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.
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 also
References for pregnancy information
- (2001) "Product Information. Prevpac (amoxicillin/clarithromycin/lansoprazole)." TAP Pharmaceuticals Inc
References for breastfeeding information
- (2001) "Product Information. Prevpac (amoxicillin/clarithromycin/lansoprazole)." TAP Pharmaceuticals Inc
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- Department of Adolescent and Child Health and Development. UNICEF. World Health Organization (2014) Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.