BECONASE AQ
  • BECONASE AQ

  • QTY 25 • 42 MCG • SPRAY • Near 77381

BECLOMETHASONE (be kloe METH a sone) is a corticosteroid. It helps decrease inflammation in your nose. This medicine is used to treat the symptoms of allergies like sneezing, itching, and runny or stuffy nose. This medicine is also used to prevent the return of nasal polyps.

BECONASE AQ Pediatric Monographs
  • General Administration Information
    For storage information, see the specific product information within the How Supplied section.

    Route-Specific Administration

    Inhalation Administration
    Oral Inhalation Administration
    -If the patient is also using a bronchodilator, instruct them to use the bronchodilator first and wait 5 to 15 minutes, then use beclomethasone.
    -Educate patients and caregivers that beclomethasone is not a bronchodilator and should not be used as a rescue medication.
    -Instruct patient and/or caregiver on proper inhalation technique.

    Aerosol for Oral Inhalation (e.g., QVAR, metered-dose inhaler [MDI])
    -Qvar is a solution aerosol. The canister does not require shaking prior to administration.
    -Use of Qvar with a spacer device in children younger than 5 years is not recommended. Studies have shown a rapid decrease in medication delivery secondary to short (5 to 10 seconds) wait times when a spacer was used by this population.
    -For patients 5 years and older who are unable to coordinate inhalation and actuation, a spacer or valved holding chamber (VHC) may be beneficial. If a spacer device is used, the patient should be instructed to inhale immediately as the medication delivered through the device decreases rapidly with increasing wait times. Limited data are available regarding the use of spacers/VHC devices with ultrafine-particle-generated HFA MDIs.
    -Prime the inhaler prior to first use and in cases where the inhaler has not been used for more than 10 days. Prime by spraying 2 actuations of the inhaler into the air, away from the eyes and face. When the patient initially receives the inhaler, a black dot will be apparent in the dose counter window until the inhaler has been primed, at which point the total number of actuations will display.
    -The dose counter displays how many doses are left in units of 2 (e.g., 120, 118, 116, etc.). When the counter reaches 20, the color of the numbers changes to red reminding the patient to refill the medication. When the dose counter reaches 0, the background will change to solid red.
    -Instruct patient to rinse mouth (and gargle, if possible) thoroughly with water or mouthwash after administration to remove beclomethasone deposited in the mouth.
    -For normal hygiene, the mouthpiece of the inhaler should be cleaned weekly with a clean dry tissue or cloth. Do not wash the Qvar inhaler or put any part of the inhaler in water.
    -To avoid the spread of infection, do not use the inhaler for more than 1 person.
    -Instruct the patient to safely dispose of the inhaler when the dose counter displays 0 or the product expires, whichever comes first.
    -Storage: Store so that the inhaler rests on the concave end of the canister with the plastic actuator on top when not being used.

    Aerosol for Oral inhalation (e.g., QVAR Redihaler, metered-dose inhaler [MDI])
    -The canister does not require shaking prior to administration; do not shake the inhaler with the cap open to avoid possible actuation of the device.
    -The white cap on the Redihaler must be closed before each inhalation; advise the patient not to open the white cap until ready to take the inhalation. If the dose requires more than 1 inhalation, the white cap must be closed between inhalations.
    -Instruct patient on proper inhalation technique.
    -Do not use with a spacer device or volume holding chamber.
    -The Redihaler does not require priming.
    -The Redihaler has a dose counter attached to the actuator. When the patient receives the inhaler, the number 120 will be displayed.
    -The dose counter will count down each time a spray is released. When the dose counter reaches 20, red numbers appear warning the patient to refill the medication.
    -After administration, instruct patient to rinse mouth (and gargle, if possible) thoroughly with water or mouthwash to remove beclomethasone deposited in the mouth.
    -For normal hygiene, the mouthpiece of the inhaler should be cleaned weekly with a clean dry tissue or cloth. Do not wash the Redihaler or put any part of the inhaler in water; the patient should replace the Redihaler if washed or placed in water. Never take the Redihaler apart.
    -Instruct the patient to safely dispose of the inhaler when the dose counter displays 0 (background color will change to solid red) or the product expires, whichever comes first.
    -Storage: Store so the inhaler rests on the concave end of the canister with the plastic actuator on top when not being used. Store at room temperature and avoid exposure to extreme heat and cold.



    Other Administration Route(s)
    Intranasal Administration
    -Different nasal dosage forms are commercially available. Products are not always interchangeable due to differences in the amount of active drug released per spray.
    -Instruct patient to avoid spraying in the eyes.
    -To avoid the spread of infection, do not use the container for more than 1 person.

    Metered-dose Aerosol (e.g., QNASL)
    -Instruct patient on proper administration technique (see manufacturer-provided patient instructions).
    -Prior to first use, instruct the patient to prime the canister by actuating 4 times into the air, away from eyes and face. After the initial priming, the dose-counter should read 120 (120-actuation products) or 60 (60-actuation products).
    -If the canister is not used for 7 consecutive days, instruct the patient to re-prime by actuating 2 times.
    -After administration, wipe the nasal actuator tip with a clean, dry tissue or cloth. Replace the cap right after cleaning.

    Metered Nasal Spray (e.g., Beconase AQ)
    -Instruct patient to shake the nasal sprayer well before administering.
    -Instruct patient on proper administration technique (see manufacturer-provided patient instructions).
    -Prior to first use, instruct the patient to prime the pump by actuating 6 times; if the pump is not used for 7 consecutive days, instruct the patient to re-prime until a fine spray appears.
    -After administration, rinse the tip of the bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after cleaning.
    -The drug may not reach the site of intended action in patients with excessive nasal secretions or nasal mucosal edema. In these cases, it is recommended to use a nasal vasoconstrictor during the first 2 to 3 days of therapy.

