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brand qvar redihaler 80 mcg

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Uses

Asthma

Beclomethasone dipropionate is used by oral inhalation for the long-term prevention of bronchospasm in patients with asthma.

Beclomethasone dipropionate oral inhalation therapy should not be used in the treatment of nonasthmatic bronchitis. Oral inhalation of beclomethasone dipropionate is contraindicated in the primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required. Beclomethasone dipropionate oral inhaler is not a bronchodilator, and patients should be warned that the drug should not be used for rapid relief of bronchospasm. Beclomethasone dipropionate oral inhalation therapy is not effective for all patients with bronchial asthma (e.g., in patients with bronchorrhea or severe pulmonary obstruction when proper penetration of the drug into the lungs is prevented). In addition, the drug is not always effective at all stages of the disease in a particular patient.

Mild Persistent Asthma

Drugs for asthma may be categorized as relievers (e.g., bronchodilators taken as needed for acute symptoms) or controllers (principally inhaled corticosteroids or other anti-inflammatory agents taken regularly to achieve long-term control of asthma). In the stepped-care approach to antiasthmatic drug therapy, current asthma management guidelines and most clinicians recommend initiation of a controller drug such as an anti-inflammatory agent, preferably a low-dose orally inhaled corticosteroid (e.g., 88-264, 88-176, or 176 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler in adolescents and adults, children 5-11 years of age, or children 4 years of age or younger, respectively) as first-line therapy for persistent asthma (i.e., patients with daytime symptoms of asthma more than twice weekly, but less than once daily, and nocturnal symptoms of asthma 3-4 times per month), supplemented by as-needed use of a short-acting, inhaled β2-agonist. For equivalent orally inhaled dosages of corticosteroids,

Moderate Persistent Asthma

According to current asthma management guidelines, therapy with a long-acting inhaled β2-agonist such as salmeterol or formoterol generally is recommended in adults and adolescents who have moderate persistent asthma and daily asthmatic symptoms that are inadequately controlled following addition of low-dose inhaled corticosteroids to as-needed inhaled β2-agonist treatment. However, the National Asthma Education and Prevention Program (NAEPP) recommends that the beneficial effects of long-acting inhaled β2-agonists should be weighed carefully against the increased risk (although uncommon) of severe asthma exacerbations and asthma-related deaths associated with daily use of such agents. Current asthma management guidelines also state that an alternative, but equally preferred option for management of moderate persistent asthma that is not adequately controlled with a low dosage of inhaled corticosteroid is to increase the maintenance dosage to a medium dosage (e.g., exceeding 264 but not more than 440 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler in adults and adolescents).

In children 5-11 years of age with moderate persistent asthma that is not controlled with a low dosage of an inhaled corticosteroid, a long-acting inhaled β2-agonist (e.g., salmeterol, formoterol), a leukotriene modifier (i.e., montelukast, zafirlukast), or extended-release theophylline (with appropriate monitoring) may be added to low-dose inhaled corticosteroid therapy according to current asthma management guidelines; another preferred option is to increase the maintenance dosage of the inhaled corticosteroid to a medium dosage (e.g., exceeding 176 but not more than 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler). In infants and children 4 years of age or younger with moderate persistent asthma that is not controlled by a low dosage of an inhaled corticosteroid, the only preferred option is to increase the maintenance dosage of the inhaled corticosteroid to a medium dosage (e.g., exceeding 176 but not more than 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler).

Severe Persistent Asthma

Maintenance therapy with an inhaled corticosteroid at medium or high dosages (e.g., exceeding 440 mcg of fluticasone propionate in adults and adolescents or 352 mcg of the drug in children 5-11 years of age [or its equivalent] daily via a metered-dose inhaler) and adjunctive therapy with a long-acting inhaled β2-agonist is the preferred treatment according to current asthma management guidelines for patients 5 years of age or older with severe persistent asthma (i.e., continuous daytime asthma symptoms, nighttime symptoms 7 times per week). In infants and children 4 years of age or younger with severe asthma, maintenance therapy with an inhaled corticosteroid at medium or high dosages (e.g., exceeding 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler) and adjunctive therapy with either a long-acting inhaled β2-agonist or montelukast is recommended in current asthma management guidelines as the only preferred treatment.

