Pill Identifier App

Generic Name: Beclomethasone Dipropionate
Class: Adrenals
VA Class: NT200
Molecular Formula: C28H37ClO7
CAS Number: 5534-09-8

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

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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  • Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.1 2 112 113 144 149 (See Withdrawal of Systemic Corticosteroid Therapy under Warnings.)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 02/2014. 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

AHFS DI Essentials. © Copyright, 2004-2014, 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.

References

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