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Hydrocodone / phenylephrine Pregnancy and Breastfeeding Warnings

Hydrocodone / phenylephrine is also known as: Lortuss HC, Nalex-DH, Phenylephrine HD, Tusdec-HC

Hydrocodone / phenylephrine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Comments:
-This drug crosses the placenta.
-Opioids may cause life-threatening respiratory depression in exposed infants.
-Have naloxone readily available if this drug is used in this population.
-Prolonged opioid use during pregnancy may cause life-threatening Neonatal Opioid Withdrawal Syndrome (NOWS).
-Abrupt discontinuation of opioids during pregnancy may cause complications such as miscarriage or fetal death; taper slowly under medical supervision to minimize adverse effects.
-Monitor patients for respiratory depression, especially during therapy initiation or dose increases.
-Phenylephrine is a sympathomimetic used in emergencies to treat hypotension and alleviate eye and ear allergic symptoms.
-Phenylephrine could cause constriction in uterine vessels (that are normally maximally dilated during pregnancy), reducing uterine blood flow, potentially causing fetal hypoxia.
-Phenylephrine may interact with oxytocic or ergot derivatives to cause persistent maternal hypertension; cerebral vessel rupture is possible.
-Sympathomimetic amines are teratogenic in some animal models, but are not suspected to cause human teratogenicity.

Animal studies are not available for the combination product. There are no controlled data in human pregnancy. This drug crosses the placenta.

Hydrocodone: Animal studies administering 102 mg/kg hydrocodone subcutaneously during CNS organogenesis showed 3.4% of offspring had malformations, including cranioschisis. There are no controlled data in human pregnancy. A surveillance study including 332 mother-child pairs that had first trimester hydrocodone exposure showed a 7.2% rate if major malformations (24 birth defects, 14 expected; 5 were cardiovascular defects of which 3 were expected), but no anomalies for 5 defect categories (oral clefts, spina bifida, polydactyly, limb reduction defects, hypospadias).

Phenylephrine: A monitoring study including 1249 mother-child pairs that had first trimester phenylephrine exposure showed an increase in malformation, with association greater with minor defects than major defects (8 eye and ear defects, 6 syndactyly, 4 preauricular skin tags, and 3 clubfoot cases); 4149 any time pregnancy exposures were associated with 15 congenital dislocation of the hip, 6 umbilical hernia, and 4 other musculoskeletal defects. Placental transfer is likely with phenylephrine's low molecular weight (about 167).

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Hydrocodone / phenylephrine Breastfeeding Warnings

Use is not recommended unless benefits outweigh risks.

Excreted into human milk: Yes (hydrocodone)/ Data not available (phenylephrine)
Excreted into animal milk: Data not available (phenylephrine)

Comments:
-Opioids may cause life-threatening respiratory depression in exposed infants.
-Have naloxone readily available if this drug is used in this population.
-Phenylephrine oral bioavailability is about 40%, making it unlikely an infant would receive large doses from breast milk.
-Phenylephrine may decrease milk production.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

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. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):

Further information

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

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