Poorly Controlled Asthma

If asthma symptoms in patients with moderate to severe asthma are very poorly controlled (i.e., at least 2-3 exacerbations per year requiring oral corticosteroids), a short course (3-10 days) of an oral corticosteroid may be added to gain prompt control of asthma. Regular use of oral corticosteroids as add-on therapy in adults and children 5 years of age or older with severe asthma who are inadequately controlled with high-dose inhaled corticosteroid, intermittent oral corticosteroid therapy, and a long-acting inhaled β2-agonist bronchodilator is suggested, based on consensus and clinical experience. A short course (2 weeks) of oral corticosteroids may be considered to confirm clinical response prior to implementing long-term therapy with these agents. Once long-term oral corticosteroid therapy is initiated, the lowest possible effective dosage (i.e., alternate-day or once-daily administration) should be used, and the patient should be monitored carefully for adverse effects. Once asthma is well controlled, repeated attempts should be made to reduce the oral corticosteroid dosage. Use of orally inhaled beclomethasone dipropionate as adjunctive therapy in patients who require chronic administration of systemic corticosteroids to control asthma symptoms may permit a reduction in dosage or discontinuance of systemic corticosteroids. For additional details on the stepped-care approach to drug therapy in asthma, and

Clinical Experience with Beclomethasone Dipropionate

Well-controlled clinical studies have shown that oral inhalation of beclomethasone dipropionate relieves symptoms of bronchial asthma (cough, dyspnea, wheezing) and improves lung function (e.g., forced expiratory volume in 1 second [FEV1]) in most adults and children. Although some improvement may occur shortly after therapy is initiated, optimum symptomatic relief may require 1-4 weeks of continuous beclomethasone dipropionate oral inhalation therapy in patients who have not previously received systemic corticosteroid therapy. In corticosteroid-dependent asthmatic patients being switched to beclomethasone dipropionate oral inhalation therapy, withdrawal of systemic corticosteroid therapy and management of asthma with orally inhaled beclomethasone dipropionate may be delayed, since recovery from hypothalamic-pituitary-adrenal (HPA) axis suppression occurs slowly. Clinical studies have shown that therapy with orally inhaled beclomethasone dipropionate may allow eventual dosage reduction or total replacement of systemic corticosteroid therapy.

When beclomethasone dipropionate is administered by oral inhalation, the principal sites of action are the bronchi and bronchioles. Limited data suggest that substantially more drug is deposited into the airways of the lung and less reaches the oropharynx with beclomethasone dipropionate inhalation aerosols containing tetrafluoroethane (HFA-134a, a non-chlorofluorocarbon [CFC] propellant) (QVAR) than with inhalation aerosols containing CFC propellant (e.g., Beclovent, Vanceril, Vanceril Double Strength; all no longer commercially available in the US). In clinical studies of 6 weeks' to 12 months' duration, treatment with beclomethasone dipropionate with non-CFC propellant, administered at approximately half the daily dosage of beclomethasone dipropionate with CFC propellant, was associated with similar efficacy (i.e., control of moderate or moderately severe asthma) and safety; however, a definitive comparative therapeutic ratio has not been demonstrated to date. Unlike dexamethasone sodium phosphate, beclomethasone dipropionate appears to have higher topical anti-inflammatory activity with fewer adverse systemic effects following oral inhalation; however, no direct comparison of the adverse effects of these drugs has been performed.

Concomitant Therapy

In corticosteroid-dependent patients, use of beclomethasone dipropionate oral inhalation therapy usually permits a substantial reduction in the daily maintenance dosage of the systemic corticosteroid, conversion from daily to alternate-day corticosteroid therapy, or gradual discontinuance of corticosteroid maintenance dosages.(See Cautions: Hypothalamic-Pituitary-Adrenal Axis Suppression.)

