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Acetaminophen / caffeine / dihydrocodeine Pregnancy and Breastfeeding Warnings

Acetaminophen / caffeine / dihydrocodeine is also known as: DHC Plus, Panlor DC, Panlor SS, Trezix, Zerlor

Acetaminophen / caffeine / dihydrocodeine Pregnancy Warnings

Use is not recommended unless clearly needed US FDA pregnancy category: C Comment: -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.

Animal reproduction studies have not been conducted. Epidemiologic data for acetaminophen including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. Dihydrocodeine use in pregnant women may lead to neonatal abstinence syndrome. There are no controlled data on this combination product in human pregnancy. 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.

See references

Acetaminophen / caffeine / dihydrocodeine Breastfeeding Warnings

Dihydrocodeine is a semi-synthetic narcotic analgesic related to codeine; it is secreted into human milk in low, dose-dependent quantities in women with normal metabolism (normal CYP450 2D6 activity). However, in women who are ultra-rapid metabolizers (those with multiple copies of the gene for CYP450 2D6), higher-than-expected levels of dihydromorphine may be excreted in breast milk and result in dangerously high serum dihydromorphine levels in breastfed infants. In most cases, a person's specific CYP2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that codeine may have been causative in episodes of apnea, bradycardia, and cyanosis in the first weeks 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. Due to the potential for serious adverse reactions in nursing infants, other agents are preferred.

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 (acetaminophen); Yes (caffeine); Yes (dihydrocodeine) Comments: -The American Academy of Pediatrics recommends against use of codeine during breastfeeding as other agents are preferred. -Monitor breastfed infants for signs of morphine toxicity including increase sleepiness, difficulty breastfeeding, breathing difficulties, or limpness; seek medical attention promptly if these signs occur.

See references

References for pregnancy information

  1. "Product Information. APAP/Caffeine/Dihydrocodeine Bitartrate (acetaminophen/caffeine/dihydrocodeine)." Xspire Pharma, Ridgeland, MS.
  2. "Product Information. Trezix (acetaminophen/caffeine/dihydrocodeine)." WraSer Pharmaceuticals, Madison, MS.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Trezix (acetaminophen/caffeine/dihydrocodeine)." WraSer Pharmaceuticals, Madison, MS.
  3. "Product Information. APAP/Caffeine/Dihydrocodeine Bitartrate (acetaminophen/caffeine/dihydrocodeine)." Xspire Pharma, Ridgeland, MS.

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