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Beclomethasone (Nasal)

Medically reviewed by Drugs.com. Last updated on Jun 17, 2020.

Pronunciation

(be kloe METH a sone)

Index Terms

  • Beclomethasone Dipropionate
  • Vancenase AQ

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol Solution, Nasal, as dipropionate:

Qnasl: 80 mcg/actuation (8.7 g [DSC], 10.6 g)

Qnasl Childrens: 40 mcg/actuation (4.9 g [DSC], 6.8 g)

Suspension, Nasal, as dipropionate:

Beconase AQ: 42 mcg/spray (25 g) [contains benzalkonium chloride]

Brand Names: U.S.

  • Beconase AQ
  • Qnasl
  • Qnasl Childrens

Pharmacologic Category

  • Corticosteroid, Nasal

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

Distribution

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

Metabolism

BMP is a prodrug; undergoes rapid conversion to 17-BMP (major active metabolite) during absorption; followed by additional metabolism via CYP3A4 to other, less active metabolites (beclomethasone-21-monopropionate [21-BMP] and beclomethasone [BOH])

Excretion

Feces (60%); urine (<10% to 12%; as free and conjugated metabolites)

Onset of Action

Within a few days up to 2 weeks

Half-Life Elimination

BDP: 0.5 hours; 17-BMP: 2.7 hours

Protein Binding

BDP 87%; 17-BMP: 94% to 96%

Use: Labeled Indications

Nasal polyps, postsurgical prophylaxis (Beconase AQ only): Prevention of recurrence of nasal polyps following surgical removal in adults and children 6 years and older.

Rhinitis, allergic:

Beconase AQ: Relief of symptoms of seasonal or perennial allergic rhinitis in adults and children 6 years and older.

Qnasl: Treatment of the nasal symptoms associated with seasonal or perennial allergic rhinitis in adults and children 4 years and older.

Rhinitis, nonallergic (vasomotor): Beconase AQ: Relief of symptoms of nonallergic (vasomotor) rhinitis in adults and children 6 years and older.

Off Label Uses

Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment)

Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults and the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, beclomethasone (nasal), among other intranasal corticosteroids, is effective and recommended as an adjunctive treatment to antibiotic therapy for the management of ABRS, primarily when a history of allergic rhinitis exists (according to IDSA guidelines).

Chronic Rhinosinusitis

Based on the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, beclomethasone (nasal), among other intranasal corticosteroids, is effective and recommended (with or without nasal saline irrigation) for the symptomatic relief of chronic rhinosinusitis

Contraindications

Hypersensitivity to beclomethasone or any component of the formulation

Documentation of allergenic cross-reactivity for intranasal steroids is limited. However, the possibility of cross-sensitivity cannot be ruled out with certainty because of similarities in chemical structure and/or pharmacologic actions.

Canadian labeling: Additional contraindications (not in US labeling): Active or quiescent tuberculosis or untreated fungal, bacterial and viral infections.

Dosing: Adult

Nasal polyps (postsurgical prophylaxis): Beconase QA: Intranasal: 1 or 2 inhalations (42 or 84 mcg) in each nostril twice daily; total dose: 168 to 336 mcg/day.

Rhinitis, allergic:

Beconase AQ: Intranasal: 1 or 2 inhalations (42 or 84 mcg) in each nostril twice daily; total dose: 168 to 336 mcg/day.

Qnasl: Intranasal: 2 inhalations (160 mcg) in each nostril once daily (maximum: 320 mcg/day).

Rhinitis, nonallergic (vasomotor): Beconase AQ: Intranasal: 1 or 2 inhalations (42 or 84 mcg) in each nostril twice daily; total dose: 168 to 336 mcg/day.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Product formulations are not interchangeable: Beconase AQ: One spray delivers 42 mcg; Qnasl: One spray delivers 40 mcg or 80 mcg

Allergic rhinitis: Intranasal:

Beconase AQ (42 mcg/spray):

Children 6 to <12 years: Initial: 1 spray (42 mcg) per nostril twice daily (total dose: 168 mcg daily); if response inadequate, may increase to 2 sprays (84 mcg) per nostril twice daily (total dose: 336 mcg daily); once symptoms are adequately controlled, decrease dose to 1 spray (42 mcg) per nostril twice daily (total dose: 168 mcg daily).

