Last update: May 11, 2019
Poorly safe. Evaluate carefully.
Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives).
Read the Comment.
An opioid analgesic with a similar structure to methadone indicated for mild to moderate pain relief.
Oral administration every 4 hours.
It is metabolized to norpropoxyphene, which has a very long elimination half-life (30 to 36 hours).
It is excreted in breastmilk in very small quantities (Mylan 2009, Kunka 1985 and 1984), but potentially serious side effects have been reported (hypotonia, lack of weight gain, apneas, bradycardia, cyanosis) in newborns whose breastfeeding mothers were taking it. (Soasan 2014, Rigourd 2008, Naumburg 1988). It is believed that this may be due to the slow elimination of the norpropoxyphene metabolite in adults, which is still much slower in newborns, so there may be accumulation in young infants (Mylan 2009, Spigset 2000).
The American Academy of Pediatrics initially considered it to be a medication which is usually compatible with breastfeeding (AAP 2001). Subsequently, it does not recommend its use during breastfeeding (Sachs 2013),
During breastfeeding, safer known alternatives are preferable, especially during the neonatal period and in cases of prematurity.
It has been withdrawn from sale due to lack of efficacy and potentially serious side effects (EMA 2010, FDA 2010).
Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.
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