Tramadol Pregnancy and Breastfeeding Warnings
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.
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, this drug 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.
Tramadol Breastfeeding Warnings
A study in 75 mothers reported an average milk concentration of 748 mcg/L; this translates to an average infant dose of 112 mcg/kg and a maternal weight-adjusted dose of 2.24% and 0.64% for the drug and its metabolite, respectively. Reanalysis of the data using a population pharmacokinetic model showed a maternal weight adjusted dose of 2.2% for extensive metabolizers and 2.6% for poor metabolizers. The amount of drug present in breast milk represents a maximum of 2.6% of the proposed IV newborn dose. This drug can increase prolactin levels; however, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Use is not recommended; however, discontinuation of breastfeeding following a single dose of this drug is not necessary. Excreted into human milk: Yes Comments: This drug is excreted in very small amounts in breast milk and has not been shown to adversely affect the nursing infant; if used, the infant should be monitored for increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.
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