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Qvar

Qvar(beclomethasone dipropionate) – Teva

THERAPEUTIC CLASS

Corticosteroid

INDICATIONS

Maint treatment of asthma as prophylactic therapy in patients ≥5 yrs. To reduce or eliminate the need for systemic corticosteroids in asthma patients requiring systemic corticosteroid administration.

ADULT DOSAGE

Adults: Previously on Bronchodilators Alone: Initial: 40-80mcg bid. Max: 320mcg bid. Previously on Inhaled Corticosteroids: Initial: 40-160mcg bid. Max: 320mcg bid. Taper to the lowest effective dose once desired effect is achieved. Maintained on Systemic Corticosteroids: Initial: Should be used concurrently with the usual maint dose of systemic corticosteroids. May attempt gradual reduction of systemic corticosteroid dose after 1 week on inhaled therapy by reducing the daily or alternate daily dose. Reductions may be made after an interval of 1 or 2 weeks, depending on the response. Elderly: Start at lower end of dosing range.

PEDIATRIC DOSAGE

Pediatrics: ≥12 yrs: Previously on Bronchodilators Alone: Initial: 40-80mcg bid. Max: 320mcg bid. Previously on Inhaled Corticosteroids: Initial: 40-160mcg bid. Max: 320mcg bid. 5-11 yrs: Previously on Bronchodilators Alone/Inhaled Corticosteroids: Initial: 40mcg bid. Max: 80mcg bid. Taper to the lowest effective dose once desired effect is achieved. Maintained on Systemic Corticosteroids: Initial: Should be used concurrently with the usual maint dose of systemic corticosteroids. May attempt gradual reduction of systemic corticosteroid dose after 1 week on inhaled therapy by reducing the daily or alternate daily dose. Reductions may be made after an interval of 1 or 2 weeks, depending on the response.

HOW SUPPLIED

MDI: 40 mcg/inh [7.3g, 8.7g], 80 mcg/inh [4.2g, 7.3g, 8.7g]

CONTRAINDICATIONS

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

WARNINGS/PRECAUTIONS

Deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids to inhaled corticosteroids; monitor carefully. Resume oral corticosteroids (in large doses) immediately during stress or severe asthmatic attack. Transfer from systemic to inhalation therapy may unmask allergic conditions (eg, rhinitis, conjunctivitis, eczema). Risk for more severe/fatal course of infections (eg, chickenpox, measles); avoid exposure in patients who have not had these diseases or been properly immunized. If exposed, consider prophylaxis/treatment. Not a bronchodilator and is not indicated for rapid relief of bronchospasm. D/C, treat, and institute alternative therapy if bronchospasm occurs after dosing. Observe for systemic corticosteroid effects (eg, hypercorticism and adrenal suppression); if such changes appear, reduce dose slowly. Potential for reduced growth velocity in pediatrics. Caution with active or quiescent tuberculosis (TB) infection, untreated systemic fungal, bacterial, parasitic, or viral infections, or ocular herpes simplex. Rare instances of glaucoma, increased intraocular pressure (IOP), and cataracts reported. Caution in elderly.

ADVERSE REACTIONS

Headache, pharyngitis, upper respiratory tract infection, rhinitis, increased asthma symptoms, oral symptoms (inhalation route), sinusitis, dysphonia, dysmenorrhea, coughing.

PREGNANCY

Category C, not for use in nursing.

MECHANISM OF ACTION

Corticosteroid; has multiple anti-inflammatory effects, inhibiting both inflammatory cells (eg, mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and release of inflammatory mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines). These anti-inflammatory actions contribute to the efficacy in asthma.

PHARMACOKINETICS

Absorption: (Beclomethasone) Cmax=88pg/mL, Tmax= 0.5 hr; (Beclomethasone-17-monopropionate [17-BMP]) Cmax=1419pg/mL, Tmax=0.7hr. Distribution: Found in breast milk; plasma protein binding (94-96%, 17-BMP) (in vitro). Metabolism: Liver (biotransformation) via CYP3A; 17-BMP, beclamethasone-21-monopropionate, beclomethasone (major metabolites). Elimination: Feces, urine (<10%); T1/2= 2.8 hrs (17-BMP).

ASSESSMENT

Assess for status asthmaticus, active or quiescent TB infections, untreated systemic fungal, bacterial, parasitic or viral infections, ocular herpes simplex, exposure to chickenpox or measles, and pregnancy/nursing status.

MONITORING

Monitor for bronchospasm, growth velocity in children, glaucoma, increased IOP, cataracts, hypercorticism, adrenal suppression/insufficiency, hypersensitivity reactions, and other adverse effects.

PATIENT COUNSELING

Inform about the risks and benefits of therapy. Advise to avoid exposure to chickenpox or measles; consult physician if exposed. Instruct to use drug at regular intervals as directed and should not be stopped abruptly. Inform that drug is not intended for treatment of acute asthma. Counsel about the proper priming/use of inhaler and advise to rinse mouth after use. Advise to seek medical attention if worsening of existing TB, infections, or ocular herpes simplex occur, if symptoms do not improve or worsen, or during periods of stress or severe asthmatic attack.

ADMINISTRATION/STORAGE

Administration: Oral inhalation route. Prime prior to initial use or if not used for over 10 days. Refer to PI for directions for use. Should only be used with product's actuator and should not be used with any other inhalation drug product. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). For optimal results, canister should be at room temperature when used.


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    QVAR

    QVAR

    Pronunciation Generic Name: Beclomethasone Dipropionate
    Class: Adrenals

    VA Class: NT200

    Molecular Formula: C28H37ClO7

    CAS Number: 5534-09-8

    For ProfessionalsSide EffectsInteractionsMore…

    Introduction

    Synthetic corticosteroid;2 149 minimal mineralocorticoid activity.149 a

    Uses for QVAR

    Asthma

    Used for the long-term prevention of bronchospasm in patients with asthma.1 2 8 21 24 25 26 103 112 113 116 144 149 152

    Should not be used in the treatment of nonasthmatic bronchitis.1 28 112 113 144

    Chronic Obstructive Pulmonary Disease

    Efficacy in patients with chronic obstructive pulmonary disease (e.g., bronchitis)† who are stabilized with oral corticosteroids33 34 37 117 or whose disease is corticosteroid responsive117 118 remains to be fully evaluated.

    Inflammatory Conditions of the GI Tract

    Has been used as an oral solution35 or rectal suspension36 (these dosage forms not commercially available in the US) in the management of inflammatory diseases of the GI tract† (e.g., inflammatory bowel disease†, eosinophilic gastroenteritis†).35 36 However, the role of beclomethasone dipropionate in the management of inflammatory conditions of the GI tract remains to be established.35 36

    QVAR Dosage and Administration

    General

    • Adjust dosage carefully according to individual requirements and response.1 2 61 83 112 113 144 149

    • After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response.149 150 Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth.149 150 (See Pediatric Use under Cautions.)

    Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

    • When switching from systemic corticosteroids to orally inhaled beclomethasone dipropionate, asthma should be reasonably stable before initiating treatment with the oral inhalation.1 2 112 113 144 149

    • Initially, administer the aerosol concurrently with the maintenance dosage of the systemic corticosteroid.1 2 112 113 144 149 After about 1 week, gradually withdraw the systemic corticosteroid.1 2 112 113 144 149
    • Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.1 2 112 113 144 149 (See Withdrawal of Systemic Corticosteroid Therapy under Warnings.)
    • If exacerbations of asthma occur after transfer to oral inhalation therapy, administer short courses of systemic corticosteroids, then taper dosage as symptoms subside.1 2 112 113 144 149

    Administration

    Oral Inhalation

    Administer by oral inhalation using an oral aerosol inhaler.149

    Test-spray inhalation aerosol (2 times) before first use or whenever the aerosol not used for prolonged periods (>10 days).149 b

    Oral inhalation aerosol is formulated as a solution, which does not require shaking.149

    Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed firmly around it; keep the tongue below the mouthpiece.b Inhale slowly and deeply through the mouth while actuating the inhaler.b Hold the breath for as long as possible (about 5–10 seconds), withdraw the mouthpiece, and exhale gently.b If additional inhalations are required, repeat the procedure.b

    Rinse the mouth thoroughly with water to remove drug deposited in the oropharyngeal area.33 48 49 52 59 149 b

    Clean the mouthpiece weeklyb using a clean, dry tissue or cloth.b Do not wash or place any part of the inhaler canister in water.b

    Dosage

    Available as beclomethasone dipropionate; dosage expressed in terms of the salt.b 149

    Oral inhalation aerosol releases 50 or 100 mcg of beclomethasone dipropionate, and delivers 40 or 80 mcg, respectively, from the actuator (mouthpiece) per metered spray.149

    Pediatric Patients

    Asthma
    Oral Inhalation

    Children 5–11 years of age receiving bronchodilators alone or inhaled corticosteroids previously: Initially, 40 mcg twice daily.149 If required, dosage may be increased to a maximum 80 mcg twice daily.149

    Children ≥12 years of age receiving bronchodilators alone previously: Initially, 40–80 mcg twice daily.149 If required, dosage may be increased to a maximum 320 mcg twice daily.149

    Children ≥12 years of age receiving inhaled corticosteroids previously: Initially, 40–160 mcg twice daily. If required, dosage may be increased to a maximum 320 mcg twice daily.

    Adults

    Asthma
    Oral Inhalation

    In adults receiving bronchodilators alone previously: Initially, 40–80 mcg twice daily.149 If required, dosage may be increased to a maximum 320 mcg twice daily.149

    Adults receiving inhaled corticosteroids: Initially, 40–160 mcg twice daily. If required, dosage may be increased to a maximum of 320 mcg twice daily.

    Prescribing Limits

    Pediatric Patients

    Asthma
    Oral Inhalation

    Children 5–11 years of age: Maximum 80 mcg twice daily.149

    Children ≥12 years of age: Maximum 320 mcg twice daily.149

    Adults

    Asthma
    Oral Inhalation

    Maximum 320 mcg twice daily.149

    Special Populations

    Geriatric Patients

    Consider initial dosages at the lower end of the usual range due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.149

    Cautions for QVAR

    Contraindications

    • Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures1 2 29 112 113 149 (e.g., oxygen, parenteral bronchodilators, IV corticosteroids)147 are required.

    • Known hypersensitivity to the drug or any ingredient in the formulation.1 2 112 113 144 149

    Warnings/Precautions

    Warnings

    Withdrawal Of Systemic Corticosteroid Therapy

    Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression);1 2 112 113 144 149 acute adrenal insufficiency;1 2 112 113 144 life-threatening exacerbation of asthma;1 2 112 113 144 149 pulmonary infiltrates with eosinophilia;1 112 113 or symptomatic exacerbation of allergic conditions1 2 27 44 52 58 70 112 113 144 if prolonged systemic corticosteroid therapy is replaced with oral inhalation corticosteroid therapy.1 2 112 113 144 149 Such symptoms may be observed especially in patients maintained on ≥20 mg of prednisone (or its equivalent) daily and particularly during the later part of the transfer.149

    In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by orally inhaled corticosteroids.73

    Taper the dosage of the systemic corticosteroid, and carefully monitor patients during dosage reduction for objective signs of adrenal insufficiency (e.g., hypotension, weight loss).1 2 112 113 144 149

    Immunosuppressed Patients

    Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals.113 134 135 136 137 138 139 140 141 142 143 144 Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children.113 134 135 136 137 138 139 140 141 142 143 144

    Exposure to varicella and measles should be avoided in previously unexposed patients.b If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or immune globulin (IG), respectively.b Consider treatment with an antiviral agent if varicella develops.b

    Concomitant Therapy

    Use with caution in patients receiving systemic prednisone for any disease.45 47 Concomitant use with prednisone in an alternate-day or daily dosing regimen could increase the likelihood of HPA-axis suppression compared with therapeutic dosages of either drug alone.45 47

    Resume systemic corticosteroids during periods of stress (e.g., infection, trauma, surgery) or a severe asthma exacerbation in patients who were attempting a switch from systemic to orally inhaled corticosteroid therapy.149

    Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

    Avoid higher than recommended dosages of the drug, since suppression of HPA function may occur.149 If higher than recommended dosages are used, carefully consider the relative risks of adrenal suppression and potential therapeutic benefits.149 Recommended dosages of orally inhaled drug provide less than normal physiologic amounts of glucocorticoid systemically and do not provide mineralocorticoid activity.149 Orally inhaled drug will not compensate for insufficient endogenous cortisol production caused by previous systemic corticosteroid therapy.149

    Respiratory Effects

    Bronchospasm,1 2 57 112 113 133 149 cough,20 25 58 131 132 149 and/or wheezing57 58 131 132 133 149 may occur, especially in asthmatic patients with hyperactive airways.20 25 57 58 101 131 132 133

    If bronchospasm occurs, treat immediately with a short-acting bronchodilator, and discontinue treatment with beclomethasone dipropionate and institute alternative therapy.149

    Infection

    Use with caution, if at all, in patients with clinical tuberculosis or latent M. tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, or parasitic infections; or ocular herpes simplex or untreated, systemic viral infections.1 2 100 144 149

    Sensitivity Reactions

    Immediate or delayed hypersensitivity reactions, including bronchospasm, anaphylactic/anaphylactoid reactions,2 urticaria, angioedema, and rash reported rarely.1 2 112 113 149

    General Precautions

    Systemic Corticosteroid Effects

    Possible signs and symptoms of Cushing’s syndrome (e.g., hypertension, glucose intolerance, cushingoid features) in patients who are particularly sensitive to corticosteroid effects or when usual dosages of the drug are exceeded.100 149

    Carefully monitor neonates exposed to prenatal corticosteroids for manifestations of hypoadrenalism.2 61 112 144 149

    Ocular Effects

    Glaucoma, increased intraocular pressure, and cataracts reported rarely.149

    Other Effects

    Unknown long-term, systemic, and local effects of the drug in humans, particularly developmental or immunologic processes in the mouth, pharynx, trachea, and lung.149

    Specific Populations

    Pregnancy

    Category C.149 (See Systemic Corticosteroid Effects under Cautions.)

    Lactation

    Distributed into milk.144 149 Discontinue nursing or the drug.144 149

    Pediatric Use

    Safety and efficacy not established in children <5 years of age.149 No overall differences in the pattern, severity, or frequency of adverse events in children 5–12 years of age compared with those in adults.149 Monitor periodically children receiving prolonged therapy for possible adverse effects on growth and development.62 149

    Geriatric Use

    Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.149

    Use caution due to the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric patients.149 (See Geriatric Patients under Dosage and Administration.)

