125 mg (2.5 ml). The dose is increased gradually in small increments every few days until the fits are controlled.
Children between 2 and 6 years:
The treatment is started at a daily dose of 250 mg (5 ml). The dose is increased gradually in small increments every few days until the fits are controlled.
The optimum daily dose for most children is 20 mg/kg. The maximum daily dose is 1000 mg.
The data available from clinical studies of the use of ethosuximide in children and adolescents are described in section 5.1.
Ethosuximide is for oral use.
The solution can be taken during or after meals.
The pack contains a 10 ml graduated oral syringe (0.5 ml steps) and an adapter for the oral syringe. A single dose of the oral solution is drawn into the oral syringe up to the required level and transferred into a glass of water or mixed with milk pudding. Alternatively, the oral solution can directly be applicated into the mouth. Afterwards, the patient should drink half a glass of water.
Whenever evaluating an overdose, potential multiple intoxication should principally not be excluded e.g. several medicinal products have been taken with a suicidal intent. The symptoms of overdose are potentiated under the influence of alcohol and other CNS depressants.
Ethosuximide has a low toxicity. The symptoms listed as undesirable effects such as tiredness, lethargy, depression and agitation, also irritability, are more frequent or severe in the case of intoxication.
If intoxication is suspected, it is recommended to determine the plasma concentration of the antiepileptics.
Significant overdoses require initial gastric lavage and the administration of activated charcoal as well as monitoring of the cardiovascular and respiratory systems in an intensive care unit. There is no specific antidote. Haemodialysis may be useful.
Shelf life: 36 months.
After first opening: 3 months.
This medical product does not require any special storage conditions.
Brown glass bottle (glass type III) with screw cap (polypropylene/polyethylene).
Packs of 125 ml or 250 ml (2 × 125 ml) oral solution in a carton containing also a 10 ml graduated oral syringe, graduated in 0.5 ml steps and an adapter for the oral syringe.
Not all pack sizes may be marketed.
No special requirements.
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