Pregnancy of Acetaminophen/codeine phosphate in details
[US Boxed Warning]: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Refer to individual monographs for additional information.
Acetaminophen/codeine phosphate breastfeeding
Acetaminophen/codeine phosphate 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
References
- DailyMed. "CODEINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Codeine (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