    Nasal septum perforation has been rarely reported after intranasal beclomethasone use. Although not reported during adolescent or adult trials, there was a single incident observed in the dose-ranging pediatric clinical trial. Additionally, in a clinical study of beclomethasone nasal aerosol in 715 children, 1 case of nasal septum perforation was reported; however, the child was at higher risk for nasal septum perforation (i.e., history of epistaxis and 2 previous nasal surgeries). In clinical trials of beclomethasone nasal aerosol (QNASL), nasal erosions occurred in 4 and nasal ulceration in 1 out of 415 patients. Nasal irritation is a common adverse effect of the nasal formulations. Other adverse effects occurring after nasal administration of beclomethasone include nasal itching, nasal burning, bloody mucus, nasal dryness, unpleasant smell, loss of smell (anosmia), dysgeusia, naso-pharyngitis (2%), upper respiratory tract infection (2.5%), and fever (3%). Occasional sneezing attacks occurred in 4% of patients and nasal stuffiness, rhinorrhea, and tearing eyes were reported in < 3% of patients after use of beclomethasone nasal spray (Beconase AQ). Epistaxis and nasal discomfort occurred in <= 11% and 5.2% of patients, respectively, receiving intranasal beclomethasone. Possible adverse nasopharyngeal effects after oral inhalation of beclomethasone include xerostomia (dry mouth) and tongue and mouth irritation. Pharyngitis (8%), rhinitis (6%), increased asthma symptoms (3%), oral symptoms (3%), and sinusitis (3%) were also reported in clinical trials of inhaled beclomethasone. Upper respiratory tract infection was reported by 9% of patients who received beclomethasone via oral inhalation in clinical trials. Rarely, localized infections of the nose and pharynx with Candida albicans have occurred in patients who received intranasal beclomethasone. When such an infection develops, begin appropriate antifungal therapy; discontinuation of treatment with beclomethasone may be necessary.

    In rare cases, patients on inhaled corticosteroids may present with eosinophilia and clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition often treated with systemic corticosteroids. These events have happened most commonly in association with systemic corticosteroid withdrawal in conjunction with the introduction of inhaled corticosteroid therapy. Patients presenting with eosinophilia, vasculitis with granulomas, worsening pulmonary symptoms, and/or neuropathy may have this condition, which may be severe.

    Inhalation of corticosteroids can occasionally trigger mild cough or wheezing, probably because of upper airway irritation caused by propellants and detergents mixed with the corticosteroid. These effects can be reduced by pretreating with a bronchodilator or using an add-on spacing device. In clinical trials of inhaled beclomethasone, cough occurred in 1-3% of patients.

    Inhaled corticosteroid therapy has been rarely associated with the development of cataracts, increased ocular pressure or ocular hypertension, and glaucoma in adults; the risk in pediatric patients is unclear. In adults, the risk of cataracts increases with long-term and high-dose inhaled corticosteroid use. In a cross-sectional study of adults for vision and common eye diseases, the incidence of both nuclear and posterior subcapsular cataracts was higher in patients receiving inhaled beclomethasone compared to those who had never received inhaled corticosteroids. The mechanism of corticosteroid-induced cataract formation is uncertain but may involve disruption of sodium-potassium pumps in lens epithelium leading to accumulation of water in lens fibers and agglutination of lens proteins. Rare occurrences of cataracts, glaucoma, blurred vision, central serous chorioretinopathy (CSC), and increased intraocular pressure have been reported with intranasal beclomethasone. In clinical trials of beclomethasone nasal aerosol (QNASL), increased intraocular pressure (21 mmHg or more) occurred in 5% of patients. Blurred vision and CSC have also been reported during postmarketing experience with beclomethasone dipropionate oral inhalation (Qvar). Close monitoring is necessary for those who develop visual impairment or those with a history of increased intraocular pressure, glaucoma, and/or cataracts during corticosteroid therapy. Consider referral to an ophthalmologist in patients who develop ocular symptoms or who use inhaled or intranasal beclomethasone long term.

    Local immunosuppression associated with inhaled beclomethasone use may be manifested as an overgrowth of fungus in the nose, mouth, and throat, potentially precipitating infection. Oral candidiasis (thrush) is a well-known adverse reaction of oral inhalation steroid therapy. The incidence (<= 13%) is correlated with daily dose, and appears to occur less frequently in children. Using an add-on spacer device, reducing the frequency of use, and rinsing the mouth following use may minimize the incidence of oropharyngeal thrush. If oropharyngeal thrush develops, it should be treated with appropriate local or systemic antifungal therapy while still continuing ICS therapy; temporary interruption of inhaled corticosteroid therapy should only occur under close medical supervision. Candidiasis of the nose and pharynx has also been reported after intranasal beclomethasone use; monitor patients on long-term beclomethasone therapy for signs of infection. Discontinuation of beclomethasone may be required.

    Dysphonia (hoarseness) has been reported in 5-50% of patients in the general population receiving inhaled corticosteroids. It is thought to be due to dyskinesia of the muscles controlling vocal cord tension. Elimination of voice strain, rinsing of the mouth after inhaler use, and the use of a spacing device may hasten recovery, but in some cases, a temporary withdrawal of the corticosteroid is necessary.

