budesonide inhaled (Rx)

>10%

Respiratory infection (34-38%)

Rhinitis (7-12%)

Otitis media (1-12%)

1-10%

Nasopharyngitis (10%)

Nasal congestion (3%)

Pharyngitis (3%)

Allergic rhinitis (2%)

Viral gastroenteritis (2%)

Viral upper respiratory tract infection (2%)

Oral candidiasis (1%)

Contraindications

Hypersensitivity

Status asthmaticus, acute bronchospasm

Cautions

Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex

Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure

Localized infections with Candida albicans in mouth and pharynx in some patients; mouth must be rinsed after inhalation to reduce risk

Deaths from adrenal insufficiency have occurred after abrupt withdrawal of oral steroids; taper withdrawal gradually

Potential decrease in growth velocity in children

Immunocompromised patients

Hepatic impairment

Risk of infections of nose and pharynx, including C albicans

Decrease in bone mineral density after long-term administration of corticosteroids; monitor patients at risk

Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress

During periods of stress or severe status asthmaticus, supplementary systemic corticosteroids may be immediately required

Not to be administered for rapid relief of acute bronchospasm (agent is not a bronchodilator)

Nasal septum perforation, wheezing

Cataracts, glaucoma, increased intraocular pressure

Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome

Pregnancy category: B

Lactation: Drug enters breast milk; use only if benefits greatly outweigh risks

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity

Absorption

Bioavailability: 6-13%

Onset: 24 hr to 2 wk

Peak plasma time: 1-2 hr

Distribution

Protein bound: 85-90%

Vd: 3 L/kg

Metabolism

Metabolized in liver by CYP3A4

Metabolites: 16-Alpha hydroxyprednisolone, 6-beta hydroxybudesonide

Elimination

Half-life: 2-3 hr

Excretion: Urine (60%), feces (40%)