Pulmicort Flexhaler

  • Asthma/COPD

Pulmicort Flexhaler Generic Name & Formulations

General Description

Budesonide (micronized) 90mcg/inh, 180mcg/inh; dry pwd for inhalation.

Pharmacological Class


How Supplied

Flexhaler (90mcg/dose)—1 (60 inh); Flexhaler (180mcg/dose)—1 (120 inh); Respules—30

How Supplied

Pulmicort Flexhaler is available as a dry powder for inhalation containing budesonide in the following 2 strengths: 90 mcg and 180 mcg. Each dosage strength contains 60 or 120 actuations per device. 180 mcg/dose with a target fill weight of 225 mg (range 200-250), and 90 mcg/dose, 60 dose with a target fill weight of 165 mg (range 140-190). 


Pulmicort Flexhaler should be stored in a dry place at controlled room temperature 20-25°C (68-77°F) with the cover tightly in place. Keep out of the reach of children. 

Generic Availability

Flexhaler (NO); Respules (YES)

Pulmicort Flexhaler Indications


Maintenance treatment of asthma as prophylactic therapy. Asthma requiring systemic corticosteroid therapy, to reduce need for systemic corticosteroids.

Pulmicort Flexhaler Dosage and Administration


≥18yrs: Initially 360mcg twice daily; may consider starting at 180mcg twice daily, if appropriate. Max 720mcg twice daily. Rinse mouth after use.


<6yrs: not established. ≥6yrs: Initially 180mcg twice daily; may consider starting at 360mcg twice daily, if appropriate. Max 360mcg twice daily. Rinse mouth after use.

Hepatic Impairment

Monitor closely in patients with hepatic disease.

Pulmicort Flexhaler Contraindications


Not for primary treatment of acute attack.

Pulmicort Flexhaler Boxed Warnings

Not Applicable

Pulmicort Flexhaler Warnings/Precautions


Maintain regular regimen. Infections. If exposed to chickenpox or measles, consider antiinfective prophylactic therapy. Adrenal insufficiency may occur when transferring patients from systemic corticosteroids to inhaled corticosteroids: see full labeling. Monitor for growth suppression in children. Post-op or during stress: monitor adrenal response. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually). Transferring from oral corticosteroids: see full labeling. Pregnancy. Nursing mothers.


Local Effects

  • Localized infections with Candida albicans may occur in the mouth and pharynx in some patients.

  • If these infections develop, patients may require treatment with appropriate local or systemic antifungal therapy and/or discontinuation of treatment.

  • Rinse mouth after each inhalation. 

Deterioration of Disease and Acute Asthma Episodes

  • Pulmicort Flexhaler or Respules is not a bronchodilator and is not indicated for the rapid relief of acute bronchospasm or other acute episodes of asthma. 

  • During treatment, patients should contact their physician immediately if episodes of asthma are not responsive to their usual doses of bronchodilators. Treatment with oral corticosteroids may be needed during such episodes.

Hypersensitivity Reactions Including Anaphylaxis 

  • Discontinue treatment if hypersensitivity reactions occur, including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm.


  • If exposed to chicken pox, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated.

  • If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information).

  • May consider treatment with antiviral agents if chicken pox develops.

  • Use caution in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections; or ocular herpes simplex. 

Transferring Patients from Systemic Corticosteroid Therapy

  • Use particular care when transferring patients from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency may occur.

  • The most susceptible patients are those who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent).

  • A number of months are required for recovery of HPA-axis function after withdrawal from systemic corticosteroids. During this period of HPA-axis suppression, patients exposed to trauma, surgery, infection, or other conditions associated with severe electrolyte loss may exhibit signs and symptoms of adrenal insufficiency.

  • During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and contact their physicians. These patients should carry a medical identification card.

  • If oral corticosteroids are required, patients should be weaned slowly from systemic corticosteroid use after transferring to Pulmicort Flexhaler or Respules. For these patients, use Pulmicort Flexhaler or Respules initially with their usual maintenance dose of systemic corticosteroid. Gradually withdraw systemic corticosteroid after approximately 1 week - do not exceed decrements of 25% of the prednisone dose or its equivalent. A slow rate of withdrawal is strongly recommended.

  • Monitor carefully lung function (FEV1 or AM PEF), beta-agonist use, and asthma symptoms during withdrawal of oral corticosteroids. Observe for signs and symptoms of adrenal insufficiency.

  • Transfer from systemic corticosteroid therapy to Pulmicort Flexhaler or Respules may unmask allergic or other immunologic conditions previously suppressed by the systemic corticosteroid therapy.

