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Pronunciation:

(be kloe METH a sone)

U.S. Brand Names:

Beconase® [DSC]; Beconase® AQ; QVAR®

Synonyms:

Beclomethasone Dipropionate

Generic Available:

Canadian Brand Names:

Apo-Beclomethasone®; Gen-Beclo; Nu-Beclomethasone; Propaderm®; QVAR®; Rivanase AQ; Vanceril® AEM

Use:

Oral inhalation: Maintenance and prophylactic treatment of asthma; includes those who require corticosteroids and those who may benefit from a dose reduction/elimination of systemically administered corticosteroids. Not for relief of acute bronchospasm

Nasal aerosol: Symptomatic treatment of seasonal or perennial rhinitis and to prevent recurrence of nasal polyps following surgery

Pregnancy Risk Factor:

Pregnancy Implications:

Data does not support an association between drug and congenital defects in humans. No data on beclomethasone crossing the placenta or effects on the fetus.

Lactation:

Enters breast milk (oral)/use caution

Contraindications:

Hypersensitivity to beclomethasone or any component of the formulation; status asthmaticus

Warnings/Precautions:

Not to be used in status asthmaticus or for the relief of acute bronchospasm; safety and efficacy in children <6 years of age have not been established. May cause suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. 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. Withdrawal and discontinuation of the corticosteroid should be done slowly and carefully.

Controlled clinical studies have shown that orally-inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. (In studies of orally-inhaled corticosteroids, the mean reduction in growth velocity was approximately 1 centimeter per year [range 0.3-1.8 cm per year] and appears to be related to dose and duration of exposure.) The growth of pediatric patients receiving inhaled corticosteroids, should be monitored routinely (eg, via stadiometry). To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose.

May suppress the immune system, patients may be more susceptible to infection. Use with caution in patients with systemic infections or ocular herpes simplex. Avoid exposure to chickenpox and measles. Corticosteroids should be used with caution in patients with diabetes, hypertension, osteoporosis, peptic ulcer, glaucoma, cataracts, or tuberculosis. Use caution in hepatic impairment.

Adverse Reactions:

Frequency not defined.

Central nervous system: Agitation, depression, dizziness, dysphonia, headache, lightheadedness, mental disturbances

Dermatologic: Acneiform lesions, angioedema, atrophy, bruising, pruritus, purpura, striae, rash, urticaria

Endocrine & metabolic: Cushingoid features, growth velocity reduction in children and adolescents, HPA function suppression, weight gain

Gastrointestinal: Dry/irritated nose, throat and mouth, hoarseness, localized Candida or Aspergillus infection, loss of smell, loss of taste, nausea, unpleasant smell, unpleasant taste, vomiting

Local: Nasal spray: Burning, epistaxis, localized Candida infection, nasal septum perforation (rare), nasal stuffiness, nosebleeds, rhinorrhea, sneezing, transient irritation, ulceration of nasal mucosa (rare)

Ocular: Cataracts, glaucoma, increased intraocular pressure

Respiratory: Cough, paradoxical bronchospasm, pharyngitis, sinusitis, wheezing

Miscellaneous: Anaphylactic/anaphylactoid reactions, death (due to adrenal insufficiency, reported during and after transfer from systemic corticosteroids to aerosol in asthmatic patients), immediate and delayed hypersensitivity reactions

Overdosage/Toxicology:

Symptoms of overdose include irritation and burning of the nasal mucosa, sneezing, intranasal and pharyngeal Candida infections, nasal ulceration, epistaxis, rhinorrhea, nasal stuffiness, and headache. When consumed in high doses over prolonged periods, systemic hypercorticism and adrenal suppression may occur. In those cases, discontinuation of the corticosteroid should be done judiciously.

Drug Interactions:

Salmeterol: The addition of salmeterol has been demonstrated to improve response to inhaled corticosteroids (as compared to increasing steroid dosage).

Stability:

Do not store near heat or open flame. Do not puncture canisters. Store at room temperature. Rest QVAR® on concave end of canister with actuator on top.

Mechanism of Action:

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

Pharmacodynamics/Kinetics:

Onset of action: Therapeutic effect: 1-4 weeks

Absorption: Readily; quickly hydrolyzed by pulmonary esterases prior to absorption

Distribution: Beclomethasone: 20 L; active metabolite: 424 L

Protein binding: 87%

Metabolism: Hepatic via CYP3A4 to active metabolites

Bioavailability: Of active metabolite, 44% following nasal inhalation (43% from swallowed portion)

Half-life elimination: Initial: 3 hours

Excretion: Feces (60%); urine (12%)

Dosage:

Nasal inhalation and oral inhalation dosage forms are not to be used interchangeably