    Beclomethasone can cause hypothalamic-pituitary-adrenal (HPA) suppression. Adrenal insufficiency and withdrawal symptoms may occur after treatment discontinuation or when transitioning from systemic corticosteroids to inhaled corticosteroids in some patients. The severity of glucocorticoid-induced secondary adrenocortical insufficiency varies among individuals and is dependent on the dose, frequency, time of administration, and duration of therapy. Adrenal suppression and increased intracranial pressure have been reported with the use and/or withdrawal of intranasal and orally inhaled steroids in pediatric patients. Symptoms of hypercorticism may occur with beclomethasone oral inhalation or nasal formulations if recommended doses are exceeded or if patients are particularly sensitive to the effects of beclomethasone. In an open-label clinical trial, < 1% of patients who had received inhaled beclomethasone had an abnormal response to the short-cosyntropin test. Manifestations of Cushing's syndrome and Cushingoid features have been observed during clinical practice with the use of inhaled and intranasal corticosteroids. In addition, data from a prospective study of asthmatic children and adolescents (n = 143) on orally inhaled corticosteroids reported HPA suppression in 65.1% of patients. Concomitant intranasal corticosteroid use and a forced expiratory volume (FEV1)/forced vital capacity (FVC) < 80% were linked to an increased incidence of adrenal suppression. If HPA suppression is noted, attempts to gradually withdraw the drug or transition to a less potent steroid should be made. Signs and symptoms of glucocorticoid insufficiency may require systemic corticosteroids; patients with HPA suppression will require increased doses of corticosteroid therapy during periods of physiologic stress (e.g., trauma, surgery, infection).

    Orally inhaled or intranasal corticosteroids may cause growth inhibition in pediatric patients. Although data suggest that the effects on growth are small, the lowest effective dose of any corticosteroid dosage form should be utilized. In general, the benefits of regular inhaled corticosteroid (ICS) use outweigh the potential risk of relatively small and non-cumulative growth suppression in children with asthma; however, growth should be monitored. The National Asthma Education and Prevention Program Expert Panel warns that prolonged use (e.g., > 1 year) of high doses of ICS, especially when used in combination with frequent courses of systemic corticosteroids, may increase the risk of adverse growth effects. Growth inhibition has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients. Controlled clinical studies have shown that ICS may cause a mean reduction in growth velocity of approximately 1 centimeter (cm) per year (range: 0.3-1.8 cm/year) and that this reduction appears to depend on dose and duration of exposure. While not specifically addressing beclomethasone, the Childhood Asthma Management Program (CAMP) trial suggested that ICS use to control asthma in children may affect final adult height (median follow-up 7 years) by approximately 1 cm. Meta-analysis suggests regular use of low or medium daily dose ICS is associated with a mean reduction of 0.48 cm per year in linear growth velocity (14 trials, n = 5717; 95% CI -0.65 to -0.3, p < 0.0001) and a 0.61 cm change from baseline in height (15 trials, n = 3275; 95% CI -0.83 to -0.38, p < 0.00001) in children with mild to moderate asthma during a 1 year treatment period. Specifically, CFC-beclomethasone 400 mcg/day caused a mean reduction in growth velocity of 0.91 cm/year (3 trials, n = 439; 95% CI -1.26 to -0.55), which appears to be a greater reduction than those seen with other ICS; however, head-to-head comparisons are needed to directly assess the effects of different agents. Growth velocity reduction appears to be less pronounced subsequent to the first year of therapy and is not cumulative. In addition, a mean difference of -0.2 cm (n = 728; 95% CI 0.02-0.39) in growth velocity within the first year has been observed between low (50-100 mcg/day beclomethasone equivalent; 5.94 cm/year) and medium (200 mcg/day beclomethasone equivalent; 5.74 cm/year) dose ICS, indicating lower growth velocity in the those treated with higher dose ICS. Intranasal corticosteroids may also affect growth. In a controlled study in 100 children (age range: 6-9.5 years), approximately 50% of the children who used intranasal beclomethasone dipropionate (n = 51) to treat allergic rhinitis had growth velocity rates below the 10th-percentile, and a significantly lower growth velocity rate than children treated with placebo. The mean change in standing height after 1 year was 5 cm and 5.9 cm in the beclomethasone and placebo groups, respectively (p < 0.01). The long-term effects of this reduction in growth velocity, including the impact on final adult height, are unknown.

    Prolonged use (e.g., > 1 year) of high doses of inhaled corticosteroids, such as beclomethasone, especially when used in combination with frequent courses of systemic corticosteroids, may be associated with skeletal changes including reduced bone mineral density. This may in turn result in the development of osteopenia or osteoporosis. Because bone development is crucial during the pediatric period, bone health should be a primary concern for all patients receiving high-dose inhaled corticosteroids and/or frequent courses of systemic corticosteroids. Major risk factors for decreased bone mineral density include family history of osteoporosis, prolonged immobilization, tobacco use, malnutrition, and use of other chronic drugs that may reduce bone mass (e.g., anticonvulsants, oral corticosteroids). Caregivers of patients with risk factors should be counseled on age appropriate calcium and vitamin D intake. Adverse effects on bone may also occur with intranasal beclomethasone due to systemic absorption, particularly in susceptible patients or when used in high doses. Use of the lowest effective dose is recommended to minimize the occurrence of systemic adverse effects.

    Purpura or easy bruising has been associated with high dose inhaled corticosteroids in adult patients. In one survey of 202 adult patients receiving inhaled corticosteroids and 204 controls, easy bruising was reported twice as often in the group receiving inhaled corticosteroids (47% vs. 22%). The risk apparently increases with age, dose, and duration of inhaler use. The significance of these findings and the risk in children are unknown.

