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Hydrocodone / pseudoephedrine Pregnancy and Breastfeeding Warnings

Hydrocodone / pseudoephedrine is also known as: ColdCough HCM, Detussin, Entuss-D Liquid, H-C Tussive D, Histinex D, Histussin D, Hytussin, Iotussin D Liquid, Liquituss HD, P-V-Tussin, Pancof HC, Rezira, SymTan, Tussafin, Tussgen

Hydrocodone / pseudoephedrine Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus

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.

Animal studies have not been conducted with this combination product, but studies with hydrocodone have shown teratogenicity in hamsters with doses approximately 35 times the maximum recommended human daily dose. Babies born to mothers taking opioids regularly during pregnancy may become physically dependent. Opioids given to mothers shortly before delivery may produce some degree of respiratory depression in the newborn, especially if high doses are used. There are no controlled data in human pregnancy.

US 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

Hydrocodone / pseudoephedrine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother

Excreted into human milk: Yes (hydrocodone); Yes (pseudoephedrine)

Comments: Breastfed infants should be closely monitored for increased sedation, difficulty breastfeeding, breathing difficulties, or limpness; mothers should be counseled to seek immediate medical assistance if these develop.

See references

References for pregnancy information

  1. "Product Information. Rezira (hydrocodone-pseudoephedrine)." Hawthorn Pharmaceuticals, Madison, MS.

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. "Product Information. Rezira (hydrocodone-pseudoephedrine)." Hawthorn Pharmaceuticals, Madison, MS.

Further information

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

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