Fertility, pregnancy and lactation
There are no or limited data from the use of buprenorphine in pregnant women.
Animal studies do not indicate reproductive toxicity.
Buprenorphine should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Towards the end of pregnancy, buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Long-term administration during the last 3 months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
The syndrome is generally delayed from several hours to several days after birth.
Due to the long half-life of buprenorphine, neonatal monitoring for several days after birth should be considered to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Buprenorphine and its metabolites are excreted in human breast milk and Buvidal® should be used with caution during breast-feeding.
There are no or limited data on effects of buprenorphine on human fertility.
An effect of buprenorphine on fertility in animals has not been seen.