In the management of asthma, the need for single- vs multiple-drug therapy must be determined on an individual basis. Beclomethasone dipropionate oral inhalation therapy has been administered to patients receiving bronchodilator and/or cromolyn sodium therapy. In a well-controlled study in corticosteroid-dependent asthmatic patients receiving either orally inhaled beclomethasone dipropionate or alternate-day prednisone, the addition of theophylline to either regimen at dosages that maintained therapeutic serum theophylline concentrations resulted in greater symptomatic relief and improved pulmonary function compared with therapy that did not include theophylline. In several controlled studies in asthmatic patients, concurrent therapy with orally inhaled beclomethasone dipropionate and cromolyn sodium did not provide a clinical advantage over beclomethasone dipropionate therapy alone; however, in an uncontrolled study, symptomatic relief of bronchial asthma was greater during concurrent therapy with orally inhaled beclomethasone dipropionate and cromolyn sodium than with either drug alone.

Other Uses

The efficacy of orally inhaled beclomethasone dipropionate in the management of patients with chronic obstructive pulmonary disease (e.g., bronchitis) who are stabilized with oral corticosteroids or whose disease is corticosteroid responsive remains to be fully evaluated. Limited data suggest that orally inhaled beclomethasone dipropionate may be useful in some patients with chronic obstructive pulmonary disease, but is probably not an adequate substitute for oral corticosteroid therapy in patients with steroid-responsive disease. Whether orally inhaled beclomethasone can maintain improvement in pulmonary function initially produced by oral corticosteroid therapy has not been established.

Beclomethasone dipropionate has been used as an oral solution or rectal suspension in the management of inflammatory diseases of the GI tract. In a group of patients with inflammatory bowel disease, treatment with enemas containing beclomethasone dipropionate resulted in symptomatic improvement without producing adverse systemic effects. In a patient with eosinophilic gastroenteritis, administration of an oral solution of beclomethasone dipropionate improved intestinal absorptive function. The role of beclomethasone dipropionate in the management of inflammatory conditions of the GI tract remains to be established.

For other uses of beclomethasone dipropionate,

Dosage and Administration

Administration

Beclomethasone dipropionate is administered by oral inhalation using an oral aerosol inhaler. Patients should be carefully instructed in the use of the oral inhaler. To obtain optimum results, patients should also be given a copy of the patient instructions provided by the manufacturer. An adult should carefully supervise a child in the administration of beclomethasone dipropionate for oral inhalation.The manufacturer states that beclomethasone dipropionate oral inhaler should be used by oral inhalation only. The manufacturer states that the regular- (40 mcg/metered dose) and double-strength inhalation aerosols with tetrafluoroethane (non-CFC) propellant (QVAR) should be tested by spraying twice into the air before using the device for the first time or whenever the aerosol has not been used for more than 10 days.

Because the commercially available beclomethasone dipropionate oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR) is formulated as a solution, it is not necessary to shake the inhaler prior to use. After exhaling as fully as is comfortable, the mouthpiece of the inhaler should be placed well into the mouth and the lips closed firmly around it, keeping the tongue below the mouthpiece. The patient should then inhale slowly and deeply through the mouth while pressing the metal canister down with the forefinger. After holding the breath for as long as possible (about 5-10 seconds), the mouthpiece should be removed and the patient should exhale gently. If additional inhalations are required, the patient should repeat the procedure. Following each treatment, the patient should rinse the mouth thoroughly with water to remove drug deposited in the oropharyngeal area. The patient instructions provided by the manufacturer should be referred to for further information regarding use of beclomethasone dipropionate for oral inhalation.

Weekly cleansing of the mouthpiece of the beclomethasone dipropionate oral inhaler is recommended. The mouthpiece should be cleaned using a clean, dry tissue or cloth. The patient should be instructed not to wash or place any part of the inhaler canister in water.

According to the manufacturer of beclomethasone dipropionate inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR), lung deposition does not differ when the drug is administered with or without a spacer device, and administration with a spacer device is not necessary. However, the manufacturer states that the QVAR inhaler is compatible with the AeroChamber spacer device, which may be used if preferred by the clinician or patient.

Dosage

The commercially available 7.3-g regular- or double-strength oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR) delivers about 40 or 80 mcg of beclomethasone dipropionate per metered spray and provides 100 metered sprays. Dosage of orally inhaled beclomethasone dipropionate must be carefully adjusted according to individual requirements and response.

