Beclomethasone Dipropionate 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

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

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If systemic effects occur, therapy with the drug should gradually be withdrawn (tapered).103

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

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

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

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.)

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

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

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

Specific Populations

Category C.103

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

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

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

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

Storage

15–30°C.103

Discard the nasal pump spray after 180 sprays.103 104

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Beclomethasone dipropionate inhalation aerosols containing chlorofluorocarbon (CFC) propellants are no longer marketed in the US.