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Beclomethasone dipropionate, USP, the active component of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol, is an anti-inflammatory corticosteroid having the chemical name 9-Chloro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone 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 the 9(alpha) carbon in place of fluorine and in having a 16(beta)-methyl group instead of a 16(alpha)-methyl group.
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Beclomethasone dipropionate is a white to creamy white, odorless powder with a molecular formula of C 28 H 37 ClO 7 , 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.
VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is a pressurized metered-dose aerosol unit containing a microcrystalline suspension of beclomethasone dipropionate-trichloromonofluoromethane clathrate in a mixture of propellants (trichloromonofluoromethane and dichlorodifluoromethane) with oleic acid. Each canister contains beclomethasone dipropionate-trichloromonofluoromethane clathrate having a molecular proportion of beclomethasone dipropionate, USP, to trichloromonofluoromethane between 3:1 and 3:2. Each actuation delivers a quantity of clathrate equivalent to 84 mcg of beclomethasone dipropionate, USP from the mouthpiece and 100 mcg of beclomethasone dipropionate from the valve. The contents of the 5.4 g and 12.2 g canisters provide 40 and 120 oral inhalations, respectively (see HOW SUPPLIED ).
Animal studies showed that beclomethasone dipropionate has potent anti-inflammatory activity. When 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.
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 principal 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 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% to 15% of an orally administered dose of beclomethasone dipropionate was excreted in the urine as both conjugated and free metabolites of the drug.
The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. The precise mechanism of the aerosolized drug' action in the lung is also unknown.
Clinical Trials: The efficacy of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol was compared with VANCERIL Inhaler (42 mcg/actuation) 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 BID dosing. FEV 1 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 Inhaler were both significantly more effective (p</=0.01) than placebo in improving FEV 1 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 Inhaler when administered at the same total daily dose.
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.
The potential for VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol (84 mcg/actuation) to cause HPA axis suppression was compared with VANCERIL Inhaler (42 mcg/actuation) 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; 2) 420 mcg twice daily of VANCERIL Inhaler; 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 Inhaler preparations as compared with placebo. However, there were significant (p</=0.01) attenuations of the plasma cortisol concentration responses to cosyntropin stimulation in the prednisone-treated group compared with the placebo-treated group.
In another study with VANCERIL Inhaler, 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 beclomethasone 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<0.01) reduction in plasma cortisol responses to tetracosactrin stimulation. The effects of a more prolonged period of beclomethasone dipropionate administration on HPA function have not been evaluated.
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.
VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy. VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is also indicated for asthma patients who require systemic corticosteroid administration, where adding VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol may reduce or eliminate the need for systemic corticosteroids.
VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
VANCERIL 84 mcg DOUBLE STRENGTH 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.
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Particular care is needed in patients who are transferred from systemically active corticosteroids to VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate . After withdrawal 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 insufficiency when exposed to trauma, surgery, or infections, particularly gastroenteritis. Although VANCERIL 84 mcg DOUBLE STRENGTH 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 emergencies. During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume systemic corticosteroids (in large doses) immediately and to contact their physician for further instruction. 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 asthmatic 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 periodically in all patients. An early morning resting cortisol level may be accepted as normal only if it falls at or near the normal mean level. |
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 84 mcg DOUBLE STRENGTH Inhalation Aerosol.
VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is not a bronchodilator and is, therefore, not indicated for rapid relief of bronchospasm.
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 84 mcg DOUBLE STRENGTH Inhalation Aerosol. During such episodes, patients may require therapy with systemic corticosteroids.
Transfer of patients from systemic corticosteroid therapy to VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, eg, rhinitis, conjunctivitis, and eczema.
Patients who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken-pox and measles, for example, can have a more serious or even fatal course in non-immune 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 disseminated infection is not known. The contribution of 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 in eyes.
During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, eg, joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement of respiratory function. (See DOSAGE AND ADMINISTRATION for details.)
In responsive 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 can be systemically active, lack of HPA suppression by VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol may be expected only when recommended dosages are not exceeded.
The long-term local and systemic effects of VANCERIL 84 mcg DOUBLE STRENGTH 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.
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.
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.
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 an mg/m 2 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 an mg/m 2 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 (approximately 11 times the maximum recommended human daily inhalation dose on an mg/m 2 basis
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/m 2 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 an mg/m 2 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.
Nursing Mothers: Corticosteroids are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from VANCERIL 84 mcg DOUBLE STRENGTH 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: Safety and effectiveness in pediatric patients below the age of 6 years have not been established.
Information for Patients: Patients being treated with VANCERIL 84 mcg DOUBLE STRENGTH 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.
Patients should use VANCERIL 84 mcg 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 the condition worsens.
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.
Patients should also be advised that VANCERIL 84 mcg 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.
Patients should be advised to rinse his/her mouth each time after using VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol.
VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol should not be stopped abruptly. If discontinuing use of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is necessary, the patient' physician should be contacted immediately.
In a 4-week, randomized, double-blind, placebo-controlled clinical trial, the incidence of adverse events reported for VANCERIL 84 mcg DOUBLE STRENGTH 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 84 mcg DOUBLE STRENGTH Inhalation Aerosol (regardless of relationship to treatment) and that occurred more frequently than placebo are displayed in the following table.
In a 4-week, randomized, double-blind clinical study, there were no reports of oral candidiasis in patients receiving VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol (0/103) (see ).
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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).
Autonomic Nervous System: Lacrimation.
Body as a Whole: Increased allergy symptoms, chest pain, fever, rigors.
Gastrointestinal System: Diarrhea, nausea, rectal hemorrhage.
