Amoxicillin / clarithromycin / lansoprazole Pregnancy and Breastfeeding Warnings

Amoxicillin / clarithromycin / lansoprazole is also known as: Prevpac

Amoxicillin / clarithromycin / lansoprazole Pregnancy Warnings

Amoxicillin/clarithromycin/lansoprazole has been assigned to pregnancy category C by the FDA. Animal studies have revealed adverse effects of pregnancy outcome and/or embryo-fetal development (a low incidence of cardiovascular anomalies and cleft palate) at doses that produced plasma levels 2 to 17 times the serum levels achieved in humans treated at the maximum clarithromycin recommended human doses. A prospective, controlled, multicenter study of 157 pregnant women found clarithromycin to be safe when taken at the usual prescribed dosage during pregnancy. There are no controlled data in human pregnancy. Amoxicillin/clarithromycin/lansoprazole is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

A transient decrease in plasma concentration of total conjugated estriol, estriol-glucoronide, conjugated estrone, and estradiol has been reported following the administration of ampicillin to pregnant women. This effect may also occur with amoxicillin.

Amoxicillin / clarithromycin / lansoprazole Breastfeeding Warnings

Amoxicillin is excreted into human milk in small amounts. Sensitization of the infant may occur. The American Academy of Pediatrics considers the use of amoxicillin to be compatible with breast-feeding. There are no data on the excretion of clarithromycin into human milk. Clarithromycin is excreted in the milk of lactating animals, and other drugs in the macrolide class are known to be excreted in human milk. There are no data on the excretion of lansoprazole into human milk. Lansoprazole or its metabolites are excreted into the milk of rats. The manufacturer suggests that, because of the risk of tumorigenicity in animals, and due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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