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Estradiol / levonorgestrel Pregnancy and Breastfeeding Warnings

Estradiol / levonorgestrel is also known as: Climara Pro

Estradiol / levonorgestrel Pregnancy Warnings

There are no controlled data in human pregnancy. There appears to be little or no increased risk of birth defects when estrogens and progestins as oral contraceptives were inadvertently used during early pregnancy. 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.

Contraindicated (US) Use is not indicated during pregnancy (UK) US FDA pregnancy category: Not assigned Comments: -If pregnancy occurs, discontinue treatment immediately.

See references

Estradiol / levonorgestrel Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Yes Comments: -Estrogen use during lactation has been shown to decrease the quantity and quality of breast milk. -Detectable amounts of estrogens and progestins have been found in breast milk.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Climara Pro (estradiol-levonorgestrel)." Berlex Laboratories, Wayne, NJ.

References for breastfeeding information

  1. "Product Information. Climara Pro (estradiol-levonorgestrel)." Berlex Laboratories, Wayne, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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