From the FDA Drug Label
8 USE IN SPECIFIC POPULATIONS
- 1 Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Inj dicyclomine can be given in pregnancy, but only if clearly needed, as it is classified as Pregnancy Category B. However, it is essential to note that adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses. The decision to use this drug during pregnancy should be made with caution, considering the potential risks and benefits 1.
- Key points:
- No increased risk of structural malformations was found in epidemiologic studies at doses up to 40 mg/day.
- Reproduction studies in rats and rabbits showed no evidence of harm to the fetus.
- The drug should be used during pregnancy only if clearly needed.
From the Research
Dicyclomine injection is generally not recommended during pregnancy, especially during the first trimester, due to its potential to affect the developing fetus and the lack of sufficient well-controlled studies in pregnant women. The medication works by relaxing smooth muscles in the gastrointestinal tract to treat irritable bowel syndrome and intestinal spasms, but it crosses the placenta and could potentially affect the developing fetus 2, 3, 4, 5, 6. If treatment for gastrointestinal spasms is necessary during pregnancy, safer alternatives should be considered first. Non-pharmacological approaches like dietary modifications, adequate hydration, and stress management are preferable initial steps.
- Key considerations for the use of dicyclomine in pregnancy include:
- The medication's potential to affect the developing fetus
- The lack of sufficient well-controlled studies in pregnant women
- The need to weigh the risks and benefits of treatment
- The importance of consulting an obstetrician to evaluate specific situation and medical needs If medication is absolutely necessary, your healthcare provider might consider other options with better established safety profiles in pregnancy. The risks of dicyclomine must be carefully weighed against potential benefits, and this decision should be made in consultation with an obstetrician who can evaluate your specific situation and medical needs. Any use during pregnancy should involve the lowest effective dose for the shortest duration possible. According to the most recent study available, which is from 2022 4, dicyclomine has shown potential in other areas, but its use in pregnancy is still not well established.