Aqueous inhalation, nasal (Beconase® AQ): Children 6 years and Adults: 1-2 inhalations each nostril twice daily; total dose 168-336 mcg/day

Intranasal (Beconase®):

Children 6-12 years: 1 inhalation in each nostril 3 times/day; total dose 252 mcg/day

Children 12 years and Adults: 1 inhalation in each nostril 2-4 times/day or 2 inhalations each nostril twice daily (total dose 168-336 mcg/day); usual maximum maintenance: 1 inhalation in each nostril 3 times/day (252 mcg/day)

Oral inhalation (doses should be titrated to the lowest effective dose once asthma is controlled) (QVAR®):

Children 5-11 years: Initial: 40 mcg twice daily; maximum dose: 80 mcg twice daily

Children 12 years and Adults:

Patients previously on bronchodilators only: Initial dose 40-80 mcg twice daily; maximum dose: 320 mcg twice day

Patients previously on inhaled corticosteroids: Initial dose 40-160 mcg twice daily; maximum dose: 320 mcg twice daily

Administration:

Aerosol inhalation: Shake container thoroughly before using

Aerosol inhalation, oral: Consider use of a spacer device for children <8 years of age requiring a metered dose inhaler (MDI)

Patient Education:

Use as directed; do not increase dosage or discontinue abruptly without consulting prescriber. It may take 1-4 weeks for you to realize full effects of treatment. Review use of inhaler or spray with prescriber or follow package insert for directions. Keep oral inhaler clean and unobstructed. Always rinse mouth and throat after use of inhaler to prevent infection. If you are also using an inhaled bronchodilator, wait 10 minutes before using this steroid aerosol. Report adverse effects such as skin redness, rash, or irritation; pain or burning of nasal mucosa; white plaques in mouth or fuzzy tongue; unresolved headache; or worsening of condition or lack of improvement. Discard after date calculated by prescriber; the amount of medication in canister cannot be guaranteed after using the labeled number of actuations (sprays) even though it may not feel empty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Inhalation: Sit when using. Take deep breaths for 3-5 minutes, and clear nasal passages before administration (use decongestant as needed). Hold breath for 5-10 seconds after use, and wait 1-3 minutes between inhalations. Follow package insert instructions for use. Do not exceed maximum dosage. If also using inhaled bronchodilator, use before beclomethasone. Rinse mouth and throat after use to reduce aftertaste and prevent candidiasis.

Additional Information:

Effects of inhaled/intranasal steroids on growth have been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally-inhaled and intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with inhaled corticosteroids has not been adequately studied.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Oral candidiasis, xerostomia (normal salivary flow resumes upon discontinuation), nasal dryness, and dry throat. Localized infections with Candida albicans or Aspergillus niger occur frequently in the mouth and pharynx with repetitive use of oral inhaler; may require treatment with appropriate antifungal therapy or discontinuance of inhaler use.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

[DSC] = Discontinued product

Aerosol for oral inhalation, as dipropionate (QVAR®): 40 mcg/inhalation [100 metered doses] (7.3 g); 80 mcg/inhalation [100 metered doses] (7.3 g)

Aerosol, intranasal, as dipropionate (Beconase® [DSC]): 42 mcg/inhalation: [80 metered doses] (6.7 g); [200 metered doses] (16.8 g)

Suspension, intranasal, aqueous, as dipropionate [spray] (Beconase® AQ): 42 mcg/inhalation [180 metered doses] (25 g)

International Brand Names:

Apo-Beclomethasone® (CA); Gen-Beclo (CA); Nu-Beclomethasone (CA); Propaderm® (CA); QVAR® (CA); Rivanase AQ (CA); Vanceril® AEM (CA)

References

Demain JG and Goetz DW, "Pediatric Adenoidal Hypertrophy and Nasal Airway Obstruction: Reduction With Aqueous Nasal Beclomethasone,"Pediatrics, 1995, 95(3):355-64.

Expert Panel Report 2, "Guidelines for the Diagnosis and Management of Asthma,"Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 94-4051, April, 1997.

Kobayashi RH, Tinkelman DG, Reese ME, et al, "Beclomethasone Dipropionate Aqueous Nasal Spray for Seasonal Allergic Rhinitis in Children,"Ann Allergy, 1989, 62(3):205-8.

Tinkelman DG, Reed CE, Nelson HS, et al, "Aerosol Beclomethasone Dipropionate Compared With Theophylline as Primary Treatment of Chronic, Mild to Moderately Severe Asthma in Children,"Pediatrics, 1993, 92(1):64-77.

Wyatt R, Waschek J, Weinberger M, et al, "Effects of Inhaled Beclomethasone Dipropionate and Alternate-Day Prednisone on Pituitary-Adrenal Function in Children With Chronic Asthma,"N Engl J Med, 1978, 299(25):1387-92.

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