Zoresan Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential must use effective contraception during treatment with Zonisamide (Zoresan), and for one month after discontinuation.
Zonisamide (Zoresan) must not be used in women of childbearing potential not using effective contraception unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus. Specialist medical advice should be given to women treated with zonisamide who are of childbearing potential. Women planning a pregnancy should meet with their specialists to reassess treatment with zonisamide and to consider other therapeutic options.
As with all antiepileptic medicines, sudden discontinuation of zonisamide should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medicinal product. The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect. Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy.
Pregnancy: There are limited data from the use of zonisamide in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Data from a registry study suggest an increase in the proportion of babies born at a low birth weight (LBW), pre-term or small for gestational age (SGA). These increases are from about 5% to 8% for LBW, from about 8% to 10% for pre-term birth and from about 7% to 12% for SGA, all compared with mothers treated with lamotrigine monotherapy.
Zonisamide (Zoresan) must not be used during pregnancy unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus. If Zonisamide (Zoresan) is prescribed during pregnancy, patients should be fully informed of the potential harm to the foetus and use of the minimal effective dose is advised along with careful monitoring.
Breast-feeding: Zonisamide is excreted in human milk; the concentration in breast milk is similar to maternal plasma. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zonisamide (Zoresan) therapy. Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after Zonisamide (Zoresan) therapy is completed.
Fertility: There are no clinical data available on the effects of zonisamide on human fertility. Studies in animals have shown changes in fertility parameters.