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Transfer of cyproterone acetate to the milk of lactating women.

Abstract：

:Cyproterone acetate (CPA) was administered in a dose of 50 mg to 6 lactating women delivered by caesarean section. All women had to discontinue breast feeding the day before treatment. Prior to, and 3 and 9 hours after ingestion of the drug, plasma and milk specimens were taken. Total daily milk volume was recorded. Concentration of CPA in plasma and milk was determined by RIA. The plasma levels of CPA were in the range of 65 - 450 ng/ml at 3 h and 76 - 270 ng/ml after 9 hours. The respective concentrations in milk were 16 - 260 ng/ml (3 h) and 55 - 130 ng/ml (9 h). The plasma/milk ratio of drug concentration varied between 1.1 and 9.3 (3 h) and 0.6 and 2.9 (9 h). The mean of all values amounted to 2.8 +/- 2.3. Taking into account a daily milk production of 1050 +/- 230 ml, 0.2% of the dose administered (range: 0.06 - 0.41 % of dose) would have been transferred to the newborn. Use of the CPA-containing oral contraceptive DIANER (2 mg of CPA + 50 microgram of ethinyl estradiol) by nursing women would therefore result in the transfer of 1 microgram/kg to the child. :Cyproteone acetate (CPA), an antiandrogenic, antigonadotrophic, and progestogenic synthetic sex steroid, has clinical use in treatment of acne and hirsutism. Since these skin conditions may occur in the postpartum, breastfeeding woman, this study was undertaken to evaluate the degree of transfer to CPA from plasma to milk of lactating women and to calculate the dose passed to the newborn by breastfeeding during maternal therapy with CPA. 6 women, who all delivered by caesarean section, were given 50 mg of CPA. Before, and 3 and 9 hours after, ingestion of CPA, plasma and milk specimens were taken. Total daily milk volume was also recorded. Radioimmunoassay was used to determine levels of CPA in both milk and plasma. CPA plasma levels ranged 65-450 ng/ml at 3 hours and 76-270 9 hours after drug ingestion. In milk, respective concentrations were 16-260 and 55-130 ng/ml. Plasma/milk radio of drug concentration varied from 1.1-9.3 at 3 hours and from .6-2.9 at 9 hours postingestion. Based on milk volume measurement, daily milk production has a mean of 1050+ or -230 ml. Taking this measurement into account, .2% of the dose administered is transferred to the newborn. Therefore, use of a CPA-containing agent in nursing women results in transfer of 1 mcg/kg of body weight to the newborn.

journal_name

Contraception

journal_title

Contraception

authors

Stoppelli I,Rainer E,Hümpel M

doi

10.1016/0010-7824(80)90101-8

subject

Has Abstract

pub_date

1980-11-01 00:00:00

pages

485-93

issue

eissn

0010-7824

issn

1879-0518

pii

0010-7824(80)90101-8

journal_volume

pub_type

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Transfer of cyproterone acetate to the milk of lactating women.