Brand name: Beconase AQ
Drug class: Corticosteroids

Medically reviewed by Drugs.com on Sep 23, 2024. Written by ASHP.

Introduction

Synthetic corticosteroid.^a

Uses for Beclomethasone (EENT)

Seasonal and Perennial Rhinitis

Symptomatic treatment of seasonal or perennial rhinitis.¹⁰³

Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing (including morning sneezing attacks), and nasal and pharyngeal itching.^a

Generally does not relieve signs and symptoms of conjunctivitis or those involving the lower respiratory tract (e.g., coughing), although improvement in ophthalmic and respiratory manifestations may occur.^a

Relieves symptoms in both allergic and nonallergic rhinitis, although intranasal route appears to provide greater relief in allergic rhinitis.^a

Continuous concomitant therapies (e.g., oral or orally inhaled corticosteroids, bronchodilators, antihistamines, decongestants) may be required for optimum symptomatic relief, especially in patients with concurrent asthmatic conditions.^a

Symptomatic relief is usually evident within several days of initiating continuous intranasal therapy; however, up to 2 weeks may be required for optimum effectiveness.^a

Nasal Polyposis

Used principally to prevent nasal polyp recurrence after surgical removal.^a

May delay need for subsequent surgery, but should not preclude polypectomy when polyp size prevents adequate penetration of drug into nasal passages.^a

May reduce polyp size and the degree of nasal obstruction, but apparently does not alter underlying disease; manifestations usually recur when the drug is discontinued.^a

Periodically monitor patients receiving prolonged intranasal corticosteroid therapy with rhinoscopic examinations, since risk for atrophic rhinitis is increased.^a

Beclomethasone (EENT) Dosage and Administration

Administration

Intranasal Inhalation

Administer by nasal inhalation only using a metered-dose nasal spray pump.^{103 104 a}

Prime spray pump prior to initial use (6 actuations or until a fine spray appears) and after ≥7days of non-use (until a fine spray appears).¹⁰⁴

Shake spray pump well immediately prior to use.¹⁰⁴

Avoid contact with the eyes.¹⁰⁴

Blow nose to clear nasal passages prior to administration.¹⁰⁴ Adequate penetration of the drug may require a topical nasal vasoconstrictor in patients with blocked nasal passages during the first 2–3 days of therapy.¹⁰³

For each inhalation, support the base of the spray bottle with the thumb and place the middle finger and forefinger on the white collar of the bottle.¹⁰⁴ Tilt the head slightly forward, keep the bottle upright, and insert the nasal applicator into one nostril while holding the other nostril closed.¹⁰⁴

Spray the drug into one nostril by pressing down firmly on the white collar of the bottle and concurrently inhaling gently through the nose, then exhale through the mouth.¹⁰⁴

Repeat procedure for the other nostril.¹⁰⁴

To clean nasal applicator, remove dust cap and safety clip and press applicator collar gently upward to free applicator.¹⁰⁴ Wash dust cap and nasal applicator in cold water, then dry and replace applicator, safety clip, and dust cap.¹⁰⁴

To unblock nasal applicator, remove dust cap, unscrew complete pump mechanism, and soak in warm water for a few minutes.¹⁰⁴ Rinse with cold water, dry, replace on bottle, and reprime the pump.¹⁰⁴

Dosage

Available as beclomethasone dipropionate monohydrate; dosage expressed in terms of the anhydrous salt.¹⁰³

After initial priming, each actuation of the nasal aqueous suspension spray pump delivers a 100-mg dose of beclomethasone dipropionate suspension equivalent to 42 mcg of anhydrous beclomethasone dipropionate.¹⁰³ Each 25-g spray bottle delivers 180 metered doses, after which the correct amount of drug in each spray cannot be assured.^{103 104} Discard the bottle after 180 sprays have been used.^{103 104}

Adjust dosage according to individual requirements and response.^a

Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate.¹⁰³

Use of topical nasal decongestants or oral antihistamines may be necessary until the effects of intranasal beclomethasone dipropionate are fully manifested.¹⁰³

Symptomatic relief is usually evident within several days of continuous therapy; however, up to 2 weeks may be required for relief in some patients.¹⁰³

Do not continue therapy beyond 3 weeks in the absence of substantial symptomatic improvement.¹⁰³

Pediatric Patients

Seasonal Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Adults

Seasonal Rhinitis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dose: 168–336 mcg/day).¹⁰³

