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Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. Duocetz should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported with tramadol HCl during post-marketing.
Use in Lactation: Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hrs post-dose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1.
