Morris Nejat MD NY Allergist Specializing in Allergy and Allergy Triggers is a Board Certified Pediatrician and an NY Allergist in New York and Midtown and Downtown New York with information on allergy asthma and triggers Morris Nejat for NY allergy, NYC Allergist and Manhattan Allergy treatment and therapy in NYC new york city. NY allergist asthma ny allergy ny allergy dust mites cockroach pollen grass weed count sinus nasal polyps testing skin shots allergyshots NYC new york city allergist asthma ny allergist allergy nyc  allergy dust mites cockroach pollen grass weed count sinus nasal polyps testing skin shots allergyshots Morris Nejat MD Allergist in Allergy Testing, Specializing in Allergy and Allergy Triggers is a Board Certified Pediatrician Allergist in New York and Midtown and Downtown New York with information on allergy asthma sinus and triggers Morris Nejat Arthur Lubitz Feingold Finegold Gregory Pollack Cliff Bassett. Health Insurance Medicare Medicaid Aetna USHC Allmerica Financial AmeriChoice of NJ AmeriHealth Administrators Anthem Healthcare of NY BC/BS BC/BS HMO Beech Street Network Center Care Chickering Claims Administrators Child Health Plus Cigna First Health Network GHI Great West Healthsource HIP Home Care Industry Horizon of NJ Horizon of NY Insurance Design Administrators (IDA) Local Insurances Magnacare MasterCare Medicaid w/Medicare Medicare Multiplan New England Financial NY Government Employee One Health Care Network Oxford PHCS Network PHS Network Pomco Prudential Select Pro Unicare United Healtcare 1199 32-BJ. All insurance accepted. Medication therapy flonase advair claritine clarityne claritin patanol and allergy medication from board certified allergist clarinex clarinext allegra zyrtec glaxo nasonex nasanex.

Indications: Asthma; Polyps, nasal, prevention; Rhinitis, perennial allergic; Rhinitis, seasonal allergic; Rhinitis, vasomotor

Pregnancy Category C

WHO Formulary

FDA Approved 1976 May

DRUG CLASS: Corticosteroids, inhalation

BRAND NAMES: Aerobec (Mexico, Germany, South-Africa); Alanase (New-Zealand); Aldecin (Denmark, Switzerland, Hong-Kong, Malaysia, Netherlands, Belgium, Denmark, Bulgaria, Taiwan); Aldecina (Portugal, Costa-Rica, Dominican-Republic, El-Salvador, Guatemala, Honduras, Nicaragua, Panama); Anceron (South-Africa); Andion (Denmark); Asmabec Clickhaler (France); Atomase (New-Zealand); Beceze (Israel); Beclate (India, South-Africa); Beclazone (Israel); Beclo-Asma (Hong-Kong); Beclocort Nasel (Poland); Becloforte (New-Zealand, Hong-Kong, South-Africa); Beclomet (Germany, Switzerland, Malaysia, Taiwan, Bulgaria); Beclomet Easyhaler (Thailand, Indonesia); Beclomet Nasal (Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates); Beclomet Nasal Aqua (Indonesia, Thailand); Beclone (France); Beclo-Rhino (France); Beclorhinol (Germany); Beclo Siozwo Nasenspray (Germany); Becloturmant (Germany); Beclovent (US); Beconase (Australia, Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South-Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe; Bahamas, Barbados, Belize, Bermuda, Curacao, Guyana, Jamaica, Netherland-Antilles, Puerto-Rico, Surinam, Trinidad; Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, Netherlands, Germany, England, Belgium, France, Philippines, Taiwan, Thailand, Hong-Kong, Indonesia, Malaysia, Austria, Hungary, Finland, Portugal, Bulgaria, Spain, Costa-Rica, Dominican-Republic, El-Salvador, Guatemala, Honduras, Nicaragua, Panama, Ecuador, Mexico, Canada, South-Africa, Colombia, Peru); Beconase AQ (US); Becotide (Hong-Kong, Indonesia, China, Korea, Malaysia, Philippines, Taiwan, Thailand; Bahamas, Barbados, Belize, Bermuda, Curacao, Guyana, Jamaica, Netherland-Antilles, Puerto-Rico, Surinam, Trinidad; Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates; Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South-Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe; Australia, New-Zealand; Austria, Belgium, Bulgaria, Czech-Republic, Denmark, England, Finland, France, Greece, Hungary, Italy, Netherlands, Norway, Portugal, Russia, Spain, Sweden, Switzerland, , New-Zealand, Bulgaria, South-Africa, Israel, Mexico, Ecuador, Costa-Rica, Dominican-Republic, El-Salvador, Guatemala, Honduras, Nicaragua, Panama, Peru); Belax (Taiwan); Bemedrex Easyhaler (France); Bronconox (Colombia); Bronconox Forte (Colombia); Clenil (Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, Hong-Kong, Philippines, Taiwan, South-Africa); Clenil Forte (Philippines); Nobec (South-Africa); Q Var (New-Zealand, South-Africa); Qvar Autohaler (Australia, France); Qvar Inhaler (Australia); RatioAllerg (Germany); Respocort (New-Zealand, Malaysia, Philippines); Rhino Clenil (Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates); Rhinocort (Israel); Rinaze (South-Africa); Rynconox (Colombia); Vancenase (US); Vanceril (US); Viarex (Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates; Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South-Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe, Israel); Viarox (Germany, South-Africa); Xiten (Peru);
(International brand names outside U.S. in italics)

