Acetaminophen / tramadol Pregnancy and Breastfeeding Warnings
Acetaminophen / tramadol is also known as: Tramapap, Ultracet
Acetaminophen / tramadol Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: Chronic use during pregnancy may lead to neonatal withdrawal symptoms.
This fixed combination product is not recommended for obstetrical preoperative use or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Epidemiological studies in human pregnancy have not shown ill effects from acetaminophen when used in recommended doses. Tramadol has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83. Animal studies have shown at very high doses, tramadol has an effect on organ development, bone growth, and mortality rate. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Acetaminophen / tramadol Breastfeeding Warnings
This fixed combination product is not recommended for obstetrical preoperative use or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Acetaminophen/paracetamol is excreted in small amounts into breast milk and available published data have shown no ill effects when used in recommended doses. Tramadol is also found in small amounts in breast milk and an infant could ingest about 0.1% of the dose given to the mother. This amount in breast milk has not been shown to adversely affect the nursing infant. If this product is used, the infant should be monitored for increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.
Use is not recommended Excreted into human milk: Yes Comment: If used, the infant should be monitored for increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.
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