Women of child-bearing potential and contraceptive measures: Oxcarbazepine may result in a failure of the therapeutic effect of oral contraceptive drugs containing ethinylestradiol (EE) and levonorgestrel (LNG) (see Precautions and Interactions). Women of child bearing potential should be advised to use highly effective contraception (preferably non-hormonal; e.g. intrauterine implants) while on treatment with Oxcarbazepine.
Pregnancy: Risk related to epilepsy and antiepileptic medicinal products in general: In the treated population, an increase in malformations has been noted with polytherapy, particularly in polytherapy including valproate.
Moreover, effective anti-epileptic therapy must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Risk related to oxcarbazepine: There is moderate amount of data on pregnant women (300-1000 pregnancy outcomes). However, the data on oxcarbazepine associated with congenital malformation is limited. There is no increase in the total rate of malformations with Oxcarbazepine as compared with the rate observed in the general population (2-3%). Nevertheless, with this amount of data, a moderate teratogenic risk cannot be completely excluded.
Taking these data into consideration: If women receiving Oxcarbazepine become pregnant or plan to become pregnant, the use of this product should be carefully re-evaluated. Minimum effective doses should be given, and monotherapy whenever possible should be preferred at least during the first three months of pregnancy.
During pregnancy, an effective antiepileptic oxcarbazepine treatment must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Monitoring and prevention: Some antiepileptic medicinal products may contribute to folic acid deficiency, a possible contributory cause of foetal abnormality. Folic acid supplementation is recommended before and during pregnancy. As the efficacy of this supplementation is not proved, a specific antenatal diagnosis should be offered even for women with a supplementary treatment of folic acid.
Data from a limited number of women indicate that plasma levels of the active metabolite of oxcarbazepine, the 10-monohydroxy derivative (MHD), may gradually decrease throughout pregnancy. It is recommended that clinical response should be monitored carefully in women receiving Oxcarbazepine treatment during pregnancy to ensure that adequate seizure control is maintained. Determination of changes in MHD plasma concentrations should be considered. If dosages have been increased during pregnancy, postpartum MHD plasma levels may also be considered for monitoring.
In the newborn child: Bleeding disorders in the newborn have been reported with hepatic inductor antiepileptic drugs. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn.
Breast-feeding: Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. A milk-to-plasma concentration ratio of 0.5 was found for both. The effects on the infant exposed to Oxcarbazepine by this route are unknown. Therefore, Oxcarbazepine should not be used during breast-feeding.
Fertility: There are no human data on fertility. In rats, oxcarbazepine had no effects on fertility.
Effects on reproductive parameters in female rats were observed for MHD at doses comparable to those in humans.