Hypercorticism and Adrenal Suppression  

  • Use particular care when observing patients post-operatively or during periods of stress for evidence of inadequate adrenal response

  • Systemic corticosteroid effects may occur, including hypercorticism, and adrenal suppression (including adrenal crisis), particularly when budesonide is administered at higher than recommended doses over prolonged periods of time. Reduce dose of Pulmicort Flexhaler or Respules slowly if these effects occur.

Reduction in Bone Mineral Density

  • Decreases in bone mineral density (BMD) have been observed with long-term administration of inhaled corticosteroids.

  • Monitor and treat appropriately in patients with major risk factors for decreased BMD, such as prolonged immobilization, family history of osteoporosis, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids).

Effects on Growth

  • May cause a reduction in growth velocity when administered to pediatric patients.

  • Monitor growth routinely if administered to pediatric patients. These systemic effects can be minimized by titrating each patient to their lowest effective dose.

Glaucoma and Cataracts

  • Monitor closely in patients with a change in vision or with a history of increased  intraocular pressure, glaucoma, and/or cataracts.

Paradoxical Bronchospasm and Upper Airway Symptoms 

  • Discontinue treatment and institute alternative therapy if paradoxical bronchospasm occurs, and treat immediately with a fast-acting inhaled bronchodilator.

Eosinophilic Conditions and Churg-Strauss Syndrome 

  • In rare cases, may present with systemic eosinophilic conditions.

  • Health care providers should be alert to eosinophilia, vasculitis rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.

Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

  • Use caution when considering using ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) with Pulmicort Flexhaler or Respules because may potentiate systemic exposure to budesonide. 

Pregnancy Considerations

Risk Summary

  • There are no adequate well-controlled studies of Pulmicort Flexhaler or Respules in pregnant women.

Clinical Considerations 

  • Disease-Associated Maternal and/or Embryo/Fetal risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.  

  • Labor or Delivery: There are no well-controlled human studies that have investigated the effects of Pulmicort Flexhaler or Respules during labor and delivery.

Nursing Mother Considerations

Risk Summary

  • Consider the developmental and health benefits of breastfeeding with the mother’s clinical need for Pulmicort Flexhaler or Respules and any potential adverse effects on the breastfed infant or from the underlying maternal condition.

Pediatric Considerations

Safety and effectiveness in asthma patients below 6 years of age have not been established.

Geriatric Considerations

No overall differences in safety were observed between these patients and younger patients.

Hepatic Impairment Considerations

Monitor closely in patients with hepatic disease.

Pulmicort Flexhaler Pharmacokinetics


Peak steady-state plasma concentrations of budesonide delivered from Pulmicort Flexhaler in adults with asthma (n=39) occurred at approximately 10 minutes post-dose and averaged 0.6 and 1.6 nmol/L at doses of 180 mcg once daily and 360 mcg twice daily, respectively. In asthmatic patients, budesonide showed a linear increase in AUC and Cmax with increasing dose after both a single dose and repeated dosing of inhaled budesonide.  


The volume of distribution of budesonide was approximately 3 L/kg. It was 85-90% bound to plasma proteins. Protein binding was constant over the concentration range (1-100 nmol/L) achieved with, and exceeding, recommended doses of Pulmicort Flexhaler. Budesonide showed little or no binding to corticosteroid binding globulin. Budesonide rapidly equilibrated with red blood cells in a concentration independent manner with a blood/plasma ratio of about 0.8.


In vitro studies with human liver homogenates have shown that budesonide is rapidly and extensively metabolized. Two major metabolites formed via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) catalyzed biotransformation have been isolated and identified as 16α-hydroxyprednisolone and 6β-hydroxybudesonide. The corticosteroid activity of each of these two metabolites is less than 1% of that of the parent compound. No qualitative difference between the in vitro and in vivo metabolic patterns has been detected. Negligible metabolic inactivation was observed in human lung and serum preparations. 


Budesonide is primarily cleared by the liver. Budesonide is excreted in urine and feces in the form of metabolites. In adults, approximately 60% of an intravenous radiolabeled dose was recovered in the urine. No unchanged budesonide was detected in the urine. In asthmatic children 4-6 years of age, the terminal half-life of budesonide after nebulization is 2.3 hours, and the systemic clearance is 0.5 L/min, which is approximately 50% greater than in healthy adults after adjustment for differences in weight. 

Pulmicort Flexhaler Interactions


Caution with CYP3A4 inhibitors (eg, ketoconazole, itraconazole, atazanavir, ritonavir, indinavir, nefazodone, nelfinavir, saquinavir, clarithromycin, telithromycin).

