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`@`<\#128>```<\#9>@@4XCL2CMSD4<\#255><\#255><\#255><\#139>4t0<\#160>0<\#176>0<\#192><\#208>0p0<\#148><\#184><\#220>00  4 H \p<\#152>0<\#192>0<\#208><\#224><\#144> QGRYQRGB<\#9>QHSB QLAB QXYZQCMKPnHxPnCoToy0Dic0Tru0Foc0PnPrPnPS<\#255><\#255><\#255><\#134>the 9-a carbon in place of fluorine and in having a 16b-methyl group instead of a 16a-methyl group. <\#9>Beclomethasone dipropionate is a white to creamy white, odorless powder with a molecular formula of C28H37CIO7, and a molecular weight of 521.05. It is very slightly soluble in water, very soluble in chloroform, and freely soluble in acetone and in alcohol. <\#9>VANCERIL 42 mcg Inhalation Aerosol is a pressurized metered-dose aerosol unit containing a microcrystalline suspension of beclo-methasone dipropionate-trichloromonofluoromethane clathrate in a mixture of propellants (trichloromonofluoromethane and dichloro-difluoromethane) with oleic acid. Each canister contains beclomethasone dipropionate-trichloromonofluoromethane clathrate having a molecular proportPnUnPnHUPnHCGeneric Gray ProfileGeneric Gray ProfileApple Multiple Scan 14Apple Multiple Scan 14int#0int#0int#1int#1Color LW 12/600 PS ProfileColor LW 12/600 PS Profile<\#159><\#234><\#150>hen administered systemically to mice, the anti-inflammatory activity was accompanied by other typical features of glucocorticoid action including thymic involution, liver glycogen deposition, and pituitary-adrenal suppression. However, after systemic administration to rats, the anti-inflammatory action was associated with little or no effect on other tests of glucocorticoid activity. <\#9>Beclomethasone dipropionate is sparingly soluble and is poorly mobilized from subcutaneous or intramuscular 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 prin-cipal bronchi, and in 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 beclometha-sone 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% to 15% of an orally administered dose of beclomethasone dipropionate was excreted in the urine as both conjugated and free metabolites of the drug. <\#9>The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. The precise mechanism of the aerosolized drug<\#213>s action in the lung is also unknown. CLINICAL TRIALS The efficacy of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol was compared with VANCERIL 42 mcg Inhalation Aerosol in a 28-day, randomized, parallel-group, double-blind, placebo-controlled study in patients with moderate to severe asthma. A total of 336 mcg/day of each VANCERIL formulation or placebo was administered based on BIDdosing. FEV1 at endpoint (last valid visit for each patient) was regarded as the primary measure of efficacy. VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol and VANCERIL 42 mcg Inhalation Aerosol were both significantly more effective (p<\#178>0.01) than placebo in improving FEV1 at all time points, but were not significantly different from each other at any time point (p>0.05). Thus VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol administered twice daily to give a total daily dose of 336 mcg was comparable in efficacy to VANCERIL 42 mcg Inhalation Aerosol when administered at the same total daily dose. <\#9>The effects of beclomethasone dipropionate on hypothalamic-pituitary-adrenal (HPA) function have been evaluated in adult volunteers. There was no suppression of early morning plasma cortisol concentrations when beclomethasone dipropionate was administered at a dose of 840 mcg/day for 1 month as an aerosol or 1000 mcg/day for 3 days by intramuscular injection. However, partial suppression of plasma cortisol concentration was observed when beclomethasone dipropionate was administered at doses of 2000 mcg/day intramuscularly or 1680 mcg/day by aerosol. Immediate suppression of plasma cortisol concentrations was observed after single doses of 4000 mcg of beclomethasone dipropionate intramuscularly. <\#9>The potential for VANCERIL84 mcg DOUBLESTRENGTH Inhala-tion Aerosol (84 mcg/actuation) to cause HPA axis suppression was compared with VANCERIL 42 mcg Inhalation Aerosol in a randomized, parallel, placebo- and positive-controlled study. Sixty-four adult patients with moderate asthma received doses of either: 1) 420 mcg twice daily of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol; 2) 420 mcg twice daily of VANCERIL 42 mcg Inhalation Aerosol; 3) 10 mg of prednisone orally; or 4) placebo, for 35.5 days. The potential for HPA axis suppression was evaluated via a cosyntropin stimulation test administered on the 36th day. In response to a 6-hour cosyntropin 250 mcg infusion, there was no evidence of HPA axis suppression associated with either VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol or VANCERIL 42 mcg Inhalation Aerosol preparations as compared with placebo. However, there were significant (p<\#178>0.01) attenuations of the plasma cortisol concentration responses to cosyntropin stimulation in the prednisone-treated group compared with the placebo-treated group. <\#9>In another 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 mcg of beclo-methasone dipropionate for 28 days. After daily aerosol administration of 1344 mcg for 28 days, there was a slight reduction in basal cortisol concentrations and a statistically significant (p<.01) reduction in plasma cortisol responses to tetracosactrin stimulation. The effects of a more prolonged period of beclomethasone dipro-pionate administration on HPA function have not been evaluated. <\#9>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 corticosteroid 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 VANCERIL 42 mcg Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy. VANCERIL 42 mcg Inhalation Aerosol is also indicated for asthma patients who require systemic corticosteroid administration, where adding VANCERIL 42 mcg Inhalation Aerosol may reduce or eliminate the need for systemic corticosteroids. <\#9>VANCERIL 42 mcg Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. CONTRAINDICATIONS VANCERIL 42 mcg Inhalation Aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. <\#9>Hypersensitivity to any of the ingredients of this preparation contraindicates its use. WARNINGS Particular care is needed in patients who are transferred from systemicalD<\#255><\#255>$d<<\#200>'<\#148><\#255><\#255><\#255><\#255>$<\#128>$<\#128>$<\#128>$<\#128> <\#225>Hda<\#132>$d<<\#200>'&<\#184><\#255><\#255><\#255>$<\#128>$<\#128>$<\#128>$<\#128> <\#225>H$<\#200><,'-H<\#255><\#255>wal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insuffi-ciency when exposed to trauma, surgery, or infections, particularly gastroenteritis. Although VANCERIL 42 mcg Inhalation Aerosol may provide control of asthmatic symptoms during these episodes, it does NOT provide the systemic steroid which is necessary for coping with these emePRODUCT INFORMATION VANCERIL<\#168> Inhaler 42 mcg (beclomethasone dipropionate, 42 mcg), USP Inhalation Aerosol For Oral Inhalation Only<\#144>\<\#143>J<\#172><\#138>g /,<\#138>?<(<\#169><\#231>?</,~ ln h<\#202>N<\#144>\<\#143> ln h<\#146> <\#172>z`<\#136> l<\#138> PJhLgz?,<\#136>/,<\#138>N<\#186><\#239>J\<\#143>-@<\#253><\#170>gd n<\#253><\#170><\#160>)/*<\#160><\#169><\#217> n<\#253><\#170> PHhN<\#186>!<\#246>X<\#143>Bg lrgencies. During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroiids should be instructed to resume systemic steroids (in large doses) immediately and to contact their physician for further inruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack. To assess the risk of adrenal insufficiency in emergency situations, routine tests of adrenal cortical function, including measurement of early morning resting cortisol levels, should be performed periodi-cally in all patients. An early morning resting cortisol level may be accepted as normal only if it falls at or neeear the normal mean level. <\#9>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 discontinuance of treatment with VANCERIL 42 mcg Inhalation Aerosol. <\#9>VANCERIL 42 mcg Inhalation Aerosol is not a broncho-dilator and is, therefore, not indicated for rapid relief of bronchospasm. <\#9>Patients should be instructed to contact their physician immediately when episodes of asthma which are not responsive to bronchodilators occur during the course of treatment with VANCERIL 42 mcg Inhalation Aerosol. During such episodes, patients may require therapy with systemic corticosteroids. <\#9>Transfer of patients from systemic corticosteroid therapy to VANCERIL 42 mcg Inhalation Aerosol may unmask allergic conditions previously suppressed by the systemic steroid therapy, eg, rhinitis, conjunctivitis, and eczema. <\#9>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 children or adults who have not had these diseases, particular care should be taken to avoid exposure to these infectious agents. How the dose, route, and duration of corticosteroid administration affects 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 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 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 into eyes. Precautions During withdrawal from oral corticosteroids, some patily active corticosteroids to VANCERIL 42 mcg Inhala-tion Aerosol because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate. After withdraaents may experience symptoms of systemically active cortico-steroid withdrawal, eg, joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement of respira-tory