Hydromorphone Pregnancy and Breastfeeding Warnings
Hydromorphone Pregnancy Warnings
This drug crosses the placental barrier. No signs of teratogenicity have been observed in rats and rabbits, but teratogenicity has been observed in mice and hamsters, possibly attributed to maternal toxicity associated with hypoxia and sedation. Like all opioid analgesics, this drug may cause respiratory depression in the neonate. Closely observe neonates whose mothers have received opioid analgesics during labor for signs of respiratory depression. Neonates whose mothers have been taking opioids chronically during pregnancy may exhibit neonatal withdrawal syndrome. The intensity of this syndrome does not always correlate with the duration of maternal opioid use or dose; monitor and treat appropriately. 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.
UK: Use is contraindicated AU and US: Use is not recommended unless the benefit to the mother clearly outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available. -Long-acting opioids should not be used during and immediately prior to labor, when short acting analgesics or other analgesic techniques are more appropriate. -Use in obstetrical analgesia is contraindicated with some products; product information should be consulted.
Hydromorphone Breastfeeding Warnings
Use is not recommended. Excreted into human milk: Yes Comments: -Breastfed infants should be closely monitored; if signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness occur, physician should be contacted immediately. -Withdrawal symptoms can occur when maternal administration is stopped.
Maternal use of oral narcotics during breastfeeding can cause infant drowsiness, CNS depression, and even death. It is best to provide pain control with a nonnarcotic analgesic and limit maternal intake to a few days at low doses with close infant monitoring. In a study of single dose intranasal hydromorphone 2 mg in 8 lactating women, calculations showed an exclusively breastfed infant would receive 0.67% of the maternal weight-adjusted dose. From this same study, using average milk levels, it was calculated an exclusively breastfed infant would receive 0.15 mcg/kg daily from a single 2 mg intranasal dose (non-marketed formulation).
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