Beclomethasone: uses, appearance and warnings

Beclomethasone dipropionate HFA inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: Beclomethasone dipropionate HFA inhalation aerosol is NOT indicated for the relief of acute bronchospasm. Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. (1) Important Limitations: Not indicated for the relief of acute bronchospasm. (1)

Inhalation Aerosol: Beclomethasone dipropionate HFA inhalation aerosol is a pressurized, metered-dose aerosol with a dose counter intended for oral inhalation containing beclomethasone dipropionate, USP in the following 2 strengths: Beclomethasone dipropionate HFA inhalation aerosol 40 mcg is supplied in a pressurized aluminum canister with a plastic actuator (beige actuator with light blue dust cap). Each actuation delivers 50 mcg of beclomethasone dipropionate, USP from the valve and 40 mcg from the actuator. Beclomethasone dipropionate HFA inhalation aerosol 40 mcg is available as a 120-inhalation/8.7 g canister. Beclomethasone dipropionate HFA inhalation aerosol 80 mcg is supplied in a pressurized aluminum canister with a plastic actuator (dark pink actuator with gray dust cap). Each actuation delivers 100 mcg of beclomethasone dipropionate, USP from the valve and 80 mcg from the actuator. Beclomethasone dipropionate HFA inhalation aerosol 80 mcg is available as a 120-inhalation/8.7 g canister. Inhalation aerosol: 40 or 80 mcg per actuation (3)

16.1 How Supplied Beclomethasone dipropionate HFA inhalation aerosol is supplied in 2 strengths: Beclomethasone dipropionate HFA inhalation aerosol 40 mcg is available in a box of one 8.7 g canister containing 120 actuations with a beige plastic actuator with a dose counter and light blue dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 69238-1289-4. Beclomethasone dipropionate HFA inhalation aerosol 80 mcg is available in a box of one 8.7 g canister containing 120 actuations with a dark pink plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 69238-1290-4. The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 8.7 g canister even though the canister is not completely empty. Patients should be informed to discard the beclomethasone dipropionate HFA inhalation aerosol inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15º to 30ºC (59º to 86ºF) (see USP Controlled Room Temperature). For optimal results, the canister should be at room temperature when used. Beclomethasone dipropionate HFA inhalation aerosol canister should only be used with the beclomethasone dipropionate HFA inhalation aerosol actuator and the actuator should not be used with any other inhalation drug product. Store beclomethasone dipropionate HFA inhalation aerosol when not being used, so that the product rests on the concave end of the canister with plastic actuator on top. CONTENTS UNDER PRESSURE Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49ºC (120ºF) may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children.

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. (4) Hypersensitivity to any of the ingredients of beclomethasone dipropionate HFA inhalation aerosol. (4) 4.1 Status Asthmaticus Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. 4.2 Hypersensitivity Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in beclomethasone dipropionate HFA inhalation aerosol [see Warnings and Precautions (5.6) ] .

Localized infections: 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. (5.1) Deterioration of asthma and acute episodes: Do not use beclomethasone dipropionate HFA inhalation aerosol for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.2) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to beclomethasone dipropionate HFA inhalation aerosol. (5.3) 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. (5.4) Paradoxical Bronchospasm: Bronchospasm, with an immediate increase in wheezing, may occur after dosing. Treat bronchospasm immediately with inhaled, short-acting bronchodilator and discontinue beclomethasone dipropionate HFA inhalation aerosol. (5.5) Hypersensitivity Reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm may occur. Discontinue beclomethasone dipropionate HFA inhalation aerosol if such reactions occur. (5.6) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue beclomethasone dipropionate HFA inhalation aerosol slowly. (5.7) Effects on growth: Monitor growth of pediatric patients. (5.8) Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.9) Eye Disorders: Monitor patients with change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts closely. (5.10) 5.1 Local Effects Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving beclomethasone dipropionate HFA inhalation aerosol. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with beclomethasone dipropionate HFA inhalation aerosol therapy, but at times therapy with beclomethasone dipropionate HFA inhalation aerosol may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised. 5.2 Deterioration of Asthma and Acute Episodes Beclomethasone dipropionate HFA inhalation aerosol 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 beclomethasone dipropionate HFA inhalation aerosol, 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 beclomethasone dipropionate HFA inhalation aerosol. During such episodes, patients may require therapy with oral corticosteroids. 5.3 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed in patients who are transferred from systemically active corticosteroids to beclomethasone dipropionate HFA inhalation aerosol because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infections (particularly gastroenteritis) or other conditions with severe electrolyte loss. Although beclomethasone dipropionate HFA inhalation aerosol may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid that is necessary for coping with these emergencies. During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physician for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack. Patients requiring oral or other systemic corticosteroids should be weaned slowly from oral or other systemic corticosteroid use after transferring to beclomethasone dipropionate HFA inhalation aerosol. Lung function (FEV 1 or PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral or other systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension. …

Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.1) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7) ] Growth effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Eye Disorders [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥3% and > placebo) include headache, pharyngitis, oral symptoms (inhalation route), and sinusitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …