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Amoxicillin / clarithromycin / lansoprazole Pregnancy and Breastfeeding Warnings

Amoxicillin / clarithromycin / lansoprazole is also known as: Prevpac

Amoxicillin / clarithromycin / lansoprazole Pregnancy Warnings

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs risk to the fetus. US FDA pregnancy category: C Comment: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies of clarithromycin have revealed evidence of adverse effects on pregnancy outcome and/or embryofetal development. Animal studies of lansoprazole and amoxicillin have failed to reveal evidence of fetal harm and/or impaired fertility. There are no controlled data for any drug 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.

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Amoxicillin / clarithromycin / lansoprazole 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 (amoxicillin, clarithromycin); Unknown (lansoprazole) Excreted into animal milk: Yes (lansoprazole) Comments: -The American Academy of Pediatrics considers amoxicillin compatible with breastfeeding. -Exposed infants should be monitored for sensitization (e.g., rash), diarrhea, appetite loss, and/or somnolence.

Animal models receiving lansoprazole in breastmilk have revealed evidence of tumorigenicity in carcinogenicity studies; there is a potential risk of serious adverse reactions to the nursing infant.

See references

References for pregnancy information

  1. "Product Information. Prevpac (amoxicillin/clarithromycin/lansoprazole)." Tap Pharmaceuticals Inc, Dearfield, IL.

References for breastfeeding information

  1. "Product Information. Prevpac (amoxicillin/clarithromycin/lansoprazole)." Tap Pharmaceuticals Inc, Dearfield, 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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