Prescribing Limits

No evidence that higher than recommended dosages or increased frequency of administration is beneficial.¹⁰³

Exceeding the maximum recommended daily dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing’s syndrome) and should be avoided.¹⁰³

Pediatric Patients

Seasonal Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adults

Seasonal Rhinitis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Cautions for Beclomethasone (EENT)

Contraindications

• Known hypersensitivity to beclomethasone or any ingredient in the formulation.¹⁰³

• Do not use in the presence of untreated localized nasal mucosa infections.¹⁰³

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Patients being switched from prolonged systemic corticosteroids to intranasal therapy should be monitored carefully since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, and/or severe symptomatic exacerbation of asthma or other clinical conditions may occur.¹⁰³

In patients being switched to intranasal therapy, systemic corticosteroid dosage should be tapered and patients carefully monitored during dosage reduction.¹⁰³

Systemic Corticosteroid Effects

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may cause systemic corticosteroid effects (e.g., menstrual irregularities, acneiform lesions, cataracts, cushingoid features).¹⁰³

Avoid larger than recommended dosages; potential for systemic effects increases with excessive dosage.¹⁰³

If systemic effects occur, therapy with the drug should gradually be withdrawn (tapered).¹⁰³

Immunosuppression

Although risk with intranasal use is unknown, consider the possibility that corticosteroid-induced immunosuppression could occur.^a Avoid exposure to varicella and measles in previously unexposed patients and those who have not been properly immunized.¹⁰³

If exposure to varicella or measles occurs in such individuals, administration of varicella zoster immune globulin (VZIG) or immune globulin, respectively, may be indicated.¹⁰³ If varicella develops, treatment with an antiviral agent may be considered.¹⁰³

Sensitivity Reactions

Immediate or delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, wheezing, and bronchospasm, have occurred rarely.¹⁰³

General Precautions

Nasopharyngeal Effects

Persistent nasopharyngeal irritation may require discontinuance of beclomethasone therapy.¹⁰³

Rarely, nasal septal perforations.¹⁰³

Rarely, localized candidal infections of the nose and/or pharynx.¹⁰³ Treat suspected infection with appropriate local therapy;¹⁰³ may require discontinuance of beclomethasone therapy.¹⁰³

Avoid use until healing occurs in patients with recurrent epistaxis, recent nasal septal ulcers, nasal surgery, or nasal trauma.¹⁰³

Ophthalmic Effects

Increased intraocular pressure (IOP), glaucoma, cataracts, and conjunctivitis have been reported rarely.¹⁰³

Hypothalamic-Pituitary-Adrenal Axis Suppression

Avoid higher than recommended dosages since suppression of hypothalamic-pituitary-adrenal (HPA) function may occur.¹⁰³

Reductions in plasma cortisol concentrations have occurred when intranasal and orally inhaled beclomethasone dipropionate were used concomitantly.^a

Cases of growth suppression also have been reported.¹⁰³ (See Pediatric Use under Cautions.)

Infection

Use cautiously, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex infections.¹⁰³

Nasal Polyposis

Treatment with beclomethasone should be considered adjunctive to surgical removal and/or use of other drugs that will permit effective penetration of the drug into the nose; polyps may recur after any treatment.¹⁰³

Nasal Mucosal Changes

During long-term intranasal therapy (several months or longer), periodically examine nasal passages for mucosal changes.¹⁰³

Specific Populations

Pregnancy

Category C.¹⁰³

Lactation

Other corticosteroids known to be distributed into milk.¹⁰³ Caution if used in nursing women.¹⁰³

Corticosteroids may cause adverse effects (e.g., growth suppression) in nursing infants if distributed into milk.^a

Pediatric Use

May be a useful therapeutic alternative to oral corticosteroids in children ≥6 years of age with seasonal or perennial allergic rhinitis, since intranasal administration is associated with a decreased risk of adverse systemic effects.^a

Intranasal corticosteroids, including beclomethasone, may reduce growth velocity in pediatric patients; use lowest effective dosage and monitor growth routinely.¹⁰³ In a placebo-controlled, 1-year study, approximately 50% of beclomethasone dipropionate-treated children were below the 10th percentile for growth velocity.¹⁰³

Safety and efficacy not established in children <6 years of age.¹⁰³

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether such patients respond differently than younger adults; select dosage with caution due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients.¹⁰³

