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Moclobemide excretion in human breast milk
G Pons1, M P Schoerlin, Y K Tam
1Département de Pharmacologie Clinique Périnatale et Pédiatrique, Hôpital Saint-Vincent de Paul, Paris, France.
British Journal of Clinical Pharmacology
|January 1, 1990
Summary
Moclobemide and its metabolites show minimal excretion into breast milk, with levels undetectable after 12 hours. Infant exposure is very low, suggesting it is unlikely to pose a hazard to nursing newborns.
Area of Science:
- Pharmacokinetics
- Lactational Pharmacology
- Neonatal Safety
Background:
- Maternal antidepressant use during lactation requires careful assessment of drug transfer to the infant.
- Moclobemide is a reversible inhibitor of monoamine oxidase A (RIMA) used for treating depression.
Purpose of the Study:
- To quantify the excretion of moclobemide and its metabolites into human breast milk.
- To estimate the potential dose exposure for a breast-fed neonate.
Main Methods:
- Six lactating women received a single 300 mg oral dose of moclobemide.
- Milk and plasma samples were collected serially for up to 24 hours post-dose.
- Moclobemide and its metabolites (Ro 12-8095, Ro 12-5637) were quantified using high-performance liquid chromatography (HPLC).
Main Results:
- Moclobemide and its major metabolite (Ro 12-8095) were detected in milk, peaking at 3 hours and undetectable by 12 hours.
- The active metabolite (Ro 12-5637) was not detected in milk.
- Total excretion of moclobemide and Ro 12-8095 in milk represented less than 0.1% of the maternal dose.
Conclusions:
- Moclobemide exhibits very low transfer into human breast milk.
- The estimated infant dose is approximately 1% of the maternal dose on a mg/kg basis.
- Moclobemide excretion into breast milk is unlikely to be hazardous to nursing infants.