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Ivabradine Pregnancy and Breastfeeding Warnings

Ivabradine is also known as: Corlanor

Ivabradine Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicity, teratogenicity, increased postimplantation loss, and increased intrauterine and postnatal mortality. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. 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 decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

AU and UK: Use is contraindicated. US: Benefit should outweigh risk; monitor for congestive heart failure destabilization, especially during the first trimester; monitor for preterm birth during the third trimester in pregnant women with chronic heart failure. AU TGA pregnancy category: D US FDA pregnancy category: Not assigned Comments: -Adequate methods of contraception should be encouraged. -Advise a pregnant woman of the potential risk to the fetus.

See references

Ivabradine Breastfeeding Warnings

AU and UK: Use is contraindicated. US: Use is not recommended. Excreted into human milk: Data not available Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Corlanor (ivabradine)." Amgen USA, Thousand Oaks, CA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Corlanor (ivabradine)." Amgen USA, Thousand Oaks, CA.

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