Budesonide is the ONLY ICS* with a
Pregnancy Category B rating
- Because studies in humans cannot rule out the possibility of fetal harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed
*Inhaled corticosteroid.
In pediatric patients with asthma
Growth in patients taking budesonide and placebo over 4 years3
Growth: budesonide inhalation powder vs placebo at 4 years3
Childhood Asthma Management Program (CAMP) study
Adapted from CAMP Research Group.
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Study design
Childhood Asthma Management Program (CAMP) study: In a double-blind multicenter study, 1041 pediatric patients (ages 5 to 12 years) with mild to moderate asthma were randomized to receive budesonide 200 mcg twice daily via a dry-powder inhaler (n=311), a mast-cell stabilizer (n=312), or placebo (n=418) over a 4- to 6-year period. In this study, the primary efficacy endpoint was not met. Note: Recommended starting dosage of PULMICORT FLEXHALER for pediatric patients is 180 mcg, BID.1,3
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- The growth of pediatric patients receiving orally inhaled corticosteroids, including PULMICORT FLEXHALER, should be monitored routinely, and the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks and benefits associated with alternative therapies. Each patient should be titrated to his or her lowest effective dose
- The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown
- Controlled clinical trials have shown that orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity in pediatric patients. A reduction in growth velocity may occur as a result of inadequate control of asthma or from use of corticosteroids for treatment
- Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study
In adult and pediatric patients with asthma
HPA*-axis function in adults and children taking budesonide for up to 52 weeks4,5
HPA-axis function over 52 weeks4,5
52-week study in adults and children with mild to severe asthma.
View footnotes and study designView footnotes and study design
Footnotes
*Hypothalamic-pituitary-adrenal.
aStandard deviation.
bAdrenocorticotropic hormone.
Study design
52-week study in adults and children with mild to severe asthma: An open-label 52-week trial involving 1133 patients with mild to severe asthma who received budesonide via a dry-powder inhaler (dose range: 200 mcg/day to1600 mcg/day). Patients included adults (n=249) who did not receive corticosteroids, adults (n=384) and children (n=356) previously maintained on ICSs, and adults (n=144) previously maintained on oral corticosteroids. Patients were aged 6 to 70 years (mean age 33 ± 18 years).5
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- Since budesonide is absorbed into the circulation and can be systemically active, the beneficial effects of PULMICORT FLEXHALER in minimizing HPA-axis dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose
- Since individual sensitivity to effects on cortisol production varies, physicians should consider this information when prescribing PULMICORT FLEXHALER
- Because of the possibility of systemic absorption of ICSs, patients treated with PULMICORT FLEXHALER should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response
- It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when budesonide is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of PULMICORT FLEXHALER should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms
Adverse reactions with an incidence of ≥1%a
View footnote
Footnotes
aIn non–placebo-controlled long-term studies in children (at doses up to 360 mcg daily) and adolescent and adult subjects (at doses up to 720 mcg daily) treated for up to 1 year with PULMICORT FLEXHALER, a similar pattern and incidence of adverse reactions were revealed.
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IMPORTANT INFORMATION ABOUT PULMICORT FLEXHALER
Important Safety Information
- PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm
- Particular care is needed for patients who are transferred from systemically active corticosteroids to PULMICORT FLEXHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
- Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles
- It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses
- Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown
- Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids
- Hypersensitivity reactions, including anaphylaxis, have been reported with budesonide
- PULMICORT FLEXHALER contains small amounts of lactose, which contains trace levels of milk proteins. In patients who have severe milk protein allergy (not those who are lactose intolerant) cough, wheezing, or bronchospasm may occur
- Adverse reactions that occurred at a rate of ≥1% are: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, and oral candidiasis
Indication
- PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older
Please click here for full Prescribing Information for PULMICORT FLEXHALER.
PULMICORT FLEXHALER is a registered trademark of the AstraZeneca group of companies.
This product information is intended for US health care professionals only.
©2011 AstraZeneca. All rights reserved. 1093306 1/12