The recommended dosage of orally inhaled beclomethasone dipropionate administered via metered-dose aerosol with tetrafluoroethane (non-CFC) propellant (QVAR is lower than that with inhalation aerosols containing CFC propellant (e.g., Beclovent, Vanceril, Vanceril Double Strength; all no longer commercially available in the US), although a definitive comparative therapeutic ratio between non-CFC and CFC-containing beclomethasone preparations has not been demonstrated. The usual initial dosage of beclomethasone dipropionate oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR) for adults and children 12 years of age or older in whom previous asthma therapy consisted of bronchodilators alone is 40 or 80 mcg twice daily. The usual initial dosage of the drug for adults and children 12 years of age or older in whom previous asthma therapy consisted of inhaled corticosteroids is 40-160 mcg twice daily. In children 5-11 years of age in whom previous asthma therapy consisted of bronchodilators alone or inhaled corticosteroids, the usual initial dosage of the drug is 40 mcg twice daily. After a satisfactory response is obtained, dosage should be decreased gradually to the lowest dosage that maintains an adequate clinical response, particularly in children, since inhaled corticosteroids have the potential to affect growth.(See Cautions: Pediatric Precautions.) The manufacturer of QVAR states that the safety and efficacy of dosages exceeding 320 mcg twice daily in adults and children 12 years of age or older or 80 mcg twice daily in children 5-11 years of age have not been established.

Patients who respond to beclomethasone dipropionate oral inhalation usually show improvement in pulmonary function within 1-4 weeks of continuous therapy.

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

When orally inhaled beclomethasone dipropionate is administered to patients receiving systemic corticosteroids, the patient's asthma should be reasonably stable before treatment with the oral inhalation begins. Initially, the aerosol is given concurrently with the maintenance dosage of the systemic corticosteroid. After about 1 week, gradual withdrawal of the systemic corticosteroid is begun.Gradual withdrawal of systemic corticosteroids following long-term therapy is strongly recommended, since death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.(See Cautions: Hypothalamic-Pituitary-Adrenal Axis Suppression.) After systemic corticosteroids have been withdrawn, if exacerbations of asthma occur during beclomethasone dipropionate oral inhalation therapy, short courses of systemic corticosteroids should be given, then tapered as symptoms subside.

Cautions

Hypothalamic-Pituitary-Adrenal Axis Suppression

Suppression of hypothalamic-pituitary-adrenal (HPA) axis function below the clinical normal range was not observed with beclomethasone dipropionate inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR) at dosages up to 640 mcg daily during clinical trials; however, a dose-dependent reduction in adrenal cortisol production was detected. In a comparative study, corticosteroid-naive patients receiving beclomethasone dipropionate inhalation aerosol with tetrafluoroethane (non-CFC) propellant (320 mcg twice daily) or the drug formulated with CFC propellant (336 mcg twice daily; preparation no longer commercially available in the US) experienced a reduction in 24-hour urinary free cortisol concentrations of approximately 37 or 47%, respectively. In an open-label study of 354 patients receiving beclomethasone oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant at recommended dosages for 1 year, less than 1% had an abnormal response to rapid corticotropin (ACTH) stimulation tests. Mean changes from baseline in morning plasma cortisol concentrations were similar in patients receiving beclomethasone dipropionate inhalation aerosol with tetrafluoroethane (non-CFC) propellant (exceeding 320-640 mcg daily) or CFC propellant (exceeding 420-840 mcg daily; preparation no longer commercially available in the US) after 12 months of treatment and were not considered clinically meaningful.

Reductions in plasma cortisol concentrations did not occur in adults when beclomethasone dipropionate was administered by IM injection at dosages of 1000 mcg daily for 3 days. Partial suppression of adrenal function has been observed when beclomethasone dipropionate was administered by IM injection at dosages of 2000 mcg daily. Following IM administration of single 4000-mcg doses of beclomethasone dipropionate, immediate adrenal suppression has been observed.

Concurrent administration of a systemic and orally inhaled corticosteroid may increase the risk of HPA-axis suppression. Following concurrent therapy with alternate-day prednisone and orally inhaled beclomethasone dipropionate in a group of asthmatic children, reductions in plasma cortisol concentrations were greater than those produced by therapeutic dosages of either drug alone; however, studies have not been performed to date comparing the systemic effects of alternate-day systemic corticosteroid therapy alone with therapeutically equivalent doses of orally inhaled beclomethasone dipropionate. Reductions in plasma cortisol concentrations have occurred when intranasal and orally inhaled beclomethasone dipropionate were used concomitantly.