    Common Adverse Effects

    Headache, pharyngitis, upper respiratory tract infection, rhinitis.149

    Interactions for QVAR

    Metabolized by CYP3A4.149

    Drugs Affecting Hepatic Microsomal Enzymes

    Inhibitors of CYP3A4: potential pharmacokinetic interaction (increased plasma beclomethasone dipropionate concentrations).a

    Inducers of CYP3A4: potential pharmacokinetic interaction (decreased plasma beclomethasone dipropionate concentrations).a

    Specific Drugs

    Drug

    Interaction

    Comments

    Antidiabetic agents

    May increase blood glucose concentrations in patients with diabetes mellitus

    Adjust insulin and/or oral hypoglycemic dosages as needed

    NSAIAs

    Possible increased risk of GI ulcerationa

    Decreased serum salicylate concentrations.a When corticosteroids are discontinued, serum salicylate concentration may increase possibly resulting in salicylate intoxicationa

    Use salicylates and corticosteroids concurrently with cautiona

    Observe patients receiving both drugs closely for adverse effects of either druga

    May be necessary to increase salicylate dosage when corticosteroids are administered concurrently or decrease salicylate dosage when corticosteroids are discontinueda

    Vaccines and Toxoids

    May cause a diminished response to toxoids and live or inactivated vaccinesa

    May potentiate replication of some organisms contained in live, attenuated vaccinesa

    Can aggravate neurologic reactions to some vaccines (supraphysiologic dosages) a

    Generally defer routine administration of vaccines or toxoids until corticosteroid therapy is discontinueda

    May need serologic testing to ensure adequate antibody response for immunizationa

    Additional doses of the vaccine or toxoid may be necessarya

    May undertake immunization procedures in patients receiving nonimmunosuppressive doses of glucocorticoids or in patients receiving glucocorticoids as replacement therapy (e.g., Addison’s disease)a

    QVAR Pharmacokinetics

    Absorption

    Bioavailability

    Absorbed into circulation following oral inhalation, 149 with peak plasma concentrations usually attained at 0.5 hour.149 After oral inhalation, 51–60% of the dose is deposited in the respiratory tract.154

    Onset

    Relief of respiratory symptoms usually is evident within 24 hours; however, about 1–4 weeks of continuous therapy may be required for optimum effectiveness.149

    Distribution

    Extent

    Glucocorticoids cross the placenta and are distributed into milk.144 149 a No evidence of tissue storage of parent drug or metabolites.149

    Elimination

    Metabolism

    Metabolized to active metabolites via CYP3A4.149

    Elimination Route

    Beclomethasone dipropionate and its metabolites eliminated principally in feces and to a lesser extent in the urine (<10%).149

    Half-life

    2.8 hours.149

    Stability

    Storage

    Oral Inhalation

    25°C (may be exposed to 15–30°C).149

    Do not puncture aerosol containers, use or store near heat or an open flame, expose to temperatures >49°C, or place into a fire or incinerator for disposal.1 112 113 144 149

    Actions

    • Potent glucocorticoid and minimal mineralocorticoid activity.149 a c At recommended dosages, provides less than normal physiologic amounts of glucocorticoid systemically.149

    • Inhibits inflammatory cells and release of inflammatory mediators in the respiratory tract.149 Improves lung function (e.g., FEV1, morning peak expiratory flow).149
    • Principal sites of action are the bronchi and bronchioles.149
    • May reduce the following: number of mediator cells (basophils, leukocytes, and mast cells) at the epithelial level, number of eosinophils, sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity.c
    • May inhibit capillary dilation and permeability, stabilize lysosomal membranes, and prevent subsequent release of proteolytic enzymes.c

    Advice to Patients

    • Importance of providing the patient a copy of the manufacturer’s patient information.149

    • Importance of understanding proper storage, preparation, and administration techniques.149 b
    • Advise that oral inhalation must be used at regular intervals to be therapeutically effective.100 103 144 149
    • Importance of understanding that although improvement may occur within the first 24 hours, at least 1–4 weeks of continuous therapy may be required for optimal effectiveness.1 2 61 77 100 112 113 144 149
    • Importance of rinsing the mouth after inhalation and not exceeding the recommended dosage.1 2 71 112 113 144 149 b
    • Importance of not using orally inhaled beclomethasone dipropionate as a bronchodilator or for emergency use (e.g., relief of acute bronchospasm).1 2 103 112 113 144 149
    • Importance of contacting a clinician immediately when asthmatic attacks that are not controlled by bronchodilator therapy occur.1 2 112 113 149
    • Advise patients being transferred from systemic corticosteroid to beclomethasone dipropionate oral inhalation therapy to carry special identification (e.g., card, bracelet) indicating the need for supplementary systemic corticosteroids during periods of stress.1 2 112 113 144 149 (See Concomitant Therapy under Cautions.)
    • Importance of immunosuppressed patients avoiding exposure to certain infections (e.g., chickenpox, measles) and if exposed, of immediately consulting their clinician.113 134 135 136 142 143 144 149
    • Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.149
    • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.149
    • Importance of advising patients of other important precautionary information.149 (See Cautions.)

    Preparations

    Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

    Beclomethasone Dipropionate
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Oral Inhalation

    Aerosol

    40 mcg/metered spray

    QVAR Oral Inhaler (with tetrafluoroethane propellants)

    Teva

    80 mcg/metered spray

    QVAR Oral Inhaler (with tetrafluoroethane propellants)

    Teva

    Comparative Pricing

    This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

    Qvar 40MCG/ACT Aerosol (IVAX PHARMACEUTICALS): 9/$115.99 or 26/$326.97

    Qvar 80MCG/ACT Aerosol (IVAX PHARMACEUTICALS): 9/$146.98 or 26/$414.95

    Disclaimer

    This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

    The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

    AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions February 15, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    † Use is not currently included in the labeling approved by the US Food and Drug Administration.

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    44. Clark TJH. Beclomethasone dipropionate treatment of asthma in adults. In: Mygind N, Clark TJH, eds. Topical steroid treatment for asthma and rhinitis. London: Bailliere Tindall; 1980:94-106.

    45. Wyatt R, Waschek J, Weinberger M et al. Effects of inhaled beclomethasone dipropionate and alternate-day prednisone on pituitary-adrenal function in children with chronic asthma. N Engl J Med. 1978; 299:1387-92. [IDIS 91444] [PubMed 362207]

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    Qvar

    Qvar

    Pronunciation Generic Name: beclomethasone inhalation (be kloe METH a sone)

    Brand Name: Qvar

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is Qvar (beclomethasone inhalation)?

    Beclomethasone is a steroid. It prevents the release of substances in the body that cause inflammation.

    Beclomethasone inhalation is used to prevent asthma attacks. This medication will not treat an asthma attack that has already begun.

    Beclomethasone inhalation may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about Qvar (beclomethasone inhalation)?

    Beclomethasone inhalation will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

    Contact your doctor if your asthma symptoms do not improve after using beclomethasone for 2 weeks.

    Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

    If you switched to beclomethasone inhalation from an oral (taken by mouth) steroid, you may need to restart the oral medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

    What should I discuss with my healthcare provider before using Qvar (beclomethasone inhalation)?

    You should not use beclomethasone if you are allergic to it.

    To make sure this medicine is safe for you, tell your doctor if you have been sick or had an infection of any kind (especially tuberculosis). You may not be able to use beclomethasone until you are well.

