Is Lealgin compositum Safe in Breastfeeding

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

It is excreted into breast milk in quite variable amounts that may be clinically significant, however, no clinical or developmental issues have been observed in infants whose mothers were treated with this drug. In two out of four infants whose mothers took Lealgin compositum and chlorpromazine simultaneously, showed decreased development scores between 12 and 18 months (Yoshida 1998).On the other hand, no long-term developmental problems were observed in breastfed infants up to 12 months while the mother was taking Lealgin compositum and Olanzapine or Lealgin compositum and Amisulpride (Uguz 2015). Lealgin compositum may induced an increase in prolactin release and can cause galactorrhea.

Limited information indicates that maternal doses of Lealgin compositum up to 10 mg daily produce low levels in milk and do not affect the breastfed infant. Very limited long-term follow-up data indicate no adverse developmental effects when Lealgin compositum is used alone. However, use with chlorpromazine occasionally might negatively affect development. Monitor the infant for developmental milestones, especially if other antipsychotics are used concurrently.

In one breastfed infant, there were no sedative effects and the baby fed well during maternal intake of 5 mg orally twice daily. The mother took Lealgin compositum during six weeks of breast feeding and at 6 and 12 months of age, the baby had achieved all milestones of growth and development.[2] One infant was breastfed for 5 weeks beginning at 2 weeks of age during maternal Lealgin compositum (dose not stated) and imipramine (150 mg daily) therapy. The infant showed normal development when tested once between 1 and 4 months and once between 12 and 18 months of age.[7] In a small prospective study on the long-term effects of antipsychotics in breastfed infants, a decline in developmental scores was found at 12 to 18 months of age in 2 of the 4 the infants of mothers taking both chlorpromazine and Lealgin compositum. The other 2 infants and all infants exposed to either drug alone developed normally.[6] One woman with schizophrenia took Lealgin compositum and trihexyphenidyl during 3 pregnancies and postpartum. Lealgin compositum doses were 7.5 to 10 mg daily in the first 2 pregnancies and 15 mg daily in the third. She breastfed (extent not stated) all 3 children for 6 to 8 months using the same doses. Development was age-appropriate in all children aged 16 months at 8 years of age at the time of assessment.[8] Two women, one with bipolar disorder and the other with long-standing schizophrenia, were treated with Lealgin compositum 5 mg daily during pregnancy and breastfeeding (extent not stated). One mother also received olanzapine 10 mg daily and the other received amisulpride 400 mg daily. Follow-up of the breastfed infants for 11 to 13 months found no adverse effects and normal development of the infants.[9]

Galactorrhea has been reported with Lealgin compositum.[10] Hyperprolactinemia appears to be the cause of the galactorrhea.[10][11][12][13][14][15] The hyperprolactinemia is caused by the drug's dopamine-blocking action in the tuberoinfundibular pathway.[16] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.