Pulmicort Flexhaler Adverse Reactions

Adverse Reactions

Pulmicort Flexhaler: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, oral candidiasis, viral gastroenteritis, nausea, otitis media, bronchospasm (rare). Pulmicort Respules: Respiratory or other infection, GI upset, moniliasis, fatigue, cough, dysphonia, rash, epistaxis, hypersensitivity reactions (discontinue if occurs).

Pulmicort Flexhaler Clinical Trials

Clinical Trials

The efficacy of Pulmicort Flexhaler was evaluated in two 12-week, double-blind, randomized, parallel-group, placebo-controlled clinical studies (Study 1 and Study 2) which included 1137 patients aged 6 to 80 years with mild to moderate asthma. Both studies had a 2-week placebo treatment run-in period followed by a 12-week randomized treatment period. The primary endpoint was the difference between baseline and the mean of the treatment-period FEV1 (adults) or FEV1% predicted (children).


Study 1 (Patients aged ≥18 years)

  • The study included 621 patients 18 to 80 years of age with mild to moderate asthma previously treated with inhaled corticosteroids.

  • Patients were randomly assigned to receive either Pulmicort Flexhaler 180mcg, Pulmicort Turbuhaler 200mcg, or placebo administered as 1 inhalation once daily or 2 inhalations twice daily.

  • Results showed that patients treated with Pulmicort Flexhaler 180mcg (2 inhalations twice daily) achieved a mean change from baseline in FEV1 of 0.28 liters compared with 0.10 liters in the placebo arm (P <.001).

  • Patients treated with Pulmicort Flexhaler also met secondary endpoints of morning and evening peak expiratory flow rate, daytime asthma symptom severity, nighttime asthma symptom severity, and daily rescue medication use compared with placebo (P <.001).


Study 2 (Patients aged 6 to 17 years)

  • The study included 516 patients 6 to 17 years of age and older with mild to moderate asthme previously treated with inhaled corticosteroids.

  • Patients were randomly assigned to receive either Pulmicort Flexhaler 90mcg 2 inhalations twice daily or 4 inhalations twice daily; or Pulmicort Turbuhaler 200mcg 1 inhalation once daily or 2 inhalations twice daily; or placebo.

  • Results showed that patients treated with Pulmicort Flexhaler 90mcg 4 inhalations twice daily achieved a mean change from baseline in % predicted FEV1 of 5.6 compared with 0.2 in the placebo arm (P <.001).

  • Patients treated with Pulmicort Flexhaler also met secondary endpoints of morning and evening PEF compared with placebo (P <.001).

Pulmicort Flexhaler Note

Not Applicable

Pulmicort Flexhaler Patient Counseling

Patient Counseling

Oral Candidiasis

  • Advise patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients.

  • Treat with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with Pulmicort Flexhaler or Respules if oropharyngeal candidiasis develops; at times, may need to temporarily interrupt Pulmicort Flexhaler or Respules under close medical supervision.

  • Advise patients to rinse their mouth after inhalation.

Not for Acute Symptoms

  • Do not use to relieve acute asthma symptoms, and do not use extra doses for that purpose.

  • Use inhaled, short-acting beta2-agonist (i.e., albuterol) to treat acute symptoms.

  • Notify health care professional immediately if patients experience:

    • Decreasing effectiveness of inhaled, short-acting beta2- agonists 

    • Need for more inhalations than usual of inhaled, short-acting beta2-agonists

    • Significant decrease in lung function as outlined by the physician

  • Do not stop therapy without physician/provider guidance.

Hypersensitivity Including Anaphylaxis

  • Discontinue if hypersensitivity reactions occur, including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm.


  • Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles. If exposed, consult their physician without delay.

 Hypercorticism and Adrenal Suppression 

  • Advise patients that treatment may cause systemic corticosteroid effects of hypercorticism and adrenal suppression.

  • Slowly taper patients form systemic corticosteroids if transferring to Pulmicort Flexhaler or Respules.

Reduction in Bone Mineral Density

  • Advise that the use of corticosteroids may pose increased risk for decreased BMD.

Reduced Growth Velocity 

  • May cause a reduction in growth velocity when given to pediatric patients.

Ocular Effects

  • Long-term use may increase the risk of cataracts or glaucoma. Consider regular eye examinations.

Use Daily 

  • Advise to use at regular intervals. Maximum benefit may not occur for 1 to 2  weeks or longer after starting treatment.