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Generic Name
Clidinium bromide and Chlordiazepoxide
Trade Name
Bralix
Risk Category
D*
  • Positive evidence of human fetal risk exists.
  • Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
The risk category is C for Clidinium.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Parasympatholytic.
  • Sedative for treatment of dyspepsia.
  • Fetal Risk
    Fetal Risk
  • Use of parasympatholytic agents in general has been reported to cause minor malformations in 1st trimester. No data for clidinium.
  • No adequate human data for chlordiazepoxide but suggested possible association with increased risk of malformations (microcephaly, duodenal atresia, meckels diverticulum and deafness), growth and mental retardation, increased fetal death rate.
  • Chronic maternal ingestion of the drug can cause neonatal withdrawal.
  • If used in labor it causes hypotonia, hypothermia and poor feeding in the newborns.
  • Breast Feeding
    Breast Feeding
  • No data available for chlordiazepoxide, should be avoided
  • No data for clidinium.
  • Other Trade Names
     
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