Tramox Use In Pregnancy & Lactation

Pregnancy: Animal studies (rats and rabbits, exposure to tramadol up to 7 times that expected in man) have not revealed teratogenic effects and minimal embryotoxicity (delayed ossification). Fertility, reproductive performance and development of offspring were unaffected. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant woman. Safe use in pregnancy has not been established. Tramox is not recommended for pregnant women.
Lactation: Tramadol and its metabolites are found in small amounts in human breast milk. 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.