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Aspirin / oxycodone Pregnancy and Breastfeeding Warnings

Aspirin / oxycodone is also known as: Endodan, Percodan, Percodan-Demi, Roxiprin

Aspirin / oxycodone Pregnancy Warnings

Aspirin-oxycodone has not been formally assigned to pregnancy category by the FDA. Aspirin has been assigned to pregnancy category D by the FDA and oxycodone has been assigned to pregnancy category B by the FDA. Salicylates readily cross the placenta and inhibit prostaglandin synthesis, which may cause constriction of ductus arteriosus resulting in pulmonary hypertension and increased fetal mortality. Use of aspirin in pregnancy has been associated with alterations in both maternal and fetal hemostasis. Maternal aspirin use during later stages of pregnancy may cause low birth weight, increased incidence of intracranial hemorrhage in premature infants, stillbirths, and neonatal death. Use of aspirin during pregnancy, especially in the third trimester, should be avoided. Use of narcotic analgesics in late pregnancy has been associated with the risk of neonatal withdrawal. There are no controlled data in human pregnancy. Aspirin-oxycodone should only be given during pregnancy only when there are no alternatives and benefit outweighs risk.

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Aspirin / oxycodone Breastfeeding Warnings

Aspirin is excreted into human milk in small amounts. Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dl). Because of a single case report of metabolic acidosis, the American Academy of Pediatric characterizes aspirin as a drug that has been "associated with significant effects on some nursing infants and should be given to nursing mothers with caution". Oxycodone is excreted into human milk, but the clinical significance is unknown.

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References for pregnancy information

  1. Schoenfeld A, Bar Y, Merlob P, Ovadia Y "NSAIDs: maternal and fetal considerations." Am J Reprod Immunol 28 (1992): 141-7
  2. "Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women." Lancet 343 (1994): 619-29
  3. Parazzini F, Bortolus R, Chatenoud L, Restelli S, Benedetto C "Follow-up of children in the italian study of aspirin in pregnancy." Lancet 343 (1994): 1235
  4. Werler MM, Mitchell AA, Shapiro S "The relation of aspirin use during the first trimester of pregnancy to congenital cardiac defects." N Engl J Med 321 (1989): 1639-42
  5. Karlowicz MG, White LE "Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion." Clin Pediatr (Phila) 32 (1993): 740-3
  6. "Product Information. Tylox (acetaminophen-oxycodone)." McNeil Pharmaceutical, Raritan, NJ.
  7. "Product Information. Percocet (acetaminophen-oxycodone)." DuPont Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. Erickson SH, Oppenheim GL "Aspirin in breast milk." J Fam Pract 8 (1979): 189-90
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

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