Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure of these infectious agents. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk of developing a more severe infection is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscualr immunoglobulin (IG), may be indicated. (See the respective product information for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Localized infections with Candida albicans or Aspergillus niger have occurred frequently in the mouth and pharynx and occasionally in the larynx. Positive cultures for oral Candida may be present in up to 75% of patients. Although the frequency of clinically apparent infection is considerably lower, these infections can develop with any inhaled corticosteroid and may require treatment with appropriate antifungal therapy or discontinuation of treatment with beclomethasone dipropionate inhaler.

Beclomethasone dipropionate inhaler is not a bronchodilator and is not indicated for rapid relief of bronchospasm.

Patients should be instructed to contact their physicians immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with beclomethasone dipropionate. During such episodes, patients may require therapy with systemic corticosteroids.

Transfer of patients from systemic steroid therapy to beclomethasone dipropionate inhaler may unmask allergic conditions previously suppressed by the systemic steroid therapy (e.g., rhinitis, conjunctivitis, and eczema).

Avoid spraying in eyes.

Additional Information for 84 mcg Inhalation Aerosol: Studies have shown that the combined administration of alternate-day prednisone systemic treatment and orally inhaled beclomethasone increases the likelihood of HPA suppression compared to a therapeutic dose of either one alone.

Because of the possibility of systemic absorption of orally inhaled corticosteroids, including beclomethasone, patients should be monitored for symptoms of systemic effects such as mental distrubances, increased bruising, weight gain, cushingoid features, acneiform lesions, and cataracts. Therefore, if such changes occur, beclomethasone dipropionate inhaler should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroids.

There is no evidence that control of asthma can be achieved by the administration of beclomethasone dipropionate inhalation aerosol in amounts greater than the recommended doses.

The management of asthma should follow a stepwise program, and patient response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled beta₂¾agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. In patients considered at risk, daily wflow monitoring may be instituted.

If patients find that short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.

General

During withdrawal from oral steroids, some patients may experience symptoms of systemically active steroid withdrawal (e.g., joint and/or muscular pain, lassitude and depression) despite maintenance or even improvement of respiratory function (see DOSAGE AND ADMINISTRATION).

In responsive patients, beclomethasone dipropionate may permit control of asthmatic symptoms without suppression of HPA function, as discussed in CLINICAL PHARMACOLOGY. Since beclomethasone dipropionate is absorbed into the circulation and can be systemically active, the beneficial effects of beclomethasone dipropionate inhalation aerosol in minimizing or preventing HPA dysfunction may be expected only when recommended dosages are not exceeded.

Pulmonary infiltrates with eosinophilia may occur in patients receiving orally inhaled beclomethasone dipropionate. Although it is possible that in some patients this state may become manifest because of systemic corticosteroid withdrawal when inhalational corticosteroids are administered, a causative role for beclomethasone dipropionate and/or its vehicle cannot be ruled out.

Additional Information for 42 mcg Inhalation Aerosol: Because of the possibility of systemic absorption of orally inhaled corticosteroids, including beclomethasone, patients should be monitored for symptoms of systemic effects such as mental disturbances, increased bruising, weight gain, cushingoid features, acneiform lesions, and cataracts. Therefore, if such changes occur, beclomethasone dipropionate should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroids.

Additional Information for 84 mcg Inhalation Aerosol: Children should be monitored for a reduction in growth velocity, although the relationship between growth velocity and final adult height is not known.

The long-term effects of beclomethasone dipropionate in human subjects are still unknown. In particular, the local effects of the agent on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown. There is also no information about the possible long-term systemic effects of the agent.

This drug should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.

Pregnancy Category C

42 mcg Inhalation Aerosol: Like other corticosteroids, beclomethasone dipropionate was teratogenic and embryocidal in the mouse and rabbit at a subcutaneous dose of 0.1 mg/kg in mice or 0.025 mg/kg in rabbits (approximately ½ the maximum recommended daily inhalation dose in adults on a mg/m² basis). No teratogenicity or embryocidal effects were seen in rats when exposed to an inhalation dose of 0.1 mg/kg plus oral doses of up to 10 mg/kg per day for a combined dose of 10.1 mg/kg (approximately 80 times the maximum recommended daily inhalation dose in adults on a mg/m² basis). There are no adequate and well-controlled studies in pregnant women. Beclomethasone dipropionate inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

