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Generic Name
Estradiol valerate and Norgestrel
Trade Name
Progyluton
Manufacturer
Schering AG
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

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Indication
Indication
  • Hormonal replacement therapy.
  • Fetal Risk
    Fetal Risk
  • 1st trimester exposure to estrogens is a possible cause of cardio-vascular, eye, ear defects and down’s syndrome.
  • 1st trimester exposure to progestational agents reported to cause cardiovascular defects and hypospadia.
  • No adequate data for norgestrel.
  • Males exposed in utero to estrogenprogesterone may have psychosexual Changes (less heterosexual experience, fewer musculine interests).
  • Breast Feeding
    Breast Feeding
  • Excreted into milk.
  • Safe in breast feeding although Estradiol causes decreased milk production.
  • 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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