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Beclomethasone (Nasal)

Pronunciation

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.

Aerosol Solution, Nasal, as dipropionate:

Qnasl: 80 mcg/actuation (8.7 g)

Qnasl Childrens: 40 mcg/actuation (4.9 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 Beconase AQ only: Prevention of recurrence of nasal polyps following surgical removal

Rhinitis:

Beconase AQ: Relief of symptoms of seasonal or perennial allergic rhinitis and nonallergic (vasomotor) rhinitis

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

Use: Unlabeled

Adjunct to antibiotics in empiric treatment of acute bacterial rhinosinusitis (ABRS) (Chow, 2012)

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 U.S. labeling): Active or quiescent tuberculosis or untreated fungal, bacterial and viral infections.

Dosing: Adult

Beconase AQ: Rhinitis, nasal polyps (postsurgical prophylaxis): Inhalation, nasal: One or two inhalations (42 or 84 mcg) in each nostril twice daily; total dose: 168 to 336 mcg daily; maximum dose: 336 mcg daily

Qnasl: Allergic rhinitis: Inhalation, nasal: Qnasl 80 mcg: Two inhalations (160 mcg) in each nostril once daily (maximum: 320 mcg daily)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Beconase AQ: Rhinitis, nasal polyps (postsurgical prophylaxis): Inhalation, nasal

Children 6 to 11 years: Initial: One inhalation (42 mcg) in each nostril twice daily (total dose: 168 mcg daily); if response inadequate, may increase to 2 inhalations (84 mcg) in each nostril twice daily (total dose: 336 mcg daily); once adequate control is achieved, decreased to 1 inhalation (42 mcg) in each nostril twice daily (total dose: 168 mcg daily)

Children ≥12 years and Adolescents: Refer to adult dosing.

Qnasl: Allergic rhinitis: Inhalation, nasal

Children 4 to 11 years: Qnasl 40 mcg: One inhalation (40 mcg) in each nostril once daily (maximum: 80 mcg daily)

Children ≥12 years and Adolescents: Qnasl 80 mcg: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

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: Shake well prior to each use. Prior to initial use, prime pump 4 times. If product not used for ≥7 days, prime pump 2 times. Spray in nostril(s); avoid spraying in eyes or mouth.

Storage

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

Qnasl: Store at 25°C (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

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Adverse Reactions

Frequency not always defined.

>10%: Respiratory: Nasopharyngitis (≤24%; children: 2%)

1% to 10%:

Central nervous system: Dizziness (≤5%), headache (≤5%), altered sense of smell, anosmia

Dermatologic: Skin rash, urticaria

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

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

Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioedema

Immunologic: Immunosuppression

Neuromuscular & skeletal: Decreased linear skeletal growth rate

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

Respiratory: Epistaxis (2% to 11%), sneezing (4%), upper respiratory tract infection (children: 3%), nasal congestion (≤3%), rhinorrhea (≤3%), nasal mucosa irritation (erosion) (≤1%), bronchospasm, dry nose, nasal candidiasis (rare; more likely with aqueous solution), pharyngeal candidiasis (rare; more likely with aqueous solution), wheezing

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

<1% (Limited to important or life-threatening): Nasal mucosa ulcer, nasal septum perforation

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercorticism 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. 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 hypercorticism (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; ocular changes; signs/symptoms of Candida infection (long-term therapy)

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP, 2005; Wallace, 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, rhinorrhea, or pharyngitis. Have patient report immediately to prescriber signs of infection, severe dizziness, passing out, severe nose irritation, nosebleed, nasal sores, wheezing, thrush, sneezing, severe nausea, severe vomiting, severe loss of strength and energy, or vision changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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