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Dobutamine Pregnancy and Breastfeeding Warnings

Brand names: Dobutrex

Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.

Dobutamine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus and there are no alternatives.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of fetotoxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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

Dobutamine Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

According to some authorities, if this drug does appear in breast milk, it is unlikely to affect the infant due to poor bioavailability and short half-life.

See references

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References for pregnancy information

  1. (2002) "Product Information. Dobutrex (dobutamine)." Lilly, Eli and Company
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2020) "Product Information. DOBUTamine Hydrochloride (DOBUTamine)." Hospira Inc
  5. (2023) "Product Information. DOBUTamine Hydrochloride-Dextrose (DOBUTamine)." Baxter I.V. Systems Division

References for breastfeeding information

  1. (2002) "Product Information. Dobutrex (dobutamine)." Lilly, Eli and Company
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.