    Rare cases of immediate and delayed hypersensitivity and anaphylactoid reactions have been reported after oral and intranasal inhalation of beclomethasone. These reactions include angioedema, urticaria, rash (unspecified), and bronchospasm. If there is an immediate increase in wheezing after use, initiate treatment with a fast-acting inhaled bronchodilator immediately, discontinue corticosteroid inhalation therapy, and institute alternative therapy.

    Headache (<= 12%) and nausea (< 5%) occurred in patients receiving inhaled or intranasal beclomethasone in clinical trials. Other adverse events reported in clinical trials of inhaled beclomethasone include pain (2%), back pain (1%), and dysmenorrhea (1-3%). Lightheadedness was also reported in < 5% of patients receiving intranasal beclomethasone in clinical trials.

    During post-marketing experience with beclomethasone, psychiatric events and behavioral changes such as aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported; these effects were primarily reported in children.

    Use of beclomethasone does not contraindicate administration of live-virus vaccines. According to the Advisory Committee on Immunization Practices (ACIP), administration of live-virus vaccines is safe and effective when steroid therapy is administered by the inhalation route.

    Beclomethasone is contraindicated for use in anyone who is hypersensitive to the medication or any components of the products. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to beclomethasone should not receive any form of beclomethasone. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and after the administration of any corticosteroid.

    Inhaled beclomethasone is contraindicated in the primary treatment of patients with status asthmaticus or other types of acute bronchospasm for which intensive therapy is warranted. Advise patients that beclomethasone is not a bronchodilator and is not indicated for relief of acute bronchospasm. Quick-relief medications (e.g., short-acting beta agonists, anticholinergics, systemic corticosteroids) should be used to treat acute symptoms and exacerbations. Although inhaled corticosteroids (ICSs) should not be used as primary therapy, if the patient is already on a routine ICS for chronic control it is not necessary to discontinue its use during an exacerbation. ICS therapy can be initiated at any time regardless of oral corticosteroid dosing.

    As with other inhaled asthma medications, paradoxical bronchospasm can occur with an immediate increase in wheezing after administration of inhaled beclomethasone that may be life-threatening. If bronchospasm occurs after dosing, treat the patient immediately with a fast-acting inhaled bronchodilator, discontinue beclomethasone, and institute alternative therapy.

    Systemic absorption of inhaled or intranasal beclomethasone may result in varying complications depending on the clinical situation and type of administration. Carefully observe patients for evidence of systemic corticosteroid effects and adrenal insufficiency, particularly during periods of physiologic stress (e.g., trauma, surgery, infection). Systemic absorption of inhaled or intranasal corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients; use with caution in patient's with underlying Cushing's syndrome. Pediatric patients may be more susceptible to developing systemic toxicity; adrenal suppression and increased intracranial pressure have been reported with the use and/or withdrawal of intranasal and orally inhaled corticosteroids in young patients. To minimize the risk of HPA dysfunction, do not exceed recommended dosages and titrate patients to the lowest effective dosage. If signs of HPA suppression occur, the drug should be slowly reduced; intranasal corticosteroids should be ultimately discontinued. If HPA suppression occurs with any beclomethasone formulation, patients will require systemic corticosteroids during periods of physiologic stress. If surgery is required, patients should notify all health care providers that they have received corticosteroids within the last 12 months. Use beclomethasone with caution when substituting it for systemic corticosteroid administration and avoid abrupt discontinuation; deaths due to adrenal insufficiency have been reported in asthma patients during and after such a change. Beclomethasone may not produce systemic concentrations high enough to avoid adrenocortical insufficiency in patients transitioning from systemic corticosteroids. Adult patients who have been maintained on at least 20 mg of prednisone equivalent may be most susceptible; the precise dosage that increases risk in children is not as clearly defined. Recommended doses of inhaled corticosteroids (ICSs) provide less than normal physiologic amounts of systemic glucocorticoid and do not provide the mineralocorticoid necessary for coping with stress. Patients receiving ICS may require initiation or resumption of systemic corticosteroids during periods of stress or during severe asthma attacks. When transferring patients to ICS therapy, systemic corticosteroids should be weaned slowly. Monitor patients closely for asthma control (e.g., lung function, beta-agonist use, asthma symptoms) as well as signs and symptoms of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, and hypotension). Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children with asthma should be appropriately monitored. Concomitant intranasal corticosteroid use and a forced expiratory volume (FEV1)/forced vital capacity (FVC) less than 80% has been linked to an increased incidence of HPA suppression in pediatric asthma patients on ICS therapy. Patients with poor adherence to corticosteroid therapy had a negative risk. There also may be an increased risk of HPA suppression in patients with low body mass index (BMI); some experts recommend adrenal screening in this population.

    Systemic absorption of inhaled corticosteroids has produced reversible hyperglycemia and glucosuria in some patients. Inhaled and intranasal corticosteroids should generally be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with significant systemic absorption of the inhaled corticosteroid.

