Aethosuximide Other names: Ethosuccimide Ethosuxide Ethosuccinimide Etosuximida Ethosuximide

The treatment with ethosuximide should not be interrupted during pregnancy without the consent of a physician as the sudden discontinuation of the treatment or uncontrolled reduction of the dose may result in recurrence of epileptic seizures which may harm the pregnant woman and/or the unborn child. Ethosuximide crosses the placenta. Studies in animals have shown reproductive toxicity. Specific congenital malformations have not been observed in children of mothers exposed to ethosuximide monotherapy during pregnancy. The risk of malformations during anti-epileptic therapy is increased by a factor of 2 to 3 compared to the expected incidence of about 3% in the general population. Most common malformations reported are cleft lip, cardiovascular malformations and neural tube defects. Multiple antiepileptic drug therapies are associated with a higher risk of congenital malformation so that monotherapy should be practised during pregnancy whenever possible.

Patients should be informed of the increased risk of malformations and prenatal diagnostic measures should be offered.

The lowest effective dose ensuring seizure control must not be exceeded, particularly during the 20th and 40th day of pregnancy. The ethosuximide serum concentration of the pregnant woman must be regularly monitored.

Folic acid supplementation is recommended in patients planning to have a baby and during pregnancy. To prevent vitamin K1 deficiency and reduce the risk for haemorrhages in newborn infants, women should be given vitamin K1 during the last month of pregnancy.

Ethosuximide is excreted into breast milk reaching concentrations up to 94% of the maternal serum concentrations. Sedation, poor suckling and irritability have been observed in individual breast-fed infants.

Breast-feeding should be discontinued during treatment with ethosuximide.

Women of childbearing potential

Women of childbearing potential should be advised by their doctor of the necessity of planning and monitoring a pregnancy before starting the treatment with ethosuximide. Patients should be advised to tell their doctor immediately if they have become pregnant during the treatment.

During the adjustment phase, at higher doses and in combination with other medicinal products affecting the central nervous system reactivity can be impaired to an extent that the ability to drive or operate machines is affected. This may even be the case when ethosuximide is taken as prescribed, and especially in connection with alcohol.

Therefore patients should not drive, operate machines or perform any other potentially hazardous activities, at least not during the adjustment phase of the treatment. The decision will be taken in each case by the attending doctor considering the patient’s individual response and the respective dose.