Zuclopenthixol use while Breastfeeding

Zuclopenthixol Levels and Effects while Breastfeeding

Summary of Use during Lactation

Zuclopenthixol is not approved for marketing in the United States by the US Food and Drug Administration, but is available in Canada and other countries. Limited information indicates that maternal oral doses of up to 50 mg daily or depot injections of 72 mg every 2 weeks produce low levels in breastmilk and no detectable short-term adverse effects in the breastfed infants. No long-term data are available. Until more data are available, zuclopenthixol should be used with careful monitoring during breastfeeding.

Drug Levels

Maternal Levels. Six women received zuclopenthixol during nursing. Five of the women were receiving the drug orally and one was receiving a depot injection. Oral dosages ranged from 4 to 50 mg daily of zuclopenthixol and the depot decanoate injection dosage was 72 mg every 2 weeks. Milk samples were obtained in the morning before the first oral dose of the day. Milk zuclopenthixol concentrations for 5 of the patients were between 1 and 2 mcg/L. The patient receiving the high oral dose of 50 mg daily had a breastmilk zuclopenthixol level of about 9 mcg/L.[1]

One woman received zuclopenthixol for depression beginning 2 weeks postpartum. She initially received a dose of 24 mg daily (4 mg in the morning and 20 mg at night), but the dose was reduced to 14 mg daily (4 mg in the morning and 10 mg at night) after 4 days. Seven milk samples in total were obtained on days 2, 3, 6, and 8 of therapy. The average of the milk level with the 24 mg daily dosage was 20 mcg/L and with the 14 mg daily dosage it was 5 mcg/L. The authors estimated that an exclusively breastfed infant would receive 0.8 to 3 mcg/kg daily with the maternal doses given or 0.3 to 0.8% of the maternal weight-adjusted dosage.[2]

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

Effects in Breastfed Infants

Six women received zuclopenthixol during nursing. Five of the women were receiving 4 to 50 mg daily by mouth and one was receiving a depot injection of 72 mg every 2 weeks. Their breastfed infants range in age from 3 days to 10 months old, 5 of whom were 2 months or under. No immediate adverse effects such infant drowsiness were noted.[1]

Possible Effects on Lactation

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

Alternate Drugs to Consider

Haloperidol, Olanzapine, Risperidone

References

1. Aaes-Jorgensen T, Bjorndal F, Bartels U. Zuclopenthixol levels in serum and breast milk. Psychopharmacology (Berl). 1986;90:417-8. PMID: 2878463

2. Matheson I, Skjaeraasen J. Milk concentrations of flupenthixol, nortriptyline and zuclopenthixol and between-breast differences in two patients. Eur J Clin Pharmacol. 1988;35:217-20. PMID: 3191943

Zuclopenthixol Identification

Substance Name

Zuclopenthixol

CAS Registry Number

53772-83-1

Drug Class

  • Antipsychotic Agents
  • Dopamine Antagonists

Administrative Information

LactMed Record Number

860

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

Last Revision Date

2013-09-07

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Disclaimer: This information is not intended as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. Use of this website signifies your agreement to the Terms of Use and Online Privacy Policy.

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