    Nasal septal perforation and ulceration have been reported with intranasal beclomethasone use. As with any long-term topical treatment of the nasal cavity, patients using intranasal beclomethasone over several months or longer should be examined periodically for possible changes in the nasal mucosa. Furthermore, because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal perforation or ulcer, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

    The incidence or course of acute viral or bacterial infection is probably minimally affected by inhaled corticosteroids in most immunocompetent individuals. However, the use of inhaled beclomethasone in the presence of infection, specifically active or latent tuberculosis of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infection (e.g., herpes infection, measles, or varicella); or ocular herpes infection should be initiated or continued cautiously, if at all. Because of the potential for worsening infection, beclomethasone therapy may need to be interrupted during some active infections. Chickenpox and measles can have a more serious or even fatal course in susceptible children using corticosteroids; the exact risk associated with inhaled beclomethasone is unclear. If an unimmunized patient is exposed to chickenpox or measles, proper prophylaxis may be indicated. Corticosteroid therapy can reactivate tuberculosis and should not be used except when chemoprophylaxis is instituted concomitantly. The use of nasal or orally inhaled beclomethasone may result in localized fungal infection of the nose, mouth, and pharynx with Candida albicans. Instruct patients to rinse mouth after each use of orally inhaled beclomethasone to minimize risk. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic antifungal therapy while still continuing beclomethasone therapy; temporary interruption of inhaler use should only be done under close medical supervision. Patients using beclomethasone nasal spray for extended periods (i.e., months) should be examined periodically for evidence of infection or other adverse effects on the nasal mucosa.

    Detrimental effects on bone metabolism are expected to be much lower with inhaled corticosteroids compared to systemically-administered corticosteroids. However, some data suggest that high-dose inhaled steroids may also decrease bone formation and increase resorption, and decreases in bone mineral density have been reported in patients receiving long-term therapy of inhaled corticosteroids. Because bone development is critical in pediatric patients, monitoring is warranted in patients receiving high-doses or chronic corticosteroid treatment, particularly patients with major risk factors for decreased bone mineral content (e.g., preexisting osteopenia, prolonged immobilization, family history of osteoporosis, tobacco smoking, malnutrition, and use of other medications that may reduce bone mass). Adverse effects on bone may also occur with intranasal beclomethasone due to systemic absorption, particularly in susceptible patients or when used in high doses. Use of the lowest effective dose is recommended to minimize the occurrence of systemic adverse effects.

    Monitor patients with a history of increased intraocular pressure, glaucoma, cataracts, or any other visual disturbance closely during corticosteroid therapy. Glaucoma and/or cataracts have occurred during use of nasal and inhaled corticosteroids. To minimize adverse ophthalmic effects related to drug administration, remind patients to avoid unintended ocular exposure by actuating the medication properly. Consider referral to an ophthalmologist in patients who develop ocular symptoms or who use beclomethasone long term.

    Use beclomethasone with caution in patients with psychosis. During post-marketing experience, psychiatric events and behavioral changes such as aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported; these effects were primarily reported in children.

    Use inhaled and intranasal beclomethasone cautiously in patients with severe hepatic disease as the drug is primarily eliminated by the liver. Adverse effects may be more pronounced in this population.

    In utero exposure to corticosteroids may result in hypoadrenalism. Monitor neonates of mothers receiving corticosteroids during pregnancy carefully.

    Orally inhaled or intranasal corticosteroids may cause growth inhibition in pediatric patients. Although data suggest that the effects on growth are small, the lowest effective dose of any corticosteroid dosage form should be utilized and growth should be routinely monitored during use. In general, the benefits of regular inhaled corticosteroid (ICS) use outweigh the potential risk of relatively small and non-cumulative growth suppression in children with asthma. The National Asthma Education and Prevention Program Expert Panel warns that prolonged use (e.g., more than 1 year) of high doses of ICS, especially when used in combination with frequent courses of systemic corticosteroids, may increase the risk of adverse growth effects. Growth inhibition has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients. Controlled clinical studies have shown that ICS may cause a mean reduction in growth velocity of approximately 1 centimeter (cm) per year (range: 0.3 to 1.8 cm/year) and that this reduction appears to depend on dose and duration of exposure. While not specifically addressing beclomethasone, the Childhood Asthma Management Program (CAMP) trial suggested that ICS use to control asthma in children may affect final adult height (median follow-up 7 years) by approximately 1 cm. Meta-analysis suggests regular use of low or medium daily dose ICS is associated with a mean reduction of 0.48 cm per year in linear growth velocity (14 trials, n = 5,717; 95% CI -0.65 to -0.3, p is less than 0.0001) and a 0.61 cm change from baseline in height (15 trials, n = 3,275; 95% CI -0.83 to -0.38, p is less than 0.00001) in children with mild to moderate asthma during a 1 year treatment period. Specifically, CFC-beclomethasone 400 mcg/day caused a mean reduction in growth velocity of 0.91 cm/year (3 trials, n = 439; 95% CI -1.26 to -0.55), which appears to be a greater reduction than those seen with other ICS; however, head-to-head comparisons are needed to directly assess the effects of different agents. Growth velocity reduction appears to be less pronounced subsequent to the first year of therapy and is not cumulative. In addition, a mean difference of -0.2 cm (n = 728; 95% CI 0.02 to 0.39) in growth velocity within the first year has been observed between low (50 to 100 mcg/day beclomethasone equivalent; 5.94 cm/year) and medium (200 mcg/day beclomethasone equivalent; 5.74 cm/year) dose ICS, indicating lower growth velocity in the those treated with higher dose ICS. Intranasal corticosteroids may also affect growth. In a controlled study in 100 children (age range: 6 to 9.5 years), approximately 50% of the children who used intranasal beclomethasone dipropionate (n = 51) to treat allergic rhinitis had growth velocity rates below the 10th-percentile, and a significantly lower growth velocity rate than children treated with placebo. The mean change in standing height after 1 year was 5 cm and 5.9 cm in the beclomethasone and placebo groups, respectively (p is less than 0.01). The long-term effects of this reduction in growth velocity, including the impact on final adult height, are unknown.