Children ≥12 years and Adolescents: 1 or 2 sprays (42 mcg or 84 mcg) per nostril twice daily (total dose: 168 to 336 mcg daily); maximum daily dose: 336 mcg/day.

Qnasl:

Children 4 to <12 years: Qnasl 40 mcg: 1 spray (40 mcg) per nostril once daily (total dose: 80 mcg/day); maximum daily dose: 80 mcg/day.

Children ≥12 years and Adolescents: Qnasl 80 mcg: 2 sprays (160 mcg) per nostril once daily (total daily dose: 320 mcg/day); maximum daily dose: 320 mcg/day

Nasal airway obstruction/adenoidal hypertrophy: Limited data available; dosing regimens variable: Intranasal: Beconase AQ (42 mcg/spray): Children 5 to 12 years: Initial: 2 sprays (84 mcg) per nostril twice daily (total dose: 336 mcg daily) for 4 weeks, followed by 1 spray (42 mcg) per nostril twice daily (total dose: 168 mcg daily). Dosing based on a double-blind, placebo-controlled crossover study (n=17, age range: 5 to 11 years); results showed significant reduction in adenoid hypertrophy and related obstructive nasal symptoms following 4 weeks of beclomethasone therapy vs placebo (Demain 1995). Positive efficacy findings were also observed in a single-blind, placebo-controlled crossover study of 53 children (mean age: 3.8 ± 1.3 years) using a total daily dose of 400 mcg/day (200 mcg twice daily [using 50 mcg/spray formulation, not available in US]) delivered as 100 mcg (2 sprays) per nostril twice daily (Criscuoli 2003). Lower daily dosage (200 mcg/day) have not been found effective (Lepcha 2002).

Nasal polyps (postsurgical prophylaxis), vasomotor rhinitis: Intranasal: Beconase AQ (42 mcg/spray):

Children 6 to 12 years: Initial: 1 spray (42 mcg) per nostril twice daily (total dose: 168 mcg daily); if response inadequate, may increase to 2 sprays (84 mcg) per nostril twice daily (total dose: 336 mcg daily); once symptoms are adequately controlled, decrease dose to 1 spray (42 mcg) per nostril twice daily (total dose: 168 mcg daily).

Children and Adolescents ≥12 years: 1 or 2 sprays (42 mcg or 84 mcg) per nostril twice daily (total dose: 168 to 336 mcg daily); maximum daily dose: 336 mcg/day

Administration

Beconase AQ: Shake well prior to each use. Prior to initial use, prime pump 6 times (or until fine spray appears); repeat priming if product not used for ≥7 days. Spray in nostril(s); avoid spraying in eyes or mouth. Nasal applicator and dust cap may be washed in warm water and dry thoroughly.

Qnasl: Spray in nostril(s); avoid spraying in eyes or mouth. Note: A formulation requiring priming was distributed prior to January 2019. As of January 2019, a primeless formulation was made available. Confirm formulation being used to determine appropriate administration requirements.

Storage

Beconase AQ: Store between 15°C to 30°C (59°F to 86°F).

Qnasl: Store between 20°C and 25°C (68°F and 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not puncture. Do not store near heat or open flame. Do not expose to temperatures higher than 49°C (120°F).

Drug Interactions

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

Esketamine: Corticosteroids (Nasal) may diminish the therapeutic effect of Esketamine. Management: Patients who require a nasal corticosteroid on an esketamine dosing day should administer the nasal corticosteroid at least 1 hour before esketamine. Consider therapy modification

Adverse Reactions

Frequency not always defined.

