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Levonorgestrel, Oral use while Breastfeeding

Levonorgestrel, Oral Levels and Effects while Breastfeeding

Summary of Use during Lactation

This record contains information specific to oral levonorgestrel used alone. Those with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined."

Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as levonorgestrel are considered the hormonal contraceptives of choice during lactation. Fair quality evidence indicates that levonorgestrel does not adversely affect the composition of milk, the growth and development of the infant or the milk supply. Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.[1][2][3][4] Some evidence indicates that progestin-only contraceptives may offer protection against bone mineral density loss during lactation, or at least do not exacerbate it.[5][6][7]

After use of levonorgestrel as a postcoital contraceptive, nursing can resume 3 to 4 hours after the dose (or after each dose if the two-dose method is used). Postcoital levonorgestrel appears to have no long-term adverse effects on breastfeeding.[8][9][10]

Drug Levels

Levonorgestrel is a synthetic progestin that is the active isomer of the racemate norgestrel. It is considered to be twice as potent on a weight basis as the racemic mixture.

Maternal Levels. Fifteen women who were fully breastfeeding and 8 weeks postpartum were given oral levonorgestrel either alone in a dose of 30 mcg daily or in an estrogen-containing oral contraceptive in a dose of 150 mcg or 250 mcg daily. Five women received each dose for 10 days before breastmilk sample collection. With the 30 mcg dose, the drug was undetectable in all of the women in prenursing milk (<0.05 mcg/L) or postnursing milk (<0.1 mcg/L) at 3 to 23 hours after the dose. With the 150 mcg dose, the highest levels in milk were found 3 hours after the dose with foremilk and hindmilk levels of 0.34 and 0.54 mcg/L, respectively; levels decreased to 0.11 and 0.17 mcg/L, respectively, at 23 hours after the dose. With the 250 mcg dose, the highest levels in milk were found 3 hours after the dose with foremilk and hindmilk levels of 0.51 and 1.05 mcg/L, respectively; levels decreased to 0.22 and 0.38 mcg/L, respectively, at 23 hours after the dose. The authors estimated that fully breastfed infants would receive 0.4 to 0.5 mcg daily in breastmilk, or about 0.1% of the total (not weight-adjusted) maternal dose.[11]

Two women with well-established lactation (exact time postpartum not stated) were given an oral contraceptive containing 150 mcg of levonorgestrel daily. Each had breastmilk levels measured on 2 occasions 10 to 12 hours after a dose between days 6 and 20 of use. The average of their levonorgestrel milk levels was 0.18 mcg/L (range 0.135 to 0.223 mcg/L).[12]

Milk levonorgestrel levels were measured in 4 women after daily ingestion of oral levonorgestrel 50 or 150 mcg started after 3 months postpartum. Peak milk levonorgestrel levels occurred between 1 and 3 hours and were in the ranges of 0.06 to 0.2 mcg/L after the 50 mcg dose and 0.35 to 0.45 mcg/L after the 150 mcg dose. After the 50 mcg dose, milk levels dropped to undetectable (<0.05 mcg/L) by 4 hours after the dose. After the 150 mcg dose, milk levels dropped to about 0.35 mcg/L at 4 hours after the dose and remained there for the next 2 hours.[13]

At 6 to 20 weeks postpartum, 10 women received single tablets containing 30 mcg of levonorgestrel and another 15 women received a single tablet of a combination oral contraceptive containing 250 mcg of levonorgestrel. 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 2 samples were pooled for assay. After the 30 mcg dose, milk levels averaged 0.05 mcg/L (range 0.03 to 0.076 mcg/L); after the 250 mcg dose, milk levels averaged 0.64 mcg/L (range 0.3 to 1.3 mcg/L).[14]

Twelve breastfeeding women averaging 11.1 weeks postpartum (range 6 and 12 weeks) received a single dose of 1.5 mg of levonorgestrel orally. Blood and milk samples were obtained over the next 72 hours. Peak milk levels of levonorgestrel occurred 3.9 hours after the dose; milk levels fell with a mean half-life in milk of 26 hours. The mean concentration in milk was 1.7 mcg/L during the first day, 0.4 mcg/L the second day and 0.2 mcg/L on the third day after the dose. The authors estimated that a fully breastfed infant would receive 1.6 mcg of levonorgestrel in the first 24 hours, 0.3 mcg in the second 24 hours, and 0.2 mcg in the third 24 hours after the dose.[15]

Infant Levels. Two 8-week old infants whose mothers were taking a combination oral contraceptive containing 250 mcg of levonorgestrel had plasma levels measured 5 hours after the maternal dose and 2 hours after nursing (i.e., nursed at the time of peak milk level). Plasma levels were 0.058 and 0.115 mcg/L in the 2 infants. A third infant whose mother was taking 30 mcg daily had undetectable (<0.005 mcg/L) plasma levonorgestrel. The authors concluded that these results indicate that the infants are able to metabolize levonorgestrel and that no accumulation occurs in infant plasma.[11]

At 6 to 20 weeks postpartum, 10 women received single tablets containing 30 mcg of levonorgestrel and another 15 women received a single tablet of a combination oral contraceptive containing 250 mcg of levonorgestrel. 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 after the 30 and 250 mcg doses averaged 0.019 and 0.078 mcg/L, respectively. These levels were 2% and 1%, respectively, of peak maternal serum levels drawn at 2 to 2.5 hours after the dose.[14]

Thirty mothers received 30 mcg oral levonorgestrel tablets daily for 5 weeks. Ten began at 4 weeks postpartum, 10 began at 12 weeks postpartum and 10 began at 24 weeks postpartum. Because of assay and serum sample size limitations, serum samples were obtained from some of the breastfed infants during the first and fifth weeks of maternal therapy as representative of the entire group. Based on infant serum levels, the authors concluded that absorption of the drug was not great until 12 weeks postpartum and metabolism was not well developed until 24 weeks postpartum.[16] The unusual and incomplete blood sampling scheme casts some doubt on the results of this study.

