Hyoscyamine Pregnancy and Breastfeeding Warnings
Hyoscyamine is also known as: A-Spas S/L, Anaspaz, Cystospaz, Cystospaz-M, Donnamar, Ed-Spaz, Gastrosed, HyoMax, HyoMax DT, HyoMax SL, Hyosol, Hyospaz, Hyosyne, IB-Stat, Levbid, Levsin, Levsin SL, Levsinex, Levsinex SR, NuLev, Oscimin, Spasdel, Symax Duotab, Symax FasTab, Symax SL
Medically reviewed by Drugs.com. Last updated on Oct 10, 2018.
Hyoscyamine Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: C
Animal studies have not been conducted. There are no controlled data in human pregnancy. This drug crosses the placenta. It is unknown if this drug can cause fetal harm or affect reproduction capacity.
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.
Hyoscyamine Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Yes
References for pregnancy information
- "Product Information. Symax SR (hyoscyamine)." Capellon Pharmaceuticals, Fort Worth, TX.
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
References for breastfeeding information
- "Product Information. Symax SR (hyoscyamine)." Capellon Pharmaceuticals, Fort Worth, TX.
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Further information
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