Summary of Use during Lactation

Drospirenone is a progestin that is an analogue of spironolactone. It has antimineralocorticoid and antiandrogenic activities. Amounts in milk are very low and no adverse effects on the breasted infant or milk supply are expected. Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.[1,2] For further information, consult the record entitled, Contraceptives, Oral, Combined.

Drug Levels

Maternal Levels. Six women who were between 1 week and 3 months postpartum received a single dose of drospirenone 3 mg plus ethinyl estradiol 30 mcg. Milk was collected for 72 hours after the dose in 2 of the women in whom half-lives in breastmilk were 8.3 and 15.5 hours. The average peak milk level in the 6 women was 13.5 mcg/L at 2.8 hours after the dose. The average drospirenone milk level in the first 24 hours was 3.7 mcg/L (range 1.4 to 7 mcg/L). The authors estimated that a fully breastfed infant would receive a drospirenone dose of about 3 mcg daily.[3] Using the average milk level of drospirenone, an exclusively breastfed infant would receive 1.1% of the weight-adjusted maternal dosage of drospirenone.

Twelve women who had weaned their infants, but were still lactating were given non-micronized oral drospirenone 4 mg daily (Slinda-Exeltis, Germany). Blood and milk samples were obtained at 12 time points up to 120 hours after at least 7 days of use. The average peak concentration in milk was 10.3 mcg/L at 3 hours after the dose and the average milk concentration over 24 hours would be 5.6 mcg/L. Using the standard milk intake value of 150 mL/kg daily, the infant would receive an average of 0.84 mcg/kg of drospirenone daily, which represent a weight-adjusted relative infant dose of 1.25% of the maternal dose.[4]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Etonogestrel, Intrauterine Copper Contraceptive, Oral Levonorgestrel, Intrauterine Levonorgestrel, Levonorgestrel Implant, Medroxyprogesterone Acetate, Norethindrone, Progesterone

References

1.

World Health Organization. Medical Eligibility Criteria For Contraceptive Use: Sixth Ed. 2025. https://www​.who.int/publications​/i/item/9789240115583 [PubMed: 41325508]

2.

Nguyen AT, Curtis KM, Tepper NK, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2024. MMWR Recomm Rep 2024;73:1–126. [PMC free article: PMC11315372] [PubMed: 39106314]

3.

Blode H, Foidart JM, Heithecker R. Transfer of drospirenone to breast milk after a single oral administration of 3 mg drospirenone + 30 mcg ethinylestradiol to healthy lactating women. Eur J Contracept Reprod Health Care 2001;6:167–71. [PubMed: 11763981]

4.

Melka D, Kask K, Colli E, et al. A single-arm study to evaluate the transfer of drospirenone to breast milk after reaching steady state, following oral administration of 4 mg drospirenone in healthy lactating female volunteers. Womens Health (Lond) 2020;16:1745506520957192. [PMC free article: PMC7485149] [PubMed: 32903172]

Substance Name

Drospirenone

CAS Registry Number

67392-87-4

Drug Class

Breast Feeding

Lactation

Milk, Human

Aldosterone Antagonists

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Mineralocorticoid Receptor Antagonists