Monograph Details

Respiratory Tract > Asthma/COPD
PULMICORT FLEXHALER
Manufacturer
AstraZeneca Pharmaceuticals
Legal Classification
Rx
Pharmacological Class
Steroid.
Generic Name
Budesonide (micronized) 90micrograms/inh, 180micrograms/inh; dry pwd for inhalation.
Also
PULMICORT RESPULES
Indications
Maintenance treatment of asthma as prophylactic therapy. Asthma requiring systemic corticosteroid therapy, to reduce need for systemic corticosteroids.
Children
<6 years: not recommended. ≥6 years: Initially 180micrograms twice daily; may consider starting at 360micrograms twice daily, if appropriate. Max 360micrograms twice daily. Rinse mouth after use.
Adults
≥18 years: Initially 360micrograms twice daily; may consider starting at 180micrograms twice daily, if appropriate. Max 720micrograms twice daily. Rinse mouth after use.
Contraindications
Not for primary treatment of acute attack.
Precautions
Maintain regular regimen. Infections. If exposed to chickenpox or measles, consider antiinfective prophylactic therapy. Adrenal insufficiency may occur when transferring patients from systemic corticosteroids to inhaled corticosteroids: see literature. Monitor for growth suppression in children. Post-op or during stress: monitor adrenal response. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually). Transferring from oral corticosteroids: see literature. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions
Caution with CYP3A4 inhibitors (eg, ketoconazole).
Adverse Reactions
Pulmicort Flexhaler: nasal congestion, allergic rhinitis, viral upper respiratory tract infection, oral candidiasis, viral gastroenteritis, nausea, bronchospasm (rare). Pulmicort Respules: Respiratory or other infection, GI upset, moniliasis, fatigue, cough, dysphonia, rash, epistaxis, bronchospasm (rare).
How Supplied
Flexhaler (90mcg/dose)—1 (60 inh)
Flexhaler (180mcg/dose)—1 (120 inh)
Respules—30
Additional Resources
Related Prescribing Note