Zyrotram Use In Pregnancy & Lactation

Pregnancy: Tramadol has been shown to cross the placenta. There are no adequate and well controlled studies in pregnant women. Safe use in pregnancy has not been established. ZYROTRAM is not recommended for pregnant women.
Tramadol - administered before or during birth - does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant. Chronic use during pregnancy may lead to neonatal withdrawal symptoms.
Lactation: Approximately 0.1% of the maternal dose of tramadol is excreted in breast milk.
In the immediate post-partum period, for maternal oral daily dosage up to 400 mg, this corresponds to a mean amount of tramadol ingested by breast-fed infants of 3% of the maternal weight-adjusted dosage. For this reason, tramadol should not be used during lactation or alternatively, breast-feeding should be discontinued during treatment with tramadol. Discontinuation of breast-feeding is generally not necessary following a single dose of tramadol.
Fertility: Post marketing surveillance does not suggest an effect of Tramadol on fertility. Animal studies did not show an effect of Tramadol on fertility.