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Dinoprostone topical Pregnancy and Breastfeeding Warnings

Dinoprostone topical is also known as: Cervidil, Prepidil, Prostin E2

Dinoprostone topical Pregnancy Warnings

This drug should be used during pregnancy only for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor or for termination of pregnancy under certain circumstances. AU TGA pregnancy category: -Vaginal insert: C -Vaginal gel: C US FDA pregnancy category: -Subcutaneous: X -Vaginal insert: Not assigned -Vaginal gel: C -Vaginal suppository: C Comment: -Any dose of this drug that produces sustained increased uterine tone could put the embryo or fetus at risk.

Animal studies do not indicate that this drug is teratogenic; however, it has been shown to be embryotoxic and any dose which produces increased uterine tone could put the embryo or fetus at risk. There are no controlled data in human pregnancy. 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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. 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.

See references

Dinoprostone topical Breastfeeding Warnings

-This drug is a normal component of breastmilk in small amounts where it may help protect the infant GI tract. -Given orally in the first few days postpartum, this drug can suppress lactation. -Whether vaginal or endocervical administration might suppress lactation if given postpartum is not known, but it should probably not be used postpartum in mothers who wish to breastfeed. By one month postpartum, the drug appears not to suppress lactation.

There are no indications for the use of this drug in breast-feeding women. Excreted into human milk: Yes

See references

References for pregnancy information

  1. "Product Information. Cervidil (dinoprostone topical)." Forest Pharmaceuticals, St. Louis, MO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Prostin E2 Suppository (dinoprostone topical)." Pharmacia and Upjohn, Kalamazoo, MI.
  5. "Product Information. Prepidil (dinoprostone topical)" Pharmacia and Upjohn, Kalamazoo, MI.

References for breastfeeding information

  1. "Product Information. Prepidil (dinoprostone topical)" Pharmacia and Upjohn, Kalamazoo, MI.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Prostin E2 Suppository (dinoprostone topical)." Pharmacia and Upjohn, Kalamazoo, MI.
  4. "Product Information. Cervidil (dinoprostone topical)." Forest Pharmaceuticals, St. Louis, MO.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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