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Aspirin / codeine Pregnancy and Breastfeeding Warnings

Aspirin / codeine is also known as: Empirin with Codeine

Aspirin / codeine Pregnancy Warnings

Aspirin (acetylsalicylic acid) inhibits prostaglandin synthesis. When given late in pregnancy, it may cause premature closure of the fetal ductus arteriosus, delay labour and birth. Aspirin increases the bleeding time both in the newborn infant and in the mother because of its antiplatelet effects. Low-dose aspirin (100 mg/day) does not affect bleeding time. Opioid analgesics cross the placenta. The use of opioids during labor may cause respiratory depression in the newborn infant. Prolonged use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. 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.

Contraindicated during the third trimester of pregnancy

AU TGA pregnancy category: C

Comments:
-The safety of aspirin (acetylsalicylic acid) and codeine during pregnancy has not been established and use during this period should be avoided; when given late in pregnancy, it may cause premature closure of the fetal ductus arteriosus, delay labour and birth.
-Regular use of opioid analgesics during pregnancy may cause physical dependence in the fetus, leading to withdrawal symptoms in the neonate.

See references

Aspirin / codeine Breastfeeding Warnings

Aspirin (acetylsalicylic acid) is rapidly metabolized to salicylate after ingestion; salicylic acid is excreted into human milk. Metabolic acidosis has been reported in one breastfed infant following long-term, high-dose maternal aspirin ingestion. Regular/high doses of maternal aspirin could impair platelet function in the breastfed infant. Reye's syndrome is associated with aspirin use in infants with viral infections, but the risk from salicylate in breastmilk is unknown.

Codeine is present in breast milk and for women with normal codeine metabolism (normal CYP450 2D6 activity) the amount of codeine secreted is low and dose-dependent; however, in women who are ultra-rapid metabolizers of codeine (those with a specific CYP450 2D6 genotype) higher-than-expected serum levels of morphine, codeine's active metabolite, may be present in their breast milk which may lead to dangerously high serum morphine levels in their breastfed infants. In most cases, a person's specific CYP450 2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. A death of a breastfeed infant due to respiratory depression has been reported; the mother was found to be a CYP450 2D6 ultrarapid metabolizer.

Use is contraindicated

Excreted into human milk: Yes

Comments:
-Breastfeeding is not recommended due to the risks of serious adverse reactions in breastfed infants such as excess sleepiness, difficulty breastfeeding, and serious breathing problems that may result in death.

See references

References for pregnancy information

  1. 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
  2. Bracken MB, Holford TR "Exposure to prescribed drugs in pregnancy and association with congenital malformations." Obstet Gynecol 58 (1981): 336-44
  3. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  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. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  7. "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
  8. Mangurten HH, Benawra R "Neonatal codeine withdrawal in infants of nonaddicted mothers." Pediatrics 65 (1980): 159-60
  9. Schoenfeld A, Bar Y, Merlob P, Ovadia Y "NSAIDs: maternal and fetal considerations." Am J Reprod Immunol 28 (1992): 141-7

References for breastfeeding information

  1. 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 -]):
  2. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  3. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  4. "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
  5. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. Erickson SH, Oppenheim GL "Aspirin in breast milk." J Fam Pract 8 (1979): 189-90

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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