Dosing & Uses
Dosage Forms & Strengths
intranasal spray
- 32mcg/actuation (Rhinocort Allergy [OTC], generic [Rx])
Allergic Rhinitis
Indicated for seasonal or perennial allergic rhinitis
Rx
- Initial dose: 1 spray/nostril qDay (64 mcg/day)
- Not to exceed 4 sprays/nostril qDay (256 mcg/day)
Rhinocort Allergy (OTC)
- <12 years: Safety and efficacy not established
- 2 sprays/nostril qDay (128 mcg/day); once allergy symptoms improve, reduce dose to 1 spray/nostril qDay (64 mcg/day)
Dosage Forms & Strengths
intranasal spray
- 32mcg/actuation (Rhinocort Allergy [OTC], generic [Rx])
Allergic Rhinitis
Indicated for seasonal or perennial allergic rhinitis
Rx
- <6 years: Safety and efficacy not established
- Initial dose: 1 spray/nostril qDay (64 mcg/day)
- 6-11 years: Not to exceed 2 sprays/nostril qDay (128 mcg/day)
- ≥12 years: Not to exceed 4 sprays/nostril qDay (256 mcg/day)
Rhinocort Allergy (OTC)
- <6 years: Safety and efficacy not established
- 6-12 years: 1 spray/nostril qDay (64 mcg/day); iff allergy symptoms do not improve, may increase to 2 sprays/nostril qDay (128 mcg/day)
- ≥12 years: 2 sprays/nostril qDay (128 mcg/day); once allergy symptoms improve, reduce dose to 1 spray/nostril qDay (64 mcg/day)
Adverse Effects
1-10%
Epistaxis (8%)
Pharyngitis (4%)
Bronchospasm (2%)
Cough (2%)
Nasal irritation (2%)
Postmarketing Reports
Immune system disorders: immediate and delayed hypersensitivity reactions (including anaphylactic reaction, urticaria, rash, dermatitis, angioedema and pruritus)
Eye disorders: glaucoma, increased intraocular pressure, cataracts
Respiratory, thoracic, and mediastinal disorders: nasal septum perforation, anosmia, pharynx disorders (throat irritation, throat pain, swollen throat, burning throat, and itchy throat), and wheezing
Cardiac disorders: palpitations
Musculoskeletal and connective tissue disorders: growth suppression
Warnings
Contraindications
Hypersensitivity
Cautions
Reports of epistaxis, Candida albicans infections, nasal septal perforation, and impaired wound healing; avoid with recent nasal ulcers, surgery, or trauma
Anaphylaxis, urticaria, rash, dermatitis, angioedema, and pruritus may occur
Potential worsening of infections (eg, existing tuberculosis, fungal bacterial, viral, or parasitic infections; or ocular herpes simplex); more serious or even a fatal course of chickenpox or measles can occur in susceptible patients
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dose in susceptible individuals
Because of potential for HPA-axis suppression, monitor growth of pediatric patients
May increase risk for glaucoma and cataracts
Pregnancy & Lactation
Pregnancy
Adverse events (eg, hypoadrenalism) observed with systemic corticosteroids in animal reproduction studies
Increased risk of abnormalities has not been demonstrated in pregnant women using intranasal budesonide
Clinical considerations: Intranasal corticosteroids are recommended for allergic rhinitis during pregnancy
Lactation
Excreted in breast milk after oral inhalation (~0.3-1% of the maternal dose)
Plasma budesonide levels obtained from infants after breast-feeding were below the limit of quantification
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.Pharmacology
Mechanism of Action
Anti-inflammatory corticosteroid that elicits potent glucocorticoid activity (week mineralocorticoid activity)
Corticosteroids have a wide range of inhibitory activities against multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and nonallergic-mediated inflammation
Absorption
Bioavailability: Low (~10% PO); 34% (nasal mucosa absorption)
Peak Plasma Time: 0.5 hr
Peak Plasma Concentration: 0.3 nmol/L
Distribution
Protein Bound: 85-90%
Vd: 2-3 L/kg
Metabolism
Metabolized by CYP3A4
Metabolites: 16-alpha-hydroxyprednisolone; 6-beta-hydroxybudesonide (negligible activity)
Elimination
Half-life, terminal: 2-3 hr
Total body clearance: 1-1.4 L/min
Excretion: as metabolites in feces (33%) and urine (66%)
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Patient Handout
Formulary
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