Beclomethasone Drug Information
Generic name: BECLOMETHASONE DIPROPIONATE
Uses of Beclomethasone
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.
Dosage & Administration of Beclomethasone
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. Patients should be instructed on the proper use of their inhaler. 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.
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. 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: 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 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.
Side Effects of Beclomethasone
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. 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. 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.
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.
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).
| 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 |
Warnings & Cautions for Beclomethasone
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pregnancy Safety for Beclomethasone
Pregnancy Risk Summary There are no adequate and well-controlled studies with beclomethasone dipropionate HFA inhalation aerosol or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women. Also, no published studies, including studies of large birth registries, have to date related the use of ICS to any increases in congenital malformations or other adverse perinatal outcomes.
Thus, available human data do not establish the presence or absence of drug-associated risk to the fetus. In animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times the maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day). In rats exposed to beclomethasone dipropionate by inhalation, dose-related gross injury to the fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryolethality at inhalation doses up to 440 times the MRHDID.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the US general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk The risk of complications to the mother and developing fetus from inadequate control of asthma must be balanced against the risks from exposure to beclomethasone dipropionate.
In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight and small for gestational age for the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Labor or Delivery There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery.
Data Animal Data In an embryofetal development study in pregnant rats, beclomethasone dipropionate administration during organogenesis from gestation days 6 to 15 at inhaled doses 180 times the MRHDID in adults and higher (on a mg/m 2 basis at maternal doses of 11.5 and 28.3 mg/kg/day) produced dose-dependent gross injury (characterized by red foci) of the adrenal glands in fetuses. There were no findings in the adrenal glands of rat fetuses at an inhaled dose that was 40 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 2.4 mg/kg/day). There was no evidence of external or skeletal malformations or embryolethality in rats at inhaled doses up to 440 times the MRHDID (on a mg/m 2 basis at maternal doses up to 28.3 mg/kg/day).
In an embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 18 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 basis at maternal doses of 0.1 mg/kg/day and higher) produced adverse developmental effects (increased incidence of cleft palate). A no-effect dose in mice was not identified. In a second embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 13 at subcutaneous doses equal to and greater than 2.3 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 0.3 mg/kg/day) produced embryolethal effects (increased fetal resorptions) and decreased pup survival.
In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 basis at maternal doses of 0.025 mg/kg/day and higher) produced external and skeletal malformations and embryolethal effects (increased fetal resorptions). There were no effects in fetuses of pregnant rabbits administered a subcutaneous dose 0.2 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 0.006 mg/kg/day).
Pediatric Use of Beclomethasone
L/min years
Flow rate 8.2 L/min years, Flow rate 8.2 L/min years, Flow rate 11.0 L/min i Summary Report; Pediatric Dose Characterization of beclomethasone dipropionate HFA inhalation aerosol with Spacer; 3M Pharmaceutical Development, July 21, 2004 ii CDC Growth charts, developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion. iii Includes an estimated 20% loss in the masks iv Beclomethasone dipropionate HFA inhalation aerosol 40mcg in an average adult without using a spacer delivers approximately 0.4 mcg/kg, or bid, 0.8 mcg/kg/day. Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. A 12-month, randomized, controlled clinical trial evaluated the effects of HFA beclomethasone dipropionate without spacer versus CFC beclomethasone dipropionate with large-volume spacer on growth in children age 5 to 11.
Similar control of asthma was noted in each treatment arm. When comparing results at month 12 to baseline, the mean growth velocity in children treated with HFA-BDP was approximately 0.5 cm/year less than that noted with children treated with CFC-BDP via large-volume spacer. The long-term effects of the reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown.
The potential for "catch-up" growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. The growth of children and adolescents receiving orally inhaled corticosteroids, including beclomethasone dipropionate HFA inhalation aerosol, should be monitored routinely (e.g., via stadiometry). If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect should be considered.
The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including beclomethasone dipropionate HFA inhalation aerosol, each patient should be titrated to his/her lowest effective dose.
Contraindications for Beclomethasone
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.
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.
Clinical Studies of Beclomethasone
Adult and Adolescent Patients Greater Than 12 Years of Age
Patients not Previously Receiving Corticosteroid Therapy In a 6-week clinical trial, 270 steroid-naive patients with symptomatic asthma being treated with as-needed beta-agonist bronchodilators, were randomized to receive either 40 mcg twice daily of beclomethasone dipropionate HFA inhalation aerosol, 80 mcg twice daily of beclomethasone dipropionate HFA inhalation aerosol, or placebo. Both doses of beclomethasone dipropionate HFA inhalation aerosol were effective in improving asthma control with significantly greater improvements in FEV 1, AM PEF, and asthma symptoms than with placebo. Shown below is the change from baseline in AM PEF during this trial.
A 6-Week Clinical Trial in Patients with Mild to Moderate Asthma Not on Corticosteroid Therapy Prior to Study Entry: Mean Change in AM PEF In a 6-week clinical trial, 256 patients with symptomatic asthma being treated with as-needed beta-agonist bronchodilators, were randomized to receive either 160 mcg twice-daily of beclomethasone dipropionate HFA inhalation aerosol (delivered as either 40 mcg/actuation or 80 mcg/actuation) or placebo. Treatment with beclomethasone dipropionate HFA inhalation aerosol significantly improved asthma control, as assessed by FEV 1, AM PEF, and asthma symptoms, when compared to treatment with placebo. Comparable improvement in AM PEF was seen for patients receiving 160 mcg twice-daily beclomethasone dipropionate HFA inhalation aerosol from the 40 mcg and 80 mcg strength products.
Patients Responsive to a Short Course of Oral Corticosteroids In another clinical trial, 347 patients with symptomatic asthma, being treated with as-needed inhaled beta-agonist bronchodilators and, in some cases, inhaled corticosteroids, were given a 7 to 12-day course of oral corticosteroids and then randomized to receive either 320 mcg daily of beclomethasone dipropionate HFA inhalation aerosol, 672 mcg of CFC-BDP, or placebo. Patients treated with either beclomethasone dipropionate HFA inhalation aerosol or CFC-BDP had significantly better asthma control, as assessed by AM PEF, FEV 1 and asthma symptoms, and fewer study withdrawals due to asthma symptoms, than those treated with placebo over 12 weeks of treatment. A daily dose of 320 mcg beclomethasone dipropionate HFA inhalation aerosol administered in divided doses provided comparable control of AM PEF and FEV 1 as 672 mcg of CFC-BDP.
Shown below are the mean AM PEF results from this trial. A 12-Week Clinical Trial in Moderate Symptomatic Patients with Asthma Responding to Oral Corticosteroid Therapy: Mean AM PEF by Study Week Patients Previously on Inhaled Corticosteroids In a 6-week clinical trial, 323 patients who exhibited a deterioration in asthma control during an inhaled corticosteroid washout period were randomized to daily treatment with either 40, 160, or 320 mcg twice-daily beclomethasone dipropionate HFA inhalation aerosol or 42, 168 or 336 mcg twice-daily CFC-BDP. Treatment with increasing doses of both beclomethasone dipropionate HFA inhalation aerosol and CFC-BDP resulted in increased improvement in FEV 1, FEF 25-75% (forced expiratory flow over 25% to 75% of the vital capacity) and asthma symptoms.
Shown below is the change from baseline in FEV 1 as percent predicted after 6 weeks of treatment.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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