Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol Breath Activated, Inhalation, as dipropionate:
Qvar RediHaler: 40 mcg/actuation (10.6 g); 80 mcg/actuation (10.6 g)
Aerosol Solution, Inhalation, as dipropionate:
Qvar: 40 mcg/actuation (8.7 g [DSC]); 80 mcg/actuation (8.7 g [DSC])
Mechanism of Action
Controls the rate of protein synthesis; depresses the migration of polymorphonuclear leukocytes, fibroblasts; reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation
Readily; quickly hydrolyzed by pulmonary esterases to active metabolite (beclomethasone-17-monopropionate [17-BMP]) during absorption
Vd: Beclomethasone dipropionate (BDP): 20 L; 17-BMP: 424 L
BDP is a pro-drug (inactive); undergoes rapid conversion to 17-BMP during absorption; followed by additional metabolism via CYP3A4 to other, less active metabolites (beclomethasone-21-monopropionate [21-BMP] and beclomethasone [BOH])
Primary route of excretion is via feces (~60%); <10% to 12% of oral dose excreted in urine as metabolites
Onset of Action
Within 1 to 2 days in some patients; usually within 1 to 2 weeks; Maximum effect: 3 to 4 weeks
Time to Peak
QVAR: BDP: 0.5 hours; 17-BMP: 0.7 hours
RediHaler: BDP: 2 minutes; 17-BMP: 10 minutes
QVAR: BDP: 0.5 hours; 17-BMP: 2.8 hours
RediHaler:; BDP: 2 minutes; 17-BMP: 4 hours
BDP 87%; 17-BMP: 94% to 96%
Use: Labeled Indications
Asthma: Maintenance and prophylactic treatment of asthma in patients ≥5 years of age (QVAR) or ≥4 years of age (QVAR RediHaler).
Limitations of use: Not for relief of acute bronchospasm.
Guideline recommendations: A low-dose inhaled corticosteroid (in addition to an as-needed short acting beta2-agonist) is the initial preferred long-term control medication for children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a step-wise treatment approach (GINA 2018; NAEPP 2007).
Use: Off Label
Chronic obstructive pulmonary disease (stable)yes
Based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 update to the guidelines for the management of chronic obstructive pulmonary disease (COPD), long-term monotherapy with inhaled corticosteroids (ICS) is not recommended. Regular treatment with ICS has been shown to increase the risk of pneumonia, especially in those with severe disease. Per the 2018 GOLD guideline update, combining two long acting bronchodilators (ie, long acting beta agonist [LABA] and long acting antimuscarinic [LAMA]) is more effective in reducing exacerbations than monotherapy or the combination of ICS and LABA. If symptoms are inadequately controlled on a bronchodilator regimen, addition of an ICS may be considered. Triple inhaled therapy of ICS/LAMA/LABA has been shown to improve lung function, symptoms, and health status and reduces exacerbations compared to ICS/LABA or LAMA monotherapy GOLD 2018.
Hypersensitivity to beclomethasone or any component of the formulation; status asthmaticus, or other acute asthma episodes requiring intensive measures
Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Moderate to severe bronchiectasis requiring intensive measures; untreated fungal, bacterial, or tubercular infections of the respiratory tract
Dosage and Administration
Note: Titrate to the lowest effective dose once asthma is controlled.
Asthma: Oral inhalation: Note: To decrease the severity or duration of an asthma exacerbation, may consider temporarily quadrupling the dose (early in the course of illness) in patients with mild to moderate asthma with a mild flare in symptoms. Reserve this approach for patients with no prior history of life-threatening asthma exacerbations, and in those with good self-management skills; return to baseline dose after normalization of symptoms or at a maximum of 14 days of the quadrupled dose (Fanta 2019; GINA 2018; McKeever 2018).
US labeling: Metered-dose inhaler:
QVAR/QVAR RediHaler: Note: Dosing based on previous asthma therapy and asthma severity. May increase dose after 2 weeks of therapy in patients who are not adequately controlled.
Patients not currently on inhaled corticosteroids: Initial: 40 to 80 mcg twice daily; maximum dose: 320 mcg twice daily
Patients previously on inhaled corticosteroids: Initial: 40 to 320 mcg twice daily; maximum dose: 320 mcg twice daily
Canadian labeling: Metered-dose inhaler:
Mild asthma: 50 to 100 mcg twice daily; maximum dose: 100 mcg twice daily
Moderate asthma: 100 to 250 mcg twice daily; maximum dose: 250 mcg twice daily
Severe asthma: 300 to 400 mcg twice daily; maximum dose: 400 mcg twice daily
National Asthma Education and Prevention Program guidelines (NAEPP 2007): Metered-dose inhaler:
Low-dose therapy: 80 to 240 mcg/day
Medium-dose therapy: >240 to 480 mcg/day
High-dose therapy: >480 mcg/day
Global Initiative for Asthma guidelines (GINA 2018): Metered-dose inhaler:
Low-dose therapy: 100 to 200 mcg/day
Medium-dose therapy: >200 to 400 mcg/day
High-dose therapy: >400 mcg/day
Chronic obstructive pulmonary disease (stable) (off-label use): Oral inhalation: 50 to 400 mcg daily in combination with a long-acting bronchodilator (GOLD 2014; GOLD 2018).
