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Generic Name
Flumazenil
Trade Name
Romazicon
Risk Category
C
  • Studies on animals show adverse effect and toxicity on fetus.
  • No adequate and well controlled studies done on pregnant women.
  • Drugs should be given only if the potential benefit outweighs the potential risk to the fetus.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Benzodiazepine antagonist for reversal of the central sedative effects.
  • Fetal Risk
    Fetal Risk
  • Not teratogenic but embryocidal in animals at high doses.
  • Also can cause decreased survival rate, delayed ear opening in offspring of animals given high doses.
  • No adequate human data and the safety of the drug to reverse the effects of benzodiazepines in labor or delivery has not been established.
  • Breast Feeding
    Breast Feeding
  • Unknown passage into milk.
  • Can be used in emergencies.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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