Beclomethasone Dipropionate (Intranasal)

DESCRIPTION:

CLINICAL PHARMACOLOGY:

Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a synthetic halogenated corticosteroid. Animal studies show that beclomethasone dipropionate has potent glucocorticoid and weak mineralocorticoid activity.

The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. The precise mechanism of the aerosolized drug's action in the nose is also unknown. Biopsies of nasal mucosa obtained during clinical studies showed no histopathologic changes when beclomethasone dipropionate was administered intranasally.

The effects of beclomethasone dipropionate on hypothalamic-pituitary-adrenal (HPA) function have been evaluated in adult volunteers by other routes of administration. Studies with beclomethasone dipropionate by the intranasal route may demonstrate that there is more or that there is less absorption by this route of administration. There was no suppression of early morning plasma cortisol concentrations when beclomethasone dipropionate was administered in a dose of 1000 μg/day for 1 month as an oral aerosol or for 3 days by intramuscular (IM) injection. However, partial suppression of plasma cortisol concentrations was observed when beclomethasone dipropionate was administered in doses of 2000 μg/day either by oral aerosol or IM injection. Immediate suppression of plasma cortisol concentrations was observed after single doses of 4000 μg of beclomethasone dipropionate. Suppression of HPA function (reduction of early morning plasma cortisol levels) has been reported in adult patients who received 1600 μg daily doses of oral beclomethasone dipropionate for 1 month. In clinical studies using beclomethasone dipropionate aerosol intranasally, there was no evidence of adrenal insufficiency. The effect of beclomethasone dipropionate, monohydrate nasal spray on HPA function was not evaluated but would not be expected to differ from intranasal beclomethasone dipropionate aerosol.

In 1 study in children with asthma, the administration of inhaled beclomethasone at recommended daily doses for at least 1 year was associated with a reduction in nocturnal cortisol secretion. The clinical significance of this finding is not clear. It reinforces other evidence, however, that topical beclomethasone may be absorbed in amounts that can have systemic effects and that physicians should be alert for evidence of systemic effects, especially in chronically treated patients (see PRECAUTIONS).

