Budesonide
PULMICORT
Pronunciation: byoo-DES-oe-nide
“Air Bud’s Palm court”
What it isInhaled or enteric corticosteroid; asthma, COPD, and — as the enteric form — Crohn disease and microscopic colitis.
Why this oneExtensive first-pass metabolism means the oral form acts largely on the gut with limited systemic exposure.
What limits itOral candidiasis when inhaled. CYP3A4-dependent, so strong inhibitors can produce systemic corticosteroid effects.
FDA-approved for
- asthma/rhinitis (1994)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Asthma maintenance/prophylaxis — prior therapy bronchodilators alone | Peds 12 months–8 yr | 0.5 mg nebulized QD or 0.25 mg BID | 0.5 mg/day | 0.5 mg/day |
| Asthma maintenance/prophylaxis — prior inhaled corticosteroids | Peds 12 months–8 yr | 0.5 mg nebulized QD or 0.25 mg BID | up to 0.5 mg BID | 1 mg/day |
| Asthma maintenance/prophylaxis — prior oral corticosteroids | Peds 12 months–8 yr | 0.5 mg nebulized BID or 1 mg QD | 1 mg/day | 1 mg/day |
Renal Undefined
Hepatic No dose adjustment specified; monitor closely (hepatic clearance — may accumulate).
Not for acute bronchospasm. Symptomatic children not responding to non-steroidal therapy: may start 0.25 mg QD. If QD inadequate, increase total daily dose and/or divide; down-titrate to lowest effective dose once stable.
Instructions
- Jet nebulizer with air compressor and mouthpiece or face mask only; not ultrasonic nebulizers. Not for injection.
- Gently shake ampule in a circular motion before use.
- Do not mix with other nebulizable drugs; administer separately.
- Rinse mouth after inhalation.
- Switching from oral corticosteroids: overlap ~1 week, then taper systemic steroid slowly (decrements ≤25% every 1–2 weeks).
Available strengths
- susp 0.25, 0.5, 1 mg/2 mL (Respules)
- inhaler 90, 180 mcg (Flexhaler)
Contraindications
- Primary treatment of status asthmaticus or other acute asthma episodes requiring intensive measures
Cautions
- Oropharyngeal Candida infection
- Deterioration of disease/acute asthma episodes (not a bronchodilator)
- Hypersensitivity reactions incl. anaphylaxis
- Immunosuppression (varicella, measles, TB, ocular HSV)
- Adrenal insufficiency when transferring from systemic corticosteroids
- Hypercorticism and adrenal suppression
- Reduced bone mineral density
- Growth velocity reduction in children
- Glaucoma and cataracts
- Paradoxical bronchospasm
- Eosinophilic conditions/Churg-Strauss syndrome
- Strong CYP3A4 inhibitors increase exposure
Adverse reactions
- Respiratory infection
- Rhinitis
- Coughing
- Otitis media
- Viral infection
- Moniliasis
- Gastroenteritis
- Vomiting
- Diarrhea
- Abdominal pain
- Ear infection
- Epistaxis
Pregnancy No adequate controlled studies; large Swedish registry data show no increased malformation risk with inhaled budesonide; SC animal studies showed fetal harm.
Lactation Present in human milk (~0.3–1% of maternal inhaled dose, DPI data); weigh breastfeeding benefits against maternal need.
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 0.25 mg/2 mL | susp | per unit | $0.70/mL | offered |
| 0.5 mg/2 mL | susp | per unit | $0.68/mL | offered |
| 1 mg/2 mL | susp | per unit | $3.43/mL | offered |
| 90 mcg | inhaler | per unit | not offered | |
| 180 mcg | inhaler | per unit | not offered |
Available combined with: budesonide / formoterol · budesonide / glycopyrrolate / formoterol
Generic entry2008
NO BOXED WARNINGS
Principal riskOral candidiasis when inhaled
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityHyperglycemia, infection, osteoporosis and potentially severe mood, sleep or psychotic effects.