Acetaminophen / phenyltoloxamine Pregnancy and Breastfeeding Warnings

Acetaminophen / phenyltoloxamine is also known as: Acuflex, Ali-Flex, Alpain, Apagesic, BP Poly-650, Dologesic, Duogesic, Flextra-650, Flextra-DS, Genasec, Hyflex-650, Hyflex-DS, Lagesic, Major-gesic, Myophen, Percogesic, Phenagesic, Phenylgesic, Q-Gesic, Relagesic, RhinoFlex, RhinoFlex 650, Staflex, Uni-Perr, Vitoxapap

Acetaminophen / phenyltoloxamine Pregnancy Warnings

Acetaminophen 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-phenyltoloxamine has not been formally assigned to a pregnancy category by the FDA. Animal studies not been reported. There are no controlled data in human pregnancy. Acetaminophen-phenyltoloxamine should only be given during pregnancy when need has been clearly established.

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 / phenyltoloxamine 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.

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. There are no data on the excretion of phenyltoloxamine into human milk.

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