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Acetaminophen / hydrocodone Pregnancy and Breastfeeding Warnings

Acetaminophen / hydrocodone is also known as: Anexsia, Co-Gesic, Dolacet, Duocet, Duradyne DHC, Hy-Phen, Hycet, Hydrocet, Hydrogesic, Liquicet, Lorcet, Lorcet 10/650, Lorcet HD, Lorcet Plus, Lortab, Margesic H, Maxidone, Norco, Stagesic, T-Gesic, Verdrocet, Vicodin, Vicodin ES, Xodol, Zydone

Medically reviewed on Oct 15, 2018

Acetaminophen / hydrocodone Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: C

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.

Opioid analgesics cross the placenta. Hydrocodone use 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. The onset, duration, and severity of the condition will vary based on maternal use (duration of use, timing, and amount of last use) and rate of elimination in the newborn. Acetaminophen has not been associated with major congenital malformations, although animal studies have identified adverse effects at clinically relevant doses. Epidemiologic data do not clearly report an association with oral acetaminophen and major birth defects, miscarriage, or adverse maternal or fetal outcomes when this drug is used during pregnancy, but due to methodological limitations cannot definitively establish the absence of any risk. In pregnant rats receiving oral drug at doses up to 0.88 times maximum human daily dose (MHDD) during organogenesis, fetotoxicity (reduced fetal weight and length) and dose-related increases in bone variations (reduced ossification and rudimentary rib changes) were observed. Areas of necrosis in both the liver and kidney of pregnant rats and fetuses were observed when pregnant rats were given oral drug throughout gestation at doses 1.2 times the maximum human daily dose. There are no controlled data in human pregnancy.

Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible.

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.

See references

Acetaminophen / hydrocodone Breastfeeding Warnings

Breastfed infants of mothers who receive opioids, especially newborns, can experience drowsiness and CNS depression, even death. A study in 30 breastfeeding women found mean and median hydrocodone infant daily doses of 3.9 and 2.1 mcg/kg, respectively, which calculates to 2.4% and 1.6% of weight-adjusted maternal doses. Hydrocodone is metabolized to 6 active metabolites including hydromorphone. Mean and median hydromorphone daily doses of 2.1 and 0.3 mcg/kg, respectively, were found. Of interest was that 2 women excreted much more hydromorphone than others which might represent ultrarapid CYP450 2D6 metabolizers.

A decision should be made to discontinue breast-feeding or discontinue this drug, considering the importance of the drug to the mother

Excreted into human milk: Yes (acetaminophen) Yes (hydrocodone)

Comments:
-Breastfed infants should be monitored for excess sedation and respiratory depression; immediate medical attention should be sought if infant develops breathing difficulties or limpness.
-Withdrawal symptoms can occur in breastfed infants when maternal drug use or breastfeeding are stopped.

See references

References for pregnancy information

  1. "Product Information. Lortab (acetaminophen-hydrocodone)." Akorn Inc, Buffalo Grove, IL.
  2. "Product Information. Norco (acetaminophen-hydrocodone)." Allergan Inc, Irvine, CA.
  3. "Product Information. Acetaminophen-Hydrocodone Bitartrate (acetaminophen-hydrocodone)." Mikart Inc, Atlanta, GA.

References for breastfeeding information

  1. "Product Information. Acetaminophen-Hydrocodone Bitartrate (acetaminophen-hydrocodone)." Mikart Inc, Atlanta, GA.
  2. "Product Information. Norco (acetaminophen-hydrocodone)." Allergan Inc, Irvine, CA.
  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. Lortab (acetaminophen-hydrocodone)." Akorn Inc, Buffalo Grove, IL.

Further information

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

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