Document Detail

Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diacetate administration.
MedLine Citation:
PMID:  4042659     Owner:  NLM     Status:  MEDLINE    
Twelve women with established lactation of 4-8 weeks duration were given a low-dose progestogen-only contraceptive, ethynodiol diacetate 0.5 mg (Femulen) daily. On the seventh and eight day of the study, prior to the mother's taking the pill, a blood sample was taken from her and from the infant. Further blood samples were collected from the mother 4 and 12 hours later. Breast milk samples were collected at every feed on day 7 and day 8. Ethynodiol diacetate is rapidly metabolised in humans, changing into the metabolite norethisterone which is found in both blood and milk. Hence, norethisterone concentrations were estimated. On day 7 and day 8, four hours after ingestion of the pill, the median norethisterone maternal plasma concentration was 1.60 ng/ml and it fell to a median level of 0.30 ng/ml prior to the next dose of the pill. At this time the median infant concentration was 0.10 ng/ml but the maximum observed level was 0.50 ng/ml. In the breast milk the norethisterone concentration appears to peak at around 4-8 hours following the ingestion of the pill. The maximum observed concentration in breast milk was 0.84 ng/ml. The amount of norethisterone ingested by the infant averaged 0.02% (6.65 micrograms) of the dose of ethynodiol diacetate ingested by the mother. The maximum observed on any one day was 0.07% (27.52 micrograms). The above results indicate that the amount of progestogen ingested by the infant from its mother's milk is small and is unlikely to pose a risk to the infant.
I D Cooke; D J Back; N E Shroff
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Contraception     Volume:  31     ISSN:  0010-7824     ISO Abbreviation:  Contraception     Publication Date:  1985 Jun 
Date Detail:
Created Date:  1985-11-18     Completed Date:  1985-11-18     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0234361     Medline TA:  Contraception     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  611-21     Citation Subset:  IM; J    
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MeSH Terms
Contraceptives, Oral, Synthetic / administration & dosage*,  adverse effects,  metabolism
Ethynodiol Diacetate / administration & dosage*,  adverse effects,  metabolism
Infant, Newborn
Milk, Human / metabolism*
Norethindrone / blood,  metabolism*
Reg. No./Substance:
0/Contraceptives, Oral, Synthetic; 297-76-7/Ethynodiol Diacetate; 68-22-4/Norethindrone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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