Refer to adult dosing.
Note: Doses should be titrated to the lowest effective dose once asthma is controlled.
Manufacturer's labeling: Qvar RediHaler: Oral inhalation: Note: Twice daily doses should be administered approximately 12 hours apart.
Children 4 to 11 years: Initial: 40 mcg twice daily; maximum dose: 80 mcg twice daily.
Children ≥12 years and Adolescents:
No previous inhaled corticosteroids: Initial: 40 to 80 mcg twice daily; maximum dose: 320 mcg twice daily.
Previous inhaled corticosteroid use: Initial: 40 to 160 mcg twice daily; maximum dose: 320 mcg twice daily.
Note: Therapeutic ratio between Qvar Redihaler and other beclomethasone inhalers (eg, CFC formulations; however, none are currently available in US) has not been established.
National Asthma Education and Prevention Program Guidelines (NAEPP 2007): HFA formulation (Qvar RediHaler): Oral inhalation:
Children 5 to 11 years: Administer in divided doses:
"Low" dose: 80 to 160 mcg/day (40 mcg/puff: 2 to 4 puffs/day or 80 mcg/puff: 1 to 2 puffs/day).
"Medium" dose: >160 to 320 mcg/day (40 mcg/puff: 4 to 8 puffs/day or 80 mcg/puff: 2 to 4 puffs/day).
"High" dose: >320 mcg/day (40 mcg/puff: >8 puffs/day or 80 mcg/puff: >4 puff/day).
Children ≥12 years and Adolescents:
"Low" dose: 80 to 240 mcg/day (40 mcg/puff: 2 to 6 puffs/day or 80 mcg/puff: 1 to 3 puffs/day).
"Medium" dose: >240 to 480 mcg/day (40 mcg/puff: 6 to 12 puffs/day or 80 mcg/puff: 3 to 6 puffs/day).
"High" dose: >480 mcg/day (40 mcg/puff: >12 puffs/day or 80 mcg/puff: 6 puffs/day).
Mild flare, exacerbation: Limited data available:
Children ≥12 years and Adolescents with mild to moderate asthma, no prior history of life-threatening asthma exacerbations, and with good self-management skills:
It is recommended to temporarily quadruple the inhaled corticosteroid dose early in the course of a mild flare to decrease the severity of an asthma exacerbation. After symptoms stabilize or after a maximum of 14 days of quadrupled dose, whichever occurs first, patients should be returned to their baseline dose (GINA 2019). Quadrupling the inhaled corticosteroid dose has been shown to decrease the severity of an asthma exacerbation in select patients. In a randomized trial of adolescents ≥16 years and adults (n=1,871), temporarily quadrupling the inhaled corticosteroid dose when asthma control began to deteriorate resulted in fewer severe asthma exacerbations (ie, less treatment with systemic glucocorticoids or unscheduled appointments for asthma) compared to patients who maintained their inhaled corticosteroid dose (McKeever 2018). No data for quadrupling the dose in patients <16 years of age has been published. Quintupling the dose of inhaled corticosteroids (fluticasone) in children 5 to 11 years of age was not shown to reduce the rate of severe exacerbations and may have been associated adverse effects (decreased linear growth, particularly in patients <8 years of age) (GINA 2019; Jackson 2018).
Conversion from oral systemic corticosteroid to orally-inhaled corticosteroid: Initiation of oral inhalation therapy in patients on oral corticosteroids (OCS) should include a gradual dose reduction of OCS. If adrenal insufficiency occurs, temporarily increase the OCS dose and follow with a more gradual withdrawal. Note: When transitioning from systemic to inhaled corticosteroids, supplemental systemic corticosteroid therapy may be necessary during periods of stress or during severe asthma attacks.
Canadian labeling: Maintenance therapy: Metered-dose inhaler: Oral inhalation:
Children 5 to 11 years: Initial: 50 mcg twice daily; maximum dose: 100 mcg twice daily.
Children ≥12 years of age and Adolescents:
Mild asthma: 50 to 100 mcg twice daily; maximum dose: 100 mcg twice daily.
