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Acetaminophen Pregnancy and Breastfeeding Warnings

Acetaminophen is also known as: Aceta, Altenol, Children's Tylenol, Dafalgan, Doliprane, Efferalgan, Infant's Tylenol, Mapap, Ofirmev, Panadol, Panadol ActiFast, Panadol Osteo, Paracetamol, Paracetamol Merck, Paracetamol Ranbaxy, Paracetamol Sandoz, Paracetamol Teva, Perfalgan, Promax, Q-Pap, Q-Pap Extra Strength, Tempra, Tylenol, Tylenol Arthritis Pain, Tylenol Extra Strength

Acetaminophen Pregnancy Warnings

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.

Acetaminophen in oral or rectal form has not been formally assigned to a pregnancy category by the FDA. It 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. Acetaminophen oral or rectal should only be given during pregnancy when need has been clearly established. Acetaminophen in IV form has been assigned to FDA pregnancy category C. There are no studies of intravenous acetaminophen in pregnant women; however, epidemiological data on oral acetaminophen use in pregnant women show no increased risk of major congenital malformations. Animal reproduction studies have not been conducted with acetaminophen, and it is not known whether IV acetaminophen can cause fetal harm when administered to a pregnant woman. IV acetaminophen should be given to a pregnant woman only if clearly needed.

Acetaminophen Breastfeeding Warnings

Oral acetaminophen is excreted into human milk in small concentrations. Studies with acetaminophen IV have not been conducted. Based on data from more than 15 nursing mothers, the calculated infant daily dose of acetaminophen is approximately 1 to 2% of the maternal dose. 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. The manufacturer recommends caution when administering acetaminophen in IV form to a nursing mother.

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.

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