Beclomethasone dipropionate is sparingly soluble. When given by nasal inhalation in the form of an aqueous or aerosolized suspension, the drug is deposited primarily in the nasal passages. A portion of the drug is swallowed. Absorption occurs rapidly from all respiratory and gastrointestinal tissues. There is no evidence of tissue storage of beclomethasone dipropionate or its metabolites. In vitro studies have shown that tissue other than the liver (lung slices) can rapidly metabolize beclomethasone dipropionate to beclomethasone 17-monopropionate and more slowly to free beclomethasone (which has very weak anti-inflammatory activity). However, irrespective of the route of entry, the principal route of excretion of the drug and its metabolites is the feces. In humans, 12-15% of an orally administered dose of beclomethasone dipropionate is excreted in the urine as both conjugated and free metabolites of the drug.

Studies have shown that the degree of binding to plasma proteins is 87%.

INDICATIONS AND USAGE:

Beclomethasone dipropionate, monohydrate nasal spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis.

Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. However, symptomatic relief may not occur in some patients for as long as 2 weeks. Beclomethasone dipropionate, monohydrate nasal spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. Beclomethasone dipropionate, monohydrate nasal spray should not be used in the presence of untreated localized infection involving the nasal mucosa.

Beclomethasone dipropionate, monohydrate nasal spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal.

Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.

CONTRAINDICATIONS:

Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

WARNINGS:

The replacement of a systemic corticosteroid with beclomethasone dipropionate, monohydrate nasal spray can be accompanied by signs of adrenal insufficiency.

Careful attention must be given when patients previously treated for prolonged periods with systemic corticosteroids are transferred to beclomethasone dipropionate, monohydrate nasal spray. This is particularly important in those patients who have associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

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. Therefore, beclomethasone dipropionate, monohydrate nasal spray treatment should be used with caution in patients already on alternate-day prednisone regimens for any disease.

If recommended doses of intranasal beclomethasone are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapy, symptoms of hypercorticism may occur, including very rare cases of menstrual irregularities, acneiform lesions, cataracts, and cushingoid features. If such changes occur, beclomethasone dipropionate, monohydrate nasal spray should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy.

Persons who are on drugs that 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. 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 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 intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

PRECAUTIONS:
General

Rarely, immediate hypersensitivity reactions may occur after the intranasal administration of beclomethasone (see ADVERSE REACTIONS).

Rare instances of nasal septum perforation have been spontaneously reported.

Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the use of intranasal beclomethasone.

In clinical studies with beclomethasone dipropionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops, it may require treatment with appropriate local therapy or discontinuation of treatment with beclomethasone dipropionate, monohydrate nasal spray.

If persistent nasopharyngeal irritation occurs, it may be an indication for stopping beclomethasone dipropionate, monohydrate nasal spray.

Beclomethasone dipropionate is absorbed into the circulation. Use of excessive doses of beclomethasone dipropionate, monohydrate nasal spray may suppress HPA function.

Beclomethasone dipropionate, monohydrate nasal spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract; untreated fungal, bacterial, or systemic viral infections; or ocular herpes simplex.

For beclomethasone dipropionate, monohydrate nasal spray to be effective in the treatment of nasal polyps, the spray must be able to enter the nose. Therefore, treatment of nasal polyps with beclomethasone dipropionate, monohydrate nasal spray should be considered adjunctive therapy to surgical removal and/or the use of other medications that will permit effective penetration of beclomethasone dipropionate, monohydrate nasal spray into the nose. Nasal polyps may recur after any form of treatment.

As with any long-term treatment, patients using beclomethasone dipropionate, monohydrate nasal spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or trauma should not use a nasal corticosteroid until healing has occurred.

Although systemic effects have been minimal with recommended doses, this potential increases with excessive doses. Therefore, larger than recommended doses should be avoided.

Information for the Patient

Patients being treated with beclomethasone dipropionate, monohydrate nasal spray 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 use beclomethasone dipropionate, monohydrate nasal spray at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. It is not acutely effective, and the prescribed dosage should not be increased. Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of beclomethasone dipropionate, monohydrate nasal spray are fully manifested. One (1) to 2 weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, if the condition worsens, or if sneezing or nasal irritation occurs. For the proper use of the unit and to attain maximum improvement, the patient should read and follow carefully the accompanying patient's instructions.

