Dosing and uses of Pulmicort Respules, Pulmicort Flexhaler (budesonide inhaled)
Adult dosage forms and strengths
suspension for nebulizer
- 0.25mg/2mL
- 0.5mg/2mL
- 1mg/2mL
powder for inhalation
- 90mcg/actuation
- 180mcg/actuation
Asthma
Maintenance treatment
Inhaled powder: 360 mcg PO q12hr; in some patients, may be initiated at 180 mcg q12hr; not to exceed 720 mcg q12hr
Administration
Suspension should be administered via jet nebulizer connected to air compressor with adequate air flow and equipped with mouthpiece or suitable face mask; ultrasonic nebulizer should not be used
Pediatric dosage forms and strengths
suspension for nebulizer
- 0.25mg/2mL
- 0.5mg/2mL
- 1mg/2mL
powder for inhalation
- 90mcg/actuation
- 180mcg/actuation
Asthma
Maintenance treatment
Nebulized suspension
- <1 years: Safety and efficacy not established
- 1-8 years (prior therapy with bronchodilators alone): 0.5 mg once daily or divided q12hr; not to exceed 0.5 mg/day
- 1-8 years (prior therapy with inhaled corticosteroids): 0.5 mg once daily or divided q12hr; not to exceed 1 mg/day
- 1-8 years (prior therapy with PO corticosteroids): 1 mg once daily or divided q12hr; not to exceed 1 mg/day
- Symptomatic children not responding to nonsteroidal therapy: May be initiated at 0.25 mg q12hr
Inhaled powder
- <6 years: Safety and efficacy not established
- >6 years: 180 mcg PO q12hr; in some patients, may be initiated at 360 mcg q12hr; not to exceed 360 mcg q12hr
Pulmicort Respules, Pulmicort Flexhaler (budesonide inhaled) adverse (side) effects
>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%)
Warnings
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 and lactation
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.
Pharmacology of Pulmicort Respules, Pulmicort Flexhaler (budesonide inhaled)
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%)