Common Adverse Effects

Mild nasopharyngeal irritation, sneezing attacks, headache, nausea, lightheadedness, nasal stuffiness, nosebleeds, rhinorrhea, tearing eyes.¹⁰³

Beclomethasone (EENT) Pharmacokinetics

Absorption

Bioavailability

Most of an intranasal dose is swallowed.^{103 105}

Systemic bioavailability (as active metabolite) is 44% (43% from swallowed portion, 1% from nasal mucosa).^{103 105}

Distribution

Extent

Moderate distribution, more extensive for active metabolite.^{103 105} Beclomethasone dipropionate and its metabolites are not stored in tissues.¹⁰³

Not known whether beclomethasone crosses the placenta or is distributed into milk; other corticosteroids are distributed into milk.^{a 103}

Plasma Protein Binding

Approximately 87%.¹⁰³

Elimination

Metabolism

Beclomethasone dipropionate is a weakly active prodrug, rapidly hydrolyzed to highly active beclomethasone-17-monopropionate (B-17-MP) by esterase enzymes found in most tissues.^{a 103 105}

Elimination Route

Excreted mainly as metabolites in feces (60%) and in urine (12%) following oral administration.¹⁰³

Half-life

Not determined following intranasal administration.^a Terminal half-life averages 0.5 hours (beclomethasone dipropionate) and 2.7 hours (active metabolite) following IV administration.¹⁰³

Stability

Storage

Nasal Suspension

15–30°C.¹⁰³

Discard the nasal pump spray after 180 sprays.^{103 104}

Actions

• Potent glucocorticoid and weak mineralocorticoid effects.^a

• Topical anti-inflammatory potency of beclomethasone dipropionate is about 5000 times greater than hydrocortisone; 500 times greater than beclomethasone, betamethasone, or dexamethasone; and about 5 times greater than fluocinolone or the acetonides of fluocinolone or triamcinolone, as measured by vasoconstrictor assay.^a Beclomethasone dipropionate is 6–7 times more potent as a glucocorticoid than hydrocortisone when administered orally or subcutaneously.^a

• Local anti-inflammatory and vasoconstrictor effects following topical application to the nasal mucosa.^{a 103}

• Reduces number of mediator cells (basophil leukocytes and mast cells) at the epithelial level, number of eosinophils, sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity.^a

• May inhibit capillary dilation and permeability, stabilize lysosomal membranes and prevent proteolytic enzyme release.^a

• Adrenal suppression has not been observed when beclomethasone dipropionate inhalation aerosol (no longer commercially available in the US) was administered in clinical trials,¹⁰³ but decreases in nocturnal cortisol secretion have been reported with usual dosages of beclomethasone oral inhalation in children.¹⁰³ (See Hypothalamic-Pituitary-Adrenal Axis Suppression under Cautions.)

Advice to Patients

• Importance of giving patient a copy of the manufacturer’s patient instructions.^{103 104}

• Importance of instructing patient about proper techniques for assembly and priming of nasal spray pump and for administration and storage of the nasal solution.^{103 104}

• Importance of shaking nasal spray well prior to each use.¹⁰⁴

• Importance of discarding container after 180 actuations or once the expiration date on the label is reached.^{103 104}

• Avoid spraying into eyes.¹⁰⁴

• Importance of advising patient that effects are not immediate; full benefit may require ≤2 weeks of continuous use.¹⁰³

• Importance of using at regular intervals as directed.¹⁰³

• Importance of not continuing therapy for longer than 3 weeks in the absence of substantial symptomatic improvement.¹⁰³

• Importance of informing clinician if symptoms fail to improve or worsen or if sneezing or nasal irritation occurs.¹⁰³

• Importance of not increasing dosage unless directed by a clinician.¹⁰³

• Importance of using concomitant nasal vasoconstrictor and/or oral antihistamines for 1–2 weeks if needed until the effects of beclomethasone are optimal.¹⁰³

• Importance of avoiding exposure to chickenpox or measles if receiving immunosuppressive doses of corticosteroids; if exposed, notify a clinician.¹⁰³

• Importance of patients with severe allergies avoiding exposure to allergens during intranasal beclomethasone dipropionate therapy to prevent the occurrence of severe allergic symptoms in the eyes and/or lower respiratory tract.^a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹⁰³

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰³

• Importance of informing patients of other important precautionary information.¹⁰³ (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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