Pulmicort Flexhaler

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.

Immunosuppression

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• During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and contact their physicians.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