Introduction

Synthetic corticosteroid.

Uses for Beclomethasone (EENT)

Seasonal and Perennial Rhinitis

Symptomatic treatment of seasonal or perennial rhinitis.

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

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.

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

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.

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

Nasal Polyposis

Used principally to prevent nasal polyp recurrence after surgical removal.

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

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.

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

Beclomethasone (EENT) Dosage and Administration

Administration

Intranasal Inhalation

Administer by nasal inhalation only using a metered-dose nasal spray pump.

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).

Shake spray pump well immediately prior to use.

Avoid contact with the eyes.

Blow nose to clear nasal passages prior to administration. 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.

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. Tilt the head slightly forward, keep the bottle upright, and insert the nasal applicator into one nostril while holding the other nostril closed.

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.

Repeat procedure for the other nostril.

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

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

Dosage

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

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. Each 25-g spray bottle delivers 180 metered doses, after which the correct amount of drug in each spray cannot be assured. Discard the bottle after 180 sprays have been used.

Adjust dosage according to individual requirements and response.

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

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

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

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

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).

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.

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

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

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).

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.

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

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

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).

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.

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

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

Adults

Seasonal Rhinitis

Intranasal Inhalation

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

Perennial Rhinitis

Intranasal Inhalation

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

Nasal Polyposis

Intranasal Inhalation

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

Prescribing Limits

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

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.

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).

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

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).

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

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).

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

Adults

Seasonal Rhinitis

Intranasal Inhalation

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

Perennial Rhinitis

Intranasal Inhalation

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

Nasal Polyposis

Intranasal Inhalation

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

Contraindications

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

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

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.

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

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).

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

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

Immunosuppression

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

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

Sensitivity Reactions

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

General Precautions

Nasopharyngeal Effects

Persistent nasopharyngeal irritation may require discontinuance of beclomethasone therapy.

Rarely, nasal septal perforations.

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

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

Ophthalmic Effects

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

Hypothalamic-Pituitary-Adrenal Axis Suppression

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

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

Cases of growth suppression also have been reported. (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.

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.

Nasal Mucosal Changes

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

Specific Populations

Pregnancy

Category C.

Lactation

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

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

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.

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

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

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.

Common Adverse Effects

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

Administration

Intranasal Inhalation

Administer by nasal inhalation only using a metered-dose nasal spray pump.

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).

Shake spray pump well immediately prior to use.

Avoid contact with the eyes.

Blow nose to clear nasal passages prior to administration. 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.

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. Tilt the head slightly forward, keep the bottle upright, and insert the nasal applicator into one nostril while holding the other nostril closed.

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.

Repeat procedure for the other nostril.

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

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

Dosage

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

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. Each 25-g spray bottle delivers 180 metered doses, after which the correct amount of drug in each spray cannot be assured. Discard the bottle after 180 sprays have been used.

Adjust dosage according to individual requirements and response.

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

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

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

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

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).

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.

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

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

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).

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.

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

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

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).

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.

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

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

Adults

Seasonal Rhinitis

Intranasal Inhalation

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

Perennial Rhinitis

Intranasal Inhalation

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

Nasal Polyposis

Intranasal Inhalation

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

Prescribing Limits

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

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.

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).

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

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).

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

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).

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

Adults

Seasonal Rhinitis

Intranasal Inhalation

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

Perennial Rhinitis

Intranasal Inhalation

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

Nasal Polyposis

Intranasal Inhalation

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