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Ethinyl estradiol / norelgestromin Pregnancy and Breastfeeding Warnings

Ethinyl estradiol / norelgestromin is also known as: Ortho Evra, Xulane

Medically reviewed on Sep 17, 2018

Ethinyl estradiol / norelgestromin Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not formally assigned to a pregnancy category.

Comments:
-Discontinue use if pregnancy is confirmed.
-Avoid administration to induce withdrawal bleeding as a test for pregnancy.
-Avoid administration during pregnancy to treat threatened or habitual abortion.
-Increased risk of venous thromboembolism during the postpartum period should be considered when restarting this drug.

Epidemiological data have failed to reveal an increased risk of genital or nongenital birth defects when this drug was taken before pregnancy nor evidence of teratogenicity when used inadvertently in early pregnancy. There are no controlled data in human pregnancy.

See references

Ethinyl estradiol / norelgestromin Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-Other forms of contraception should be used until the child is completely weaned.
-Small amounts of contraceptive steroids/metabolites are present in breast milk.
-Postpartum women who are breastfeeding should not use combined hormonal contraceptives during the first 3 weeks after delivery due increased risk for venous thromboembolism.
-Postpartum women who are breastfeeding with other risk factors for venous thromboembolism should not use combined hormonal contraceptives 4 to 6 weeks after delivery.
-Nursing mothers should not use combined hormonal contraceptives during the fourth week postpartum due to the potential to adversely affect the milk supply.
-The World Health Organization suggest that combined oral contraceptives should not be used in nursing mothers before 42 days postpartum and the disadvantages of using the method generally outweigh the advantages between 6 weeks and 6 months postpartum.

Combined hormonal contraceptives have been known to reduce milk production and change the composition of breast milk.

See references

References for pregnancy information

  1. "Product Information. Ortho Evra (ethinyl estradiol-norelgestromin)." Janssen Pharmaceuticals, Titusville, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Ortho Evra (ethinyl estradiol-norelgestromin)." Janssen Pharmaceuticals, Titusville, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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