Norethindrone use while Breastfeeding
Drugs containing Norethindrone: Ena, Lo Loestrin Fe, Microgestin Fe 1/20, CombiPatch, Minastrin 24 Fe, Junel Fe 1/20, Camila, Activella, Gildess Fe 1/20, Jolivette, Show all 121 »Necon 1/35, Ortho Micronor, Loestrin 24 Fe, Aygestin, Errin, Mimvey, femhrt, Lopreeza, Generess Fe, Loestrin 1/20, Lomedia 24 Fe, Nora-Be, Jinteli, Lyza, Nortrel 1/35, Microgestin 1.5/30, Ortho-Novum 1/35, Zenchent, Loestrin 21 1/20, Gildess Fe 1.5/30, Gildess 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Estrostep Fe, Junel 1.5/30, Microgestin 1/20, Junel Fe 1.5/30, Mimvey Lo, Layolis Fe, Gildess 1/20, Alyacen 1/35, Sharobel, Nor-QD, Heather, Necon 0.5/35, Aranelle, Philith, Brevicon, Ortho-Novum 7/7/7, Ovcon 35, Cyclafem 1/35, Tarina Fe 1/20, Junel 1/20, Nortrel 7/7/7, Pirmella 1/35, Femcon Fe, Gildess 1.5/30, Blisovi Fe 1/20, Deblitane, Larin Fe 1/20, Jencycla, Larin Fe 1.5/30, Modicon, Wera, Larin 24 Fe, Fyavolv, Cyclafem 7/7/7, Leena, Microgestin Fe 1.5/30, Necon 10/11, Loestrin 21 1.5/30, Ortho-Novum 1/50, Norethin 1/50 M, Lupaneta Pack, Necon 1/50, Wymzya Fe, Dasetta 1/35, Dasetta, Tilia Fe, Blisovi 24 Fe, Microgestin 24 Fe, Jevantique Lo, Vyfemla, Lo Minastrin Fe, Gildagia, Balziva, Norinyl 1+35, Pirmella 7/7/7, Ovcon 50, Necon 7/7/7, Zenchent Fe, Blisovi Fe 1.5/30, Amabelz, Norlyroc, Nelova 1/50 M, Larin 1/20, Norinyl 1+50, Genora 1/50, Larin 1.5/30, Nelova 1/35, Tri-Norinyl, Jenest, Ortho-Novum 10/11, Nelova 10/11, Norethin 1/35 E, Jevantique, Genora 0.5/35, Nelova 0.5/35, Genora 1/35, Nortrel 0.5/35, Ovcon 35 Fe, Briellyn, Dasetta 7/7/7, Zeosa, Alyacen 7/7/7, Tri-Legest Fe, Tri-Legest, Leribane, Cyclafem 0.5/35, Kaitlib Fe, Junel Fe 24
Norethindrone Levels and Effects while Breastfeeding
Summary of Use during Lactation
This record contains information specific to norethindrone used alone. Readers with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined."
Poor to fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply. Some evidence indicates that progestin-only contraceptives may offer protection against bone mineral density loss during lactation, or at least do not exacerbate it.
Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as norethindrone are considered the hormonal contraceptives of choice during lactation. Fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply. Expert opinion in the United States holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum. The World Health Association recommends introduction of progestin-only contraceptives at 6 weeks postpartum.
Maternal Levels. Five women with well-established lactation (exact time postpartum not stated) were given an oral dose of 350 mcg of norethindrone daily. Breastmilk levels were measured several times on the first day of treatment. Peak milk levels occurred at 2 or 4 hours after the dose in various individuals. Average milk levels were 0.747 mcg/L at 2 hours after the dose; 0.747 mcg/L at 4 hours; 0.396 mcg/L at 8 hours; 0.253 mcg/L at 12 hours; and, 0.174 mcg/L at 12 hours after the dose.
Milk norethindone levels were measured in 4 women after daily ingestion of oral norethindrone 350 mcg started after 3 months postpartum. Peak milk norethindrone levels in the range of 0.4 to 0.5 mcg/L occurred between 1 and 3 hours after the dose and dropped slowly over the 6-hour study interval to about 0.15 to 0.4 mcg/L.
At 6 to 20 weeks postpartum, 15 women received a single tablet of a combination oral contraceptive containing a dose of 3 mg of norethindrone. At 2 to 2.5 hours after the dose, a foremilk sample was taken. The mothers breastfed their infants and then a hindmilk sample was taken. The two samples were pooled for assay. Milk levels averaged 2.4 mcg/L (range 0.9 to 5.5 mcg/L).
Infant Levels. At 6 to 20 weeks postpartum, 15 women received a single tablet of a combination oral contraceptive containing a dose of 3 mg of norethindrone. At 2 to 2.5 hours after the dose the mothers breastfed their infants; infant serum samples were taken 1.5 to 2 hours later at about 4 hours after the maternal dose. Infant serum levels averaged 0.19 mcg/L which was 0.8% of peak maternal serum levels drawn at 2 to 2.5 hours after the dose.
Effects in Breastfed Infants
No consistent physical, mental, or radiologic differences have been found in infants whose mothers were using norethindrone enanthate (Norplant). Some studies found increased infant weight gain among the infants of treated women.
A non-blinded, randomized study of exclusively breastfeeding women compared those who received an etonogestrel implant 24-48 hours after delivery (n = 20) to those who received a 150 mg depot medroxyprogesterone acetate injection at 6 weeks postpartum (n = 20). Infants of the implant users gained more than the infants of the DMPA mothers during the first 6 weeks of life.
