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Flunisolide Pregnancy and Breastfeeding Warnings

Flunisolide is also known as: Aerobid, Aerobid-M, Aerospan HFA

Flunisolide Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus US FDA pregnancy category: C Comments: -Asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control in pregnant women. -Infants exposed to corticosteroids in utero should be observed for signs and symptoms of hypoadrenalism.

Animal studies in rats and rabbits have shown teratogenicity and fetotoxicity in doses approximately 1 and 3 times the maximum recommended daily inhalation dose (on a mg/m2 basis), respectively. Experience with pharmacologic doses of oral corticosteroids suggests rodents may be more prone to teratogenic effects than humans. There are no adequate and well-controlled studies in pregnant women. In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to flunisolide and 322 exposures anytime during pregnancy were recorded. A total of 5 birth defects were reported with first-trimester exposures (5 expected). (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association with adverse fetal outcome. 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

Flunisolide Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comment: Inhaled corticosteroids are generally considered acceptable to use during breastfeeding as the amount, if excreted into breastmilk, would probably be too small to affect a breastfed infant.

See references

References for pregnancy information

  1. "Product Information. Aerospan (flunisolide)." Meda Pharmaceuticals, Somerset, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Aerospan (flunisolide)." Meda Pharmaceuticals, Somerset, NJ.

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