Mianserin use while Breastfeeding

Mianserin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Mianserin is not approved for marketing in the United States by the US Food and Drug Administration, but is available in other countries. Limited information indicates that maternal doses up to 60 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Until more data are available, mianserin should be used with careful monitoring during breastfeeding.

Drug Levels

Maternal Levels. One woman with major depression was taking mianserin 60 mg daily for 9 days. Another woman was taking mianserin 40 mg daily for 14 days. A single milk sample was collected 15 hours after the previous dose in each woman. The first woman had breastmilk levels of 80 mcg/L of mianserin and 10 mcg/L of desmethylmianserin. The second woman had breastmilk levels of 20 mcg/L of mianserin and 20 mcg/L of desmethylmianserin. The authors estimated that the dosage was 0.012 mg/kg/day for the first infant, and 0.003 mg/kg/day for the second. These correspond to 1.4% and 0.5% of their respective mothers' weight-adjusted maternal dosages.[1]

Infant Levels. One woman with major depression was taking mianserin 60 mg daily for 9 days. Her 3-month-old breastfed (extent not stated) infant's plasma had no detectable (<10 mcg/L) mianserin or desmethylmianserin. Another 5-month-old breastfed (extent not stated) infant whose mother was taking mianserin 40 mg daily for 14 days had mianserin 12 mcg/L and desmethylmianserin 14 mcg/L detected in his urine.[1]

Effects in Breastfed Infants

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

Possible Effects on Lactation

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

References

1. Buist A, Norman TR, Dennerstein L. Mianserin in breast milk. Br J Clin Pharmacol. 1993;36:133-4. Letter. PMID: 8398582

Mianserin Identification

Substance Name

Mianserin

CAS Registry Number

24219-97-4

Drug Class

  • Antidepressive Agents
  • Antidepressive Agents, Second-Generation
  • Serotonin Antagonists

Administrative Information

LactMed Record Number

856

Information from the National Library of Medicine's LactMed Database.

Last Revision Date

2013-09-07

Disclaimer

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