Budesonide: Usage and Dosage
Asthma Management
Budesonide is a highly effective inhaled corticosteroid for persistent asthma, administered twice daily via nebulizer for children under 4 years (the only FDA-approved ICS for this age group) and via dry powder inhaler or metered-dose inhaler for older children and adults, with dosing stratified by age and disease severity. 1, 2
Pediatric Dosing for Asthma
Children under 4 years:
- Low dose: 0.25-0.5 mg total daily (0.125-0.25 mg twice daily via nebulizer) 1
- Medium dose: 0.5-1.0 mg total daily (0.25-0.5 mg twice daily) 1
- High dose: >1.0-2.0 mg total daily (>0.5-1.0 mg twice daily) 1
- Must use nebulizer with face mask fitting snugly over nose and mouth; MDIs and dry powder inhalers are ineffective due to insufficient inspiratory flow 1
- Wash face after each treatment to prevent oral candidiasis 1
Children 5-11 years:
- Low dose: 0.5 mg total daily (0.25 mg twice daily) 1
- Medium dose: 1.0 mg total daily (0.5 mg twice daily) 1
- High dose: 2.0 mg total daily (1.0 mg twice daily) 1
Adult Dosing for Asthma
- Mild to moderate asthma: 200-800 mcg twice daily via metered-dose inhaler, depending on severity 3
- Once-daily dosing (200 mcg) is as effective as twice-daily dosing (100 mcg twice daily) in mild asthma 4
- Maximum benefit typically achieved within 4-6 weeks, though symptom reduction may occur within 2-8 days 2
Critical Administration Points
- Spacer technique for children under 4: Shake MDI vigorously, actuate once into spacer, allow 3-5 tidal breaths through mask, wait 30-60 seconds between doses if multiple puffs prescribed 1
- Rinse plastic spacers monthly with dilute dishwashing detergent and air dry; replace disposable spacers every 3 months 1
- For nebulizer therapy, use jet nebulizer with 6 L/min flow rate and oxygen as driving gas when possible 1
Inflammatory Bowel Disease
Crohn's Disease
For mild to moderate ileocecal Crohn's disease, budesonide 9 mg once daily for 8 weeks is the recommended first-line therapy to induce remission, with efficacy rates of 42-67% and significantly fewer side effects than systemic corticosteroids. 5
Specific indications and dosing:
- Ileal and/or right colonic (ascending colon) Crohn's disease: 9 mg once daily for 8 weeks 5
- Evaluate response between 4-8 weeks to determine if therapy modification needed 3
- Taper over 1-2 weeks once remission achieved 5
- Superior to placebo (RR 1.93,95% CI 1.37-2.73) for inducing clinical remission 5
- Comparable to prednisolone in mild-moderate disease (51% vs 52.5% remission rates) but with significantly fewer adverse effects 5
- Inferior to prednisolone in severe disease (CDAI >300) 5
Important limitations:
- Budesonide is effective only for disease limited to ileum and/or ascending colon 5
- No evidence of benefit for distal colonic inflammation 5
- Not effective for maintenance of remission in Crohn's disease 5
Ulcerative Colitis
For mild to moderate ulcerative colitis, budesonide extended-release (MMX) 9 mg once daily for up to 8 weeks can induce remission, though standard-dose oral mesalamine is preferred as first-line therapy. 3, 6
- Swallow tablets whole; do not chew, crush, or break 6
- Take once daily in the morning with or without food 6
- Budesonide enema 2 mg/100ml for 4 weeks produces endoscopic remission/improvement in 46-84% of patients with distal ulcerative colitis or proctitis 7
Drug Interactions and Monitoring
Avoid concomitant use with strong CYP3A4 inhibitors (ketoconazole) and grapefruit juice, as these significantly increase budesonide exposure and risk of hypercorticism. 6
- If CYP3A4 inhibitor use is unavoidable, monitor closely for signs/symptoms of hypercorticism 6
- Consider discontinuing either budesonide or the CYP3A4 inhibitor 6
Safety Profile
- Adverse events at recommended doses (0.25-2.0 mg/day in children) are similar to placebo in 12-week studies 1
- At low-to-medium doses, transient suppression of growth velocity may occur in children but is typically temporary 1
- Monitor for oral candidiasis, dysphonia, and cough 1
- Budesonide has FDA pregnancy category B rating (the only ICS with this designation) 8
- Do not discontinue abruptly; taper dose carefully to prevent asthma exacerbation 1
Common Pitfalls to Avoid
- Never use nebulizers as first-line for home therapy in older children/adults—assess MDI with spacer or dry powder inhaler first 1
- Never use face masks when mouthpieces are appropriate (children ≥4 years and adults should use mouthpieces) 1
- Never actuate multiple puffs into spacer before inhalation—this reduces drug delivery 1
- Never use budesonide for maintenance therapy in Crohn's disease—it does not prevent relapse 5
- Never use ileal-release budesonide for distal colonic Crohn's disease—it is ineffective 5