    FDA pregnancy category C. It is not known whether beclomethasone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

    Beclomethasone inhalation can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

    Beclomethasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

    Beclomethasone should not be given to a child younger than 5 years old.

    How should I use Qvar (beclomethasone inhalation)?

    Beclomethasone will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

    Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

    This medication comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

    Prime the inhaler device before the first use by pumping 2 test sprays into the air, away from your face. Prime the inhaler if it has not been used for longer than 10 days.

    To reduce the chance of developing a yeast infection, rinse your mouth with water after using beclomethasone. Do not swallow.

    Do not wash your inhaler device or allow it to get wet. Wipe the mouthpiece with a clean dry tissue or cloth at least once per week.

    Keep track of the number of sprays you have used.

    • Throw away the 4.2-gram inhaler canister after 50 sprays.

    • Throw away the 7.3-gram inhaler canister after 100 sprays.
    • Throw away the 8.7-gram inhaler canister after 120 sprays.

    Get your prescription refilled before you run out of medicine completely. Always use the new device provided with the medication when you get your prescription filled.

    Beclomethasone can weaken your immune system. Your blood may need to be tested often.

    Call your doctor if your symptoms do not improve after 2 weeks of treatment.

    Asthma is usually treated with a combination of drugs. Use all medications as directed by your doctor.

    Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack. Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor’s advice.

    If you switched to beclomethasone inhalation from an oral (taken by mouth) steroid, you may need to restart the oral medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

    Store at room temperature away from moisture and heat. Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

    What happens if I miss a dose?

    Use the medicine as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    What should I avoid while using Qvar (beclomethasone inhalation)?

    Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

    Qvar (beclomethasone inhalation) side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have:

    • weakness, tired feeling, nausea, loss of appetite, weight loss;

    • white patches or sores inside your mouth or on your lips;
    • wheezing, choking, or other breathing problems after using this medication;
    • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
    • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
    • blurred vision, eye pain, or seeing halos around lights; or
    • worsening asthma symptoms.

    Common side effects may include:

    • headache;

    • dryness in your mouth, nose, or throat after use;
    • stuffy nose, sinus pain, sore throat, cough; or
    • hoarseness or deepened voice.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Qvar side effects (in more detail)

    What other drugs will affect beclomethasone inhalation??

    If you also use a bronchodilator (a drug that opens the airways to improve breathing), use it first before using the beclomethasone inhaler. This will allow more beclomethasone to reach your lungs. Bronchodilators include albuterol (Proventil, Ventolin), pirbuterol (Maxair), bitolterol (Tornalate), and others.

    Other drugs may interact with beclomethasone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

    Next Page → Side Effects

    More Qvar resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Interactions
    • Support Group
    • 8 Reviews - Add your own review/rating
    • Qvar aerosol solution MedFacts Consumer Leaflet (Wolters Kluwer)
    • beclomethasone aerosol MedFacts Consumer Leaflet (Wolters Kluwer)
    • beclomethasone Nasal Advanced Consumer (Micromedex) – Includes Dosage Information
    • QVAR Prescribing Information (FDA)
    • QVAR Monograph (AHFS DI)

    Compare Qvar with other medications

    • Asthma, Maintenance
    • Bronchitis

    Where can I get more information?

    • Your pharmacist can provide more information about beclomethasone.

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    QVAR

    QVAR

    Pronunciation Generic Name: beclomethasone dipropionate

    Dosage Form: aerosol, metered

    For ProfessionalsSide EffectsInteractionsMore…

    PRODUCT INFORMATION

     

    QVAR® 40mcg

    (beclomethasone dipropionate HFA, 40 mcg)

    INHALATION AEROSOL

    For Oral Inhalation Only

     QVAR® 80mcg

    (beclomethasone dipropionate HFA, 80 mcg)

    INHALATION AEROSOL

    For Oral Inhalation Only

    QVAR Description

    The active component of QVAR 40 mcg Inhalation Aerosol and QVAR 80 mcg Inhalation Aerosol is beclomethasone dipropionate, USP, an anti-inflammatory corticosteroid having the chemical name 9-chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone dipropionate (BDP) is a diester of beclomethasone, a synthetic corticosteroid chemically related to dexamethasone. Beclomethasone differs from dexamethasone in having a chlorine at the 9-alpha carbon in place of a fluorine, and in having a 16 beta-methyl group instead of a 16 alpha-methyl group. Beclomethasone dipropionate is a white to creamy white, odorless powder with a molecular formula of C28H37ClO7 and a molecular weight of 521.1. Its chemical structure is:

    QVAR is a pressurized, metered-dose aerosol intended for oral inhalation only. Each unit contains a solution of beclomethasone dipropionate in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. QVAR 40 mcg delivers 40 mcg of beclomethasone dipropionate from the actuator and 50 mcg from the valve. QVAR 80 mcg delivers 80 mcg of beclomethasone dipropionate from the actuator and 100 mcg from the valve. Both products deliver 50 microliters (59 milligrams) of solution formulation from the valve with each actuation. Depending on the product size prescribed, the 40 mcg canisters provide either 100 inhalations or 120 inhalations and the 80 mcg canisters provide either 50 inhalations, 100 inhalations or 120 inhalations. QVAR should be “primed” or actuated twice prior to taking the first dose from a new canister, or when the inhaler has not been used for more than ten days. Avoid spraying in the eyes or face while priming QVAR. This product does not contain chlorofluorocarbons (CFCs).

    QVAR – Clinical Pharmacology

    Airway inflammation is known to be an important component in the pathogenesis of asthma. Inflammation occurs in both large and small airways. Corticosteroids have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines). These anti-inflammatory actions of corticosteroids such as beclomethasone dipropionate contribute to their efficacy in asthma.

    Beclomethasone dipropionate is a prodrug that is rapidly activated by hydrolysis to the active monoester, 17 monopropionate (17-BMP). Beclomethasone 17 monopropionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide and 25 times that of beclomethasone dipropionate. The clinical significance of these findings is unknown.

    Studies in patients with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of QVAR.

    Pharmacokinetics

    Beclomethasone dipropionate (BDP) undergoes rapid and extensive conversion to beclomethasone-17-monopropionate (17-BMP) during absorption. The pharmacokinetics of 17-BMP has been studied in asthmatics given single doses.

    Absorption The mean peak plasma concentration (Cmax) of BDP was 88 pg/ml at 0.5 hour after inhalation of 320 mcg using QVAR (4 actuations of the 80 mcg/actuation strength). The mean peak plasma concentration of the major and most active metabolite, 17-BMP, was 1419 pg/ml at 0.7 hour after inhalation of 320 mcg of QVAR. When the same nominal dose is provided by the two QVAR strengths (40 and 80 mcg/actuation), equivalent systemic pharmacokinetics can be expected. The Cmax of 17-BMP increased dose proportionally in the dose range of 80 and 320 mcg.

    Metabolism Three major metabolites are formed via cytochrome P450-3A catalyzed biotransformation – beclomethasone-17-monopropionate (17-BMP), beclomethasone-21-monopropionate (21-BMP) and beclomethasone (BOH). Lung slices metabolize BDP rapidly to 17-BMP and more slowly to BOH. 17-BMP is the most active metabolite.

    Distribution The in vitro protein binding for 17-BMP was reported to be 94-96% over the concentration range of 1000 to 5000 pg/mL. Protein binding was constant over the concentration range evaluated. There is no evidence of tissue storage of BDP or its metabolites.

