Question

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 lactation summary

Zophrenal is safe in breastfeeding
  • DrLact safety Score for Zophrenal is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Zophrenal is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Zophrenal does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Zophrenal safe in breastfeeding are based on normal dosage and may not hold true for higher 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 Zophrenal usage in lactation

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.

Answer by DrLact: About Zophrenal usage in lactation

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]

Zophrenal Side Effects in Breastfeeding

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 Possible Effects in Breastfeeding

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.
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. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.