Hearing and Vestibular: Earache.
Heart Rate and Rhythm: Tachycardia.
Musculoskeletal Arthralgia, pain.
Psychiatric: Depression, insomnia.
Respiratory System: Bronchitis, bronchospasm, chest congestion, dysphonia, upper respiratory infection.
Skin and Appendages: Rash, skin discoloration, urticaria.
Special Senses: Taste perversion.
Urinary System: Urinary tract infection.
Vascular (Extracardiac): Migraine
White Cell and Reticuloendothelial System: Lymphadenopathy.
Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate. (See .)
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 by oral inhalation for 1 month. Some patients receiving orally inhaled beclomethasone dipropionate have complained of hoarseness or dry mouth.
Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronchospasm have been reported following the oral and intranasal inhalation of beclomethasone.
Rare cases of hypercorticism, adrenal insufficiency, growth inhibitory effects, cataracts, glaucoma, and hyperglycemia have been reported with inhaled corticosteroids.
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 times, respectively, the maximum recommended human daily inhalation dose on an mg/m 2 basis
VANCERIL 84 mcg DOUBLE STRENGTH 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.
Adults: The usual recommended dosage is two inhalations (168 mcg) given twice daily. In patients with severe asthma, it is advisable to start with 6 to 8 inhalations a day and adjust the dosage downward according to the response of the patient. The maximal daily intake should not exceed 10 inhalations, 840 mcg (0.84 mg), in adults.
Children 6 to 12 Years of Age: The usual recommended dosage is two inhalations (168 mcg) given twice daily. The maximal daily intake should not exceed 5 inhalations, 420 mcg (0.42 mg), in children 6 to 12 years of age. Insufficient clinical data exist with respect to the administration of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol in children below the age of 6.
Rinsing the mouth after inhalation is advised.
Different considerations must be given to the following groups of patients in order to obtain the full therapeutic benefit of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol.
Patients Not Receiving Systemic Corticosteroids Patients who require maintenance therapy of their asthma may benefit from treatment with VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol at the doses recommended above. In patients who respond to VANCERIL 84 mcg DOUBLE STRENGTH 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.
Patients Maintained on Systemic Corticosteroids Clinical studies have shown that beclomethasone dipropionate may be effective in the management of asthmatics dependent or maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.
The patient' asthma should be reasonably stable before treatment with VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is started. Initially, VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol should be used concurrently with the patient' 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 corticosteroid 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.
During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.
Directions for Use: Illustrated Patient' Instructions for Use accompany each package of VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol.
CONTENTS UNDER PRESSURE. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children.
VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol 12.2 g canisters containing 120 metered inhalations, in boxes of one (NDC 0085-1112-01); 5.4 g canisters containing 40 metered inhalations for Institutional Use only, in boxes of one (NDC 0085-1112-02); and 5.4 g canisters containing 40 metered inhalations, in boxes of three (NDC 0085-1112-03). Each canister is supplied with a dark-pink plastic actuator with a maroon cap and each package contains a Patient' Instructions for Use. Each actuation delivers an amount of beclomethasone dipropionate-trichloromonofluoromethane clathrate equivalent to 84 mcg of beclomethasone dipropionate from the mouthpiece and 100 mcg of beclomethasone dipropionate from the valve.
The VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol canister should only be used with the VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol mouthpiece and this mouthpiece should not be used with any other inhalation drug product.
The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 12.2 g canister or 40 actuations from the 5.4 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.
Store at 15°-30°C (59°-86°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 use. Shake well before using. If the canister is enclosed in a moisture protective package, the canister must be used within 6 months after removal.
Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).
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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 "Patient' Instructions for Use" portion of this package insert pursuant to Environmental Protection Agency (EPA) regulations. The patient' warning states that the patient should consult his or her physician if there are questions about alternatives.
Schering/Key
Kenilworth, NJ 07033 USA
Copyright © 1996, 1998, 1999, Schering Corporation.
All rights reserved.
Rev. 8/99 18682141
18691450T
DOUBLE STRENGTH
(beclomethasone dipropionate, 84 mcg)
For Oral Inhalation Only
It is important that you read these instructions before using your VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol. Correct and regular use of the inhaler may prevent or lessen the severity of asthma attacks.
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IMPORTANT: VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol is preventive therapy for asthma and must be used regularly and at the times your physician has prescribed. DO NOT CONFUSE VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol WITH OTHER ASTHMA MEDICATION. VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol WILL NOT PROVIDE IMMEDIATE RELIEF IF YOU ARE HAVING AN ASTHMA ATTACK. Your physician will decide whether other medication is needed should you require immediate relief. If you also use another medicine by inhalation, you should consult your physician for instructions on when to use it in relation to using VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol. If this is the first time you will be using VANCERIL 84 mcg DOUBLE STRENGTH Inhalation Aerosol, it may take from 1 to 4 weeks before you feel the full benefits.
Dosage Use only as directed by your physician.
CONTENTS UNDER PRESSURE. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. Avoid spraying in eyes.
Store at 15°-30°C (59°-86°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 use. Shake well before using. If the canister is enclosed in a moisture protective package, the canister must be used within 6 months after removal.
Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).
This product contains and is manufactured with dichlorodifluoromethane (CFC-12) and contains trichloromonofluoromethane (CFC-11), substances which harm the environment by destroying ozone in the upper atmosphere.
Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.
Schering/Key
Kenilworth, NJ 07033 USA
Copyright © 1996, 1998, 1999, Schering Corporation.
All rights reserved.
Rev. 8/99 18682141