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Iopromide Pregnancy and Breastfeeding Warnings

Iopromide is also known as: Ultravist

Iopromide Pregnancy Warnings

Animal studies of intravenous administration during organogenesis of doses up to 0.7 times the maximum recommended human dose (MRHD) did not show teratogenicity, but embryolethality occurred at the 0.7 times MRHD dose, but was thought to be secondary to maternal toxicity. There are no controlled data in human pregnancy. Limited case reports demonstrate that intravenous iodinated contrast agents, including this one, cross the placenta and appear in the digestive tract of exposed infants when born. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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.

Use is recommended only if clearly needed and the benefit outweighs the risk.

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

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Small amounts of this drug cross the placenta and reach the fetus.
-Animal studies of doses up to 0.7 times the maximum recommended human dose during organogenesis showed no adverse developmental effects.

See references

Iopromide Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Iodinated contrast agents have poor excretion into milk and poor gastrointestinal absorption in the infant; exposure can be minimized by discarding breast milk for 12 to 24 hours (about 5 elimination half-lives) after administration.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Ultravist (iopromide)." Berlex, Richmond, CA.

References for breastfeeding information

  1. "Product Information. Ultravist (iopromide)." Berlex, Richmond, CA.

Further information

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

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