Effects in Breastfed Infants

One study found serum thyroid stimulating hormone levels to be lower in the infants exposed to levonorgestrel than in control infants.[17]

A nonrandomized trial compared 250 breastfed infants whose mothers received 30 mcg daily of oral levonorgestrel initiated 7 days postpartum to 250 infants whose mothers received nonhormonal contraception. No differences in height and weight gain were seen during the 9-month study period between the 2 groups.[18]

Multicenter, nonrandomized studies followed infants whose mothers received levonorgestrel contraception during breastfeeding, either as oral tablets of 37.5 mcg daily (n = 246) or as Norplant (n = 453). No adverse effects on infant growth through the first year were found in comparison to standard measurements.[19][20]

In a cohort study of 71 women who took levonorgestrel as a postcoital contraceptive found no obvious decrease in milk supply after the drug was used according to maternal reports 75% of mothers re-initiated breastfeeding before 8 hours after the dose. None noticed any adverse effect in their infants.[8]

Effects on Lactation and Breastmilk

Among a cohort study of 71 women who took levonorgestrel as a postcoital contraceptive during nursing, none reported any obvious decrease in milk supply after the drug was used.[8]

A study of 1158 postpartum randomized women using the lactational amenorrhea method (LAM) for birth control randomized to be given levonorgestrel as a postcoital contraceptive or given nothing. No difference in the duration of breastfeeding was found between women who used the levonorgestrel and those who did not.[9]

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.[21]

Alternate Drugs to Consider

Etonogestrel Implant, Intrauterine Copper Contraceptive, Medroxyprogesterone Acetate, Norethindrone

References

1. World Health Organization Department of Reproductive Health and Research. Medical eligibility criteria for contraceptive use: Executive summary. Fifth ed. Geneva. 2015. PMID: 26447268

2. Curtis KM, Tepper NK, Jatlaoui TC et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65:1-103. PMID: 27467196

3. Phillips SJ, Tepper NK, Kapp N et al. Progestogen-only contraceptive use among breastfeeding women: A systematic review. Contraception. 2016;94:226-52. PMID: 26410174

4. ACOG: American College of Obstetrics and Gynecology. Committee Opinion No. 670: Immediate Postpartum Long-Acting Reversible Contraception. Obstet Gynecol. 2016;128:e32-7. PMID: 27454734

5. 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

6. 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

7. 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

8. Polakow-Farkash S, Gilad O, Merlob P et al. Levonorgestrel used for emergency contraception during lactation-A prospective observational cohort study on maternal and infant safety. J Matern Fetal Neonatal Med. 2013;26:219-11. PMID: 22928541

9. Shaaban OM, Hassen SG, Nour SA et al. Emergency contraceptive pills as a backup for lactational amenorrhea method (LAM) of contraception: a randomized controlled trial. Contraception. 2013;87:363-9. PMID: 22935323

10. Jatlaoui TC, Riley H, Curtis KM. Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception. Contraception. 2016;93:93-112. PMID: 26546020

11. Nilsson S, Nygren KG, Johansson EDB. d-Norgestrel concentrations in maternal plasma, milk, and child plasma during administration of oral contraceptives to nursing women. Am J Obstet Gynecol. 1977;129:178-84. PMID: 900181

12. 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

13. Toddywalla VS, Mehta S, Virkar KD et al. 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

14. 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

15. Gainer E, Massai R, Lillo S et al. Levonorgestrel pharmacokinetics in plasma and milk of lactating women who take 1.5 mg for emergency contraception. Hum Reprod. 2007. PMID: 17337471

16. Patel SB, Toddywalla VS, Betrabet SS et al. At what 'infant-age' can levonorgestrel contraceptives be recommended to nursing mothers. Adv Contracept. 1994;10:249-55. PMID: 7740991

17. Bassol S, Nava-Hernandez MP, Hernandez-Morales C et al. Effects of levonorgestrel implant upon TSH and LH levels in male infants during lactation. Int J Gynaecol Obstet. 2002;76:273-7. PMID: 11880130

18. McCann MF, Moggia AV, Higgins JE et al. The effects of a progestin-only oral contraceptive (levonorgestrel 0.03 mg) on breast-feeding. Contraception. 1989;40:635-48. PMID: 2515939

19. 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

20. 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

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

Levonorgestrel, Oral Identification

Substance Name

Levonorgestrel, Oral

CAS Registry Number

797-63-7

Drug Class

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Contraceptives, Postcoital

Administrative Information

LactMed Record Number

421

Last Revision Date

20170905

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