Beclomethasone - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Oropharyngeal candidiasis: Candida albicans infection of the mouth and throat may occur.

Monitor patients periodically for signs of adverse effects on the oral cavity.

Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk.

Deterioration of asthma and acute episodes: Do not use QVAR REDIHALER for relief of acute symptoms.

Patients require immediate re-evaluation during rapidly deteriorating asthma.

Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids.

Taper patients slowly from systemic corticosteroids if transferring to QVAR REDIHALER.

Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections.

More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

Use with caution in patients with these infections because of the potential for worsening of these infections.

Paradoxical bronchospasm: Bronchospasm, with an immediate increase in wheezing, may occur after dosing.

Treat bronchospasm immediately with inhaled, short-acting bronchodilator and discontinue QVAR REDIHALER.

Hypersensitivity reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm may occur.

Discontinue QVAR REDIHALER if such reactions occur.

Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals.

If such changes occur, discontinue QVAR REDIHALER slowly.

Effects on growth: Monitor growth of pediatric patients.

Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content.

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

5.1 Oropharyngeal Candidiasis Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving QVAR REDIHALER.

If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with QVAR REDIHALER therapy, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision.

After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

5.2 Deterioration of Asthma and Acute Episodes QVAR REDIHALER is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

An inhaled, short‑acting beta 2 ‑agonist, not QVAR REDIHALER, should be used to relieve acute symptoms such as shortness of breath.

Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with QVAR REDIHALER.