Beclomethasone Dipropionate

Product Type: HUMAN PRESCRIPTION DRUG

Route: RESPIRATORY (INHALATION)

Dosage Form:

NDC: 69238-1289

Application: ANDA213811

Effective: 20200731

1 INDICATIONS 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)

2 DOSAGE 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 [see Use in Specific Populations (8.4) ] . 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.

4 CONTRAINDICATIONS 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) ] .

Not available.

6 ADVERSE REACTIONS 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. 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following reporting rates of common adverse experiences are based upon 4 clinical trials in which 1196 patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with beclomethasone dipropionate HFA inhalation aerosol (doses of 40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. Table 1 below includes all events reported by patients taking beclomethasone dipropionate HFA inhalation aerosol (whether considered drug related or not) that occurred at a rate over 3% for beclomethasone dipropionate HFA inhalation aerosol. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account. Table 1 Adverse Events Reported by at Least 3% of the Patients for Beclomethasone Dipropionate HFA Inhalation Aerosol by Treatment and Daily Dose Adverse Events Placebo (N=289) % Beclomethasone Dipropionate HFA Inhalation Aerosol Total (N=624) % 80 to 160 mcg (N=233) % 320 mcg (N=335) % 640 mcg (N=56) % Headache 9 12 15 8 25 Pharyngitis 4 8 6 5 27 Upper Respiratory Tract Infection 11 9 7 11 5 Rhinitis 9 6 8 3 7 Increased Asthma Symptoms 18 3 2 4 0 Oral Symptoms Inhalation Route 2 3 3 3 2 Sinusitis 2 3 3 3 0 Pain <1 2 1 2 5 Back Pain 1 1 2 <1 4 Dysphonia 2 <1 1 0 4 Other adverse events that occurred in these clinical trials using beclomethasone dipropionate HFA inhalation aerosol with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were nausea, dysmenorrhea, and coughing. Oropharyngeal candidiasis occurred in <1% of patients in both beclomethasone dipropionate HFA inhalation aerosol and placebo treatment groups. Pediatric Studies In two 12-week placebo-controlled studies in steroid naive pediatric patients 5 to 12 years of age, no clinically relevant differences were found in the pattern, severity, or frequency of adverse events compared with those reported in adults, with the exception of conditions which are more prevalent in a pediatric population generally. 6.2 Postmarketing Experience In addition to adverse reactions experienced in the clinical trials, the following adverse events have been reported during post-approval use of beclomethasone dipropionate HFA inhalation aerosol. Because they 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. Local Effects: Localized infections with Candida albicans have occurred in patients treated with beclomethasone dipropionate HFA inhalation aerosol or other orally inhaled corticosteroids [see Warnings and Precautions (5.1) ] . Psychiatric and Behavioral Changes: Aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children). Eye Disorders: Blurred vision, central serous chorioretinopathy (CSC).