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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. Prolonged use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. The onset, duration, and severity of the condition will vary based on use (duration of use, timing, and amount of last maternal use) and rate of elimination in the newborn. Both naloxone and oxycodone pass into the placenta. There are no controlled data in human pregnancy. Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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: Not Assigned 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. -Monitor neonates exposed to opioid analgesics for signs of excess sedation and respiratory depression.

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. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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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