Medications and Drugs
Revising Pharmacy
Author: Ome Ogbru, Pharm. D.
Medical Editor: Jay
W. Marks, M.D.
GENERIC NAME: budesonide
BRAND NAME: Rhinocort, Rhinocort Aqua
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
goes directly
to 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.
PRESCRIPTION: yes
GENERIC AVAILABLE: no
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 of
symptoms 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, the
recommended starting dose of Rhinocort is 2-4 sprays in each nostril in the
morning and
again in the evening. Some physicians prescribe 4 sprays in
each nostril
in 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 of
abnormalities in infants born to mothers taking other
intranasal
glucocorticoids during pregnancy, the effects of budesonide on
the fetus
are not known.
NURSING MOTHERS: It is not known if budesonide is
secreted in breast milk. Other glucocorticoids are indeed
secreted into
breast milk. It is not known whether the small amounts of glucocorticoids that may
appear in
the milk have any effect on the infant.
SIDE EFFECTS: The most commonly noted side effects
associated
with 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 11
and 1 in 30 persons experience a side effect.
Reference: FDA Prescribing Information
Last Editorial Review: 11/30/2002
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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