Dosing and uses of Rhinocort Aqua, Rhinocort Allergy (budesonide intranasal)
Adult dosage forms and strengths
intranasal spray
- 32mcg/actuation (Rhinocort Aqua, Rhinocort Allergy, various Rx generics)
- Rhinocort Aqua (Rx)
- Rhinocort Allergy (OTC)
Allergic Rhinitis
Indicated for seasonal or perennial allergic rhinitis
Rhinocort Aqua (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)
Pediatric dosage forms and strengths
intranasal spray
- 32mcg/actuation (Rhinocort Aqua, Rhinocort Allergy, various Rx generics)
- Rhinocort Aqua (Rx)
- Rhinocort Allergy (OTC)
Allergic Rhinitis
Indicated for seasonal or perennial allergic rhinitis
Rhinocort Aqua (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)
Rhinocort Aqua, Rhinocort Allergy (budesonide intranasal) adverse (side) 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 and lactation
Pregnancy category: B
Lactation: Distributed in breast milk; estimated total daily oral dose of budesonide available in breast milk to infant is ~0.3-1% of dose inhaled by mother
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 of Rhinocort Aqua, Rhinocort Allergy (budesonide intranasal)
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%)
