Apo-Lamotrigine

Apo-Lamotrigine Use In Pregnancy & Lactation

lamotrigine

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Use In Pregnancy & Lactation
Administration of lamotrigine did not impair fertility in animal reproductive studies.
There is no experience of the effect of Apo-Lamotrigine on human fertility.
Post-marketing data from several prospective pregnancy registries have documented outcomes in over 2000 women exposed to Apo-Lamotrigine monotherapy during the 1st trimester of pregnancy. Whilst the data provide no evidence for a substantial increase in the overall risk of major birth malformations associated with Apo-Lamotrigine, one registry has reported an increase in the risk of isolated oral cleft malformations. This increased has not been confirmed in a pooled analysis of the data from six other registries.
The data on use of Apo-Lamotrigine in polytherapy combinations are insufficient to assess whether the risk of malformation associated with other agents is affected by concomitant Apo-Lamotrigine use.
As with other medicines, Apo-Lamotrigine should only be used during pregnancy if the expected benefits outweigh the potential risks.
Physiological changes during pregnancy may affect lamotrigine levels and/or therapeutic effect. There have been reports of decreased lamotrigine levels during pregnancy. Appropriate clinical management of pregnant women during Apo-Lamotrigine therapy should be ensured.
There is limited information on the use of Apo-Lamotrigine in lactation. Preliminary data indicate that lamotrigine passes into breast milk in concentrations usually of the order of 40-60% of the serum concentration. In a small number of infants known to have been breastfed, the serum concentrations of lamotrigine reached levels at which pharmacological effects may occur.
The potential benefits of breastfeeding should be weighed against the potential risk of adverse effects occurring in the infant.
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