Is Cotempla XR-ODT Safe in Breastfeeding

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

The amount excreted to breast milk is so small that it is not detected in breast-fed infants. No adverse side-effects have been reported. Check-up for milk production since it may decrease Prolactin excretion on theoretical basis.

In dosages prescribed for medical indications, limited evidence indicates that Cotempla XR-ODT levels in milk are very low and not detectable in infant serum. The effects of Cotempla XR-ODT in milk on the neurological development of the infant have not been well studied. If Cotempla XR-ODT is required by the mother, it is not a reason to discontinue breastfeeding.[1] It is possible that large dosages of Cotempla XR-ODT might interfere with milk production, especially in women whose lactation is not well established.

Seven of 8 infants, whose mothers were taking either dextroamphetamine (average dosage 25 mg daily) or Cotempla XR-ODT (average dosage 52 mg daily) were clinically evaluated. The infants had no drug-related adverse reactions and were developing normally for their ages which averaged 4.4 months.[2] One 6.4-month-old infant was mostly breastfed by a mother who had been taking Cotempla XR-ODT 40 mg twice daily 5 days/week for 5.5 weeks. The mother reported that the infant was sleeping, eating and gaining weight normally.[3] This patient might have been one of those in the report above by the same authors. An infant was being breastfed (extent not stated) by a mother who began taking sertraline 50 mg daily and Cotempla XR-ODT after 5 weeks postpartum. Dosage was started at 10 mg daily with an immediate-release product and gradually increased to 72 mg daily of an extended-release product. At 14 weeks of age, the infant was developing normally no feeding difficulties. Examinations at 6 months and 1 year of age found no developmental problems in the child.[5] A nursing mother was taking extended-release Cotempla XR-ODT (Concerta) 36 mg daily and duloxetine 90 mg daily for ADHD, generalized anxiety disorder, borderline personality disorder, and depression. She partially (amount not stated) breastfed her infant for about 1 month. At 6 months of age, the infant's development was considered to be normal, except for recurrent pneumonia caused by congenital pulmonary airway malformation.[6]

Cotempla XR-ODT reduces serum prolactin,[7] but no studies have been located as of the revision date on the effect of Cotempla XR-ODT on milk production. The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed. A 15-year-old girl had been receiving Cotempla XR-ODT 54 mg daily in an osmotic release tablet (OROS) for 2 years. Sertraline was started for depression at 50 mg daily and increased to 100 mg daily along with haloperidol 0.5 mg daily. After 12 weeks of therapy, inattentativeness at school and headaches prompted a change from the OROS product to a modified-release Cotempla XR-ODT product (brand not specified) at 30 mg daily, then increasing to 50 mg daily. Three days after the increase in dosage, the girl had spontaneous milk flow from both breasts and subsequently had an elevated serum prolactin of 67.7 mcg/L. Cotempla XR-ODT and haloperidol were discontinued, but sertraline was continued. One week later, galactorrhea resolved completely. Fifteen days after drug discontinuation, the girl's prolactin level was in the normal range at 19.4 mcg/L.[8]