    Elimination The major route of elimination of inhaled BDP appears to be via hydrolysis. More than 90% of inhaled BDP is found as 17-BMP in the systemic circulation. The mean elimination half-life of 17-BMP is 2.8 hours. Irrespective of the route of administration (injection, oral or inhalation), BDP and its metabolites are mainly excreted in the feces. Less than 10% of the drug and its metabolites are excreted in the urine.

    Special Populations Formal pharmacokinetic studies using QVAR were not conducted in any special populations.

    Pediatrics The pharmacokinetics of 17-BMP, including dose and strength proportionalities, is similar in children and adults, although the exposure is highly variable. In 17 children (mean age 10 years), the Cmax of 17-BMP was 787 pg/ml at 0.6 hour after inhalation of 160 mcg (four actuations of the 40 mcg/actuation strength of HFA beclomethasone dipropionate). The systemic exposure to 17-BMP from 160 mcg of HFA-BDP administered without a spacer was comparable to the systemic exposure to 17-BMP from 336 mcg CFC-BDP administered with a large volume spacer in 14 children (mean age 12 years). This implies that approximately twice the systemic exposure to 17-BMP would be expected for comparable mg doses of HFA-BDP without a spacer and CFC-BDP with a large volume spacer.

    Pharmacodynamics

    Improvement in asthma control following inhalation can occur within 24 hours of beginning treatment in some patients, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. The effects of QVAR on the hypothalamic-pituitary-adrenal (HPA) axis were studied in 40 corticosteroid-naive patients. QVAR, at doses of 80, 160 or 320 mcg twice daily was compared with placebo and 336 mcg twice daily of beclomethasone dipropionate in a CFC propellant based formulation (CFC-BDP). Active treatment groups showed an expected dose-related reduction in 24-hour urinary-free cortisol (a sensitive marker of adrenal production of cortisol). Patients treated with the highest recommended dose of QVAR (320 mcg twice daily) had a 37.3% reduction in 24-hour urinary-free cortisol compared to a reduction of 47.3% produced by treatment with 336 mcg twice daily of CFC-BDP. There was a 12.2% reduction in 24-hour urinary-free cortisol seen in the group of patients that received 80 mcg twice daily of QVAR and a 24.6% reduction in the group of patients that received 160 mcg twice daily. An open label study of 354 asthma patients given QVAR at recommended doses for one year assessed the effect of QVAR treatment on the HPA axis (as measured by both morning and stimulated plasma cortisol). Less than 1% of patients treated for one year with QVAR had an abnormal response (peak less than 18 mcg/dL) to short-cosyntropin test.

    Clinical Trials

    Blinded, randomized, parallel, placebo-controlled and active-controlled clinical studies were conducted in 940 adult asthma patients to assess the efficacy and safety of QVAR in the treatment of asthma. Fixed doses ranging from 40 mcg to 160 mcg twice daily were compared to placebo, and doses ranging from 40 mcg to 320 mcg twice daily were compared with doses of 42 mcg to 336 mcg twice daily of an active CFC-BDP comparator. These studies provided information about appropriate dosing through a range of asthma severity. A blinded, randomized, parallel, placebo-controlled study was conducted in 353 pediatric patients (age 5 to 12 years) to assess the efficacy and safety of HFA beclomethasone dipropionate in the treatment of asthma. Fixed doses of 40 mcg and 80 mcg twice daily were compared with placebo in this study. In these adult and pediatric efficacy trials, at the doses studied, measures of pulmonary function [forced expiratory volume in 1 second (FEV1) and morning peak expiratory flow (AM PEF)] and asthma symptoms were significantly improved with QVAR treatment when compared to placebo.

    In controlled clinical trials with adult patients not adequately controlled with beta-agonist alone, QVAR was effective at improving asthma control at doses as low as 40 mcg twice daily (80 mcg/day). Comparable asthma control was achieved at lower daily doses of QVAR than with CFC-BDP. Treatment with increasing doses of both QVAR and CFC-BDP generally resulted in increased improvement in FEV1. In this trial the improvement in FEV1 across doses was greater for QVAR than for CFC-BDP, indicating a shift in the dose response curve for QVAR.

    Patients Not Previously Receiving Corticosteroid Therapy

    In a 6-week clinical trial, 270 steroid-naive patients with symptomatic asthma being treated with as-needed beta-agonist bronchodilators, were randomized to receive either 40 mcg twice daily of QVAR, 80 mcg twice daily of QVAR, or placebo. Both doses of QVAR were effective in improving asthma control with significantly greater improvements in FEV1, AM PEF, and asthma symptoms than with placebo. Shown below is the change from baseline in AM PEF during this trial.

    A 6-Week Clinical Trial in Patients with Mild to Moderate Asthma Not on

    Corticosteroid Therapy Prior to Study Entry:

    Mean Change in AM PEF

    In a 6-week clinical trial, 256 patients with symptomatic asthma being treated with as-needed beta-agonist bronchodilators, were randomized to receive either 160 mcg twice-daily of QVAR (delivered as either 40 mcg/actuation or 80 mcg/actuation) or placebo. Treatment with QVAR significantly improved asthma control, as assessed by FEV1, AM PEF, and asthma symptoms, when compared to treatment with placebo. Comparable improvement in AM PEF was seen for patients receiving 160 mcg twice-daily QVAR from the 40 mcg and 80 mcg strength products.

    Patients Responsive to a Short Course of Oral Corticosteroids

    In another clinical trial, 347 patients with symptomatic asthma, being treated with as-needed inhaled beta-agonist bronchodilators and, in some cases, inhaled corticosteroids, were given a 7 to 12 day course of oral corticosteroids and then randomized to receive either 320 mcg daily of QVAR, 672 mcg of CFC-BDP, or placebo. Patients treated with either QVAR or CFC-BDP had significantly better asthma control, as assessed by AM PEF, FEV1 and asthma symptoms, and fewer study withdrawals due to asthma symptoms, than those treated with placebo over 12 weeks of treatment. A daily dose of 320 mcg QVAR administered in divided doses provided comparable control of AM PEF and FEV1 as 672 mcg of CFC-BDP. Shown below are the mean AM PEF results from this trial.

    A 12-Week Clinical Trial in Moderate Symptomatic Patients with

    Asthma Responding to Oral Corticosteroid Therapy: Mean AM PEF by Study Week

    Patients Previously on Inhaled Corticosteroids

    In a 6-week clinical trial, 323 patients, who exhibited a deterioration in asthma control during an inhaled corticosteroid washout period were randomized to daily treatment with either 40, 160, or 320 mcg twice-daily QVAR or 42, 168, or 336 mcg twice-daily CFC-BDP. Treatment with increasing doses of both QVAR and CFC-BDP resulted in increased improvement in FEV1, FEF25-75% (forced expiratory flow over 25-75% of the vital capacity), and asthma symptoms. Shown below is the change from baseline in FEV1 as percent predicted after 6 weeks of treatment.

    A 6-Week Dose Response Clinical Trial in Patients with Inhaled Corticosteroid Dependent Asthma:

    Mean Change in FEV1 as Percent of Predicted

    Patients Previously Maintained on Oral Corticosteroids

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

    Pediatric Experience In one 12-week clinical trial, pediatric patients (age 5 to 12 years) with symptomatic asthma (N=353) being treated with as-needed beta-agonist bronchodilators were randomized to receive either 40 mcg or 80 mcg twice daily of HFA beclomethasone dipropionate or placebo. Both doses were effective in improving asthma control with significantly greater improvements in FEV1 (9% and 10% predicted change from baseline at week 12 in FEV1 percent predicted, respectively) than with placebo (4% predicted change).

