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

Pregnancy: 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.
Risk related to Topiramate: Topiramate was teratogenic in mice, rats and rabbits. In rats, Topiramate crosses the placental barrier.
In humans, Topiramate crosses the placenta and similar concentrations have been reported in the umbilical cord and maternal blood.
Clinical data from pregnancy registries indicate that infants exposed to Topiramate monotherapy have: An increased risk of congenital malformations (particularly cleft lip/palate, hypospadias, and anomalies involving various body systems) following exposure during the first trimester. The North American Antiepileptic Drug pregnancy registry data for Topiramate monotherapy showed an approximate 3-fold higher prevalence of major congenital malformations (4.3%), compared with a reference group not taking AEDs (1.4%). In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy. The risk has been reported to be dose dependent; effects were observed in all doses. 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.
A higher prevalence of low birth weight (<2500 grams) compared with a reference group.
An increased prevalence of being small for gestational age (SGA; defined as birth weight below the 10 percentile corrected for their gestational age, stratified by sex). The long term consequences of the SGA findings could not be determined.
Indication epilepsy: It is recommended to consider alternative therapeutic options in women of child bearing potential. If Topiramate is used in women of childbearing potential, it is recommended that highly effective contraception be used (see Interactions), 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.
Indication migraine prophylaxis: Topiramate is contraindicated in pregnancy and in women of childbearing potential if a highly effective method of contraception is not used (see Contraindications and Adverse Reactions).
Breastfeeding: Animal studies have shown excretion of Topiramate in milk. 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 human milk. Effects that have been observed in breastfed newborns/infants of treated mothers, include diarrhea, drowsiness, irritability and inadequate weight gain. Therefore, a decision must be made whether to suspend breastfeeding or to discontinue/abstain from Topiramate therapy taking into account the benefit of breastfeeding for the child and the benefit of Topiramate therapy for the women (see Precautions).
Fertility: Animal studies did not reveal impairment of fertility by Topiramate. The effect of Topiramate on human fertility has not been established.
Women of childbearing potential: Topiramate may cause fetal harm and fetal growth restriction (small for gestational age and low birth weight) when administered to a pregnant woman. The North American Antiepileptic Drug pregnancy registry data for Topiramate monotherapy showed an approximate 3-fold higher prevalence of major congenital malformations (4.3%), compared with a reference group not taking AEDs (1.4%). In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy. Before the initiation of treatment with Topiramate in a woman of childbearing potential, pregnancy testing should be performed and a highly effective contraceptive method advised (see Interactions). The patient should be fully informed of the risks related to the use of Topiramate during pregnancy (see Contraindications, Use in Pregnancy & Lactation).