Persons who are on immunosuppressant doses of corticosteroids 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.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Treatment of rats for a total of 95 weeks, 13 weeks by inhalation and 82 weeks by the oral route, resulted in no evidence of carcinogenic activity. Mutagenic studies have not been performed.

Impairment of fertility, as evidenced by inhibition of the estrous cycle in dogs, was observed following treatment by the oral route. No inhibition of the estrous cycle in dogs was seen following treatment with beclomethasone dipropionate by the inhalation route.

Pregnancy Category C
Teratogenic Effects

Like other corticoids, parenteral (subcutaneous) beclomethasone dipropionate has been shown to be teratogenic and embryocidal in the mouse and rabbit when given in doses approximately 10 times the human dose. In these studies, beclomethasone was found to produce fetal resorption, cleft palate, agnathia, microstomia, absence of tongue, delayed ossification, and agenesis of the thymus. No teratogenic or embryocidal effects have been seen in the rat when beclomethasone dipropionate was administered by inhalation at 10 times the human dose or orally at 1000 times the human dose. 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.

Nonteratogenic Effects

Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.

Nursing Mothers

It is not known whether beclomethasone dipropionate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when beclomethasone dipropionate, monohydrate nasal spray is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of beclomethasone dipropionate, monohydrate nasal spray have been established in children aged 6 years and above through evidence from extensive clinical use in adult and pediatric patients. The safety and effectiveness of beclomethasone dipropionate, monohydrate nasal spray in children below 6 years of age have not been established.

Glucocorticoids have been shown to cause a reduction in growth velocity in children and teenagers with extended use. If a child or teenager on any glucocorticoid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of glucocorticoids should be considered.

Geriatric Use

Clinical studies of beclomethasone dipropionate, monohydrate nasal spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS:

Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been spontaneously reported (see PRECAUTIONS).

Reports of dryness and irritation of the nose and throat, and unpleasant taste and smell have been received. There are rare reports of loss of taste and smell.

Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the use of intranasal beclomethasone dipropionate (see PRECAUTIONS).

OVERDOSAGE:

DOSAGE AND ADMINISTRATION:
Adults and Children 12 Years of Age and Older: The usual dosage is 1 or 2 inhalations (42-84 μg) in each nostril twice a day (total dose, 168-336 μg/day).
Children 6-12 Years of Age: Patients should be started with 1 inhalation in each nostril twice a day; patients not adequately responding to 168 μg or those with more severe symptoms may use 336 μg (2 inhalations in each nostril). Beclomethasone dipropionate, monohydrate nasal spray is not recommended for children below 6 years of age.


 

HOW SUPPLIED:

Beconase AQ Nasal Spray, 0.042% (calculated on the dried basis) is supplied in an amber glass bottle fitted with a metering atomizing pump and nasal adapter with patient's instructions for use. Each bottle contains 25 g of suspension.
Storage: Store between 15 and 30°C (59 and 86°F).


Beclomethasone Dipropionate (Oral)


DESCRIPTION:
 

CLINICAL PHARMACOLOGY:

Animal studies show that beclomethasone dipropionate has potent anti-inflammatory activity. When beclomethasone dipropionate was administered systemically to mice, the anti-inflammatory activity was accompanied by other features typical of glucocorticoid action, including thymic involution, liver glycogen deposition, and pituitary-adrenal suppression. After systemic administration of beclomethasone dipropionate to rats, the anti-inflammatory action was associated with little or no effect on other tests of glucocorticoid activity.

