BECLOMETHASONE DIPROPIONATE: 5,151 Adverse Event Reports & Safety Profile

The active component of beclomethasone dipropionate HFA inhalation aerosol 40 mcg inhalation aerosol and beclomethasone dipropionate HFA inhalation aerosol 80 mcg inhalation aerosol is beclomethasone dipropionate, USP, a corticosteroid having the chemical name 9-chloro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone dipropionate, USP (BDP) is a diester of beclomethasone, a synthetic corticosteroid chemically related to dexamethasone. Beclomethasone differs from dexamethasone in having a chlorine at the 9-alpha carbon in place of a fluorine, and in having a 16 beta-methyl group instead of a 16 alpha-methyl group. Beclomethasone dipropionate, USP is a white to creamy white, odorless powder with a molecular formula of C 28 H 37 ClO 7 and a molecular weight of 521.1. Its chemical structure is: Beclomethasone dipropionate HFA inhalation aerosol is a pressurized, metered-dose aerosol with a dose counter intended for oral inhalation only. Each unit contains a solution of beclomethasone dipropionate, USP in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. Beclomethasone dipropionate HFA inhalation aerosol 40 mcg delivers 40 mcg of beclomethasone dipropionate, USP from the actuator and 50 mcg from the valve. Beclomethasone dipropionate HFA inhalation aerosol 80 mcg delivers 80 mcg of beclomethasone dipropionate, USP from the actuator and 100 mcg from the valve. Both products deliver 50 microliters (59 milligrams) of solution formulation from the valve with each actuation.

The

40 mcg canisters and the 80 mcg canisters provide 120 inhalations each. Beclomethasone dipropionate HFA inhalation aerosol should be "primed" or actuated twice prior to taking the first dose from a new canister, or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming beclomethasone dipropionate HFA inhalation aerosol. This product does not contain chlorofluorocarbons (CFCs).

Structural

Formula

AND USAGE 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)

AND ADMINISTRATION For oral inhalation only. (2.1) Starting dosage is based on prior asthma therapy and disease severity. (2.2) Treatment of asthma in patients 12 years and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily. (2.2) Treatment of asthma in patients 5 to 11 years of age: 40 or 80 mcg twice daily. (2.2) Discard beclomethasone dipropionate HFA inhalation aerosol inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. (2.1)

2.1 Administration Information Administer beclomethasone dipropionate HFA inhalation aerosol by the orally inhaled route in patients 5 years of age and older. Beclomethasone dipropionate HFA inhalation aerosol does not require shaking prior to use. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Use of beclomethasone dipropionate HFA inhalation aerosol with a spacer device in children less than 5 years of age is not recommended <span class="opacity-50 text-xs">[see Use in Specific Populations (8.4) ]</span> . Patients should be instructed on the proper use of their inhaler. Consistent dose delivery is achieved, whether using the 40 or 80 mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40 mcg strength should provide a dose comparable to 1 actuation of the 80 mcg strength). Priming : Patients should prime beclomethasone dipropionate HFA inhalation aerosol by actuating into the air twice before using for the first time or if beclomethasone dipropionate HFA inhalation aerosol has not been used for over 10 days. Avoid spraying in the eyes or face when priming beclomethasone dipropionate HFA inhalation aerosol.

Dose

Counter : Beclomethasone dipropionate HFA inhalation aerosol has a dose counter window located on the back of the actuator. When the patient receives the inhaler, “122” will appear in the viewing window until it has been primed 2 times, at which point the total number of actuations will be displayed. The dose counter will count down each time a spray is released. The dose-counter window displays the number of sprays left in the inhaler in units of one (e.g., 120, 119, 118, etc). When the dose counter reaches "20", it is a reminder to the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. Discard beclomethasone dipropionate HFA inhalation aerosol inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

2.2 Recommended Dosage Adults and Adolescents 12 years of age and older The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients 12 years of age and older who are not on an inhaled corticosteroid is 40 to 80 mcg twice daily, approximately 12 hours apart. For patients switching to beclomethasone dipropionate HFA inhalation aerosol from another inhaled corticosteroid product, select the appropriate starting dosage strength of beclomethasone dipropionate HFA inhalation aerosol based on the strength of the previous inhaled corticosteroid product and disease severity: 40, 80, 160 or 320 mcg twice daily. For patients who do not respond adequately to the initial dosage after 2 weeks of therapy, increasing the dosage may provide additional asthma control. The maximum recommended dosage for patients 12 years of age and older is 320 mcg twice daily.

Pediatric Patients

5 to 11 years The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients aged 5 to 11 years of age is 40 mcg twice daily, approximately 12 hours apart. For patients who do not respond adequately to beclomethasone dipropionate HFA inhalation aerosol 40 mcg after 2 weeks of therapy, increasing the dosage to beclomethasone dipropionate HFA inhalation aerosol 80 mcg twice daily may provide additional asthma control. The maximum recommended dosage for patients 5 to 11 years of age is 80 mcg twice daily.

