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Generic Name
Temazepam
Trade Name
Restoril
Risk Category
X
  • 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).
  • Studies in animals and/or humans have demonstrated fetal abnormalities.
  • Fetal risk involved in use of drug, clearly outweighs potential benefit.
  • Contraindicated in women who are or may become pregnant. Don’t use.
FDA Pregnancy Risk Categories

Place (not click) your mouse cursor over the bold words in the text below to receive description

Indication
Indication
  • Benzodiazepine.
  • Sedative - hypnotic.
  • Fetal Risk
    Fetal Risk
  • Crosses human placenta.
  • Fetotoxic and teratogenic in animals causing fetal resoption, skeletal variations (rudimentary ribs, fusion and asymmetry of ribs) and exencephaly.
  • Benzodiazepines in general are associated with increased risk of congenital anomalies if used in 1st trimester and with neonatal withdrawal if used in chronic doses throughout pregnancy.
  • Use of benzodiazepine in the last weeks of pregnancy may cause neonatal cns depression, poor feeding, hypothermia, flaccidity and respiratory depression.
  • Breast Feeding
    Breast Feeding
  • Unknown excretion into milk, but other similar benzodiazepines are excreted.
  • Potential to cause poor feeding, sedation and weight loss in nursing infants.
  • 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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