Acetaminophen / oxycodone Pregnancy and Breastfeeding Warnings

Acetaminophen / oxycodone is also known as: Endocet, Magnacet, Narvox, Oxycet, Percocet, Percocet 10/325, Percocet 10/650, Percocet 2.5/325, Percocet 5/325, Percocet 7.5/325, Percocet 7.5/500, Perloxx, Primlev, Roxicet, Roxilox, Tylox, Xartemis XR, Xolox

Acetaminophen / oxycodone Pregnancy Warnings

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnancy women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production.

Acetaminophen-oxycodone has been assigned to pregnancy category C by the FDA. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Use of narcotic analgesics in late pregnancy is associated with the risk of neonatal withdrawal. There are no controlled data in human pregnancy. Acetaminophen-oxycodone containing products should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Acetaminophen / oxycodone Breastfeeding Warnings

Acetaminophen is excreted into human milk in small concentrations. One case of an adverse effect (involving a rash) has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Oxycodone is excreted into human milk, but the clinical significance in regard to breast-fed infants is unknown.

One small study reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.

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