Beclomethasone dipropionate is sparingly soluble and is poorly mobilized from subcutaneous or IM injection sites. However, systemic absorption occurs after all routes of administration. When given to animals in the form of an aerosolized suspension of the trichloromonofluoromethane clathrate, the drug is deposited in the mouth and nasal passages, the trachea and principal bronchi, and the lung; a considerable portion of the drug is also swallowed. Absorption occurs rapidly from all respiratory and gastrointestinal tissues, as indicated by the rapid clearance of radioactively labeled drug from local tissues and appearance of tracer in the circulation. There is no evidence of tissue storage of beclomethasone dipropionate or its metabolites. Lung slices can metabolize beclomethasone dipropionate rapidly to beclomethasone 17-monopropionate and more slowly to free beclomethasone (which has very weak anti-inflammatory activity). However, irrespective of the route of administration (injection, oral, or aerosol), the principal route of excretion of the drug and its metabolites is the feces. Less than 10% of the drug and its metabolites is excreted in the urine. In humans, 12-15% of an orally administered dose of beclomethasone dipropionate was excreted in the urine as both conjugated and free metabolites of the drug.

The precise mechanisms of glucocorticoid action in asthma are unknown. Inflammation is recognized as an important component in the pathogenesis of asthma. Glucocorticoids have been shown to inhibit multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediator production or secretion (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the asthmatic response. These anti-inflammatory actions of glucocorticoids may contribute to their efficacy in asthma.

CLINICAL STUDIES:

The effects of beclomethasone dipropionate on HPA function have been evaluated in adult volunteers. There was no suppression of early morning plasma cortisol concentrations when beclomethasone dipropionate was administered in a dose of 840 μg/day for 1 month as an aerosol or 1000 μg/day for 3 days by IM injection. However, partial suppression of plasma cortisol concentration was observed when beclomethasone dipropionate was administered in doses of 2000 μg/day intramuscularly or 1680 μg/day by aerosol. Immediate suppression of plasma cortisol concentrations was observed after single doses of 4000 μg of beclomethasone dipropionate.

In one study the effects of beclomethasone dipropionate on HPA function were examined in patients with asthma. There was no change in basal early morning plasma cortisol concentrations or in the cortisol responses to tetracosactrin (ACTH 1:24) stimulation after daily aerosol administration of 336, 672, or 1008 μg of beclomethasone dipropionate for 28 days. After daily aerosol administration of 1344 μg for 28 days, there was slight reduction in basal cortisol concentrations and a statistically significant (P <.01) reduction in plasma cortisol responses to tetracosactrin stimulation. Following 52 weeks of aerosol treatment with 840 μg of beclomethasone dipropionate daily, 7/115 (6%) of patients exhibited a plasma cortisol measurement below the lower limit of normal (150 nmol^-1).

Clinical experience has shown that some patients with asthma who require corticosteroid therapy for control of symptoms can be partially or completely withdrawn from systemic corticosteroids if therapy with beclomethasone dipropionate aerosol is substituted. Beclomethasone dipropionate aerosol is not effective for all patients with asthma or at all stages of the disease in a given patient.

INDICATIONS AND USAGE:

Beclomethasone dipropionate inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy. Beclomethasone dipropionate inhalation aerosol is also indicated for asthma patients who require systemic corticosteroid administration, where adding beclomethasone dipropionate inhalation aerosol may reduce or eliminate the need for the systemic corticosteroids.

Beclomethasone dipropionate inhalation aerosol is NOT indicated for the relief of acute bronchospasm.

CONTRAINDICATIONS:

Beclomethasone dipropionate inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

WARNINGS:

Localized infections with Candida albicans or Aspergillus niger have occurred 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 inhalation aerosol.

Beclomethasone dipropionate inhalation aerosol 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 inhalation aerosol. During such episodes, patients may require therapy with systemic corticosteroids.

Transfer of patients from systemic corticosteroid therapy to beclomethasone dipropionate inhalation aerosol may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, and eczema.

Persons who are on drugs that 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. 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 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 intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Avoid spraying in eyes.

PRECAUTIONS:

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

In responsive patients, beclomethasone dipropionate may permit control of asthmatic symptoms without suppression of HPA function, as discussed above (see 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.

