For patients requiring inhaled corticosteroid (ICS) monotherapy for asthma control

PULMICORT FLEXHALER offers multiple dosing options
in an easy-to-use device1

Two dosage strengths of PULMICORT FLEXHALER® (budesonide inhalation powder, 90 mcg & 180 mcg)

a To titrate to the lowest level that maintains asthma control.

 

PULMICORT FLEXHALER (budesonide inhalation powder, 90 mcg & 180 mcg) contains budesonide—the only ICS for the treatment of asthma with a Pregnancy Category B rating
 

* Animal reproduction studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus. Nevertheless, because the studies in humans cannot rule out the possibility of harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed.3
Inhaled corticosteroid.

  • Because studies in humans cannot rule out the possibility of fetal harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed
  • 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

IMPORTANT SAFETY INFORMATION ABOUT PULMICORT FLEXHALER

  • 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
  • Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients
  • 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.PDF

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

  • PULMICORT FLEXHALER [package insert], 2010. AstraZeneca LP, Wilmington, DE.
  • US Food and Drug Administration. CFR-Code of Federal Regulations Title 21. http://www.accessdata.fda.gov/scripts/
    cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=201.57
    . Accessed November 27, 2012.
  • Labiris NR, Dolovich MB. Pulmonary drug delivery, Part II: the role of inhalant delivery devices and drug formulations in therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol. 2003;56(6):600-612.

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