Pulmicort

Pulmicort

budesonide

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Budesonide
Indications/Uses
Bronchial asthma. Respules: May be used when replacement or reduction in oral steroid therapy is desirable.
Dosage/Direction for Use
Turbuhaler Adult 200-1,600 mcg daily divided into 2-4 administrations. More severe: 800-1,600 mcg daily; less severe: 200-800 mcg daily. Childn ≥7 yr 200-800 mcg daily divided into 2-4 administrations, 5-7 yr 200-400 mcg daily divided into 2-4 administrations. Respules Adult Initially or during severe asthma periods or while reducing oral corticosteroids: 1-2 mg bd. Maintenance: 0.5-1 mg bd. Childn Initially or during severe asthma periods or while reducing oral corticosteroids: 0.5-1 mg bd. Maintenance: 0.25-0.5 mg bd.
Contraindications
Special Precautions
Not indicated for rapid relief of bronchospasm. Reassess therapy if worsening of underlying conditions occur; if treatment is ineffective or patient needs more inhalations than usual. Possible risk of impaired adrenal function for patients being transferred from oral corticosteroids. Recurrence of earlier allergic symptoms (eg, rhinitis, eczema) in patients previously receiving high doses of systemic steroids. Consider additional systemic glucocorticosteroid cover during periods of stress, severe asthma attack or elective surgery. Consider referral to an ophthalmologist if patient presents w/ symptoms (eg, blurred vision or other visual disturbances). Patients w/ active or quiescent pulmonary TB or fungal, bacterial or viral resp infections. Reduced liver function may affect corticosteroid elimination. Pregnancy & lactation. Turbuhaler: Instruct patient to rinse mouth w/ water after each administration to minimize risk of Candida infections. Avoid concomitant treatment w/ ketoconazole, itraconazole or other potent CYP3A4 inhibitors. May experience return of previous symptoms (eg, muscle & joint pain) during transfer from oral steroid therapy. Childn on immunosuppressant drugs. Monitor growth regularly in childn & adolescent receiving long-term treatment. Respules: Potential systemic effects of inhaled steroids (eg, HPA axis depression, bone density reduction, cataracts & glaucoma, growth rate retardation in childn). Carefully interpret bone mineral density measurements, as an increased bone area in growing childn may reflect an increased bone vol. Possible initial reduction of growth velocity w/in 1st yr of treatment. Perform height measurements to identify patients w/ increased sensitivity. May mask some signs of existing & new infections at high doses. Not to be used w/ +ve pressure delivery systems in pulmonary conditions unless special drainage is performed.
Adverse Reactions
Hoarseness, cough. Turbuhaler: Oropharyngeal Candida infection, mild throat irritation. Respules: Sore, irritated throat; tongue & mouth irritation; dry mouth; oral candidiasis.
Drug Interactions
Turbuhaler: Increased plasma conc of oral budesonide w/ ketoconazole; avoid combination or consider time interval between administration or reduce budesonide dose. Increased plasma level w/ itraconazole. Respules: Increased systemic exposure to budesonide by CYP3A inhibitors (eg, ketoconazole & itraconazole).
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
Presentation/Packing
Form
Pulmicort respules 0.25 mg/mL
Packing/Price
30 × 1's
Form
Pulmicort respules 0.5 mg/mL
Packing/Price
30 × 1's
Form
Pulmicort turbuhaler 100 mcg/dose
Packing/Price
1's
Form
Pulmicort turbuhaler 200 mcg/dose
Packing/Price
1's
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