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Naloxone / oxycodone Pregnancy and Breastfeeding Warnings

Naloxone / oxycodone is also known as: Targiniq ER

Naloxone / oxycodone Pregnancy Warnings

-There are no data on the use of naloxone-oxycodone in pregnant women and during childbirth. -Experience in the use of oxycodone during pregnancy in humans is limited and revealed no evidence of an increased risk of congenital abnormalities. -Both naloxone and oxycodone pass into the placenta. -If administered during childbirth oxycodone may cause respiratory depression in the newborn. 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.

AU: Use is contraindicated. UK, US: This drug should not be used in pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: Long-term administration of oxycodone during pregnancy may lead to withdrawal symptoms in the newborn. If administered during childbirth oxycodone may evoke respiratory depression in the newborn.

See references

Naloxone / oxycodone Breastfeeding Warnings

AU: Use is contraindicated. UK, US: Use should be avoided. Excreted into human milk: Unknown (naloxone); Yes (oxycodone) Comments: This drug can harm a nursing infant.

No information is available on the excretion of naloxone into breastmilk. Because it is not orally bioavailable, it is unlikely to affect the breastfed infant. Maternal use of opioid narcotics during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Infant sedation is common with maternal use of this drug. Newborn infants are particularly sensitive to the effects of even small dosages of narcotic analgesics. It is best to provide pain control with a nonnarcotic analgesic if possible and limit maternal intake of this drug to a few days. A maximum dosage of 30 mg daily is suggested. The infant should be monitored closely for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants.

See references

References for pregnancy information

  1. "Product Information. Targiniq ER (naloxone-oxyCODONE)." Purdue Pharma LP, Stamford, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Product Information. Targiniq ER (naloxone-oxyCODONE)." Purdue Pharma LP, Stamford, CT.

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