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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. 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.

Use is contraindicated in late pregnancy (30 weeks gestation or later) Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: C Comments: Avoid use in late pregnancy (30 weeks gestation or later) as it may cause premature closure of the ductus arteriosus.

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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