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Famotidine / ibuprofen Pregnancy and Breastfeeding Warnings

Famotidine / ibuprofen is also known as: Duexis

Famotidine / ibuprofen Pregnancy Warnings

Animal studies with ibuprofen have failed to reveal evidence of developmental abnormalities, however, administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus. Animal studies with famotidine have failed to reveal evidence of impaired fertility or fetal harm. While no direct fetotoxic effects with famotidine have been observed, sporadic abortions occurred in rabbits with marked decreased food intake who received doses of 200 mg/kg/day or higher. There are no controlled data in human pregnancy. NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. Use of NSAIDs during labor and delivery have been show to inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. 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.

Avoid use during third trimester of pregnancy. Prior to third trimester: Use only if potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: Not assigned. Risk Summary: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Comments: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -Not recommended in women attempting to conceive as may impair female fertility.

See references

Famotidine / ibuprofen Breastfeeding Warnings

Use is generally considered acceptable; according to some manufacturers, use is not recommended. Excreted into human milk: Yes (famotidine, ibuprofen) Comments: The effects in the nursing infant are unknown.

Transient growth depression was observed in animal studies at maternotoxic doses of at least 300 times the usual human dose of famotidine. Histamine H2-receptor blockade is known to stimulate prolactin secretion; while this usually does not occur with famotidine, rare cases of hyperprolactinemia and galactorrhea have been reported. Due to both ibuprofen and famotidine being used in infants at doses much higher than those excreted in breast milk, adverse effects in breastfed infants are unlikely to occur.

See references

References for pregnancy information

  1. "Product Information. Duexis (famotidine-ibuprofen)." Horizon Pharma USA Inc, Northbrook, IL.

References for breastfeeding information

  1. "Product Information. Duexis (famotidine-ibuprofen)." Horizon Pharma USA Inc, Northbrook, IL.
  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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