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Acetaminophen / codeine Pregnancy and Breastfeeding Warnings

Acetaminophen / codeine is also known as: Aceta w/ Codeine, Capital w/Codeine, Capital with Codeine Suspension, Cocet, Cocet Plus, Codrix, EZ III, Phenaphen with Codeine, Tylenol with Codeine, Tylenol with Codeine #2, Tylenol with Codeine #3, Tylenol with Codeine #4

Acetaminophen / codeine Pregnancy Warnings

Both acetaminophen and opioid analgesics cross the placenta. Acetaminophen has been used in humans without apparent harmful effects. In rats and rabbits, no teratogenicity was observed with codeine doses ranging from 5 to 120 mg/kg, but with doses greater than 120 mg/kg in the rat, an increase in embryo resorption was observed at the time of implantation. In another study in pregnant mice, a single codeine dose of 100 mg/kg dose resulted in delayed ossification in the offspring. Regular use of opioid analgesics during pregnancy may cause respiratory depression and physical dependence in the neonate. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. AU and UK: Avoid use during the third trimester of pregnancy and during labor AU TGA pregnancy category: A US FDA pregnancy category: C Comments: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

See references

Acetaminophen / codeine Breastfeeding Warnings

Acetaminophen is present in breast milk in quantities much less than doses usually given to infants. Codeine is present in breast milk and for women with normal codeine metabolism (normal CYP450 2D6 activity) the amount of codeine secreted is low and dose-dependent; however, in women who are ultra-rapid metabolizers of codeine (those with a specific CYP450 2D6 genotype) higher-than-expected serum levels of morphine, codeine's active metabolite, may be present in their breast milk which may lead to dangerously high serum morphine levels in their breastfed infants. In most cases, a person's specific CYP450 2D6 genotype is unknown. Several small series and one small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. A death of a breastfeed infant due to respiratory depression has been reported; the mother was found to be a CYP450 2D6 ultrarapid metabolizer. Once a mother's milk comes in, it is best to provide pain control with nonnarcotic analgesics; if codeine-containing drugs are prescribed, it is recommended that maternal intake of oral codeine be limited to 4 days at a low dose with close infant monitoring. If the baby shows signs of increased sleepiness, difficult breastfeeding, breathing difficulties, or limpness, medical care should be sought immediately. Excessive sedation in the mother often correlates with excess sedation in the breastfed infant. There is an FDA cleared test for determining a patient's CYP450 2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test can predict a person who can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood.

AU: Use is contraindicated A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: -The American Academy of Pediatrics recommends that other agents are preferred over codeine during breastfeeding. -Both the European Medicine Agency and UK's Medicines and Healthcare Products Regulatory Agency recommend that codeine not be used in nursing mothers

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Acetaminophen-Codeine Phosphate (acetaminophen-codeine)." Qualitest Pharmaceuticals Inc, Huntsville, ON.
  4. "Product Information. Tylenol with Codeine #3 (acetaminophen-codeine)." Janssen Pharmaceuticals, Titusville, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  3. "Product Information. Tylenol with Codeine #3 (acetaminophen-codeine)." Janssen Pharmaceuticals, Titusville, NJ.
  4. "Product Information. Acetaminophen-Codeine Phosphate (acetaminophen-codeine)." Qualitest Pharmaceuticals Inc, Huntsville, ON.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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