Because beclomethasone dipropionate is absorbed into circulation and can be systemically active, HPA axis suppression could occur when recommended dosages are exceeded or in particularly sensitive individuals. Since recommended dosages of orally inhaled beclomethasone dipropionate provide less than normal physiologic amounts of glucocorticoid systemically and do not provide mineralocorticoid activity, the drug will not compensate for insufficient endogenous cortisol production caused by previous systemic corticosteroid therapy.

In most patients, a number of months are required for recovery of HPA function following withdrawal of long-term systemic corticosteroid therapy. Since death resulting from acute adrenal insufficiency or an exacerbation of the underlying asthma has occurred rarely in asthmatic patients during and after transfer from systemic corticosteroid to beclomethasone dipropionate oral inhalation therapy, systemic corticosteroid therapy should be withdrawn gradually. Several deaths in asthmatic children have occurred about 6 months after conversion from oral corticosteroid to beclomethasone dipropionate oral inhalation therapy. Although adrenal stimulation tests performed in some of these children shortly before death indicated normal HPA function, adrenal atrophy was observed on postmortem examination.

Respiratory Effects

Infectious Complications

Increased colonization and/or localized infections with Candida albicans have occurred frequently in the mouth or pharynx and occasionally in the larynx, bronchus, or esophagus of patients receiving orally inhaled beclomethasone dipropionate;Aspergillus niger infections or overgrowth also have occurred. The frequency of positive oral Candida cultures in patients receiving orally inhaled beclomethasone dipropionate is variable.

The manufacturer of orally inhaled beclomethasone dipropionate aerosol with tetrafluoroethane (non-CFC) propellant states that no patient developed symptomatic oropharyngeal candidiasis during clinical development with this preparation. In an open-label study in 354 patients receiving beclomethasone dipropionate oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (160-640 mcg daily) or CFC propellant (336-1344 mcg daily; no longer commercially available in the US) for 1 year, oropharyngeal candidiasis was not reported in either treatment group. Approximately 4 or 8% of patients receiving the drug containing non-CFC (HFA) or CFC propellant, respectively, were instructed to use a spacer device either positive oral Candida cultures or dysphonia; however, the difference between the treatment groups was not statistically significant.

Most clinicians recommend that patients rinse their mouth and throat with water after each dose of beclomethasone dipropionate to remove residual medication in the oropharyngeal area and to minimize the development of fungal overgrowth and/or infection. If a fungal infection is suspected, appropriate local anti-infective therapy and/or discontinuance of beclomethasone dipropionate therapy should be considered, but usually oropharyngeal Candida or Aspergillus infections are of little clinical importance.

Monilial esophagitis has occurred in several asthmatic patients receiving concomitant therapy with oral prednisone and orally inhaled beclomethasone dipropionate; however, predisposing factors, other than therapy with orally inhaled beclomethasone dipropionate, were present in these patients. The development of esophagitis resulting from concurrent infection with Candida and herpes simplex has been reported in at least one corticosteroid-dependent patient receiving orally inhaled beclomethasone dipropionate.

Although not directly attributable to the drug, clinical tuberculosis developed in one patient during a 6-month period of beclomethasone dipropionate oral inhalation therapy. However, concurrent administration of beclomethasone dipropionate oral inhalation did not appear to have an adverse effect on resolution of tuberculosis in this patient. In a previous 10-month period, the patient received an oral corticosteroid without any clinical evidence of tuberculosis.

Eosinophilic pneumonia has occurred in several patients receiving orally inhaled beclomethasone dipropionate. A possible relationship of this adverse effect to systemic corticosteroid withdrawal has been suggested. A causal relationship to beclomethasone dipropionate and/or the contents of the vehicle (e.g., fluorocarbons, oleic acid) in the preparation has been suggested but remains to be established.

Dysphonia

Dysphonia (sometimes persistent and severe) has occurred in patients receiving orally inhaled beclomethasone dipropionate; a direct causal relationship to therapy with orally inhaled beclomethasone dipropionate and to chronic voice stress has been shown in at least one study. A causal relationship has not been ruled out, but in one controlled study, dysphonia did not appear to be related to the contents of the vehicle (e.g., fluorocarbons, oleic acid) in the preparation of beclomethasone dipropionate oral inhalation that was used. Dysphonia may result from dysfunction of the bilateral adductor muscles that control phonation. It has been suggested that this adverse effect may result from a local steroid myopathy. Dysphonia has occurred concomitantly with candidiasis in some patients. Although dysphonia and candidiasis were related to beclomethasone dipropionate oral inhalation therapy in some patients, they apparently were not related to each other and required different treatment (voice rest or nystatin).

Other Adverse Respiratory Effects

Bronchospasm, cough, and/or wheezing may occur in some patients following oral inhalation of beclomethasone dipropionate, especially in asthmatic patients with hyperactive airways. Administration of an orally inhaled β2-agonist a few minutes before oral inhalation of beclomethasone dipropionate has prevented or minimized these adverse respiratory effects in some patients; other patients may require a course of oral corticosteroid therapy to tolerate oral inhalation of the steroid.

The long-term and systemic effects of beclomethasone dipropionate in humans, particularly local effects on developmental or immunologic processes in the mouth, pharynx, trachea, and lung, are unknown. Although not reported to date in patients receiving orally inhaled beclomethasone dipropionate, the possibility of atrophic changes in the respiratory epithelium during prolonged therapy with orally inhaled corticosteroids should be considered, since atrophic dermatitis has occurred in patients treated with topical corticosteroids to the skin for prolonged periods. In a limited number of patients receiving beclomethasone dipropionate oral inhalation for 12-18 months, light and electron microscopic studies of bronchial and pharyngeal biopsy material did not reveal any changes attributable to the drug. Long-term studies using high doses of orally inhaled beclomethasone dipropionate in cushingoid animals also did not reveal any evidence of pulmonary changes as determined by light or electron microscopy. Following therapy with orally inhaled beclomethasone dipropionate, bronchial biopsies did not show any evidence of atrophic changes in asthmatic patients receiving the drug for up to 32 months; however, an increased number of mastocytes was observed when biopsies from these patients were compared with those from asthmatic patients not receiving therapy with the drug.

Other Adverse Effects

In addition to bronchospasm, other immediate or delayed hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, urticaria, angioedema, and rash, have occurred rarely following oral or intranasal inhalation of beclomethasone dipropionate. Other adverse effects reported with oral inhalation of beclomethasone dipropionate include flushing, dry mouth or throat, irritation of the tongue or throat, and dysgeusia; however, a causal relationship to the drug has not been established. Headache, pharyngitis, rhinitis, sinusitis, pain/back pain, and dysmenorrhea were also reported during clinical trials with beclomethasone dipropionate oral inhalation therapy.

Glaucoma, increased intraocular pressure, and cataracts have been reported rarely with administration of inhaled corticosteroids. Prolonged therapy with orally inhaled beclomethasone dipropionate has been associated with the development of bilateral posterior subcapsular cataracts in at least one patient. Several months following discontinuance of corticosteroid therapy in this patient, normal lenses were observed. In a group of asthmatic children who developed cataracts during systemic corticosteroid therapy, cataracts resolved within 6 months in 2 patients when prednisone dosage was reduced or discontinued and beclomethasone dipropionate oral inhalation therapy was initiated.

A bullous eruption of the lips and oral mucosa has been reported in at least one patient receiving oral inhalation of beclomethasone dipropionate. Since rechallenge with the drug produced the same adverse reaction in this patient, a causal relationship to beclomethasone dipropionate or an ingredient in the vehicle of the preparation has been suggested.

Precautions and Contraindications

In patients being switched from systemic corticosteroids to orally inhaled beclomethasone dipropionate, systemic corticosteroid therapy should be withdrawn gradually since a life-threatening exacerbation of asthma or adrenal insufficiency could occur.Patients who have been maintained on at least 20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly when their systemic corticosteroid therapy has been almost completely withdrawn.In most patients, up to 12 months may be required for total recovery of HPA function following withdrawal of systemic corticosteroid therapy. These patients should be carefully monitored during and for a number of months after withdrawal of systemic corticosteroids because of the risk of corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression); acute adrenal insufficiency during exposure to trauma, surgery, or infection (particularly gastroenteritis or other conditions associated with acute electrolyte loss); pulmonary infiltrates with eosinophilia; or symptomatic exacerbation of allergic conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema). In asthmatic patients, death, possibly resulting from acute adrenal insufficiency or an exacerbation of the underlying asthma, has occurred rarely during and after transfer from systemic corticosteroid to beclomethasone dipropionate oral inhalation therapy. Systemic corticosteroid dosage should be carefully tapered and patients should be monitored during dosage reduction for objective signs of adrenal insufficiency (e.g., hypotension, weight loss). In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by orally inhaled corticosteroids.

The manufacturer of beclomethasone dipropionate oral inhalation containing tetrafluoroethane (non-CFC) propellant (QVAR) states that higher than recommended dosages of the drug should be avoided, since suppression of HPA function may occur. If higher than recommended dosages are used, the relative risks of adrenal suppression and potential therapeutic benefits must be carefully considered; systemic corticosteroids will likely be necessary during prolonged periods of stress (e.g., infection, trauma, surgery), particularly in patients who received continuous oral corticosteroid therapy within the previous 12 months. Orally inhaled beclomethasone dipropionate should be used with caution in patients receiving systemic prednisone or another systemic corticosteroid in an alternate-day or daily dosing regimen for any disease, since concomitant use of the drugs could increase the likelihood of HPA-axis suppression compared with therapeutic dosages of either drug alone.

Although signs and symptoms of Cushing's syndrome (e.g., hypertension, glucose intolerance, cushingoid features) have not been associated with beclomethasone dipropionate oral inhalation therapy to date, the possibility of their occurrence should be considered in patients who are particularly sensitive to corticosteroid effects or when usual dosages of the drug are exceeded.

Patients should be advised that oral inhalation of beclomethasone dipropionate must be used at regular intervals to be therapeutically effective. In addition, patients should be advised that the drug usually will not provide immediate symptomatic relief, but 1-4 weeks of continuous therapy may be required for optimum effects to be achieved. Patients should be advised that orally inhaled beclomethasone dipropionate should not be used as a bronchodilator and is not indicated for emergency use (e.g., relief of acute bronchospasm). Patients should be instructed not to exceed the prescribed dosage, and to rinse their mouth after the inhalation procedure.(See Dosage and Administration: Administration.) Patients receiving beclomethasone dipropionate oral inhalation therapy should also be advised to contact their physician immediately when asthmatic attacks that are not controlled by bronchodilator therapy occur. The manufacturer of beclomethasone dipropionate containing tetrafluoroethane (non-CFC) propellant (QVAR) states that if bronchospasm occurs following dosing with the drug, it should be treated immediately with a short-acting bronchodilator, treatment with beclomethasone dipropionate should be discontinued, and alternative therapy should be instituted. Patients being transferred from systemic corticosteroid to beclomethasone dipropionate oral inhalation therapy should carry special identification (e.g., card, bracelet) indicating the need for supplementary systemic corticosteroids during periods of stress. Patients receiving orally inhaled beclomethasone dipropionate who are currently being withdrawn or who have been withdrawn recently from systemic corticosteroids should be advised to immediately resume full therapeutic dosages of systemic corticosteroids and to contact their physician for further instructions during stressful periods (e.g., severe infection, severe asthmatic attack).

Patients receiving beclomethasone dipropionate oral inhalation with tetrafluoroethane (non-CFC) propellant (QVAR) should be advised that this preparation may have a different taste and inhalation sensation than that of an inhaler containing CFC propellants (no longer commercially available in the US).

Patients who become immunosuppressed while receiving corticosteroids have increased susceptibility to infections compared with healthy individuals, and certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children. Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs. For additional information, and also .

The effect of beclomethasone dipropionate oral inhalation therapy on acute, recurrent, or chronic pulmonary infections, including active or latent Mycobacterium tuberculosis infections, is not known. Orally inhaled beclomethasone dipropionate should be used with caution, if at all, in patients with clinical tuberculosis or latent M. tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, or parasitic infections; or ocular herpes simplex or untreated, systemic viral infections.

