Ultracet Use In Pregnancy & Lactation

Pregnant Women: Animal reproduction studies have revealed no evidence of harm to the fetus due to tramadol and paracetamol. However, as studies in humans have not been conducted, and since tramadol and paracetamol crosses the placental barrier, ULTRACET is contraindicated in pregnant women (see Contraindications).
Prolonged maternal use of opioids during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening (see Neonatal Opioid Withdrawal Syndrome (NOWS) under Precautions; Other Clinically Significant Adverse Experiences Previously Reported in Clinical Trials or Post-marketing Reports with Tramadol under Adverse Reactions).
Labour, Delivery and Nursing Women: ULTRACET is contraindicated in nursing women (see Contraindications). Following a single 100 mg i.v. dose of tramadol, the cumulative excretion in breast milk within 16 hours post-dose was 100 μg of tramadol (0.1% of the maternal dose) and 27 μg of M1.
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 ULTRACET could potentially be exposed to high levels of M1, and experience life-threatening respiratory depression. Therefore, maternal use of tramadol can lead to serious adverse reactions, including death in nursing infants (see Respiratory under Precautions).
Since opioids can cross the placental barrier and are excreted in breast milk, ULTRACET is also contraindicated during labour and delivery. Life-threatening respiratory depression can occur in the infant if opioids are administered to the mother. Naloxone, a drug that counters the effects of opioids, should be readily available if ULTRACET is used in this population.