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Dextromethorphan / guaifenesin / phenylephrine Pregnancy and Breastfeeding Warnings

Dextromethorphan / guaifenesin / phenylephrine is also known as: Broncotron Ped, Deconex DMX, Desgen DM, Dexcon-PE, Duraphen DM, G-Tron Ped, G-Tusicof, Giltuss, Mucinex Children's Congestion & Cough, Mucinex Fast-Max Severe Congestion & Cough, Nortuss-DE, Pres Gen Pediatric, Relhist DMX, Robitussin Children's Cough & Cold CF, Robitussin Multi-Symptom Cold CF, Robitussin Multi-Symptom Cold CF Maximum Strength, Rompe Pecho CF, Sinutuss DM, Tussex, Tussidex, Tussin CF, Tusso-DMR, VanaTab DM, Zotex, Zotex Pediatric

Medically reviewed by Drugs.com. Last updated on Jun 28, 2019.

Dextromethorphan / guaifenesin / phenylephrine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Available human data does not demonstrate major teratogenicity with dextromethorphan.
-Fetuses of mothers with slow dextromethorphan may be exposed to higher concentrations, but the clinical significance is unknown.
-According to some authorities dextromethorphan is compatible with pregnancy; low birth defect incidences were seen in surveillance studies.
-Available data do not indicate developmental toxicity with guaifenesin.
-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 is not suspected to cause human teratogenicity.

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

Dextromethorphan: The only published animal study was done in chick embryos and showed a dose-related increase in embryo mortality, however no chicks were allowed to hatch and all doses given were fatal, so teratogenicity information was not obtained. Unpublished studies in rats, mice, and rabbits indicate no embryofetal harm. A monitoring study including 300 mother-child pairs that had first trimester dextromethorphan exposure showed 24 congenital abnormalities for a standardized relative risk (SRR) of 1.18, and a SRR of 1.01 for any pregnancy exposure (15 malformations/580 exposures). Placental transfer is likely with dextromethorphan's low molecular weight (about 271).

Guaifenesin: Animal studies are not available. A monitoring study including 197 mother-child pairs that had first trimester guaifenesin exposure showed an increase in inguinal hernias; 1336 any time pregnancy exposures showed no association with malformations.

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

See references

Dextromethorphan / guaifenesin / phenylephrine Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Data not available (dextromethorphan, guaifenesin, phenylephrine)
Excreted into animal milk: Data not available (dextromethorphan, guaifenesin, phenylephrine)

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Given dextromethorphan's low molecular weight, excretion into breast milk is probable.
-Guaifenesin from breast milk is not expected to adversely affect nursing infants at normal parental doses.
-Phenylephrine oral bioavailability is about 40%, making it unlikely an infant would receive large doses from breast milk.
-Phenylephrine may decrease milk production.
-Products with high alcohol content should be avoided during while breastfeeding.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. "Product Information. Presgen B (brompheniramine/dextromethorph/phenylephrine)." KramerNovis, San Juan, PR.

References for breastfeeding information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. 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 -]):

Further information

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

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