Aspirin / carisoprodol / codeine Pregnancy and Breastfeeding Warnings

Brand names: Soma Compound with Codeine

Medically reviewed by Drugs.com. Last updated on Apr 1, 2024.

Aspirin / carisoprodol / codeine Pregnancy Warnings

Use is not recommended unless clearly needed.

US FDA pregnancy category D

Comments:
-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.

There are no animal reproduction studies with this combination product. Animal studies with carisoprodol have shown effects on fetal growth and postnatal survival. Salicylic products have shown to be teratogenic and embryocidal in rodents at doses considered much greater than usual therapeutic human doses. Aspirin use within 1 week of delivery or during labor may prolong delivery or lead to excessive blood loss in the mother or baby. The use of codeine during labor and delivery may lead to respiratory depression in the neonate. There are no controlled data in human pregnancy.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Aspirin / carisoprodol / codeine Breastfeeding Warnings

Breastfeeding is not recommended

Excreted into human milk: Yes (aspirin); Yes (carisoprodol); Yes (codeine)

Comments:
-The American Academy of Pediatrics recommends that other agents are preferred over codeine during breastfeeding.
-Most experts recommend against breastfeeding while taking aspirin, especially when using higher doses.

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 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 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. Aspirin is excreted as salicylic acid in breastmilk. Higher doses of aspirin appear to result in disproportionately higher milk levels. Reye's syndrome is associated with aspirin administration in infants with viral illnesses, however the risk from breastfeeding is unknown. Maternal use of carisoprodol may lead to reduced or less effective infant feeding due to sedation and/or decreased milk production. Alternative agents are recommended.

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