Question

I am a breastfeeding mother and i want to know if it is safe to use Agomelatine? Is Agomelatine safe for nursing mother and child? Does Agomelatine extracts into breast milk? Does Agomelatine has any long term or short term side effects on infants? Can Agomelatine influence milk supply or can Agomelatine decrease milk supply in lactating mothers?

Agomelatine lactation summary

Agomelatine usage has low risk in breastfeeding
  • DrLact safety Score for Agomelatine is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of Agomelatine may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that Agomelatine may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of Agomelatine low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using Agomelatine We suggest monitoring child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Agomelatine usage in lactation

Agonista de receptores de la melatonina y antagonista de los de la serotonina. Aumenta la liberación de noradrenalina y dopamina en la corteza frontal (EMA 2017).Indicado en episodios de depresión mayor.Administración oral una vez al día al acostarse durante al menos 6 meses. No requiere disminución progresiva de dosis para la retirada del fármaco. Sus datos farmacocinéticos (baja biodisponibilidad oral, alta unión a proteínas plasmáticas y corta vida media) explican el ínfimo paso a leche observado. En una madre que tomaba 25 mg diarios, la concentración en leche alcanzó los 2 microgramos (mcg) /L a las 2 horas de la toma y fue indetectable (< 0,1 mcg/L) a las 4 horas (Schmidt 2013). Se puede minimizar más aún el riesgo esperando al menos 4 horas a amamantar. Los efectos secundarios suelen ser leves o moderados, aunque se ha descrito daño hepático en un 4% de usuarios, por lo que se ha retirado del mercado en varios países (Carvalho 2016). Su efecto dopaminérgico es antiprolactina (la dopamina inhibe la secreción de prolactina) y puede disminuir la producción de leche durante las primeras semanas tras el parto. Cuando la lactancia está bien establecida, los niveles de prolactina no se correlacionan con la producción de leche. De no poder utilizar una de las alternativas propuestas conviene vigilar la producción láctea.

Alternate Drugs for Antidepressants, other. ATC N06AX

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