Amoxicillin / clarithromycin / lansoprazole Pregnancy and Breastfeeding Warnings

Brand names: Prevpac

Medically reviewed by Drugs.com. Last updated on Aug 17, 2023.

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

Comments:
-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.
-Amoxicillin may affect combined oral estrogen/progesterone contraceptive efficacy.

Animal studies using amoxicillin have failed to reveal evidence of fetal harm and/or impaired fertility, and those using clarithromycin have revealed evidence of adverse effects on pregnancy outcomes and/or embryofetal development (e.g., cleft palate, delayed fetal growth). Animal models have revealed evidence of fetal mortality and lower fetal weight associated with potentially maternally toxic doses; however, these studies have failed to reveal teratogenic evidence. Amoxicillin may affect glut flora and could decrease estrogen absorption, resulting in a potential for reduced efficacy of hormonal contraception. 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.

See references

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.
-The WHO 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.

The WHO recommends that breastfed infants who develop a rash should not be given subsequent doses of this drug. Alternative agents may be considered.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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