PULMICORT FLEXHALER® Inhaler

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

PULMICORT Flexhaler provided significant and sustained improvement in lung function in adults and children1

See the data
 

Efficacy

PULMICORT FLEXHALER
has proven clinical efficacy in both adults and children with asthma1,2

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Safety

PULMICORT FLEXHALER contains budesonide, the ONLY ICS with a Pregnancy Category B rating1 PULMICORT FLEXHALER® the only Pregnancy Category B ICS for the treatment of asthma

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PULMICORT FLEXHALER Clinical Presentation

PULMICORT FLEXHALER® (budesonide inhalation powder, 90 mcg & 180 mcg) Clinical Presentation Explore clinical data with this interactive module.
  • Because studies in humans cannot rule out the possibility of fetal harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed

* 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.

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.

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