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Generic Name
Amiodarone
Trade Name
Pms-Amiodarone
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).
FDA Pregnancy Risk Categories

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Indication
Indication
  • Antiarrhythmic.
  • Contains 75 mg of iodine per 200-mg dose.
  • Fetal Risk
    Fetal Risk
  • embryotoxic in animals causing fetal resorption and growth retardation.
  • Crosses human placenta.
  • No well-controlled human data but reported to cause congenital hypothyroidism and goiter, intrauterine growth retardation, transient fetal bradycardia with prolonged Q-T interval on ECG.
  • Suggested possible association with congenital heart defects.
  • Having long elimination half-life (t½) with chronic use (t½ about 18-58 days), the drug should be stopped several months before conception to avoid exposure in early gestation.
  • Breast Feeding
    Breast Feeding
  • Excreted into milk.
  • Unknown effects on nursing infants and breast feeding is not recommended because of high iodine content in the drug.
  • 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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