Dolcet 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. The use of opioids during childbirth might result in respiratory depression in the newborn infant.
Prolonged use of Tramadol + Paracetamol (Dolcet), or other opioids, during pregnancy may lead to neonatal opioid withdrawal syndrome. This risk is particularly increased during the last trimester of pregnancy.
Breast-feeding: Dolcet is not recommended for breast-feeding mothers because its safety in infants and newborns has not been studied.
Tramadol is subject to the same polymorphic metabolism as codeine, with ultra-rapid metabolizers of CYP2D6 substrates being potentially exposed to life-threatening levels of O-desmethyltramadol (M1). At least one death was reported in a breast-feeding infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine. A baby breast-feeding from an ultra-rapid metabolizer mother taking Tramadol + Paracetamol (Dolcet) could potentially be exposed to high levels of M1, and experience life-threatening respiratory depression. For this reason, breast-feeding is not recommended during treatment with Tramadol + Paracetamol (Dolcet).
Fertility: The effect of tramadol or tramadol/acetaminophen combination on human fertility has not been evaluated.