Question

I am a breastfeeding mother and i want to know if it is safe to use CI-912? Is CI-912 safe for nursing mother and child? Does CI-912 extracts into breast milk? Does CI-912 has any long term or short term side effects on infants? Can CI-912 influence milk supply or can CI-912 decrease milk supply in lactating mothers?

CI-912 lactation summary

CI-912 usage has low risk in breastfeeding
  • DrLact safety Score for CI-912 is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of CI-912 may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that CI-912 may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of CI-912 low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using CI-912 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 CI-912 usage in lactation

CI-912 is excreted in breast milk in amounts that could be clinically significant, since the infant receives a relative dose well above 10% (Pack 2006, Crawford 2005, Tomson 2005, Shimoyama 1999, Kimura 1998). In spite of this high excretion in breast milk, infants who were breastfed by mothers taking CI-912 had no clinical problems (Shimoyama 1999) and their plasma CI-912 levels were only 15 to 17% of those measured in the mother (Kawada 2002, abstracts-P55 2011). Due to poor pharmacokinetics for breastfeeding with low protein binding and slow drug elimination (Jacob 2016) and the limited existing literature in relation to breastfeeding (Reimers 2014), it may be advisable to choose antiepileptics whose safety is better known (Hutchinson 2013, Davanzo 2013). If it is administered during breastfeeding, use the minimum effective dose (Reimers 2014) and monitor the infant's appetite, weight curve, psychomotor development, irritability, diarrhea, dehydration or acidosis, and it may be desirable to measure monthly plasma levels in the infant (Davanzo 2013, Pennell 2003). Some authors propose partial breastfeeding to decrease the dose that the infant receives through breast milk (Ando 2014).

Answer by DrLact: About CI-912 usage in lactation

Limited information indicates that maternal doses of CI-912 up to 400 mg daily produce high levels in milk and infant serum, but serum levels in neonates decrease during the first month of life while nursing. Although no adverse reactions have been reported in breastfed infants, the number of infants reported have been small. Alternative drugs are preferred, but if it must be given, monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger or exclusively breastfed infants and when using combinations of anticonvulsant drugs. Some clinicians recommend that mothers taking CI-912 only partially breastfeed in order to reduce the exposure of the infant to the drug and to consider monitoring infants' serum CI-912 concentrations.[1]

CI-912 Side Effects in Breastfeeding

A patient taking CI-912 300 mg orally 3 times daily as well as other unspecified antipsychotics was followed at 0, 3, 14 and 30 days postpartum. Her infant exhibited no behavioral problems.[3] Two infants were breastfed postpartum by their mothers. One was exclusively breastfed for 9 days postpartum, then breastfed twice daily and supplemented with formula 7 to 8 times daily. The maternal CI-912 dose was 300 mg (6.2 mg/kg) daily. On day 34, the infant was healthy, had gained weight and had experienced no observable adverse effects. The second infant was partially breastfed by a mother taking CI-912 100 mg (2.1 mg/kg) daily. No adverse reactions were noted in the infant during the first 2 weeks postpartum, at which time breastfeeding was discontinued because of a low milk supply.[1]
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.