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Esomeprazole Pregnancy and Breastfeeding Warnings

Esomeprazole is also known as: Nexium, Nexium 24HR, Nexium IV

Esomeprazole Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk. -Some experts recommend: Use with caution. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned. Risk Summary: Epidemiological data failed to reveal evidence of major congenital malformations and other adverse pregnancy outcomes with use of this drug during the first trimester.

Animal studies have failed to reveal evidence of teratogenicity or fetal harm at therapeutic doses. However, changes in bone morphology were observed in offspring of rats, dosed through most of the pregnancy and lactation, at doses equal to or greater than 33.6 times an oral human dose of 40 mg. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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 decision 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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Esomeprazole Breastfeeding Warnings

Esomeprazole is the S-isomer of omeprazole and limited data indicate that maternal doses of omeprazole 20 mg daily produce low levels in human milk. Animal studies given high doses of esomeprazole strontium showed effects on developing bone. The effects on milk production are unknown.

Use is not recommended and 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: Unknown Excreted into animal milk: Data not available Comment: The effects in the nursing infant are unknown.

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References for pregnancy information

  1. "Product Information. Nexium (esomeprazole)" Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  2. "Product Information. NexIUM I.V. (esomeprazole)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  3. "Product Information. Esomeprazole Strontium (esomeprazole)." Amneal Pharmaceuticals, Glasgow, KY.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. NexIUM I.V. (esomeprazole)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Esomeprazole Strontium (esomeprazole)." Amneal Pharmaceuticals, Glasgow, KY.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. Nexium (esomeprazole)" Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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