... the risk to my baby? This medication is needed for anklosing spondilitis. The medication usage has been monitored by my baby doctor and my orthopedic doctor. There has been no changes in my dosage and all tests and follow up appointments have shown normal growth and development in the baby and no health risks for me.
Tramacet contains 37.5 mg tramadol hydrochloride and 325 mg acetaminophen. Please see the information below.
Tramadol/Acetaminophen has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tramadol/Acetaminophen while you are pregnant. Tramadol/Acetaminophen is found in breast milk. Do not breast-feed while taking Tramadol/Acetaminophen.
Acetaminophen/tramadol Pregnancy Warnings
Acetaminophen-tramadol has been assigned to pregnancy category C by the FDA. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Animal studies of tramadol have revealed evidence of embryotoxicity and fetotoxicity. There are no controlled data for either drug in human pregnancy. Acetaminophen-tramadol should only be given during pregnancy when benefit outweighs risk.
Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production. Tramadol has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83.
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