Esomeprazole / naproxen Pregnancy and Breastfeeding Warnings
Esomeprazole / naproxen is also known as: Vimovo
Esomeprazole / naproxen Pregnancy Warnings
AU, UK: Use is not recommended during the first two trimesters unless clearly needed and use is contraindicated during the third trimester. US: Should be used prior to 30 weeks gestation only if the potential benefit outweighs the potential risk to the fetus; and, if given starting at 30 weeks gestation, the patient should be apprised of the potential hazard to the fetus. Animal studies have revealed evidence of fetal harm. There are no controlled data in human pregnancy. Esomeprazole-naproxen is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. AU TGA pregnancy category: C US FDA pregnancy category: Category C prior to 30 weeks gestation then category D starting at 30 weeks gestation Comments: Adequate methods of contraception should be encouraged.
Animal studies with esomeprazole have failed to reveal evidence of teratogenicity; however, decreased fetal weight and an increased incidence of minor skeletal anomalies occurred at maternotoxic doses. The use of cyclooxygenase or prostaglandin synthesis inhibitors, including naproxen, may impair fertility and is not recommended in women attempting to conceive. Discontinuation of naproxen should be considered in women who have difficulty conceiving or are undergoing investigation of infertility. Starting at 30 weeks gestation, naproxen, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Naproxen can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation. If this drug is used during this time period in pregnancy, the patient should be apprised of the potential hazard to a fetus. Animal studies with esomeprazole magnesium revealed changes in bone morphology in offspring of rats dosed through most of the pregnancy and lactation with doses equal to or greater than approximately 33.6 times an oral human dose of 40 mg. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. 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.
Esomeprazole / naproxen Breastfeeding Warnings
There are no data on the excretion of esomeprazole into human milk. The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. There are possible adverse effects of prostaglandin-inhibiting drugs on neonates. The manufacturer recommends that 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.
AU, UK: Use is not recommended. US: Caution is recommended. Excreted into human milk: Unknown (esomeprazole); Yes (naproxen) Excreted into animal milk: Yes (esomeprazole) The effects in the nursing infant are unknown.
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