    Description: Beclomethasone is a synthetic halogenated inhaled glucocorticoid. It is used for treating steroid-dependent asthma, for relieving symptoms associated with allergic or nonallergic (vasomotor) rhinitis, and for preventing recurrent nasal polyps after surgical removal. In vitro data have shown that beclomethasone-17-monopropionate displays a binding affinity for the glucocorticoid receptor that is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide, and 25 times that of beclomethasone dipropionate. Asthma guidelines consider orally inhaled corticosteroids (ICSs) to be the preferred pharmacologic treatment in the long-term management of persistent asthma. Superior potency and efficacy of ICSs have been demonstrated over other long-term control medications including leukotriene receptor antagonists, cromolyn, and theophylline. Lung delivery with beclomethasone is among the highest for ICSs; however, systemic bioavailability is also higher which may lead to an increased risk of systemic adverse reactions. Qvar inhalation aerosol is FDA-approved for use in pediatric patients 5 years and older. Qvar Redihaler inhalation aerosol is FDA-approved for use in pediatric patients 4 years and older. The nasal spray (Beconase AQ) is FDA-approved for pediatric patients 6 years and older and the nasal aerosol (Qnasl) is FDA-approved for pediatric patients 4 years and older.

    For the maintenance treatment of asthma:
    Oral inhalation dosage (Qvar or Qvar Double Strength metered dose inhalers):
    Children 5 years: Initially, 40 mcg via oral inhalation twice daily, regardless of prior treatment. May titrate after 3 to 4 weeks if patient response not adequate to a maximum dose of 80 mcg inhaled twice daily. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 160 mcg/day, medium dose as 161 to 320 mcg/day, and high dose therapy as more than 320 mcg/day for children ages 5 to 11 years. The Global Initiative for Asthma guidelines define low dose therapy as 100 mcg/day in children 5 years and younger. Titrate to the lowest effective dose once asthma stability is achieved. Prolonged use of high doses (i.e., more than 320 mcg/day) may be associated with additional adverse effects.
    Children 6 to 11 years: Initially, 40 mcg via oral inhalation twice daily, regardless of prior treatment. May titrate after 3 to 4 weeks if patient response not adequate to a maximum dose of 80 mcg inhaled twice daily. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 160 mcg/day, medium dose as 161 to 320 mcg/day, and high dose therapy as more than 320 mcg/day for children ages 5 to 11 years. The Global Initiative for Asthma guidelines define low dose therapy as 50 to 100 mcg/day, medium dose as 101 to 200 mcg/day, and high dose therapy as more than 200 mcg/day. Titrate to the lowest effective dose once asthma stability is achieved. Prolonged use of high doses (i.e., more than 320 mcg/day) may be associated with additional adverse effects.
    Children and Adolescents 12 years and older previously treated with bronchodilators alone: Initially, 40 to 80 mcg via oral inhalation twice daily. May titrate after 3 to 4 weeks if patient response not adequate to a maximum dose of 320 mcg inhaled twice daily. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 240 mcg/day, medium dose as 241 to 480 mcg/day, and high dose therapy as more than 480 mcg/day for children 12 years and older. The Global Initiative for Asthma guidelines define low dose therapy as 100 to 200 mcg/day, medium dose as 201 to 400 mcg/day, and high dose therapy as more than 400 mcg/day. Titrate to the lowest effective dose once asthma stability is achieved. Prolonged use of high doses (i.e., more than 480 mcg/day) may be associated with additional adverse effects.
    Children and Adolescents 12 years and older previously treated with other inhaled corticosteroids: Initially, 40 to 160 mcg via oral inhalation twice daily. May titrate after 3 to 4 weeks if patient response not adequate to a maximum dose of 320 mcg inhaled twice daily. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 240 mcg/day, medium dose as 241 to 480 mcg/day, and high dose therapy as more than 480 mcg/day for children 12 years and older. The Global Initiative for Asthma guidelines define low dose therapy as 100 to 200 mcg/day, medium dose as 201 to 400 mcg/day, and high dose therapy as more than 400 mcg/day. Titrate to the lowest effective dose once asthma stability is achieved. Prolonged use of high doses (i.e., more than 480 mcg/day) may be associated with additional adverse effects.
    Oral inhalation dosage (Qvar Redihaler metered dose inhaler):
    Children 4 to 5 years: 40 mcg inhaled twice daily, approximately 12 hours apart, is the recommended starting dose. For patients who do not respond adequately to 40 mcg after 2 weeks of therapy, increasing the dosage to 80 mcg twice daily may provide additional asthma control. The maximum recommended dosage is 80 mcg twice daily. The starting dosage is based on the severity of asthma, including consideration of the patients' current control of asthma symptoms and risk of future exacerbation. 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. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 160 mcg/day, medium dose as 161 to 320 mcg/day, and high dose therapy as more than 320 mcg/day for children ages 5 to 11 years. The Global Initiative for Asthma (GINA) guidelines define low dose therapy as 100 mcg/day in this age group. Titrate to the lowest effective dose once asthma stability is achieved.
    Children 6 to 11 years: 40 mcg inhaled twice daily, approximately 12 hours apart, is the recommended starting dose. For patients who do not respond adequately to 40 mcg after 2 weeks of therapy, increasing the dosage to 80 mcg twice daily may provide additional asthma control. The maximum recommended dosage is 80 mcg twice daily. The starting dosage is based on the severity of asthma, including consideration of the patients' current control of asthma symptoms and risk of future exacerbation. 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. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 160 mcg/day, medium dose as 161 to 320 mcg/day, and high dose therapy as more than 320 mcg/day for children ages 5 to 11 years. The Global Initiative for Asthma guidelines define low dose therapy as 50 to 100 mcg/day, medium dose as 101 to 200 mcg/day, and high dose therapy as more than 200 mcg/day. Titrate to the lowest effective dose once asthma stability is achieved.
    Children and Adolescents 12 years and older not previously treated with an inhaled corticosteroid: 40 to 80 mcg inhaled twice daily, approximately 12 hours apart, is the recommended starting dose. 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 is 320 mcg twice daily. The starting dosage is based on the severity of asthma, including consideration of the patients' current control of asthma symptoms and risk of future exacerbation. 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. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 240 mcg/day, medium dose as 241 to 480 mcg/day, and high dose therapy as more than 480 mcg/day for children 12 years and older. The Global Initiative for Asthma guidelines define low dose therapy as 100 to 200 mcg/day, medium dose as 201 to 400 mcg/day, and high dose therapy as more than 400 mcg/day. Titrate to the lowest effective dose once asthma stability is achieved.
    Children and Adolescents 12 years and older previously treated with other inhaled corticosteroids: The starting dosage is based on previous asthma therapy and asthma severity, including consideration of the current control of asthma symptoms and risk of future exacerbation: 40, 80, 160, or 320 mcg inhaled 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 is 320 mcg twice daily. 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. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy as 80 to 240 mcg/day, medium dose as 241 to 480 mcg/day, and high dose therapy as more than 480 mcg/day for children 12 years and older. The Global Initiative for Asthma guidelines define low dose therapy as 100 to 200 mcg/day, medium dose as 201 to 400 mcg/day, and high dose therapy as more than 400 mcg/day. Titrate to the lowest effective dose once asthma stability is achieved.

