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Ethinyl estradiol / norgestimate Pregnancy and Breastfeeding Warnings

Ethinyl estradiol / norgestimate is also known as: Estarylla, Femynor, Mili, Mono-Linyah, Mononessa, Ortho Cyclen, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Previfem, Sprintec, Tri Femynor, Tri-Estarylla, Tri-Linyah, Tri-Lo-Estarylla, Tri-Lo-Marzia, Tri-Lo-Mili, Tri-Lo-Sprintec, Tri-Mili, Tri-Previfem, Tri-Sprintec, TriNessa, TriNessa Lo

Ethinyl estradiol / norgestimate Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse developmental effects. Epidemiological data have failed to reveal an increased risk of birth defects following maternal exposure oral contraceptives prior to conception or when taken inadvertently during early pregnancy. There are no controlled data in human pregnancy. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated. US FDA pregnancy category: X Comments: -This drug is intended to prevent pregnancy and should not be used in women who are already pregnant or suspect they may be pregnant. -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.

See references

Ethinyl estradiol / norgestimate Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Yes Comments: -Women should avoid use of oral contraceptives and use other forms of contraception until the child is completely weaned. -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 and other authorities 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.

Jaundice and breast enlargement have been reported have been reported in the nursing infant when the mother was using oral contraceptives during breastfeeding. Combined oral contraceptives have also been known to reduce milk production.

See references

References for pregnancy information

  1. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Ortho Tri-Cyclen Lo (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical, Raritan, NJ.

References for breastfeeding information

  1. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Ortho Tri-Cyclen Lo (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical, Raritan, NJ.
  4. 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 -]):

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