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Scopolamine Pregnancy and Breastfeeding Warnings

Scopolamine is also known as: Maldemar, Scopace, Transderm-Scop

Scopolamine Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B2 US FDA pregnancy category: C

Animal studies showed no harm with daily intravenous administration in one model, and embryotoxicity in another animal model at doses 100 times the human transdermal dose. There are no controlled data in human pregnancy. This drug crosses the placenta. Parenteral administration before the onset of labor may cause central nervous system depression and respiratory depression in the neonate and may contribute to neonatal hemorrhage due to reduction in vitamin K clotting factors in the neonate. One small prospective study using the transdermal system during caesarian delivery showed no increase in adverse effects except for jaundice, which occurred in 7.9% of the scopolamine group versus 1.8% of the placebo group; jaundice resolved with ultraviolet light and did not prolong hospital stays. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. 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

Scopolamine Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Yes Comments: -Small amounts of this drug are excreted in breast milk. -This drug may inhibit lactation.

See references

References for pregnancy information

  1. "Product Information. Transderm-Scop (scopolamine (hyoscine (scopolamine)))." Sandoz Inc, Broomfield, CO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Scopolamine (scopolamine (hyoscine (scopolamine)))." Perrigo, L. Company, Allegan, MI.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Transderm-Scop (scopolamine (hyoscine (scopolamine)))." Sandoz Inc, Broomfield, CO.
  2. "Product Information. Scopolamine (scopolamine (hyoscine (scopolamine)))." Perrigo, L. Company, Allegan, MI.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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