PREGNANCY AND BREASTFEEDING SAFETY: When given orally to animals, glucocorticoid steroids similar to budesonide have been shown to cause fetal abnormalities. Studies of pregnant women using inhaled budesonide during early pregnancy do not show an increase in the rate of fetal abnormalities. Nevertheless, since these studies cannot completely exclude rare abnormalities, budesonide should be used during pregnancy only if it clearly is needed. Budesonide is secreted in breast milk at concentrations of 0.3% to 1% of the inhaled dose. Budesonide should only be used by breast feeding mothers when clearly needed, and the lowest effective dose and other strategies to reduce infant exposure should be used.
STORAGE: Budesonide should be kept at room temperature, 15-30 C (59-86 F). It should be shaken well before each use.
DOSING: In adults and in children over the age of 6 years, the recommended starting dose of budesonide is 1 spray in each nostril once daily. The maximum dose for children older than 12 years of age and adults is 4 sprays per nostril once daily. The maximum dose for children younger than 12 years of age is 2 sprays per nostril once daily.
DRUG CLASS AND MECHANISM: Budesonide is a synthetic steroid belonging to the glucocorticoid family, a family in which cortisol (hydrocortisone) is the naturally occurring steroid. Hydrocortisone is produced in the adrenal glands. Glucocorticoid steroids have potent anti-inflammatory actions. When used as a nasal inhaler or spray, budesonide travels directly to the lining of the nose, and only 20% of the administered dose is absorbed into the body. Intranasal budesonide was approved by the FDA in 1994.
Medically reviewed by Eni Williams, PharmD
Reference: FDA Prescribing Information
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