84 mcg Inhalation Aerosol: Like other corticosteriods, parenteral (subcutaneous) beclomethasone dipropionate was teratogenic and embryocidal in the mouse or rabbit when given at a dose of 0.1 mg/kg/day in mice or at a dose of 0.025 mg/kg/day in rabbits. These doses in rats and rabbits were approximately one-half the maximum recommended human daily inhalation dose on a mg/m² basis. No teratogenicity or embryocidal effects were seen in rats when exposed to an inhalation dose of 0.1 mg/kg plus oral doses of up to 10 mg/kg/day for combined daily dose of 10.1 mg/kg (approximately 97 times the maximum recommended human daily inhalation dose on mg/m² basis). There are no adequate and well-controlled studies in pregnant women. Beclomethasone dipropionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Information for the Patient

Patients being treated with beclomethasone dipropionate should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Patients should use beclomethasone dipropionate double strength inhalation aerosol at regular intervals as directed. Results of clinical trials indicated significant improvement may occur within the first day or two of treatment; however, the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if condition worsens.

Patients should also be advised that beclomethasone dipropionate double strength inhalation aerosol is not intended for use in the treatment of acute asthma. Patients should be instructed to contact their physician immediately if there is any deterioration of their asthma. Additional Information for 42 mcg Inhalation Aerosol: Patients should be made aware of the prophylactic nature of therapy with inhaled beclomethasone dipropionate and that it should be taken regularly even when they are asymptomatic.

Patients should be advised to rinse his/her mouth each time after using beclomethasone dipropionate inhalation aerosol.

Beclomethasone dipropionate inhalation aerosol should not be stopped abruptly. If discontinuing use of beclomethasone dipropionate is necessary, the patient's physician should be contacted immediately.

Additional Information for 42 mcg Inhalation Aerosol: Patients should use beclomethasone dipropionate inhalation aerosol at regular intervals as directed. Results of clinical trials indicated significant improvement may occur within the first day or two of treatment; however, the full benefit may not be achieved until treatment has been administered 1 or 2 weeks or longer. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if the condition worsens.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

The carcinogenicity of beclomethasone dipropionate was evaluated in rats which were exposed for a total of 95 weeks, 13 weeks at inhalation doses up to 0.4 mg/kg/day and the remaining 82 weeks at combined oral and inhalation doses up to 2.4 mg/kg/day. There was no evidence of carcinogenicity in this study at the highest dose which is approximately, for the 42 mcg inhalation aerosol, 20 or 36 times the maximum recommended human daily inhalation dose on a mg/m² basis, and 23 times for the 84 mcg inhalation aerosol.

Impairment of fertility, as evidenced by inhibition of the estrous cycle in dogs, was observed following treatment by the oral route at a dose of 0.5 mg/kg/day which is approximately 16 times the maximum recommended human daily inhalation dose on a mg/m² basis. No inhibition of the estrous cycle in dogs was seen following 12 months of exposure to beclomethasone dipropionate by the inhaltion route at an estimated daily dose of 0.33 mg/kg (approximately 11 times the maximum recommended human daily inhalation dose on a mg/m² basis).

Additional Information for 42 mcg Inhalation Aerosol: Beclomethasone dipropionate did not induce gene mutation in bacterial cells or mammalian Chinese Hamster ovary (CHO) cells in vitro. No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo.

In rats, beclomethasone dipropionate caused decreased conception rates at an oral dose of 16 mg/kg (approximately 130 times the maximum recommended daily inhalation dose in adults on a mg/m² basis). Inhibition of the estrous cycle in dogs was observed following oral dosing at 0.5 mg/kg (approximately 15 times the maximum recommended daily inhalation dose in adults on a mg/m² basis). No inhibition of the estrous cycle in dogs was seen following 12 months' exposure at an estimated daily inhalation dose of 0.33 mg/kg (approximately 9 times the maximum recommended daily inhalation dose in adults on a mg/m² basis).

Nursing Mothers

Corticosteriods are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from beclomethasone dipropionate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children below 6 years of age have not been established.

Additional Information for 42 mcg Inhalation Aerosol: The safety and effectiveness of beclomethasone dipropionate inhalation aerosol have been established in children aged 6 years and above. The safety and effectiveness of beclomethasone dipropionate inhalation aerosol in children below 6 years of age have not been established. Corticosteroids have been shown to cause a reduction in growth velocity in children and teenagers with extended use. If a child or teenager on any corticosteroid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of corticosteroids should be considered.

Bookmark this page: