Beclomethasone (Systemic, Oral Inhalation)
Brand names: QVAR
Drug class:
Antineoplastic Agents
Usage of Beclomethasone (Systemic, Oral Inhalation)
Asthma
Used for the long-term prevention of bronchospasm in patients with asthma.
Should not be used in the treatment of nonasthmatic bronchitis.
Chronic Obstructive Pulmonary Disease
Efficacy in patients with chronic obstructive pulmonary disease (e.g., bronchitis)† [off-label] who are stabilized with oral corticosteroids or whose disease is corticosteroid responsive remains to be fully evaluated.
Inflammatory Conditions of the GI Tract
Has been used as an oral solution or rectal suspension (these dosage forms not commercially available in the US) in the management of inflammatory diseases of the GI tract† [off-label] (e.g., inflammatory bowel disease† [off-label], eosinophilic gastroenteritis† [off-label]). However, the role of beclomethasone dipropionate in the management of inflammatory conditions of the GI tract remains to be established.
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How to use Beclomethasone (Systemic, Oral Inhalation)
General
Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids
Administration
Oral Inhalation
Administer by oral inhalation using an oral aerosol inhaler.
Test-spray inhalation aerosol (2 times) before first use or whenever the aerosol not used for prolonged periods (>10 days).
Oral inhalation aerosol is formulated as a solution, which does not require shaking.
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. Inhale slowly and deeply through the mouth while actuating the inhaler. Hold the breath for as long as possible (about 5–10 seconds), withdraw the mouthpiece, and exhale gently. If additional inhalations are required, repeat the procedure.
Rinse the mouth thoroughly with water to remove drug deposited in the oropharyngeal area.
Clean the mouthpiece weekly using a clean, dry tissue or cloth. Do not wash or place any part of the inhaler canister in water.
Dosage
Available as beclomethasone dipropionate; dosage expressed in terms of the salt.
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.
Pediatric Patients
Asthma Oral InhalationChildren 5–11 years of age receiving bronchodilators alone or inhaled corticosteroids previously: Initially, 40 mcg twice daily. If required, dosage may be increased to a maximum 80 mcg twice daily.
Children ≥12 years of age receiving bronchodilators alone previously: Initially, 40–80 mcg twice daily. If required, dosage may be increased to a maximum 320 mcg twice daily.
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 InhalationIn adults receiving bronchodilators alone previously: Initially, 40–80 mcg twice daily. If required, dosage may be increased to a maximum 320 mcg twice daily.
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 InhalationChildren 5–11 years of age: Maximum 80 mcg twice daily.
Children ≥12 years of age: Maximum 320 mcg twice daily.
Adults
Asthma Oral InhalationMaximum 320 mcg twice daily.
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.
Warnings
Contraindications
Warnings/Precautions
Warnings
Withdrawal Of Systemic Corticosteroid TherapyPossible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression); acute adrenal insufficiency; life-threatening exacerbation of asthma; pulmonary infiltrates with eosinophilia; or symptomatic exacerbation of allergic conditions if prolonged systemic corticosteroid therapy is replaced with oral inhalation corticosteroid therapy. 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.
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.
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).
Immunosuppressed PatientsIncreased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals. Certain infections (e.g., varicElla [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children.
Exposure to varicella and measles should be avoided in previously unexposed patients. If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster Immune globulin (VZIG) or immune globulin (IG), respectively. Consider treatment with an antiviral agent if varicella develops.
Concomitant TherapyUse with caution in patients receiving systemic prednisone for any disease. 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.
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.
Hypothalamic-Pituitary-Adrenal (HPA) Axis SuppressionAvoid higher than recommended dosages of the drug, since suppression of HPA function may occur. If higher than recommended dosages are used, carefully consider the relative risks of adrenal suppression and potential therapeutic benefits. Recommended dosages of orally inhaled drug provide less than normal physiologic amounts of glucocorticoid systemically and do not provide mineralocorticoid activity. Orally inhaled drug will not compensate for insufficient endogenous cortisol production caused by previous systemic corticosteroid therapy.
Respiratory EffectsBronchospasm, cough, and/or wheezing may occur, especially in asthmatic patients with hyperactive airways.
If bronchospasm occurs, treat immediately with a short-acting bronchodilator, and discontinue treatment with beclomethasone dipropionate and institute alternative therapy.
InfectionUse 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.
Sensitivity Reactions
Immediate or delayed hypersensitivity reactions, including bronchospasm, anaphylactic/anaphylactoid reactions, urticaria, angioedema, and rash reported rarely.
General Precautions
Systemic Corticosteroid EffectsPossible 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.
Carefully monitor neonates exposed to prenatal corticosteroids for manifestations of hypoadrenalism.
Ocular EffectsGlaucoma, increased intraocular pressure, and cataracts reported rarely.
Other EffectsUnknown long-term, systemic, and local effects of the drug in humans, particularly developmental or immunologic processes in the mouth, pharynx, trachea, and lung.
Specific Populations
PregnancyCategory C. (See Systemic Corticosteroid Effects under Cautions.)
LactationDistributed into milk. Discontinue nursing or the drug.
Pediatric UseSafety and efficacy not established in children <5 years of age. No overall differences in the pattern, severity, or frequency of adverse events in children 5–12 years of age compared with those in adults. Monitor periodically children receiving prolonged therapy for possible adverse effects on growth and development.
Geriatric UseInsufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.
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. (See Geriatric Patients under Dosage and Administration.)
Common Adverse Effects
Headache, pharyngitis, upper respiratory tract infection, rhinitis.
What other drugs will affect Beclomethasone (Systemic, Oral Inhalation)
Metabolized by CYP3A4.
Drugs Affecting Hepatic Microsomal Enzymes
Inhibitors of CYP3A4: potential pharmacokinetic interaction (increased plasma beclomethasone dipropionate concentrations).
Inducers of CYP3A4: potential pharmacokinetic interaction (decreased plasma beclomethasone dipropionate concentrations).
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 ulceration
Decreased serum salicylate concentrations. When corticosteroids are discontinued, serum salicylate concentration may increase possibly resulting in salicylate intoxication
Use salicylates and corticosteroids concurrently with caution
Observe patients receiving both drugs closely for adverse effects of either drug
May be necessary to increase salicylate dosage when corticosteroids are administered concurrently or decrease salicylate dosage when corticosteroids are discontinued
Vaccines and Toxoids
May cause a diminished response to toxoids and live or inactivated vaccines
May potentiate replication of some organisms contained in live, atTenuated vaccines
Can aggravate neurologic reactions to some vaccines (supraphysiologic dosages)
Generally defer routine administration of vaccines or toxoids until corticosteroid therapy is discontinued
May need serologic testing to ensure adequate antibody response for immunization
Additional doses of the vaccine or toxoid may be necessary
May undertake immunization procedures in patients receiving nonimmunosuppressive doses of glucocorticoids or in patients receiving glucocorticoids as replacement therapy (e.g., Addison’s disease)
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