Trapadol

Trapadol Use In Pregnancy & Lactation

tramadol + paracetamol

Manufacturer:

Theon Pharmaceuticals

Distributor:

Littman
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Since Tramadol HCl + Paracetamol (Trapadol) is a fixed combination of active ingredients including tramadol, it should not be used during pregnancy.
Acetaminophen: Epidemiological studies in human pregnancy have shown no ill effects due to acetaminophen used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Tramadol: There are no adequate data from the use of tramadol in pregnant women. Tramadol crosses the placental barrier and chronic use during pregnancy can cause withdrawal symptoms in the newborn baby. Therefore, it should not be used during pregnancy.
Tramadol administered before or during birth does not affect uterine contractility. In neonates, it may induce changes in respiratory rate which are not usually clinically relevant.
Lactation: Since Tramadol HCl + Paracetamol (Trapadol) is a fixed combination of active ingredients including tramadol, it should not be ingested during breast feeding.
Acetaminophen: Acetaminophen is excreted in breast milk but not in a clinically significant amount. Available published data on acetaminophen does not contraindicate it for breast feeding.
Tramadol: Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest 0.1% of the dose given to the mother. Tramadol hydrochloride should not be administered during breast feeding.