General Dosing Recommendations

The onset and degree of symptom relief will vary in individual patients. Improvement in asthma symptoms can occur within 24 hours of the beginning of treatment and should be expected within the first or second week, but maximum benefit should not be expected until 3 to 4 weeks of therapy. Improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy. If a dosage regimen of beclomethasone dipropionate HFA inhalation aerosol fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g., replacing the current strength of beclomethasone dipropionate HFA inhalation aerosol with a higher strength, or adding additional controller therapies) should be considered. As with any inhaled corticosteroid, physicians are advised to titrate the dose of beclomethasone dipropionate HFA inhalation aerosol downward over time to the lowest level that maintains proper asthma control. This is particularly important in children since a controlled study has shown that beclomethasone dipropionate HFA inhalation aerosol has the potential to affect growth in 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 <span class="opacity-50 text-xs">[see Warnings and Precautions (5.6) ]</span> .

REACTIONS Systemic and local corticosteroid use may result in the following: Epistaxis, nasal discomfort, nasal ulcerations, Candida albicans infection, and impaired wound healing [see Warnings and Precautions (5.1) ]

Eye

Disorders [see Warnings and Precautions (5.2) ] Hypercorticism, adrenal suppression, and growth reduction [see Warnings and Precautions (5.5) (5.6) , Use in Specific Populations (8.4) ] Immunosuppression [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 1% and greater than placebo) in patients 12 years of age and older include nasal discomfort, epistaxis, and headache. ( 6.1 ) The most common adverse reactions (≥ 2% and greater than placebo) in children 4 to 11 years of age include headache, pyrexia, upper respiratory tract infection, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults and Adolescents 12 Years of Age and Older : The safety data described below for adults and adolescents 12 years of age and older with seasonal or perennial allergic rhinitis are based on 4 placebo-controlled clinical trials of 2 to 6 weeks duration evaluating doses of beclomethasone nasal aerosol from 80 to 320 mcg once daily. These short-term trials included a total of 1394 patients with either seasonal or perennial allergic rhinitis. Of these, 575 (378 female and 197 male) received at least one dose of QNASL Nasal Aerosol, 320 mcg once daily and 578 (360 female and 218 male) received placebo. Patient ages ranged from 12 to 82 years and the racial distribution of patients was 81% white, 16% black, and 4% other. Short-Term (2–6 Weeks) Trials : Less than 2% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received QNASL Nasal Aerosol similar to or lower than the rate among patients who received placebo.

Table

1 displays the common adverse reactions (≥ 1% and greater than placebo-treated patients).

Table

1.

Adverse Events

With ³ 1% Incidence and Greater than Placebo in QNASL Nasal Aerosol-Treated Adult and Adolescent Patients with Seasonal or Perennial Allergic Rhinitis in Controlled Clinical Trials of 2 to 6 Weeks Duration (Safety Population) Adult and Adolescent Patients 12 Years of Age and Older QNASL Nasal Aerosol 320 mcg (N=575) n (%) Placebo (N=578) n (%)

Nasal Discomfort

30 (5.2) 28 (4.8)

Epistaxis

11 (1.9) 7 (1.2)

Headache

13 (2.3) 9 (1.6) Nasal ulcerations occurred in 2 patients treated with placebo and in 1 patient treated with QNASL Nasal Aerosol. There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not have sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Long-Term 52-Week Safety Trial : In a 52-week placebo-controlled long-term safety trial in patients with PAR, 415 patients (128 males and 287 females, aged 12 to 74 years) were treated with QNASL Nasal Aerosol at a dose of 320 mcg once daily and 111 patients (44 males and 67 females, aged 12 to 67 years) were treated with placebo. Of the 415 patients treated with QNASL Nasal Aerosol, 219 patients were treated for 52 weeks and 196 patients were treated for 30 weeks. While most adverse events were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received QNASL Nasal Aerosol (45 out of 415, 11%) than in patients who received placebo (2 out of 111, 2%). Epistaxis also tended to be more severe in patients treated with QNASL Nasal Aerosol.

In

45 reports of epistaxis in patients who received QNASL Nasal Aerosol, 27, 13, and 5 cases were of mild, moderate, and severe intensity, respectively, while the reports of epistaxis in patients who received placebo were of mild (1) and moderate (1) intensity. Seventeen patients treated with QNASL Nasal Aerosol experienced adverse reactions that led to withdrawal from the trial compared to 3 patients treated with placebo. There were 4 nasal erosions and 1 nasal septum ulceration which occurred in patients who received QNASL Nasal Aerosol, and no erosions or ulcerations noted in patients who received placebo. No patient experienced a nasal septum perforation during the trial.

