Last update March 29, 2022

Norethisterone

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Norethisterone or Nornorethindrone is a contraceptive progestogen derived from 19-northstastterone used as a single product or associated with ethinylestradiol. Oral administration daily or in intramuscular injection every 8 weeks.

It is excreted in breast milk in clinically significant amount (Betrabet 1987, Toddywalla 1980, Saxena 1977) and no problems have been observed in infants whose mothers took it. (WHO 1994, Shaaban 1991, Giner 1976, Karim 1971)

Plasma levels of these infants were undetectable or very low.(Betrabet 1987)

No alterations have been observed in the amount or composition of breast milk in mothers treated with norethindrone. (Giner 1976)

WHO List of Essential Medicines 2002: rates it as compatible with breastfeeding after the 6th postnatal week. (WHO/OMS 2002)

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During breastfeeding progestin-only contraceptives are preferable to those combined with estrogen and, in this case, those with a lower dose of estrogen. (CDC 2016, WHO/OMS 2015, Altshuler 2015, Berens 2015, CLM 2012, Moretti 2000)

For the first 4-6 weeks postpartum, non-hormonal methods are the first choice, followed by IUDs and progestogen implants. (Berens 2015, Mwalwanda 2013, Rowe 2013, CLM 2012)


See below the information of these related products:

  • Estradiol (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Estradiol + Norethisterone (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Ethinylestradiol + Norethisterone (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Mestranol + Norethindrone (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Norethisterone ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Alternatives

  • Diaphragm ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Intrauterine Device ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Preservative ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Norethisterone is also known as


Norethisterone in other languages or writings:

Group

Norethisterone belongs to this group or family:

Tradenames

Main tradenames from several countries containing Norethisterone in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 64 %
Molecular weight 298 daltons
Protein Binding 99 %
VD 4 l/Kg
pKa 17.59 -
Tmax 1 - 2 hours
8 - 10 hours
M/P ratio 0.3 -
Theoretical Dose 0.0001 - 0.0004 mg/Kg/d
Relative Dose 0.7 - 1.9 %