    Indications and Usage for QVAR

    QVAR is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. QVAR is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR may reduce or eliminate the need for the systemic corticosteroids.

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

    Contraindications

    QVAR 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

    Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

    Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infections (particularly gastroenteritis) or other conditions with severe electrolyte loss. Although QVAR may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid that 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 oral 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 asthma attack.

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

    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 non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. It is not known how the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection. Nor is the contribution of the underlying disease and/or prior corticosteroid treatment 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.

    QVAR is not a bronchodilator and is not indicated for rapid relief of bronchospasm.

    As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with QVAR, it should be treated immediately with a short-acting inhaled bronchodilator. Treatment with QVAR should be discontinued and alternate therapy instituted. 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 QVAR. During such episodes, patients may require therapy with oral corticosteroids.

    Precautions

    General

    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. Although suppression of HPA function below the clinical normal range did not occur with doses of QVAR up to and including 640 mcg/day, a dose-dependent reduction of adrenal cortisol production was observed. Since inhaled beclomethasone dipropionate is absorbed into the circulation and can be systemically active, HPA-axis suppression by QVAR could occur when recommended doses are exceeded or in particularly sensitive individuals. Since individual sensitivity to effects on cortisol production exist, physicians should consider this information when prescribing QVAR. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effect. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

    It is possible that systemic corticosteroid effects, such as hypercorticism and adrenal suppression, may appear in a small number of patients, particularly at higher doses. If such changes occur, QVAR should be reduced slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic steroids.

    A 12-month, randomized, controlled clinical trial evaluated the effects of HFA beclomethasone dipropionate without spacer versus CFC beclomethasone dipropionate with large volume spacer on growth in children age 5 to 11. A total of 520 patients were enrolled, of whom 394 received HFA-BDP (100 to 400 mcg/day ex-valve) and 126 received CFC-BDP (200 to 800 mcg/day ex-valve). Similar control of asthma was noted in each treatment arm. When comparing results at month 12 to baseline, the mean growth velocity in children treated with HFA-BDP was approximately 0.5 cm/year less than that noted with children treated with CFC-BDP via large volume spacer.

    A reduction in growth velocity in growing children 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 all pediatric patients taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression.

    The long-term and systemic effects of QVAR in humans 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 tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.

    Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids.

    Information for Patients

    Patients being treated with QVAR 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.

    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 to these diseases, medical advice should be sought without delay.

    Patients should use QVAR at regular intervals as directed. Results of clinical trials indicated significant improvements may occur within the first 24 hours of treatment in some patients; 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 their physician if symptoms do not improve or if the condition worsens.

    Patients should be advised that QVAR is not intended for use in the treatment of acute asthma. The patient should be instructed to contact their physician immediately if there is any deterioration of their asthma.

    Patients should be instructed on the proper use of their inhaler. Patients may wish to rinse their mouth after QVAR use. The patient should also be advised that QVAR may have a different taste and inhalation sensation than that of an inhaler containing CFC propellant.

    QVAR use should not be stopped abruptly. The patient should contact their physician immediately if use of QVAR is discontinued.

    For the proper use of QVAR, the patient should read and carefully follow the accompanying Patient’s Instructions.

    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 30 and 55 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 the 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/day (approximately 200 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis). Impairment of fertility, as evidence 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 (approximately 20 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 of exposure to beclomethasone dipropionate by the Inhalation route at an estimated daily dose of 0.33 mg/kg (approximately 15 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis).

    Pregnancy

    Teratogenic Effects

    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 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 15 mg/kg/day (approximately 190 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 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Non-teratogenic Effects Findings of drug-related adrenal toxicity in fetuses following administration of beclomethasone dipropionate to rats suggest that infants born of mothers receiving substantial doses of QVAR during pregnancy should be observed for adrenal suppression.

    Nursing Mothers

    Corticosteroids are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from QVAR, 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

    Eight-hundred and thirty-four children between the ages of 5 and 12 were treated with HFA beclomethasone dipropionate (HFA BDP) in clinical trials. The safety and effectiveness of QVAR in children below 5 years of age have not been established.

    Use of QVAR with a spacer device in children less than 5 years of age is not recommended. In vitro dose characterization studies were performed with QVAR 40 mcg/actuation with the Optichamber and AeroChamber Plus® spacer utilizing inspiratory flows representative of children under 5 years old. These studies indicated that the amount of medication delivered through the spacing device decreased rapidly with increasing wait times of 5 to 10 seconds as shown in Table 1. If QVAR is used with a spacer device, it is important to inhale immediately.

    Based on the average inspiratory flow rates generated by children 6 months to 5 years old, the projected daily dose derived from QVAR 40 mcg at one puff per day at various wait times is depicted in the table below:

    TABLE 1
    Wait time, seconds Mean medication delivery through AeroChamber, mcg/actuation * Body Weight 50th percentile, kg † Medication delivered per dose, mcg/kg ‡,§
    *
    Summary Report; Pediatric Dose Characterization of QVAR with Spacer; 3M Pharmaceutical Development, July 21, 2004.
    CDC Growth charts, developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion (2000).
    Includes an estimated 20% loss in the masks
    §
    QVAR 40mcg in an average adult without using a spacer delivers approximately 0.4 mcg/kg, or bid, 0.8 mcg/kg/day.
    Age 6 months, Flow rate 4.8 L/min 0 11.5 7.6 1.2
    Age 2 years, Flow rate 8.2 L/min 0 14.1 13.5 0.83
    Age 2 years, Flow rate 8.2 L/min 5 5.4 13.5 0.32
    Age 2 years, Flow rate 8.2 L/min 10 3.9 13.5 0.23
    Age 5 years, Flow rate 11.0 L/min 0 17.5 18 0.78

    Oral inhaled 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, General).

    Geriatric Use

    Clinical studies of QVAR 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, usually 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

    The following reporting rates of common adverse experiences are based upon 4 clinical trials in which 1196 Patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR (doses of 40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. The table below includes all events reported by patients taking QVAR (whether considered drug related or not) that occurred at a rate over 3% for either QVAR or CFC-BDP. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account.

    Adverse Events Reported by at Least 3% of the Patients for Either QVAR or CFC-BDP by Treatment and Daily Dose
    Adverse Events QVAR CFC-BDP
    Placebo

    (N=289)

    %

    Total

    (N=624)

    %

    80-160

    mcg

    (N=233)

    %

    320

    mcg

    (N=335)

    %

    640

    mcg

    (N=56)

    %

    Total

    (N=283)

    %

    84

    mcg

    (N=59)

    %

    336

    mcg

    (N=55)

    %

    672

    mcg

    (N=169)

    %

    HEADACHE 9 12 15 8 25 15 14 11 17
    PHARYNGITIS 4 8 6 5 27 10 12 9 10
    UPPER RESP TRACT INFECTION 11 9 7 11 5 12 3 9 17
    RHINITIS 9 6 8 3 7 11 15 9 10
    INCREASED ASTHMA SYMPTOMS 18 3 2 4 0 8 14 5 7
    ORAL SYMPTOMS INHALATION ROUTE 2 3 3 3 2 6 7 5 5
    SINUSITIS 2 3 3 3 0 4 7 2 4
    PAIN <1 2 1 2 5 3 3 5 2
    BACK PAIN 1 1 2 <1 4 4 2 4 4
    NAUSEA 0 1 <1 1 2 3 5 5 1
    DYSPHONIA 2 <1 1 0 4 4 0 0 6

    Other adverse events that occurred in these clinical trials using QVAR with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were: dysphonia, dysmenorrhea and coughing.