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 inhalation aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroids.

A reduction of growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of adolescents taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression if an adolescent's growth appears slowed.

The long-term local and systemic effects of beclomethasone dipropionate inhalation aerosol in human subjects are still not fully known. In particular, the effects resulting from chronic use of beclomethasone dipropionate inhalation aerosol on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown.

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

Pulmonary infiltrates with eosinophilia may occur in patients on beclomethasone dipropionate inhalation aerosol therapy. 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.

Information for the Patient

Patients being treated with beclomethasone dipropionate inhalation aerosol 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 use beclomethasone dipropionate inhalation aerosol at regular intervals as directed. Results of clinical trials indicated significant improvement may occur within the first day or 2 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.

Patients should be advised that beclomethasone dipropionate inhalation aerosol is not intended for use in the treatment of acute asthma. 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 instructed to contact their physicians immediately if there is any deterioration of their asthma.

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

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

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.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

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

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).

Pregnancy, Teratogenic Effects, Pregnancy Category C

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/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.

Nursing Mothers

Corticosteroids are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants for beclomethasone dipropionate inhalation aerosol, 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

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 (see PRECAUTIONS).

ADVERSE REACTIONS:

Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate (see WARNINGS).

Suppression of HPA function (reduction of early morning plasma cortisol levels) has been reported in adult patients who received 1344 μg daily doses of beclomethasone dipropionate inhalation aerosol for 1 month. A few patients on beclomethasone dipropionate inhalation aerosol have complained of hoarseness or dry mouth.

In addition, the following adverse events have been reported spontaneously during worldwide postmarketing surveillance. Therefore, the frequency of events and causality cannot be reliably determined.

The adverse events reported in association with beclomethasone dipropionate inhalation aerosol include:
General: Immediate and delayed hypersensitivity reactions including anaphylactic/anaphylactoid reactions, angioedema, bronchospasm, rash, urticaria.
Ear, Nose, and Throat: Dryness and irritation of the nose, throat, and mouth; hoarseness; localized infections with Candida or Aspergillus; unpleasant taste and smell; loss of taste and smell.
Endocrine and Metabolic: Cushingoid features, growth velocity reduction in children/adolescents, weight gain.
Eye: Cataracts, glaucoma, increased intraocular pressure.
Gastrointestinal: Nausea, vomiting.
Nervous: Dizziness, headache, lightheadedness.
Psychiatry: Agitation, depression, mental disturbances.
Respiratory: Paradoxical bronchospasm, wheezing.
Skin: Acneiform lesions, atrophy, bruising, pruritus, purpura, striae.



OVERDOSAGE:

For maximum doses studied in humans, see CLINICAL STUDIES. Chronic overdosage may result in signs/symptoms of hypercorticism (see PRECAUTIONS). No deaths occurred when beclomethasone dipropionate was given as single oral doses of 3000 mg/kg to mice and 2000 mg/kg to rats (approximately 12,000 and 16,000 times, respectively, the maximum recommended human daily inhalation dose on a mg/m² basis).

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED:

Beclovent inhalation aerosol is supplied in a 6.7 g canister containing 80 metered inhalations with oral adapter and patient's instructions and in a 16.8 g canister containing 200 metered inhalations with oral adapter and patient's instructions. Also available, Beclovent inhalation aerosol refill 16.8 g canister only with patient's instructions. Each actuation delivers a quantity of clathrate equivalent to 42 μg of beclomethasone dipropionate from the mouthpiece and 50 μg from the valve.
The Beclovent inhalation aerosol canister should only be used with the tan Beclovent inhalation aerosol mouthpiece, and this mouthpiece should not be used with any other inhalation product. A dark brown cap fits over the mouthpiece when not in use.
The correct amount of medication in each inhalation cannot be assured after 80 inhalations from the 6.7 g canister or 200 inhalations from the 16.8 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations has been used.
Storage: Store between 2 and 30°C (36 and 86°F). As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold. For optimal results, the canister should be at room temperature before use. Shake well before using.
Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).
WARNING: Contains trichloromonofluoromethane (CFC-11) and dichlorodifluoromethane (CFC-12), substances which harm public health and the environment by destroying ozone in the upper atmosphere.
A notice similar to the above WARNING has been placed in the "Patient's Instructions for Use" portion of this package insert pursuant to Environmental Protection Agency (EPA) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.
 

