Pradox 25/Pradox 50/Pradox 100 Use In Pregnancy & Lactation

Pregnancy: PRADOX can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to Topiramate in utero have an increased risk of congenital malformations (e.g. craniofacial defects, such as cleft lip palate, hypospadias, and anomalies involving various body systems) and neurodevelopmental disorders (e.g., autism spectrum disorders and intellectual disability). This has been reported with Topiramate monotherapy and Topiramate as part of a polytherapy regimen.
In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of antiepileptic drugs in combination therapy. The risk has been observed in all doses and effects were reported to be dose-dependent. In women treated with Topiramate who have had a child with a congenital malformation, there appears to be an increased risk of malformations in subsequent pregnancies when exposed to Topiramate.
Epilepsy indication: It is recommended to consider alternative therapeutic options in women of childbearing potential. If Topiramate is used in women of childbearing potential, it is recommended that highly effective contraception be used, and that the woman is fully informed of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the fetus. If a woman plans a pregnancy, a preconceptional visit is recommended in order to reassess the treatment, and to consider other therapeutic options. In case of administration during the first trimester, careful prenatal monitoring should be performed.
Migraine prophylaxis indication: Topiramate is contraindicated in pregnancy and in women of childbearing potential if a highly effective method of contraception is not used.
Risk-related to epilepsy and AEDs in general: Specialist advice should be given to women who are of childbearing potential. The need for treatment with AEDs should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, sudden discontinuation of AED therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics. Topiramate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In treating and counseling women of childbearing potential, the prescribing physician should weigh the benefits of therapy against the risks and consider alternative therapeutic options. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Breastfeeding: The excretion of Topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of Topiramate into breast milk. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive Topiramate treatment. Therefore, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the benefit of breast-feeding for the child and the benefit of the drug to the mother.