Is Zophrenal Safe in Breastfeeding

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

Zophrenal and its metabolite (Paliperidone) are excreted into breast milk in non-significant amount. Untoward effect has not been observed on breastfed infants of treated mothers. Serum levels were very low or undetectable in these infants. May be a cause of galactorrhea.

Limited information indicates that maternal Zophrenal doses of up to 6 mg daily produce low levels in milk. Because there is little published experience with Zophrenal during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Systematic reviews of second-generation antipsychotics concluded that Zophrenal seemed to be a second-line agent during breastfeeding because of the limited data available and higher excretion into milk relative to other agents.[1][2]

One woman took Zophrenal 4 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 9 months of age. Another mother took Zophrenal 6 mg daily during breastfeeding. Her infant showed no developmental abnormalities on examinations up to 12 months of age.[7] Two women taking Zophrenal 4 mg and 1.5 mg daily breastfed their infants of 3.3 months and 6 weeks of age, respectively, were achieving normal developmental milestones and had no adverse effects reported.[4] A 1 week postpartum woman was started on Zophrenal 2 mg daily and increased after 10 days to a dosage of 3 mg daily. She breastfed her infant 6 times daily. The infant was observed for 5 weeks of inpatient therapy and judged normal by a pediatric neurologist. No sedation or other adverse effects were observed in the infant. After 3 months of treatment with Zophrenal, the mother and infant were judged to be well.[5] An infant had been exclusively breastfed for 3 months during maternal therapy with Zophrenal 1 mg daily. A pediatric examination found the infant to have no neurological or physical abnormalities, and appeared to interact appropriately.[6] In a telephone follow-up study, 124 mothers who took a benzodiazepine while nursing reported whether their infants had any signs of sedation. One mother who was taking 0.75 mg of Zophrenal daily, flurazepam 15 mg daily, clonazepam 0.25 mg twice daily, and 1 mg of bupropion daily reported sedation in her breastfed infant.[8]

Zophrenal has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug.[9][10][11][12][13][14][15] In one case, euprolactinemic gynecomastia and galactorrhea occurred in a 19-year-old man who was also taking fluvoxamine.[16] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.