    No patients treated with QVAR in the clinical development program developed symptomatic oropharyngeal candidiasis. If such an infection develops, treatment with appropriate antifungal therapy or discontinuance of treatment with QVAR may be required.

    Pediatric Studies

    In two 12-week placebo-controlled studies in steroid naive pediatric patients 5 to 12 years of age, no clinically relevant differences were found in the pattern, severity, or frequency of adverse events compared with those reported in adults, with the exception of conditions which are more prevalent in a pediatric population generally.

    Adverse Event Reports from Other Sources

    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 dipropionate.

    During postmarketing experience, psychiatric events and behavioral changes such as aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children). Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    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 19,000, 25,000, and 25,000 times, respectively, the maximum recommended daily inhalation in adults or 36,000, 48,000, and 48,000 times, respectively the maximum recommended daily inhalation dose in children on a mg/m2 basis.

    QVAR Dosage and Administration

    Patients should prime QVAR by actuating into the air twice before using for the first time or if QVAR has not been used for over ten days. Avoid spraying in the eyes or face when priming QVAR. QVAR is a solution aerosol, which does not require shaking. Consistent dose delivery is achieved, whether using the 40 or 80 mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40 mcg strength should provide a dose comparable to 1 actuation of the 80 mcg strength).

    QVAR should be administered by the oral inhaled route in patients 5 years of age and older. Use of QVAR with a spacer device in children less than 5 years of age is not recommended (see PRECAUTIONS, Pediatric Use). The onset and degree of symptom relief will vary in individual patients. Improvement in asthma symptoms should be expected within the first or second week of starting treatment, but maximum benefit should not be expected until 3 to 4 weeks of therapy. For patients who do not respond adequately to the starting dose after 3 to 4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of QVAR when administered in excess of recommended doses has not been established.

    Table 2: Recommended Dosing for Adults and Adolescents
    Patient’s Previous Therapy Recommended Starting Dose Highest Recommended Dose
    Bronchodilators Alone 40 to 80 mcg twice daily 320 mcg twice daily
    Inhaled Corticosteroids 40 to 160 mcg twice daily 320 mcg twice daily
    Table 3: Recommended Dosing for Children 5 to 11 Years
    Patient’s Previous Therapy Recommended Starting Dose Highest Recommended Dose
    Bronchodilators Alone 40 mcg twice daily 80 mcg twice daily
    Inhaled Corticosteroids 40 mcg twice daily 80 mcg twice daily

    As with any inhaled corticosteroid, physicians are advised to titrate the dose of QVAR downward over time to the lowest level that maintains proper asthma control. This is particularly important in children since a controlled study has shown that QVAR has the potential to affect growth in children. Patients should be instructed on the proper use of their inhaler.

    Patients Not Receiving Systemic Corticosteroids

    Patients who require maintenance therapy of their asthma may benefit from treatment with QVAR at the doses recommended above. In patients who respond to QVAR, 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

    QVAR may be effective in the management of asthmatics maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

    The patient’s asthma should be reasonably stable before treatment with QVAR is started. Initially, QVAR should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroids. After approximately one week, gradual withdrawal of the systemic corticosteroids is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two 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, e.g. 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’s Instructions for proper use accompany each package of QVAR.

    How is QVAR Supplied

    QVAR is supplied in 2 strengths:

     
    QVAR 40 mcg is supplied either in a 7.3 g canister containing 100 actuations with a beige plastic actuator and gray dust cap, and Patient’s Instructions; box of one; 100 Actuations – NDC 59310-175-40 or in an 8.7 g canister containing 120 actuations with a beige plastic actuator and gray dust cap, and Patient’s Instructions; box of one; 120 Actuations – NDC 59310-202-40
     
    QVAR 80 mcg is supplied either in a 4.2 g canister, for Institutional Use, containing 50 actuations with a dark mauve plastic actuator and a gray dust cap, and Patient’s Instructions; box of one; 50 Actuations – NDC 59310-204-50, a 7.3 g canister containing 100 actuations with a dark mauve plastic actuator and gray dust cap, and Patient’s Instructions; box of one; 100 Actuations – NDC 59310-177-80 or in an 8.7 g canister containing 120 actuations with a dark mauve plastic actuator and gray dust cap, and Patient’s Instructions; box of one; 120 Actuations – NDC 59310-204-80

    The correct amount of medication in each inhalation cannot be assured after 50 actuations from the 4.2 g canister, 100 actuations from the 7.3 g canister or 120 actuations from the 8.7 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

    Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with the plastic actuator on top.

    Store at 25°C (77°F).

    Excursions between 15° and 30°C (59° and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used. QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol actuator and the actuator should not be used with any other inhalation drug product.

    CONTENTS UNDER PRESSURE

    Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw container into fire or incinerator.

    Keep out of reach of children.

    Rx only

    Mktd by:

    Teva Respiratory, LLC– Horsham, PA 19044

    Developed and Manufactured by:

    3M Drug Delivery Systems

    Northridge, CA 91324

    OR

    3M Health Care, Ltd.

    Loughborough, UK

    July 2012

    © 2012 Teva Respiratory, LLC

    657100

    QVAR is a registered trademark of IVAX LLC, a member of the TEVA Group.

    Rev. 07/12

    OptiChamber is a registered trademark of Respironics Healthscan, Inc. and AeroChamber Plus is a registered trademark of Trudell Medical International Trudell Partnership Holdings Limited and Packard Medical Supply Centre Ltd.

    PATIENT’S INSTRUCTIONS

    QVAR®

    (beclomethasone dipropionate HFA)

    INHALATION AEROSOL

    Attention Pharmacist: Detach “PATIENT’S INSTRUCTIONS for Use” from package insert and dispense with the product.

    PATIENT’S INSTRUCTIONS

    It is important that you read these instructions before using QVAR.

    Correct and regular use of the inhaler will prevent or lessen the severity of asthma attacks.

    1. Remove the plastic cap (see Figure 1) and be sure there are no foreign objects in the mouthpiece.

    Figure 1

    2. As with all aerosol medications, it is recommended to prime the QVAR inhaler before using for the very first time after purchase, and in cases where the inhaler has not been used for more than 10 days. Prime by releasing 2 actuations into the air, away from your eyes and face. Be sure the canister is firmly seated in the plastic mouthpiece adapter before each use.

    3. BREATHE OUT AS FULLY AS YOU COMFORTABLY CAN. Hold the inhaler as shown in Figure 2. Close your lips around the mouthpiece, keeping your tongue below it.

    Figure 2

    4. WHILE BREATHING IN DEEPLY AND SLOWLY, PRESS DOWN ON THE CAN WITH YOUR FINGER. When you have finished breathing in, hold your breath as long as you comfortably can (i.e., 5 to 10 seconds).

