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Amoxicillin / clarithromycin / omeprazole Pregnancy and Breastfeeding Warnings

Amoxicillin / clarithromycin / omeprazole is also known as: Omeclamox-Pak

Amoxicillin / clarithromycin / omeprazole Pregnancy Warnings

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk. US FDA pregnancy category: Not assigned. Risk Summary: Clarithromycin use has resulted in adverse developmental effects in animal models. Malformative risk with use of omeprazole in pregnant women is unlikely. 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 omeprazole have revealed evidence of dose-related increase in fetal resorptions, embryotoxicity/lethality, pregnancy loss, and postnatal development toxicity; animal studies of clarithromycin have revealed evidence of fetal growth retardation, cleft palate, and cardiovascular anomalies. There are no controlled data in human pregnancy. A retrospective cohort study has failed to reveal evidence of increased malformations, low birth weight, and/or low Apgar scores in patients who took omeprazole during the first trimester. 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.

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Amoxicillin / clarithromycin / omeprazole Breastfeeding Warnings

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.

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, omeprazole); Unknown (clarithromycin) Excreted into animal milk: Yes (clarithromycin) Comments: -The American Academy of Pediatrics considers amoxicillin compatible with breastfeeding. -Exposed infants should be monitored for sensitization.

See references

References for pregnancy information

  1. "Product Information. Omeclamox-Pak (amoxicillin/clarithromycin/omeprazole)." Pernix Therapeutics, Magnolia, TX.

References for breastfeeding information

  1. "Product Information. Omeclamox-Pak (amoxicillin/clarithromycin/omeprazole)." Pernix Therapeutics, Magnolia, TX.
  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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