Pediatric Patients Aged

4 to 11 Years : The safety data described below for pediatric patients 4 to 11 years of age with seasonal or perennial allergic rhinitis are based on 3 placebo-controlled clinical trials. These trials were 2 to 12 weeks in duration, evaluated doses of beclomethasone nasal aerosol 80 mcg to 160 mcg once daily and included a total of 1360 patients with either seasonal or perennial allergic rhinitis. Of these, 668 (312 female and 356 male) received at least one dose of QNASL Nasal Aerosol, 80 mcg once daily, 241 (116 female and 125 male) received QNASL Nasal Aerosol 160 mcg once daily, and 451 (203 female and 248 male) received placebo. The racial distribution of patients was 73% white, 20% black, and 6% other. Based on the results from the dose ranging trial, 80 mcg once daily was chosen as the dose in pediatric patients. Less than 1.5% of patients in the clinical trials discontinued treatment because of adverse reactions with the rate of withdrawal among patients who received QNASL Nasal Aerosol 80 mcg once daily similar to or lower than the rate among patients who received placebo.

Table

2 displays the common adverse reactions (≥ 2% and greater than placebo-treated patients). Additionally, epistaxis was reported at a rate of 4% for both QNASL Nasal Aerosol 80 mcg once daily and placebo-treated patients.

Table

2.

Adverse Events

With ≥ 2% Incidence and Greater than Placebo in QNASL Nasal Aerosol-Treated Pediatric Patients with Seasonal or Perennial Allergic Rhinitis in Controlled Clinical Trials of 2 to 12 weeks Duration (Safety Population)

Pediatric Patients

4 to 11 Years of Age QNASL Nasal Aerosol 80 mcg (N=668) n (%) Placebo (N=451) n (%)

Headache

23 (3.4) 15 (3.3)

Pyrexia

19 (2.8) 7 (1.6) Upper respiratory tract infection 17 (2.5) 8 (1.8)

Nasopharyngitis

15 (2.2) 6 (1.3)

6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials for QNASL Nasal Aerosol, the following adverse events have been reported during postmarketing use of QNASL Nasal Aerosol or other intranasal and inhaled formulations of beclomethasone dipropionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to beclomethasone dipropionate or a combination of these factors.

Qnasl

Nasal Aerosol: sneezing, burning sensation Intranasal beclomethasone dipropionate : Nasal septal perforation, blurred vision, glaucoma, cataracts, central serous chorioretinopathy (CSC), loss of taste and smell, and hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported following intranasal administration of beclomethasone dipropionate. Inhaled beclomethasone dipropionate : Hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, and bronchospasm have been reported following the oral inhalation of beclomethasone dipropionate.

AND PRECAUTIONS 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. Transfer of patients from systemic corticosteroid therapy to beclomethasone dipropionate HFA inhalation aerosol may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions. During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

5.4 Immunosuppression Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. It is not known how the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection. Nor is the contribution of the underlying disease and/or prior corticosteroid treatment known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) 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.) If chickenpox develops, treatment with antiviral agents may be considered. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.

5.5 Paradoxical Bronchospasm Inhaled corticosteroids may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs following dosing with beclomethasone dipropionate HFA inhalation aerosol, it should be treated immediately with an inhaled, short-acting bronchodilator. Treatment with beclomethasone dipropionate HFA inhalation aerosol should be discontinued and alternate therapy instituted.

5.6 Immediate Hypersensitivity Reactions Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of beclomethasone dipropionate HFA inhalation aerosol. Discontinue beclomethasone dipropionate HFA inhalation aerosol if such reactions occur <span class="opacity-50 text-xs">[see Contraindications (4.2) ]</span> .

5.7 Hypercorticism and Adrenal Suppression Beclomethasone dipropionate HFA inhalation aerosol will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since beclomethasone dipropionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of beclomethasone dipropionate HFA inhalation aerosol in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with beclomethasone dipropionate HFA inhalation aerosol should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when beclomethasone dipropionate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of beclomethasone dipropionate HFA inhalation aerosol should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

5.8 Effects on Growth Orally inhaled corticosteroids, including beclomethasone dipropionate HFA inhalation aerosol, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving beclomethasone dipropionate HFA inhalation aerosol routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including beclomethasone dipropionate HFA inhalation aerosol, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms <span class="opacity-50 text-xs">[see Use in Specific Populations (8.4) ]</span> .

5.9 Reduction in Bone Mineral Density Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.

5.10 Eye Disorders Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the use of long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma and/or cataracts while using beclomethasone dipropionate HFA inhalation aerosol.

INTERACTIONS No drug interaction studies have been performed with QNASL Nasal Aerosol.