A short-term study of 12 women who received oral norethindrone 350 mcg daily starting 48 hours postpartum found no differences in infant weight gain over 14 days compared to 8 women taking a placebo.
Effects on Lactation and Breastmilk
Studies of varying size and quality on the use of long-acting norethindrone injections (acetate or enanthate) have found that the use of levonorgestrel implants (Norplant or Norplant-2) as a contraceptive beginning at 6 weeks postpartum or later either has no clinically important negative effect on the quality of breastmilk and results in either no effect or an increase in the milk supply and duration of lactation  In one study, women who received the implant at 6 days postpartum, a transient decrease in milk protein occurred 2 weeks after implant insertion. A decrease in milk phosphorus content was also observed between 2 and 4 months after implant insertion in this group and at 3 months postpartum, the early insertion group had a higher rate of supplementation. In another study, women given norethindrone enanthate depot injection less than 48 hours postpartum were 2.5 to 3 times more likely to have postpartum depression at 6 weeks postpartum. No differences were seen at 1 and 12 weeks postpartum.
A short-term study of 12 women who received oral norethindrone 350 mcg daily starting 48 hours postpartum found no differences in milk production or milk composition over 14 days compared to 8 women taking a placebo.
One small, nonrandomized study found that oral norethindrone 350 mcg daily decreased the quantity and quality (lower protein, lipids and calcium) compared to controls who received nonhormonal contraception.
In a nonrandomized, nonblinded study comparing women who were breastfeeding at discharge, 102 postpartum women received depot medroxyprogesterone acetate (dosage not stated) in the early postpartum period (average 51.9 hours postpartum; range 6.25 to 132 hours), 181 received another progestin-only contraceptive and 138 used nonhormonal contraception. No differences in breastfeeding rates were seen at 2 and 6 weeks, but women receiving any hormonal contraceptive were breastfeeding at a lower rate (72.1% vs 77.6%) at 4 weeks postpartum. The authors concluded that progestin-only contraception initiated in the early postpartum period had no adverse effects on breastfeeding rates.
Alternate Drugs to Consider
1. Truitt ST, Fraser AB, Grimes DA et al. Combined hormonal versus progestin-only contraception in lactation. Cochrane Database Syst Rev. 2003;2:CD003988 (updated 6 May 2008). PMID: 12804497
2. Queenan JT. Contraception and breastfeeding. Clin Obstet Gynecol. 2004;47:734-9. PMID: 15326435
3. Anon. FFPRHC Guidance (July 2004): Contraceptive choices for breastfeeding women. J Fam Plann Reprod Health Care. 2004;30:181-9. PMID: 15222930
4. Caird LE, Reid-Thomas V, Hannan WJ et al. Oral progestogen-only contraception may protect against loss of bone mass in breast-feeding women. Clin Endocrinol (Oxf). 1994;41:739-45. PMID: 7889609
5. Diaz S, Reyes MV, Zepeda A et al. Norplant(R) implants and progesterone vaginal rings do not affect maternal bone turnover and density during lactation and after weaning. Hum Reprod. 1999;14:2499-505. PMID: 10527977
6. Costa ML, Cecatti JG, Krupa FG et al. Progestin-only contraception prevents bone loss in postpartum breastfeeding women. Contraception. 2012;85:374-80. PMID: 22036473
7. 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;62 (RR-05):1-60. PMID: 23784109
8. World Health Organization Department of Reproductive Health and Research. Medical eligibilty criteria for contraceptive use: Executive summary. Fifth ed. Geneva. 2015. http://apps.who.int/iris/bitstream/10665/172915/1/WHO_RHR_15.07_eng.pdf?ua=1
9. Saxena BN, Shrimanker K, Grudzinskas JG. Levels of contraceptive steroids in breast milk and plasma of lactating women. Contraception. 1977;16:605-13. PMID: 606500
10. 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;21:217-22. PMID: 7389350
11. Betrabet SS, Shikary ZK, Toddywalla VS et al. 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;35:517-22. PMID: 3117488
12. Karim M, Ammar R, El Mahgoub S et al. Injected progestogen and lactation. Br Med J. 1971;1:200-3. PMID: 5099971
13. Shaaban MM. Contraception with progestogens and progesterone during lactation. J Steroid Biochem Mol Biol. 1991;40:705-10. PMID: 1835650
14. Anon. 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;50:55-68. PMID: 7924322
15. Anon. 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;50:35-53. PMID: 7924321
16. Brito MB, Ferriani RA, Quintana SM et al. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009;80:519-26. PMID: 19913145
17. Giner Velazquez J, Cortes Gallegos V, Sotelo Lopez A et al. [Effect of daily oral administration of 0.350 mg of norethindrone on lactation and on the composition of milk]. Ginecol Obstet Mex. 1976;40:31-9. PMID: 780215
18. Seth U, Yadava HS, Agarwal N et al. Effect of a subdermal silastic implant containing norethindrone acetate on human lactation. Contraception. 1977;16:383-98. PMID: 923249
19. Lawrie TA, Hofmeyr GJ, De Jager M et al. A double-blind randomised placebo controlled trial of postnatal norethisterone enanthate: the effect on postnatal depression and serum hormones. Br J Obstet Gynaecol. 1998;105:1082-90. PMID: 9800931
20. Toddywalla VS, Joshi L, Virkar K. Effect of contraceptive steroids on human lactation. Am J Obstet Gynecol. 1977;127:245-9. PMID: 835620
21. Halderman LD, Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns. Am J Obstet Gynecol. 2002;186:1250-8. PMID: 12066106
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Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
LactMed Record Number
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