Aerosol with Adapter -- Inhalation -- 0.042 mg/inh

6.70 gm $17.23 Beclovent Southwood Pharmaceuticals Inc 58016-6207-00

6.70 gm $24.70 Beclovent Glaxo Wellcome 00173-0469-00

6.70 gm $26.20 Beclovent Allscripts Pharmaceutical Company 55175-4466-01

16.80 gm $32.78 Vanceril Allscripts Pharmaceutical Company 54569-0067-00

16.80 gm $34.47 Vanceril Quality Care Pharmaceuticals Inc 60346-0226-76

16.80 gm $35.40 Vanceril Physicians Total Care 54868-1841-01

16.80 gm $36.98 Beclovent Allscripts Pharmaceutical Company 54569-1004-00

16.80 gm $38.13 Beclovent Southwood Pharmaceuticals Inc 58016-6207-01

16.80 gm $39.31 Vanceril Cheshire Drugs 55175-4435-01

16.80 gm $41.05 Beclovent Physicians Total Care 54868-1269-01

16.80 gm $43.02 Beclovent Allscripts Pharmaceutical Company 55175-4465-01

16.80 gm $44.94 Beclovent Glaxo Wellcome 00173-0312-88

16.80 gm $49.91 Vanceril Schering Corporation 00085-0736-04 Aerosol with Adapter -- Inhalation -- 0.084 mg/inh

4 gm x 3 $53.34 Vanceril Ds Schering Corporation 00085-1112-03

12 gm $53.33 Vanceril Ds Schering Corporation 00085-1112-01 Aerosol with Adapter -- Nasal -- 0.042 mg/inh

6.70 gm $17.23 Beconase Southwood Pharmaceuticals Inc 58016-6092-00

6.70 gm $32.64 Beconase Glaxo Wellcome 00173-0468-00

6.70 gm $47.15 Vancenase Schering Corporation 00085-0649-02

7 gm $40.15 Vancenase Pharma Pac 52959-0585-00

7 gm $45.55 Vancenase Allscripts Pharmaceutical Company 54569-3656-00

16.80 gm $32.78 Beconase Allscripts Pharmaceutical Company 54569-0237-00

16.80 gm $34.47 Beconase Quality Care Pharmaceuticals Inc 60346-0338-76

16.80 gm $35.41 Beconase Physicians Total Care 54868-1243-01

16.80 gm $37.44 Beconase Southwood Pharmaceuticals Inc 58016-6092-01

16.80 gm $39.21 Beconase Cheshire Drugs 55175-2570-01

16.80 gm $57.10 Beconase Glaxo Wellcome 00173-0336-02

17 gm $37.44 Vancenase Southwood Pharmaceuticals Inc 58016-6075-01 Spray -- Nasal -- 0.042 mg/inh

25 gm $32.75 Beconase Aq Allscripts Pharmaceutical Company 54569-1729-01

25 gm $37.55 Beconase Aq Quality Care Pharmaceuticals Inc 60346-0308-81

25 gm $38.10 Beconase Aq Physicians Total Care 54868-0175-01

25 gm $42.22 Beconase Aq Cheshire Drugs 55175-1893-01

25 gm $44.00 Beconase Aq Southwood Pharmaceuticals Inc 58016-6451-01

25 gm $58.56 Beconase Aq Glaxo Wellcome 00173-0388-79 Spray -- Nasal -- 0.084 mg/inh

19 gm $57.72 Vancenase Aq Ds Schering Corporation 00085-1049-01

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