Oral inhalation of beclomethasone dipropionate is contraindicated in the primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required. Oral inhalation of beclomethasone dipropionate is also contraindicated in patients who are hypersensitive to the drug or any ingredient in the formulation.

Pediatric Precautions

The safety and efficacy of beclomethasone dipropionate oral inhaler with non-CFC (tetrafluoroethane) propellant (QVAR) have not been established in children younger than 5 years of age. In several studies in children 5-12 years of age not previously treated with corticosteroids, no overall differences in the pattern, severity, or frequency of adverse events were observed compared with those in adults, with the exception of conditions that are more prevalent in the pediatric population generally. In a 12-month comparative study in children 5-11 years of age receiving 8-320 mcg daily of orally inhaled non-CFC tetrafluoroethane propellant beclomethasone dipropionate (without a spacer) or 160-640 mcg daily of the drug with CFC propellant with a spacer (no longer commercially available in the US), a small reduction in growth velocity (0.5 cm/year) was observed with the non-CFC inhalation aerosol and no spacer compared with the CFC-containing inhalation aerosol and a spacer. Children receiving prolonged therapy with orally inhaled beclomethasone dipropionate should be monitored periodically for possible adverse effects on growth and development.

Geriatric Precautions

Clinical studies of beclomethasone dipropionate did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients. While clinical experience generally has not revealed age-related differences in response to the drug, care should be taken in dosage selection of beclomethasone dipropionate. Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric patients, the manufacturer suggests that patients in this age group receive initial dosages of the drug at the lower end of the usual range.

Mutagenicity and Carcinogenicity

Beclomethasone dipropionate did not exhibit mutagenic potential in vitro in bacterial or mammalian (Chinese hamster ovary) test systems. No evidence of clastogenic potential was found in in vitro tests using cultured CHO cells or in vivo in the mouse micronucleus test.

No evidence of carcinogenicity was observed when rats were given beclomethasone dipropionate for 95 weeks (13 weeks by oral inhalation and 82 weeks by the oral route).

Pregnancy, Fertility, and Lactation

Pregnancy

Orally inhaled beclomethasone dipropionate should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Although there are no adequate and controlled studies to date in humans, 20 asthmatic patients who became pregnant and were receiving oral inhalation of beclomethasone dipropionate at usual dosages delivered healthy children. Other women with severe asthma who received orally inhaled beclomethasone dipropionate during pregnancy to reduce systemic corticosteroid dosage requirements also delivered healthy children; however, a cardiac malformation was reported in an infant whose mother had complications and was receiving other drugs. Several of these pregnancies resulted in premature deliveries and low birthweight infants, but evidence of neonatal adrenal insufficiency was not observed. Infants born to women who received substantial doses of corticosteroids during pregnancy should be carefully monitored for manifestations of hypoadrenalism. Subcutaneous beclomethasone dipropionate has been shown to be teratogenic and embryocidal in mice and rabbits at dosages about one-half the maximum recommended daily inhalation dose in adults on a mg/m basis. Teratogenic effects in these animals included fetal resorption, cleft palate, agnathia, microstomia, aglossia, delayed ossification, and agenesis of the thymus gland. Teratogenic or embryocidal effects were not observed following oral inhalation of beclomethasone dipropionate at 190 times the maximum recommended daily human dosage on a mg/m basis or following oral administration at 1000 times the usual human dosage in rats.

Fertility

It is not known whether beclomethasone dipropionate affects fertility in humans. Reproduction studies in female dogs given oral beclomethasone dipropionate dosages of 500 mcg/kg daily have shown evidence of impaired fertility (inhibition of the estrus cycle); however, no inhibition of the estrus cycle was observed in dogs following administration of orally inhaled beclomethasone dipropionate for 12 months as an estimated daily dosage of 0.33 mg/kg (about 15 times the maximum recommended daily dosage in humans on a mg/m basis).

Lactation

Since corticosteroids are distributed into milk and potentially may cause serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Pharmacokinetics

For a discussion of the absorption, distribution, and elimination of beclomethasone dipropionate, and in .

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