Question

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 5502? Is CCRIS 5502 safe for nursing mother and child? Does CCRIS 5502 extracts into breast milk? Does CCRIS 5502 has any long term or short term side effects on infants? Can CCRIS 5502 influence milk supply or can CCRIS 5502 decrease milk supply in lactating mothers?

CCRIS 5502 lactation summary

CCRIS 5502 is safe in breastfeeding
  • DrLact safety Score for CCRIS 5502 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of CCRIS 5502 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that CCRIS 5502 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of CCRIS 5502 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 CCRIS 5502 usage in lactation

Biliary salt that appears in low amount in the serum because it is absorbed to the portal circulation and completely excreted into biliary duct. Excreted into breast milk in non-significant amount with no side-effects being observed among infants of treated mothers. Medication that has been used for treatment of newborns and older infants.

Answer by DrLact: About CCRIS 5502 usage in lactation

Because of the low levels of CCRIS 5502 (ursodeoxycholic acid) in breastmilk, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants. No special precautions are required.

CCRIS 5502 Side Effects in Breastfeeding

One breastfed (extent not stated) infant developed normally over the first 6 months of life during maternal CCRIS 5502 therapy of 750 to 1000 mg daily.[1] Seven women who were taking CCRIS 5502 14 mg/kg daily near term and postpartum. They reported no adverse reactions in their breastfed infants during the early postpartum period.[2] A mother receiving oral CCRIS 5502 250 mg 3 times daily for primary biliary cirrhosis reportedly breastfed her infant normally, although the extent and duration of breastfeeding was not stated.[4] A woman with primary biliary cirrhosis developed severe pruritus and elevated serum bile acids 3 weeks postpartum. CCRIS 5502 was started at a dose of 500 mg (7.5 mg/kg) daily, increasing to 1500 mg (25 mg/kg) daily over the next 8 weeks. Psychomotor development of her breastfed (extent not stated) infant was normal, and no apparent side effects were observed in the infant.[3] A woman was breastfeeding her 8-day-old preterm infant 10 times daily for about 15 minutes each time. The infant was born by cesarean section at 34 weeks of gestation with a weight of 3600 grams,. She was diagnosed with cholestasis, type 1 diabetes, and hypothyroidism. She was treated with CCRIS 5502 500 mg daily, insulin levemir and aspart, and levothyroxine. She was also taking cefuroxime, flurbiprofen, a combination of acetaminophen, propyphenazone, and caffeine. The mother took the CCRIS 5502 for a total of 12 days, cefuroxime and the analgesic combination for 10 days and flurbiprofen for 15 days. No adverse effects were noticed during the period of CCRIS 5502 treatment.[5]
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