PULMICORT FLEXHALER—multiple dosing options
in a convenient device1
Two dosage strengths—to step up or step down therapy
- Built-in dose indicator
- Tapered mouth-piece
aTo titrate to the lowest level that maintains asthma control.
- Improvement in asthma control following inhaled administration of budesonide can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer
- Consider age and disease severity when initiating treatment with PULMICORT FLEXHALER
- For patients with asthma who require oral corticosteroid therapy, PULMICORT FLEXHALER may be able to help reduce or eliminate that requirement over time
- Each 180-mcg dose of PULMICORT FLEXHALER delivers 160 mcg of budesonide per actuation. Each 90-mcg dose of PULMICORT FLEXHALER delivers 80 mcg of budesonide per actuation
- For all patients, it is desirable to titrate to the lowest effective dose after adequate stability is achieved
References
- PULMICORT FLEXHALER [package insert]. Wilmington, DE: AstraZeneca LP; 2010.
- PULMICORT FLEXHALER [package insert]. Wilmington, DE: AstraZeneca LP; 2008.
- PULMICORT FLEXHALER [package insert]. Wilmington, DE: AstraZeneca LP; 2006.
- Lööf T, Elfman P, Ström P, Törngren A, Borgström L. Sustained mechanical and clinical functionality of the flexhaler dry powder inhaler. J Aerosol Med Pulm Drug Deliv. 2008;21(4):381-388.
- Data on File, 266665, AZPLP.
- Data on File, 268208, AZPLP.
- Tinkelman DG, Bronsky EA, Gross G, Schoenwetter WF, Spector SL. Efficacy and safety of budesonide inhalation powder (PULMICORT TURBUHALER) during 52 weeks of treatment in adults and children with persistent asthma. J Asthma. 2003;40(3):225-236.
- Data on File, DA-PTH-04, AstraZeneca Pharmaceuticals LP.
- Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000;343(15):1054-1063.
- Agertoft L, Pedersen S. Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med. 2000;343(15):1064-1069.
- Agertoft L, Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med. 1994(5);88;373-381.
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 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
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