References

  1. CDC - Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. CDC - MMWR Recommendations & Reports. 2016 Abstract Full text (link to original source) Full text (in our servers)
  2. Berens P, Labbok M; Academy of Breastfeeding Medicine. ABM Clinical Protocol #13: Contraception During Breastfeeding, Revised 2015. Breastfeed Med. 2015 Abstract Full text (link to original source) Full text (in our servers)
  3. Tepper NK, Phillips SJ, Kapp N, Gaffield ME, Curtis KM. Combined hormonal contraceptive use among breastfeeding women: an updated systematic review. Contraception. 2015 Abstract
  4. WHO. Department of Reproductive Health and Research World Health Organization. Medical eligibility criteria for contraceptive use: 20 years of global guidance. WHO/RHR/15.07. 2015 Abstract Full text (link to original source) Full text (in our servers)
  5. Altshuler AL, Gaffield ME, Kiarie JN. The WHO's medical eligibility criteria for contraceptive use: 20 years of global guidance. Curr Opin Obstet Gynecol. 2015 Abstract Full text (link to original source) Full text (in our servers)
  6. Berens P, Labbok M; Academy of Breastfeeding Medicine. Protocolo clínico de la ABM n.º 13: Anticoncepción durante la lactancia, revisado en 2015. Breastfeed Med. 2015 Full text (link to original source) Full text (in our servers)
  7. Lopez LM, Grey TW, Stuebe AM, Chen M, Truitt ST, Gallo MF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev. 2015 Abstract
  8. Mwalwanda CS, Black KI. Immediate post-partum initiation of intrauterine contraception and implants: a review of the safety and guidelines for use. Aust N Z J Obstet Gynaecol. 2013 Abstract
  9. CDC. Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC). U.S. Selected Practice Recommendations for Contraceptive Use, 2013: adapted from the World Health Organization selected practice recommendations for contraceptive use, 2nd edition. MMWR Recomm Rep. 2013 Abstract Full text (link to original source) Full text (in our servers)
  10. Urzica D, Gales C, Zamfir C, Nechifor M. The influence of oral steroidal contraceptives on magnesium concentration in breast milk. Magnes Res. 2013 Abstract
  11. Bahamondes L, Bahamondes MV, Modesto W, Tilley IB, Magalhães A, Pinto e Silva JL, Amaral E, Mishell DR Jr. Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth. Fertil Steril. 2013 Abstract Full text (link to original source) Full text (in our servers)
  12. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  13. CLM - Comité de Lactancia Materna de la AEP. Preguntas frecuentes sobre lactancia materna. Folleto. 2012 Full text (link to original source) Full text (in our servers)
  14. Centers for Disease Control and Prevention (CDC). U S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Recomm Rep. 2010 Abstract Full text (link to original source) Full text (in our servers)
  15. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  16. Díaz S. Contraceptive implants and lactation. Contraception. 2002 Abstract
  17. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Practice guidelines. Can Fam Physician. 2000 Sep;46:1753-7. Review. Abstract Full text (link to original source) Full text (in our servers)
  18. Lawrie TA, Hofmeyr GJ, De Jager M, Berk M, Paiker J, Viljoen E. A double-blind randomised placebo controlled trial of postnatal norethisterone enanthate: the effect on postnatal depression and serum hormones. Br J Obstet Gynaecol. 1998 Abstract
  19. WHO. Progestogen-only contraceptives during lactation: I. Infant growth. World Health Organization Task force for Epidemiological Research on Reproductive Health; Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1994 Abstract
  20. WHO. Progestogen-only contraceptives during lactation: II. Infant development. World Health Organization, Task Force for Epidemiological Research on Reproductive Health; Special Programme of Research, Development, and Research Training in Human Reproduction. Contraception. 1994 Abstract
  21. Shaaban MM. Contraception with progestogens and progesterone during lactation. J Steroid Biochem Mol Biol. 1991 Abstract
  22. Betrabet SS, Shikary ZK, Toddywalla VS, Toddywalla SP, Patel D, Saxena BN. ICMR Task Force Study on hormonal contraception. Transfer of norethisterone (NET) and levonorgestrel (LNG) from a single tablet into the infant's circulation through the mother's milk. Contraception. 1987 Abstract
  23. Cooke ID, Back DJ, Shroff NE. Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diacetate administration. Contraception. 1985 Abstract
  24. Fotherby K, Towobola O, Muggeridge J, Elder MG. Norethisterone levels in maternal serum and milk after intramuscular injection of norethisterone oenanthate as a contraceptive. Contraception. 1983 Abstract
  25. West CP. The acceptability of a progestagen-only contraceptive during breast-feeding. Contraception. 1983 Abstract
  26. Koetsawang S, Nukulkarn P, Fotherby K, Shrimanker K, Mangalam M, Towobola K. Transfer of contraceptive steroids in milk of women using long-acting gestagens. Contraception. 1982 Abstract
  27. Melis GB, Strigini F, Fruzzetti F, Paoletti AM, Rainer E, Düsterberg B, Fioretti P. Norethisterone enanthate as an injectable contraceptive in puerperal and non-puerperal women. Contraception. 1981 Abstract
  28. Toddywalla VS, Mehta S, Virkar KD, Saxena BN. Release of 19-nor-testosterone type of contraceptive steroids through different drug delivery systems into serum and breast milk of lactating women. Contraception. 1980 Mar;21(3):217-23. Abstract
  29. Seth U, Yadava HS, Agarwal N, Laumas KR, Hingorani V. Effect of a subdermal silastic implant containing norethindrone acetate on human lactation. Contraception. 1977 Abstract
  30. Saxena BN, Shrimanker K, Grudzinskas JG. Levels of contraceptive seroids in breast milk and plasma of lactating women. Contraception. 1977 Abstract
  31. Giner Velázquez J, Cortés Gallegos V, Sotelo López A, Bondani G. [Effect of daily oral administration of 0.350 mg of norethindrone on lactation and on the composition of milk]. Ginecol Obstet Mex. 1976 Abstract
  32. Karim M, Ammar R, el-Mahgoub S, el-Ganzoury B, Fikri F, Abdou I. Injected progestogen and lactation. Br Med J. 1971 Abstract Full text (link to original source) Full text (in our servers)

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