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Acetaminophen / phenyltoloxamine / salicylamide Pregnancy and Breastfeeding Warnings

Brand names: Anabar, Be-Flex Plus, By-Ache, Dolorex, Duraxin, Ed-Flex, Lobac

Acetaminophen / phenyltoloxamine / salicylamide Pregnancy Warnings

It is not known whether acetaminophen/phenyltoloxamine/salicylamide can cause fetal harm when administered to a pregnant women or can affect reproduction capability.

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.

The combination drug acetaminophen, phenyltoloxamine, and salicylamide has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted on this combination product. There are no controlled data in human pregnancy. The combination drug acetaminophen, phenyltoloxamine, and salicylamide should only be given during pregnancy when benefits outweigh risks.

See references

Acetaminophen / phenyltoloxamine / salicylamide Breastfeeding Warnings

There are no data on the excretion of the combination drug acetaminophen, phenyltoloxamine, and salicylamide into human milk. 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. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to the combination drug acetaminophen, phenyltoloxamine, and salicylamide in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the 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.

See references

See also

References for pregnancy information

  1. Rayburn W, Shukla U, Stetson P, Piehl E. Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women. Am J Obstet Gynecol. 1986;155:1353-6.
  2. Byer AJ, Traylor TR, Semmer JR. Acetaminophen overdose in the third trimester of pregnancy. JAMA. 1982;247:3114-5.
  3. Roberts I, Robinson MJ, Mughal MZ, Ratcliffe JG, Prescott LF. Paracetamol metabolites in the neonate following maternal overdose. Br J Clin Pharmacol. 1984;18:201-6.
  4. Miners JO, Robson RA, Birkett DJ. Paracetamol metabolism in pregnancy. Br J Clin Pharmacol. 1986;22:359-62.
  5. Galinsky RE, Levy G. Absorption and metabolism of acetaminophen shortly before parturition. Drug Intell Clin Pharm. 1984;18:977-9.
  6. Levy G, Garrettson LK, Soda DM. Evidence of placental transfer of acetaminophen. Pediatrics. 1975;55:895.
  7. Rudolph AM. Effects of aspirin and acetaminophen in pregnancy and in the newborn. Arch Intern Med. 1981;141:358-63.
  8. O'Brien WF, Krammer J, O'Leary TD, Mastrogiannis DS. The effect of acetaminophen on prostacyclin production in pregnant women. Am J Obstet Gynecol. 1993;168:1164-9.
  9. Beaulac-Baillargeon L, Rocheleau S. Paracetamol pharmacokinetics during the first trimester of human pregnancy. Eur J Clin Pharmacol. 1994;46:451-4.
  10. Product Information. Ed-Flex (acetaminophen/phenyltoloxamine/salicylamide). Edwards Pharmaceuticals Inc. 2022.

References for breastfeeding information

  1. Product Information. Ed-Flex (acetaminophen/phenyltoloxamine/salicylamide). Edwards Pharmaceuticals Inc. 2022.

Further information

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