    5. TAKE YOUR FINGER OFF THE CAN and remove the inhaler from your mouth. Breathe out gently.

    6. If your physician has told you to take more than one inhalation per treatment repeat steps 3 through 5.

    7. You should rinse your mouth with water after treatment.

    8. For normal hygiene, the mouthpiece of your inhaler should be cleaned weekly with a clean, dry tissue or cloth.

    DO NOT WASH OR PUT ANY PART OF YOUR INHALER IN WATER.

    9. DISCARD THE CANISTER AFTER the date calculated by your physician or pharmacist. The correct amount of medication in each inhalation cannot be assured after 50 actuations from the 4.2 g canister, 100 actuations from the 7.3 g canister or 120 actuations from the 8.7 g canister even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. Before the discard date you should consult your physician to determine whether a refill is needed. It is advisable to keep track of the number of doses taken from the canister to better predict when a refill is necessary. Just as you should not take extra doses without consulting your physician, you also should not stop taking QVAR without consulting your physician.

    IMPORTANT: QVAR is preventive therapy for asthma and must be used regularly and at the times your physician has prescribed.

    DO NOT CONFUSE QVAR WITH OTHER ASTHMA MEDICATION. QVAR 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 QVAR. If this is the first time you will be using QVAR, it may take from 1 to 4 weeks before you feel the full benefits.

    QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol mouthpiece and the mouthpiece should not be used with any other inhalation drug product.

    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 49°C (120°F) may cause bursting. Never throw container into fire or incinerator.

    Keep out of reach of children.

    Avoid spraying in eyes.

    Store at 25°C (77°F). For optimal results, the canister should be at room temperature when used. Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with the plastic actuator on top.

    Mktd by:

    Teva Respiratory, LLC

    Horsham, PA 19044

    Developed and Manufactured by:

    3M Drug Delivery Systems

    Northridge, CA 91324

    OR

    3M Health Care, Ltd.

    Loughborough, UK

    © 2012 Teva Respiratory, LLC

    QVAR is a registered trademark of IVAX LLC, a member of the TEVA Group.

    657100

    Rev. 07/12

    PRINCIPAL DISPLAY PANEL – 40 mcg Carton 100 Inhalations

    NDC 59310-175-40

    QVAR®

    40mcg

    (beclomethasone

    dipropionate HFA, 40 mcg)

    INHALATION AEROSOL

    For oral inhalation with

    QVAR® Actuator only

    100

    Metered Inhalations

    7.3g Net Contents

    CFC FREE

    TEVA SPECIALTY

    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL – 40 mcg Carton 120 Inhalations

    NDC 59310-202-40

    QVAR®

    40mcg

    (beclomethasone

    dipropionate HFA, 40 mcg)

    INHALATION AEROSOL

    For Oral Inhalation with

    QVAR® Actuator Only

    120

    Metered Inhalations

    8.7 g Net Contents

    CFC FREE

    TEVA

    TEVA RESPIRATORY

    PRINCIPAL DISPLAY PANEL – 80 mcg Carton 100 Inhalations

    NDC 59310-177-80

    QVAR®

    80mcg

    (beclomethasone

    dipropionate HFA, 80 mcg)

    INHALATION AEROSOL

    For oral inhalation with

    QVAR® Actuator only

    100

    Metered Inhalations

    7.3g Net Contents

    CFC FREE

    TEVA SPECIALTY

    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL – 80 mcg Carton 120 Inhalations

    NDC 59310-204-80

    QVAR®

    80mcg

    (beclomethasone

    dipropionate HFA, 80 mcg)

    INHALATION AEROSOL

    For Oral Inhalation with

    QVAR® Actuator Only

    120

    Metered Inhalations

    8.7 g Net Contents

    CFC FREE

    TEVA

    TEVA RESPIRATORY

    PRINCIPAL DISPLAY PANEL – 80 mcg Carton 50 Inhalations

    NDC 59310-204-50

    QVAR®

    80mcg

    (beclomethasone

    dipropionate HFA, 80 mcg)

    INHALATION AEROSOL

    For Oral Inhalation with

    QVAR® Actuator Only

    50

    Metered Inhalations

    4.2 g Net Contents

    CFC FREE

    TEVA

    PRINCIPAL DISPLAY PANEL – 80 mcg Carton Physician Sample 50 Inhalations

    NDC 59310-204-85

    QVAR®

    80mcg

    (beclomethasone

    dipropionate HFA, 80 mcg)

    INHALATION AEROSOL

    For Oral Inhalation with

    QVAR® Actuator Only

    Professional Sample Not For Sale

    50

    Metered Inhalations

    4.2 g Net Contents

    CFC FREE

    TEVA

    QVAR 

    beclomethasone dipropionate aerosol, metered

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59310-175
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BECLOMETHASONE DIPROPIONATE (BECLOMETHASONE) BECLOMETHASONE DIPROPIONATE 40 ug
    Inactive Ingredients
    Ingredient Name Strength
    norflurane  
    alcohol  
    Packaging
    # Item Code Package Description
    1 NDC:59310-175-40 1 CANISTER in 1 BOX
    1 100 AEROSOL, METERED in 1 CANISTER
    2 NDC:59310-175-41 1 CANISTER in 1 BOX
    2 100 AEROSOL, METERED in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020911 09/15/2000
    QVAR 

    beclomethasone dipropionate aerosol, metered

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59310-202
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    beclomethasone dipropionate (BECLOMETHASONE) beclomethasone dipropionate 40 ug
    Inactive Ingredients
    Ingredient Name Strength
    norflurane  
    alcohol  
    Packaging
    # Item Code Package Description
    1 NDC:59310-202-40 1 CANISTER in 1 BOX
    1 120 AEROSOL, METERED in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020911 01/17/2011
    QVAR 

    beclomethasone dipropionate aerosol, metered

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59310-177
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    beclomethasone dipropionate (BECLOMETHASONE) beclomethasone dipropionate 80 ug
    Inactive Ingredients
    Ingredient Name Strength
    norflurane  
    alcohol  
    Packaging
    # Item Code Package Description
    1 NDC:59310-177-80 1 CANISTER in 1 BOX
    1 100 AEROSOL, METERED in 1 CANISTER
    2 NDC:59310-177-81 1 CANISTER in 1 BOX
    2 100 AEROSOL, METERED in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020911 09/15/2000
    QVAR 

    beclomethasone dipropionate aerosol, metered

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59310-204
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    beclomethasone dipropionate (BECLOMETHASONE) beclomethasone dipropionate 80 ug
    Inactive Ingredients
    Ingredient Name Strength
    norflurane  
    alcohol  
    Packaging
    # Item Code Package Description
    1 NDC:59310-204-80 1 CANISTER in 1 BOX
    1 120 AEROSOL, METERED in 1 CANISTER
    2 NDC:59310-204-50 1 CANISTER in 1 BOX
    2 50 AEROSOL, METERED in 1 CANISTER
    3 NDC:59310-204-85 1 CANISTER in 1 BOX
    3 50 AEROSOL, METERED in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020911 01/17/2011
    Labeler - Teva Respiratory, LLC (176697907)
    Establishment
    Name Address ID/FEI Operations
    3M Drug Delivery Systems 128688199 MANUFACTURE(59310-175, 59310-202, 59310-177, 59310-204)
    Establishment
    Name Address ID/FEI Operations
    3M Health Care LTD 218829455 MANUFACTURE(59310-175, 59310-177, 59310-202, 59310-204)

    Revised: 12/2012   Teva Respiratory, LLC

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