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Nitric oxide Pregnancy and Breastfeeding Warnings

Nitric oxide is also known as: INOmax

Medically reviewed on December 1, 2017

Nitric oxide Pregnancy Warnings

This drug is not indicated for use in adult patients.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Animal studies have not been conducted. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Nitric oxide Breastfeeding Warnings

This drug is not indicated for use in adult patients, including nursing mothers

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

See references

References for pregnancy information

  1. "Product Information. INOmax (nitric oxide)." INO Therapeutics Inc, Clinton, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. INOmax (nitric oxide)." INO Therapeutics Inc, Clinton, NJ.

Further information

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

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