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Aspirin / caffeine / dihydrocodeine Pregnancy and Breastfeeding Warnings

Aspirin / caffeine / dihydrocodeine is also known as: Synalgos-DC

Aspirin / caffeine / dihydrocodeine Pregnancy Warnings

Animal reproduction studies have not been conducted. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is not recommended US FDA pregnancy category: Not assigned Comment: -Aspirin should be avoided after 30 weeks gestation as it may lead to premature closure of the fetal ductus arteriosus. -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.

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Aspirin / caffeine / dihydrocodeine Breastfeeding Warnings

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 (aspirin); 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.

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; dihydromorphine has a potency similar to morphine. 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.

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References for pregnancy information

  1. "Product Information. Synalgos-DC (aspirin/caffeine/dihydrocodeine (ASA/caffeine/dihydrocodeine))." Caraco Pharmaceutical Laboratories, Detroit, MI.

References for breastfeeding information

  1. "Product Information. Synalgos-DC (aspirin/caffeine/dihydrocodeine (ASA/caffeine/dihydrocodeine))." Caraco Pharmaceutical Laboratories, Detroit, MI.
  2. 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 -]):

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