Is Theophyllinum et ethylendiaminum Safe in Breastfeeding

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

Its active metabolite is Theophylline (see it).

An expert panel considers use of Theophyllinum et ethylendiaminum to be acceptable during breastfeeding.[1] Maternal Theophyllinum et ethylendiaminum use may occasionally cause stimulation and irritability and fretful sleep in infants. Newborn and especially preterm infants are most likely to be affected because of their slow elimination and low serum protein binding of theophylline. There is no need to avoid Theophyllinum et ethylendiaminum products; however, keep maternal serum theophylline concentrations in the lower part of the therapeutic range and monitor the infant for signs of theophylline side effects. Infant serum theophylline concentrations can help to determine if signs of agitation are due to theophylline. Avoiding breastfeeding for 2 hours after intravenous or 4 hours after an immediate-release oral Theophyllinum et ethylendiaminum product can decrease the dose received by the breastfed infant.

Irritability and fretful sleeping occurred in a 3-day-old breastfed infant on days of maternal Theophyllinum et ethylendiaminum intake of 200 mg every six hours. These effects ceased with discontinuation and recurred on rechallenge over the next 9 months. These effects were probably caused by theophylline in breastmilk. Another five infants reported in this paper showed no adverse reactions after maternal theophylline ingestion.[3] Accumulation of theophylline in infant serum appears most likely in neonates and premature infants because they eliminate theophylline slowly.[2][5]