function. (See DOSAGE AND ADMINISTRATION for details.) <\#9>In rean be systemically active, lack of HPA suppression by VANCERIL 42 mcg Inhalation Aerosol may be expected only when recommended dosages are not exceeded. <\#9>The long-term local and systemic effects of VANCERIL 42 mcg Inhalation Aerosol in human subjects are still not fully known. In particular, the effects resulting from chronic use of the agent on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown. <\#9>Inhaled corticosteroids 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. <\#9>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. <\#9>Carcinogenesis, Mutagenesis, 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 23 times the maximum recommended human daily inhalation dose on a mg/m2 basis. 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 inhalation route at an estimated daily dose of 0.33 mg/kg (or approximately 11 times the maximum recommended human daily inhalation dose on a mg/m2 basis). <\#9>Pregnancy Category C: Like other corticosteroids, parenteral (subcutaneous) beclomethasone dipropionate was teratogenic and embryocidal in the mouse and 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 mice and rabbits were approximately one half the maximum recommended human daily inhalation dose on an 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 daily dose of 10.1 mg/kg (approximately 97 times the maximum recommended human daily inhalation dose on a mg/m2 basis). There are no adequate and well-controlled studies in pregnant women. Beclomethasone dipro-pionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. <\#9>Nursing Mothers: Corticosteroids are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from VANCERIL 42 mcg 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. <\#9>Pediatric Use: Safety and effectiveness in pediatric patients below the age of 6 years have not been established. <\#9>Information for Patients: Patients being treated with VANCERIL 42 mcg Inhalation Aerosol should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. <\#9>Patients should use VANCERIL 42 mcg 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 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. <\#9>Patients should be warned to avoid exposure to chickenpox or measles. Patients should be advised that if they are exposed, medical advice should be sought without delay. <\#9>Patients should also be advised that VANCERIL 42 mcg 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. <\#9>Patients should be advised to rinse his/her mouth each time after using VANCERIL 42 mcg Inhalation Aerosol. <\#9>VANCERIL 42 mcg Inhalation Aerosol should not be stopped abruptly. If discontinuing use is necessary, the patient<\#213>s physician should be contacted immediately. ADVERSE REACTIONS In a 4-week, randomized, double-blind, placebo-controlled trial, the incidence of adverse events reported for VANCERIL 42 mcg Inhalation Aerosol was similar to that reported for placebo. Adverse event rates did not appear to differ significantly based on age, sex, or race. Adverse events that were reported by 2% or more of patients receiving VANCERIL 42 mcg Inhalation Aerosol (regardless of relationship to treatment) and that occurred more frequently than placebo are displayed in the table below. <\#9>In a 4-week, randomized, double-blind, placebo-controlled clinical study, there was one report of oral candidiasis in patients receiving VANCERIL 42 mcg Inhalation Aerosol (1/104) (see WARNINGS). ADVERSE EVENTS FROM A 4-WEEK PLACEBO-CONTROLLED CLINICAL TRIAL IN PATIENTS WITH ASTHMA PERCENT OF PATIENTS REPORTING <\#9><\#9>VANCERIL 42 mcg <\#9><\#9>Inhalation Aerosol <\#9><\#9>(336 mcg/day)<\#9>Placebo <\#9><\#9>n=104<\#9>n=109 <\#9>Headache<\#9>27<\#9>18 <\#9>Pharyngitis<\#9>11<\#9>8 <\#9>Coughing<\#9>7<\#9>4 <\#9>Dyspepsia<\#9>6<\#9>2 <\#9>Nasal Congestion<\#9>5<\#9>2 <\#9>Sneezing<\#9>2<\#9>0 <\#9>In addition to those adverse events reported in the table above, the following adverse events have been reported in fewer than 2% of patients (regardless of relationship to treatment): <\#9>Body as a Whole: Chest pain, fever, influenza-like symptoms, rigors. <\#9>Central and Peripheral Nervous System: Paresthesia. <\#9>Gastrointestinal System: Nausea, stomatitis, vomiting. <\#9>Musculoskeletal: Arthralgia, costochondritis, myalgia. <\#9>Resistance Mechanism: Cold sores, otitis media. <\#9>Respiratory System: Dyspnea, wheezing. <\#9>Skin sponsive patients, beclomethasone dipropionate may permit control of asthmatic symptoms without suppression of HPA function, as discussed above. (See CLINICAL PHARMACOLOGY.) Since inhaled beclomethasone dipropionate is absorbed into the circulation and cand Appendages: Skin disorder. <\#9>Special Senses: Taste perversion, abnormal vision. <\#9>Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate. (SDESCRIPTION Beclomethasone dipropionate, USP, the active component of VANCERIL 42 mcg (beclomethasone dipropionate, 42 mcg) Inhalation Aerosol, is an anti-inflammatory corticosteroid having the chemical name 9-Chloro-11b,17,21-trihydroxy-16b-methylpregospasm have been reported following the oral and intranasal inhalation of beclomethasone. <\#9>Rare cases of hypercorticism, adrenal insufficiency, growth inhibitory effects, cataracts, glaucoma, and hyperglycemia have been reported with inhaled corticosteroid<\#153><\#153><\#255><\#255><\#153><\#153>ff<\#255><\#255><\#153><\#153>33<\#255><\#255><\#153><\#153><\#255><\#255>ff<\#255><\#255><\#255><\#255>ff<\#204><\#204><\#255><\#255>ff<\#153><\#153><\#255><\#255>ffff<\#255><\#255>ff33<\#255><\#255>ff<\#255><\#255>33<\#255><\#255><\#255><\#255>33<\#204><\#204><\#255><\#255>33<\#153><\#153><\#255><\#255>33ff<\#255><\#255>3333<\#255><\#255>33<\#255><\#255><\#255><\#255><\#255><\#255><\#204><\#204><\#255><\#255><\#153><\#153><\#255><\#255>ff<\#255><\#255>33<\#255><\#255><\#204><\#204><\#255><\#255><\#255><\#255><\#204><\#204><\#255><\#255><\#204><\#204><\#204><\#204><\#255><\#255><\#153><\#153><\#204><\#204><\#255><\#255>ff<\#204><\#204><\#255><\#255>33<\#204><\#204><\#255><\#255><\#204><\#204><\#204><\#204><\#255><\#255><\#204><\#204><\#204><\#204><\#204><\#204><\#204><\#204><\#204><\#204><\#153><\#153><\#204><\#204><\#204><\#204>ff<\#255><\#255><\#255>3e<\#144><\#160><\#144><\#160><\#144><\#160>^<\#245>P<\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160><\#144><\#160>ely, the maximum recommended human daily inhalation dose on a mg/m2 basis. DOSAGE AND ADMINISTRATION<\#202><\#202>VANCERIL 42 mcg Inhalation Aerosol should be test sprayed 2 times into the air before using for the first time and in cases where the product has not been used for more than 7 days. <\#9>Adults: The usual recommended dosage is two inhalations (84 mcg) given three or four times a day. Alternatively, four inhalations (168 mcg) given twice daily have been shown to be effective in some patients. In patients with severe asthma, it is advisable to start with 12 to 16 inhalations a day and adjust the dosage downward according to the response of the patient. The maximal daily intake should not exceed 20 inhalations, 840 mcg (0.84 mg), in adults. <\#9>Pediatric Patients 6 to 12 Years of Age: The usual recommended dosage is one or two inhalations (42 to 84 mcg) given three or four times a day according to the response of the patient. Alternatively, four inhalations (168 mcg) given twice daily have been shown to be effective in some patients. The maximal daily intake should not exceed 10 inhalations, 420 mcg (0.42 mg), in pediatric patients 6 to 12 years of age. Insufficient clinical data exist with respect to the administration of VANCERIL 42 mcg (beclomethasone dipropionate, 42 mcg)Inhalation Aerosol in pediatric patients below the age of 6. <\#9>Rinsing the mouth after inhalation is advised. <\#9>Different considerations must be given to the following groupsof patients in order to obtain the full therapeutic benefit ofVANCERIL 444 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<\#129><\#242><\#251><\#255><\#248><\#250><\#255><\#210><\#129><\#239><\#241><\#255><\#207><\#255><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236><\#236>2 mcg (beclomethasone dipropionate, 42 mcg) Inhala-tion Aerosol. <\#9>Patients Not Receiving Systemic Corticosteroids: Patients who require maintenance therapy of their asthma may benefit from treatment with VANCERIL 42 mcg Inhalation Aerosol at the doses recommended above. In patients who respond to VANCERIL 42 mcg Inhalation Aerosol, improvement in pulmonary function is usually apparent within 1 to 4 weeks after the start of therapy. Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose. <\#9>Patients Maintained on Systemic Corticosteroids: In those patients dependent on systemic steroids, transfer to VANCERIL 42 mcg Inhalation Aerosol and subsequent management may be more difficult because recovery from impaired adrenal function is usually slow. Such suppression has been known to last for up to 12 months. Clinical studies, however, have demonstrated that VANCERIL 42 mcg Inhalation Aerosol may be effective in the management of these asthmatic patients and may permit replacement or significant reduction in the dosage of systemic cortico-steroids. <\#9>The patient<\#213>s asthma should be reasonably stable before treatment with VANCERIL 42 mcg Inhalation Aerosol is started. Initially, VANCERIL 42 mcg Inhalation Aerosol should be used concurrently with the patient<\#213>s usual maintenance dose of systemic corticosteroid. After approximately 1 week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of 1 or 2 weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. During withdrawal, some patients may experience symptoms of systemic cortico-steroid withdrawal, eg, joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. <\#9>During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids. <\#9>Directions for Use: Illustrated Patient<\#213>s Instructions for proper use accompany each package of VANCERIL 42 mcg Inhalation Aerosol. <\#9>CONTENTS UNDER PRESSURE. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120<\#161>F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. HOW SUPPLIED VANCERIL 42 mcg Inhalation Aerosol 16.8 g canisters containing 200 metered inhalations in boxes of one (NDC 0085-0736-04). Each canister is supplied with a light-pink plastic actuator with a maroon cap and Patient<\#213>s Instructions for Use. Each actuation delivers an amount of beclomethasone dipropionate-trichloromonofluoromethane clathrate equivalent to 42 mcg of beclomethasone dipropionate from the mouthpiece and 50 mcg of beclomethasone dipropionate from the valve. <\#9>The VANCERIL 42 mcg Inhalation Aerosol canister should only be used with the VANCERIL 42 mcg Inhalation Aerosol mouthpiece and this mouthpiece should not be used with any other inhalation drug product. <\#9>The correct amount of medication in each inhalation cannot be assured after 200 actuations from the 16.8 g canister or 80 actuations from the 6.7 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. <\#9>Store between 15<\#161> and 30<\#161>C (59<\#161> and 86<\#161>F). Protect from moisture and unusual temperature fluctuations. Failure to use the product within this temperature range may result in improper dosing. For optimal results, the canister should be at room temperature before using. Shake well before using. Note: The indented statement below is required by the Federal government<\#213>s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs). WARNING: Contains dichlorodifluoromethane (CFC-12) and trichloromonofluoromethane (CFC-11), and is manufactured with 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 <\#210>Patient<\#213>s Instructions For Use<\#211> portion of this package insert pursna-1,4-diene-3,20-dione 17,21-dipropionate. Beclo-methasone 17,21-dipropionate is a diester of beclomethasone, a synthetic corticosteroid which is chemically related to dexamethasone. Beclomethasone differs from dexamethasone only in having a chlorine at uant to Environmental Protection Agency (EPA) regulations. The patient<\#213>s warning states that the patient should consult his or her physician if there are questions about alternatives. Schering CorporationKenilworth, NJ 07033 USA Rev. 8/00<\#9>B-20108932 Copyds should be instructed to resume systemic steroids (in large doses) immediately and to contact their physician for further inst<\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255>y oral inhalation for 1 month. Some patients receiving orally inhaled beclomethasone dipropionate have complained of hoarsenesssor dry mouth. <\#9>Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronion of beclomethasone dipropionate, USP, to trichloromonofluoromethane between 3:1 and 3:2. Each actuation delivers a quantity of clathrate equivalent to 42 mcg of beclomethasone dipropionate, USP from the mouthpiece and 50 mcg beclo-methasone dipropion or dry mouth. <\#9>Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronch<\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255>e WARNINGS.) <\#9>Suppression of HPA function (reduction of early morning plasma cortisol levels)has been reported in adult patients who received 1344 mcg daily doses (approximately twice the maximum recommended daily dose) of beclomethasone dipropionate bate from the valve. The contents of the 6.7 g and 16.8 g canisters provide 80 and 200 oral inhalations, respec-tively (see HOW SUPPLIED). CLINICAL PHARMACOLOGY Animal studies showed that beclo-methasone dipropionate has potent anti-inflammatory activity.UPPLIED). CLINICAL PHARMACOLOGY Animal studies showed that beclo-methasone dipropionate has potent anti-inflammatory activity. WY, <\#171>0 PY*@ Y/Y*@<\#255><\#255><\#255><\#255><\#255><\#255><\#255><\#255>Y-<\#240>Y/Y*@s. OVERDOSAGE There were no deaths over 15 days following the oral administration of a single dose of 3000 mg/kg in mice, 2000 mg/kg in rats, and 1000 mg/kg in rabbits. The doses in mice, rats, and rabbits were 14,500, 19,300, and 19,300 times, respectivout alternatives. Schering CorporationKenilworth, NJ 07033 USA Rev. 8/00<\#9>20108932 Copyright <\#169> 1973, 1995, 1996, 1997, Schering Corporation. 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