beclomethasone, intranasal (Rx)

>10%

Nasopharyngeal irritation (24%)

1-10%

Headache (<5%)

Nausea (<5%)

Lightheadedness (<5%)

Sneezing attacks after administration (4%)

Nasal congestion (<3%)

Nose bleeds (<3%)

Rhinorrhea (<3%)

Increased lacrimation (<3%)

Epistaxis (<3%)

Frequency Not Defined

Nasal mucosa ulceration

Nasal septum perforation

Postmarketing Reports

Blurred vision, glaucoma, cataracts, central serous chorioretinopathy (CSC), loss of taste and smell, hypersensitivity reactions, angioedema, rash, urticaria, and bronchospasm

Contraindications

Hypersensitivity

Used as primary treatment of status asthmaticus or acute episodes of asthma where intensive measures are required

Cautions

Monitor for vision change, or with history of increased IOP, glaucoma, or cataracts; consider referral to ophthalmologist in patients who develop ocular symptoms

Recent nasal surgery, nasal trauma, nasal septum ulcers (until healing has occurred)

Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex

More serious or fatal course of chickenpox or measles in susceptible patients

Risk for hypercorticism and adrenal suppression with higher than normal doses

Potential reduction of growth velocity in children

Prolonged corticosteroid use may result in elevated IOP, glaucoma, and/or cataracts

Nasal septal perforation and localized Candida albicans infections of the nose and/or pharynx may occur

Nasal discomfort, epistaxis, and nasal ulceration reported

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Corticosteroid with potent anti-inflammatory properties; elicits effects on various cells, including mast cells and eosinophils; also elicits effects on inflammatory mediators (eg, histamine, eicosanoids, leukotrienes, cytokines)

Absorption

Bioavailability: 44% (43% from swallowing portion of intranasal dose; 1% from nasal absorption)

Peak Plasma Concentration: Undetectable (<50 pg/mL)

Distribution

Protein Bound: 87%

Vd: 20 L; 424 L for B-17-MP metabolite

Metabolism

Metabolites: B-17-MP active metabolite

Metabolized by: Esterase enzymes found in most tissues

Elimination

Half-life: 0.3 hr

Excretion: feces (60%), urine (12%); after oral administration