Detailed Drug Information:

DRUG CLASS AND MECHANISM: Budesonide is a synthetic steroid belonging tothe glucocorticoid family, a family in which cortisol (hydrocortisone) isthe naturally occurring steroid. Hydrocortisone is produced in theadrenal glands. Glucocorticoid steroids have potent anti-inflammatoryactions. When used as a nasal inhaler or spray, budesonide goes directlyto the lining of the nose, and only 20% of the administered dose is absorbed into the of the body.Intranasal budesonide was approved by the FDA in 1994.

PREPARATIONS: Rhinocort inhaler as a 7 gm canister containing 200 metered doses. Rhinocort Aqua nasal spray in bottles containing 60 or 120 metered sprays. Each metered dose or spray delivers 32 ug of budesonide.

STORAGE: Budesonide should be kept at room temperature, 15-30°C(59-86°F). It should be shaken well before each use.

PRESCRIBED FOR: Budesonide is used for the management ofsymptoms of allergic rhinitis, a condition in which fluid accumulates within the lining of the nose leading to obstruction to the flow of air. Fluid also is released into the nasal passages. In addition, budesonide is used for the treatment and prevention of nasal polyps.

DOSING: In adults and in children over the age of 6 years, therecommended starting dose of Rhinocort is 2-4 sprays in each nostril in the morning andagain in the evening. Some physicians prescribe 4 sprays in each nostrilin the morning.

In adults and in children over the age of 6 years, the recommended starting dose of Rhinocort Aqua is one spray in each nostril daily.

DRUG INTERACTIONS: Ketoconazole increases the concentration in blood of budesonide by decreasing the elimination of budesonide from the body. This may lead to an increase in the side effects of budesonide.

PREGNANCY: 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 with caution during pregnancy. Although there does not appear to be an increased risk ofabnormalities in infants born to mothers taking other intranasalglucocorticoids during pregnancy, the effects of budesonide on the fetusare not known.

NURSING MOTHERS: It is not known if budesonide is secreted in breast milk. Other glucocorticoids are indeed secreted intobreast milk. It is not known whether the small amounts of glucocorticoids that may appear inthe milk have any effect on the infant.

SIDE EFFECTS: The most commonly noted side effects associatedwith nasal budesonide are nasal irritation, sore throat, cough, and,occasionally, a bleeding discharge from the nose. Rarely, it may cause upper respiratory infections. Overall, between 1 in 11and 1 in 30 persons experience a side effect.