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Acetaminophen / tramadol Pregnancy and Breastfeeding Warnings

Acetaminophen / tramadol is also known as: Tramapap, Ultracet

Overview

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 taking 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.

Acetaminophen / tramadol Breastfeeding Warnings

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk was 100 mcg of tramadol or 0.1% of the maternal dose and 27 mcg of the active metabolite M1.

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Tramadol is excreted into human milk in small amounts. The manufacturer suggests that tramadol should not be administered to nursing women. The manufacturer of acetaminophen-tramadol does not recommend its use as obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in newborn infants has not been studied.

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