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Aspirin / butalbital / caffeine / codeine Pregnancy and Breastfeeding Warnings

Aspirin / butalbital / caffeine / codeine is also known as: Ascomp with Codeine, Fiorinal with Codeine, Fiorinal with Codeine III, Fiortal with Codeine

Aspirin / butalbital / caffeine / codeine Pregnancy Warnings

Use is not recommended unless clearly needed US FDA pregnancy category: C Comment: -Monitor for barbiturate withdrawal in neonates -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. US FDA pregnancy category: C

Animal reproduction studies have not been conducted with this combination product. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant's serum. Aspirin has not been associated with an increased risk of abnormalities when taken during the first trimester of pregnancy; therapeutic doses of aspirin close to term may cause bleeding in mother, fetus, or neonate. Codeine 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

Aspirin / butalbital / caffeine / codeine Breastfeeding Warnings

Codeine is present in breast milk. 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 (those with multiple copies of the gene for CYP450 2D6) higher-than-expected serum levels of morphine (active metabolite) may be present in their breast milk leading to dangerously high serum morphine levels in their 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 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. The significance of small amounts of aspirin, butalbital, and caffeine in human milk has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be 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 (aspirin); Yes (barbiturates); Yes (caffeine); Yes (codeine) 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. Ascomp with Codeine (aspirin/butalbital/caffeine/codeine (ASA/butalbital/caffeine/codeine))." NexGen Pharma, Irvine, CA.
  2. "Product Information. Fiorinal with Codeine (aspirin/butalbital/caffeine/codeine (ASA/butalbital/caffeine/codeine))." Watson Pharmaceuticals, Parsippany, NJ.

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. Fiorinal with Codeine (aspirin/butalbital/caffeine/codeine (ASA/butalbital/caffeine/codeine))." Watson Pharmaceuticals, Parsippany, NJ.
  3. "Product Information. Ascomp with Codeine (aspirin/butalbital/caffeine/codeine (ASA/butalbital/caffeine/codeine))." NexGen Pharma, Irvine, CA.

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