Algesia Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C.
Epidemiological studies in human pregnancy did not demonstrate detrimental effects of paracetamol used in the recommended dosages. However, tramadol crosses the placenta. Since there are no adequate and well-controlled studies in pregnant women, tramadol + paracetamol should not be used in pregnant women, unless the potential benefits outweigh the possible risks to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death, and still birth have been reported in post-marketing surveillance. Signs of neonatal opioid withdrawal syndrome should be observed in newborns and should be managed accordingly.
Labor and Delivery: The safe use of tramadol + paracetamol during pregnancy has not been established. Tramadol should not be used in pregnant women prior to or during labor when other analgesics are more appropriate unless the potential benefits outweigh the potential risks. The use of tramadol may affect the duration of labor due to its inhibitory actions on uterine contractions or facilitatory actions on cervical dilation.
Chronic use during pregnancy may lead to neonatal withdrawal symptoms (See Precautions). If tramadol will be used during labor, it may cause respiratory depression in the newborn. An opioid antagonist (e.g., naloxone) should be available to reverse the opioid-induced respiratory depression in the neonate. Monitor newborns exposed to tramadol during labor for signs of excess sedation and respiratory depression.
Tramadol has also been shown to cross the placenta. The effect of tramadol, if any, on the later growth, development and functional maturation of the child is unknown.
Lactation: The use of tramadol as an obstetric preoperative medication or for post-delivery analgesia in breastfeeding mothers is not recommended.
Low levels of tramadol have been detected in breastmilk. Moreover, paracetamol is excreted in human breastmilk in clinically insignificant amounts. Instruct nursing mothers to monitor infants for unusually increased sleepiness, limpness, or breathing difficulties; and to seek medical care immediately. Withdrawal symptoms may occur in breastfed infants when tramadol maternal administration is stopped, or when breast-feeding is stopped.