>10%: Respiratory: Nasopharyngitis (≤24%; children: 2%), epistaxis (2% to 11%)

1% to 10%:

Central nervous system: Dizziness (≤5%), headache (≤5%)

Endocrine & metabolic: Adrenal suppression (at high doses or in susceptible individuals), hypercorticoidism (at high doses or in susceptible individuals)

Gastrointestinal: Nausea (≤5%), oral candidiasis (rare; more likely with aqueous solution)

Immunologic: Immunosuppression

Neuromuscular & skeletal: Decreased linear skeletal growth rate

Ophthalmic: Intraocular pressure increased (5%), lacrimation (≤3%)

Respiratory: Sneezing (4%), upper respiratory tract infection (children: 3%), nasal congestion (≤3%), rhinorrhea (≤3%), nasal mucosa irritation (erosion) (≤1%), nasal candidiasis (rare; more likely with aqueous solution), pharyngeal candidiasis (rare; more likely with aqueous solution)

Miscellaneous: Fever (children: 3%), wound healing impairment

<1%, postmarketing, and/or case reports: Ageusia, altered sense of smell, anaphylactoid reaction, anaphylaxis, angioedema, anosmia, blurred vision, bronchospasm, burning sensation, cataract, chorioretinitis, dry nose, glaucoma, hypersensitivity reaction, nasal mucosa ulcer, nasal septum perforation, skin rash, unpleasant taste, urticaria, wheezing

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.

• Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery or nasal trauma until healing has occurred.

• Hypersensitivity reactions: Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria, and wheezing) have been reported; discontinue for severe reactions.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infections, mask an acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines; avoid exposure to chickenpox and/or measles, especially if not immunized. Avoid use or use with caution in patients with latent/active tuberculosis, untreated bacterial or fungal infections (local or systemic), viral or parasitic infections, or ocular herpes simplex.

• Local nasal effects: Nasal septal perforation and localized Candida albicans infections of the nose and/or pharynx may occur. Nasal discomfort, epistaxis, and nasal ulceration may also occur; periodically examine nasal mucosa in patients on long-term therapy. Monitor patients for adverse nasal effects; discontinuation of therapy may be necessary if an infection occurs.

• Ocular disease: Increased intraocular pressure, open-angle glaucoma, and/or cataracts have occurred with intranasal corticosteroid use; use with caution in patients with a history of increased intraocular pressure, cataracts and/or glaucoma. Consider routine eye exams in chronic users or in patients who report visual changes.

Special populations:

• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).

Other warnings/precautions:

• Appropriate use: Rhinitis: Do not use in the presence of untreated localized infection involving the nasal mucosa. Do not continue use beyond 3 weeks in the absence of significant symptomatic improvement. Symptomatic relief may not occur for as long as 2 weeks.

• Appropriate use: Nasal polyps: Treatment may need to be continued for several weeks or more before a therapeutic result can be fully assessed. Treatment of nasal polyps with beclomethasone should be considered adjunctive therapy to surgical removal and/or the use of other medications that will permit effective penetration of beclomethasone into the nose. Recurrence can occur after stopping treatment.

Monitoring Parameters

Growth (adolescents and children); signs/symptoms of HPA axis suppression/adrenal insufficiency or hypercortisolism; ocular changes, including glaucoma and cataracts; signs/symptoms of Candida infection (long-term therapy); nasal effects (eg, epistaxis, nasal discomfort, nasal septal perforation, nasal ulcerations).

Pregnancy Considerations

Intranasal corticosteroids may be acceptable for the treatment of rhinitis during pregnancy when used at recommended doses (Lal 2016).

Pregnant females adequately controlled on beclomethasone may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant females and less systemic absorption may be preferred (Alhussien 2018; Namazy 2016).

Patient Education

What is this drug used for?

• It is used to keep nose polyps from coming back.

• It is used to ease allergy signs.

• It may be given to you for other reasons. Talk with the 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

• Nose irritation

• Common cold symptoms

• Sore throat

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:

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

• Infection

• Nosebleed

• Nasal sores

• Wheezing

• Thrush

• Vision changes

• 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.