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Atropine / hyoscyamine / phenobarbital / scopolamine Pregnancy and Breastfeeding Warnings

Atropine / hyoscyamine / phenobarbital / scopolamine is also known as: Alkabel-SR, Antispas, Antispasmodic, Barbidonna, Bellalphen, Bellatal, Bellatal ER, Chardonna-2, D-Tal, Donnaphen, Donnapine, Donnatal, Donnatal Extentabs, Elixiral, Haponal, Hyosophen, Kinesed, Me-PB-Hyos, Phenohytro, Quadrapax, RE-PB Hyos Elixir, Se-Donna PB HYOS, Servira, Spasmolin, Spasquid

Medically reviewed on December 15, 2017

Atropine / hyoscyamine / phenobarbital / scopolamine Pregnancy Warnings

Animal studies showed a marginal embryotoxic effect with high dose intravenous scopolamine. There are no controlled data in human pregnancy. Atropine, scopolamine, and phenobarbital readily cross the placenta. Atropine decreases fetal breathing; it has been used to reduce gastric secretions before caesarean without apparent fetal or neonatal effects. Retrospective studies suggest a higher than expected incidence of fetal abnormalities with phenobarbital use, and respiratory depression in the newborn, as well as the possibility of acute withdrawal.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: D

Comments:
-This drug can cause fetal harm.
-If the patient becomes pregnant while using this drug, she should be apprised of the potential hazard to the fetus.

See references

Atropine / hyoscyamine / phenobarbital / scopolamine Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes


Comments:
-Phenobarbital is excreted into breastmilk; this can decrease withdrawal in infants exposed in utero, and may also cause drowsiness.
-Scopolamine is excreted in breastmilk.
-Long term use of atropine or scopolamine may reduce milk production, but a single dose is unlikely to interfere with breastfeeding.
-If used during breastfeeding, monitor for infant drowsiness, adequate weight gain, and developmental milestones, especially in younger and exclusively breastfed infants.

See references

References for pregnancy information

  1. "Product Information. Phenohytro (atropine/hyoscyamine/PB/scopolamine)." Winder Laboratories LLC, Winder, GA.
  2. "Product Information. Donnatal (atropine/hyoscyamine/PB/scopolamine)." Concordia Pharmaceuticals, LaVergne, TN.
  3. "Product Information. Belladonna-PHENobarbital (atropine/hyoscyamine/PB/scopolamine)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.
  4. "Product Information. Donnatal Extentabs (atropine/hyoscyamine/PB/scopolamine)." PBM Pharmaceuticals, Gordonsville, VA.
  5. "Product Information. Quadrapax (atropine/hyoscyamine/PB/scopolamine)." Acella Pharmaceuticals LLC, Alpharetta, GA.
  6. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

References for breastfeeding information

  1. "Product Information. Belladonna-PHENobarbital (atropine/hyoscyamine/PB/scopolamine)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.
  2. "Product Information. Donnatal Extentabs (atropine/hyoscyamine/PB/scopolamine)." PBM Pharmaceuticals, Gordonsville, VA.
  3. "Product Information. Donnatal (atropine/hyoscyamine/PB/scopolamine)." Concordia Pharmaceuticals, LaVergne, TN.
  4. "Product Information. Quadrapax (atropine/hyoscyamine/PB/scopolamine)." Acella Pharmaceuticals LLC, Alpharetta, GA.
  5. 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 -]):
  6. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  7. "Product Information. Phenohytro (atropine/hyoscyamine/PB/scopolamine)." Winder Laboratories LLC, Winder, GA.

Further information

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

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