Moderate asthma: 100 to 250 mcg twice daily; maximum dose: 250 mcg twice daily.
Severe asthma: 300 to 400 mcg twice daily; maximum dose: 400 mcg twice daily.
Oral inhalation: Metered-dose inhaler: Do not shake prior to use. Avoid spraying in face or eyes. Rinse mouth with water (without swallowing) after each use. Do not wash or put inhaler in water; mouth piece may be cleaned with a dry tissue or cloth. Discard the inhaler when the dose counter displays "0".
QVAR: Prime canister by spraying twice into the air prior to initial use or if not in use for >10 days. Patients using a spacer should inhale immediately due to decreased amount of medication that is delivered with a delayed inspiration.
QVAR RediHaler: Inhaler device is breath-actuated; does not require priming before use. The white cap on the inhaler must remain closed during storage; do not open white cap until ready for use. If more than 1 inhalation is needed per dose, make sure the white cap is closed prior to next inhalation. If the white cap has been opened for >2 minutes or left in the open position, close the white cap to prepare inhaler and check dose counter to make sure the inhaler is not empty. Never breathe out into the inhaler mouthpiece. Do not use with a spacer or volume-holding chamber.
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Do not use or store near heat or open flame; do not puncture canisters. Exposure to temperatures above 49ºC (120ºF) may cause canister to burst. Never throw container into fire or incinerator. Store QVAR inhaler on concave end of canister with actuator on top.
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy
Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification
Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Monitor therapy
Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Avoid combination
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Central nervous system: Headache (1% to 25%)
Respiratory: Pharyngitis (3% to 27%)
1% to 10%:
Central nervous system: Pain (1% to 5%), voice disorder (4%)
Gastrointestinal: Oral candidiasis (1% to 8%), vomiting (children: 3%), diarrhea (children: 1% to 3%), nausea (1% to 3%)
Genitourinary: Dysmenorrhea (1% to 3%), viral gastroenteritis (children: 1% to 3%)
Infection: Influenza (children: 1% to 3%)
Neuromuscular & skeletal: Back pain (1% to 4%), myalgia (children: 1% to 3%)
Otic: Otitis (children: 1% to 3%)
Respiratory: Nasopharyngitis (2% to 9%), upper respiratory tract infection (3% to 8%), cough (1% to 7%), viral upper respiratory tract infection (2% to 4%), oropharyngeal pain (1% to 4%), sinusitis (3%), allergic rhinitis (≤3%)
Miscellaneous: Fever (children: 3%)
<1%, postmarketing, and/or case reports: Aggressive behavior, blurred vision, depression, dysgeusia (Tuccori 2011), psychomotor agitation, retinopathy, sleep disorder, suicidal ideation
Concerns related to adverse effects:
- Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroid should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).
- Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue beclomethasone and institute alternative therapy.
- Hypersensitivity reactions: Hypersensitivity reactions (eg, angioedema, bronchospasm, rash, and urticaria) may occur; discontinue use if reaction occurs.
- Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use, if possible, in patients with ocular herpes, active or quiescent respiratory tuberculosis, or untreated viral, fungal, parasitic or bacterial systemic infections. Exposure to chickenpox and measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered.
- Oral candidiasis: Local oropharyngeal Candida albicans infections have been reported; if this occurs, treat appropriately while continuing therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.
- Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Short-acting beta2-agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments. Use is contraindicated in status asthmaticus or during other acute asthma episodes requiring intensive measures.
- Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.
- Ocular disease: Use with caution in patients with cataracts and/or glaucoma; blurred vision, increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
- Pediatric: Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.
- Discontinuation of therapy: A gradual tapering of dose may be required prior to discontinuing therapy; there have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.
- Transfer to oral inhaler: When transferring to oral inhalation therapy from systemic corticosteroid therapy, previously suppressed allergic conditions (rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions) may be unmasked. Withdraw systemic corticosteroid therapy by gradually tapering the dose. Monitor lung function, beta-agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea/vomiting, hypotension) during withdrawal.
FEV1, peak flow, and/or other pulmonary function tests; bone mineral density; growth (adolescents and children via stadiometry); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]), signs/symptoms of oral candidiasis; asthma symptoms; glaucoma/cataracts
Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications (ACOG 2008; GINA 2018).
Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy (ACOG 2008; GINA 2018; Namazy 2016). Pregnant females adequately controlled on beclomethasone for asthma may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant females may be preferred (Namazy 2016).
What is this drug used for?
- It is used to treat asthma.
- Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.
Frequently reported side effects of this drug
- Common cold symptoms
- Nasal irritation
- Throat irritation
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss
- Severe loss of strength and energy
- Fast heartbeat
- Vision changes
- Trouble breathing
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.