    For exercise-induced bronchospasm prophylaxis*:
    Oral inhalation dosage:
    Children 5 years and older and Adolescents: Optimal dosing is not well established; use of typical initial daily doses for asthma may be considered. American Thoracic Society guidelines recommend daily administration of an inhaled corticosteroid (ICS) in patients with exercise-induced bronchospasm (EIB) who continue to have symptoms despite use of an inhaled short-acting beta-agonist (SABA) before exercise and in those who develop SABA tolerance due to regular (e.g., daily) use. ICSs are considered the most effective anti-inflammatory agents for EIB; they are preferred controller agents in patients with below normal baseline lung function and/or asthma. Use of an ICS as an 'as needed' treatment, only before exercise is NOT recommended. Beclomethasone doses of 50 mcg and 100 mcg daily were evaluated in a randomized, double-blind, crossover study in 25 children with asthma ages 5 to 14 years. The maximum fall in FEV1 after exercise was significantly less with active drug compared to placebo for both treatment regimens; no differences were observed between the 2 active doses.

    For the management of symptoms of seasonal allergies or perennial allergies, including allergic rhinitis:
    Nasal dosage (nasal spray [suspension]; e.g., Beconase AQ):
    Children 6 to 11 years: Initially, 1 spray (42 mcg/spray) into each nostril twice per day. Patients not responding or those with more severe symptoms may use 2 sprays into each nostril twice per day. Once symptoms are controlled, the dose should be decreased to 1 spray into each nostril twice per day. If no improvement is seen after 3 weeks of continuous administration, discontinue use.
    Children and Adolescents 12 years and older: 1 to 2 sprays (42 mcg/spray) into each nostril twice per day is the usual dosage. If no improvement is seen after 3 weeks of continuous administration, discontinue use.
    Nasal dosage (nasal aerosol; e.g., QNASL):
    Children 4 to 11 years: 1 spray using the 40 mcg/spray formulation into each nostril once daily. Max: 80 mcg/day. In a randomized, placebo-controlled study of children 6 to 11 years with seasonal allergic rhinitis (n = 713), 80 to 160 mcg/day administered as 1 spray (40 or 80 mcg/spray) into each nostril once daily resulted in significant improvements in nasal symptoms, with a safety profile similar to that of placebo.
    Children and Adolescents 12 years and older: 2 sprays using the 80 mcg/spray formulation into each nostril once daily. Max: 320 mcg/day.

    For relief of vasomotor rhinitis (nonallergic rhinitis):
    Intranasal dosage (nasal spray [suspension]; e.g., Beconase AQ):
    Children 6 to 11 years: Initially, 1 spray (42 mcg/spray) into each nostril twice per day. Patients not responding or those with more severe symptoms may use 2 sprays into each nostril twice per day. Once symptoms are controlled, the dose should be decreased to 1 spray into each nostril twice per day. If no improvement is seen after 3 weeks of continuous administration, discontinue use.
    Children and Adolescents 12 years and older: 1 to 2 sprays (42 mcg/spray) into each nostril twice per day is the usual dosage. If no improvement is seen after 3 weeks of continuous administration, discontinue use.

    For the prevention of recurrence of nasal polyps after surgical removal:
    Intranasal dosage (nasal spray [suspension]; e.g., Beconase AQ):
    Children 6 to 11 years: Initially, 1 spray (42 mcg/spray) into each nostril twice per day; the dosage may be increased to 2 sprays into each nostril twice per day if needed.
    Children and Adolescents 12 years and older: 1 to 2 sprays (42 mcg/spray) into each nostril twice per day is the usual dose.

