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Beclomethasone (Oral Inhalation)

Medically reviewed by Drugs.com. Last updated on Oct 21, 2020.

Pronunciation

(be kloe METH a sone)

Index Terms

  • Vanceril

Dosage Forms

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])

Brand Names: U.S.

  • Qvar RediHaler
  • Qvar [DSC]

Pharmacologic Category

  • Corticosteroid, Inhalant (Oral)

Pharmacology

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

Absorption

Readily; quickly hydrolyzed by pulmonary esterases to active metabolite (beclomethasone-17-monopropionate [17-BMP]) during absorption

Distribution

Vd: Beclomethasone dipropionate (BDP): 20 L; 17-BMP: 424 L

Metabolism

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])

Excretion

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

Plasma: Inhalation:

QVAR: BDP: 0.5 hours; 17-BMP: 0.7 hours

RediHaler: BDP: 2 minutes; 17-BMP: 10 minutes

Half-Life Elimination

QVAR: BDP: 0.5 hours; 17-BMP: 2.8 hours

RediHaler:; BDP: 2 minutes; 17-BMP: 4 hours

Protein Binding

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.

Off Label Uses

Chronic obstructive pulmonary disease (stable)

Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines for the management of chronic obstructive pulmonary disease (COPD), inhaled corticosteroids may be considered as part of dual or triple combination therapy (with a long-acting beta agonist [LABA] or with a LABA and long-acting muscarinic antagonist, respectively) in patients with moderate to very severe COPD. However, regular treatment with inhaled corticosteroids has been shown to increase the risk of pneumonia, especially in those with severe disease. Combination therapy is recommended in patients with a history of hospitalization(s) for exacerbations of COPD, ≥2 moderate exacerbations of COPD per year, blood eosinophils >300 cells/microliter, and concomitant or history of asthma. Combination therapy may also be considered in patients with 1 moderate exacerbation of COPD per year and blood eosinophils of 100 to 300 cells/microliter [GOLD 2019].

Contraindications

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

Dosing: Adult

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 (GINA 2020; 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

Asthma Guidelines:

Global Initiative for Asthma and National Asthma Education and Prevention Program guidelines (GINA 2020; NAEPP 2007): Metered-dose inhaler: Note: Administer in 1 to 4 inhalations/day depending on strength of inhaler.

Low-dose therapy: 80 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 as a component of dual or triple combination therapy (GOLD 2014; GOLD 2019).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Doses should be titrated to the lowest effective dose once asthma is controlled.

Asthma:

Maintenance therapy:

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.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

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.

Storage

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.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Monitor therapy

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination

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

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

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

Warnings/Precautions

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.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Use is contraindicated in status asthmaticus or during other acute episodes of asthma 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.

Special populations:

• 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.

Other warnings/precautions:

• 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.

Monitoring Parameters

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

Pregnancy Considerations

Maternal use of inhaled corticosteroids (ICS) in usual doses is not associated with an increased risk of fetal malformations; a small risk of malformations was observed in one study following maternal doses of beclomethasone >1,000 mcg/day. Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth and gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2020).

Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy (GINA 2020). Beclomethasone is one of the preferred agents. The lowest dose that maintains asthma control should be used. Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020])

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant females in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Patient Education

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Common cold symptoms

• Nasal irritation

• Throat irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Thrush

• Severe loss of strength and energy

• Irritability

• Tremors

• Fast heartbeat

• Confusion

• Dizziness

• Vision changes

• Trouble breathing

• Wheezing

• Cough

• Sweating

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.