    Maximum Dosage Limits:
    -Neonates
    Safety and efficacy have not been established.
    -Infants
    Safety and efficacy have not been established.
    -Children
    younger than 4 years: Safety and efficacy have not been established.
    4 to 5 years: 160 mcg/day via oral inhalation (Qvar Redihaler); 80 mcg/day intranasal aerosol (Qnasl).
    6 to 11 years: 160 mcg/day via oral inhalation (Qvar and Qvar Redihaler); 336 mcg/day intranasal spray (Beconase AQ); 80 mcg/day intranasal aerosol (Qnasl).
    12 years: 640 mcg/day via oral inhalation (Qvar and Qvar Redihaler); 336 mcg/day intranasal spray (Beconase AQ); 320 mcg/day intranasal aerosol (Qnasl).
    -Adolescents
    640 mcg/day via oral inhalation (Qvar and Qvar Redihaler); 336 mcg/day intranasal spray (Beconase AQ); 320 mcg/day intranasal aerosol (Qnasl).

    Patients with Hepatic Impairment Dosing
    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing
    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    *non-FDA-approved indication

    Monograph content under development

    Mechanism of Action: Beclomethasone is a corticosteroid that exhibits anti-inflammatory, antipruritic, vasoconstrictive effects as well as limiting allergic responses. The specific mechanisms of action depend on the route of administration and condition being treated.

    Treatment of asthma:
    Clinical effects in asthma include a reduction in bronchial hyperresponsiveness to allergens, a decreased number of asthma exacerbations, and an improvement in FEV1, peak-flow rate, and respiratory symptoms. Because corticosteroid effects take several hours to days to become clinically noticeable, they are ineffective for primary treatment of severe acute bronchospastic attacks or for status asthmaticus. Inhaled corticosteroids have no bronchodilatory properties. In the treatment of asthma, orally inhaled corticosteroids block the late phase allergic response to allergens. Mediators involved in the pathogenesis of asthma include histamine, leukotrienes (slow releasing substance of anaphylaxis, SRS-A), eosinophil chemotactic factor of anaphylaxis (ECF-A), neutrophil chemotactic factor (NCF), cytokines, hydroxyeicosatetraenoic acids, prostaglandin-generating factor of anaphylaxis (PGF-A), prostaglandins, major basic protein, bradykinin, adenosine, peroxides, and superoxide anions. Different cell types are responsible for release of these mediators including airway epithelium, eosinophils, basophils, lung parenchyma, lymphocytes, macrophages, mast cells, neutrophils, and platelets. Corticosteroids inhibit the release of these mediators, attenuate mucous secretion and eicosanoid generation, up-regulate beta-receptors, promote vasoconstriction, and suppress inflammatory cell influx and inflammatory processes.

    Treatment of allergies:
    Intranasal beclomethasone inhibits the activity of several cell types (e.g., mast cells and eosinophils) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the allergic response. Clinically, symptoms such as rhinorrhea and postnasal drip, nasal congestion, sneezing, and pharyngeal itching are reduced.

    Pharmacokinetics: Beclomethasone is administered by oral or nasal inhalation. It has a large Vd (approximately 84 L and 400 L for beclomethasone-17-monopropionate (17-BMP), the active metabolite, in older children and adults, respectively). Protein binding is approximately 94% to 96% over the concentration range of 1,000 to 5,000 pg/mL. The major route of elimination appears to be via metabolism. Three major metabolites of beclomethasone dipropionate are formed via hepatic cytochrome P450 3A-family catalyzed biotransformation: 17-BMP (the most active metabolite), beclomethasone-21-monopropionate (21-BMP), and beclomethasone (BOH). More than 90% of inhaled beclomethasone is found as 17-BMP in the systemic circulation. For the oral inhalation route, some metabolism occurs in the lungs before entering the systemic circulation; the lung tissues metabolize beclomethasone rapidly to 17-BMP and more slowly to BOH. The mean elimination half-life of 17-BMP is 2.8 hours. Irrespective of the route of administration, beclomethasone and its metabolites are excreted predominantly in the feces. Less than 10% of the drug and its metabolites are excreted in the urine.

    Affected cytochrome P450 isoenzymes: none
    Although beclomethasone is metabolized by the CYP3A family, clinically significant drug interactions related to CYP enzymes are not expected.


    -Route-Specific Pharmacokinetics
    Inhalation Route
    The approximate oral bioavailability of beclomethasone dipropionate in adults has been reported to be 20% to 26%; however, in children, a much higher oral bioavailability (around 65%) has been observed. Peak concentrations of 17-BMP are reached approximately 10 to 40 minutes after oral inhalation. The onset of action of the drug typically occurs within 24 hours, but full effects can take as long as 3 to 4 weeks to be apparent. The overall lung deposition of beclomethasone dipropionate HFA is approximately 50% to 60%, which is among the highest for inhaled corticosteroids. In terms of lipophilicity, beclomethasone ranks in the middle of the available inhaled corticosteroids.

    Other Route(s)
    Intranasal Route
    The systemic bioavailability of intranasal beclomethasone is approximately 44%. The swallowed portion accounts for almost all of the bioavailability (43%) with only 1% of a dose bioavailable from the nose.


    -Special Populations
    Pediatrics
    Children and Adolescents
    There are limited data regarding the pharmacokinetics of beclomethasone in pediatric patients. The pharmacokinetics of 17-BMP are comparable in children and adults, although the exposure is highly variable. In addition, the approximate oral bioavailability of beclomethasone dipropionate has been reported to be higher in children compared to adults (approximately 65% compared to about 20% to 26%). Clinical studies in children and adolescents have reported a mean elimination half-life of 2.1 to 2.7 hours for 17-BMP, which is similar to that seen in adults.

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