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Seasonal or perennial rhinitis: Children ≥6 years and Adults: Rhinocort® Aqua® (32 mcg/spray): Initial: 2 sprays (1 spray/nostril) once daily (64 mcg/day); dose may be increased if needed Maximum daily dose: Children <12 years: 4 sprays (2 sprays/nostril) once daily (128 mcg/day) Children ≥12 years and Adults: 8 sprays (4 sprays/nostril) once daily (256 mcg/day) Dosage Forms: U.S. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Suspension, intranasal [spray]: Rhinocort Aqua®: 32 mcg/inhalation (8.6 g) [120 metered actuations] Generic Equivalent Available: U.S. No Administration Clear nasal passage by blowing nose prior to use; shake container gently before use. Prime before first use; discard after 120 sprays. Do not spray into eyes or mouth. Stability Store with valve up at 15°C to 30°C (59°F to 86°F). Avoid storage in high humidity; do not store or use by heat or open flame. Use Management of seasonal or perennial allergic rhinitis (FDA approved in ages ≥6 years and adults) Adverse Reactions Reaction severity varies by dose and duration; not all adverse reactions have been reported with each dosage form. Respiratory: Bronchospasm, cough, epistaxis, nasal congestion, nasal irritation, pharyngitis, throat irritation Rare but important or life-threatening: Anosmia, growth suppression, hypersensitivity reactions (immediate and delayed [includes rash, contact dermatitis, angioedema, bronchospasm]), nasal septum perforation, pharyngeal disorders (irritation, throat pain, itchy throat)

Respiratory: Bronchospasm, cough, epistaxis, nasal congestion, nasal irritation, pharyngitis, throat irritation Rare but important or life-threatening: Anosmia, growth suppression, hypersensitivity reactions (immediate and delayed [includes rash, contact dermatitis, angioedema, bronchospasm]), nasal septum perforation, pharyngeal disorders (irritation, throat pain, itchy throat) Precautions Avoid using higher than recommended dosages; suppression of HPA function, suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercorticism (Cushing's syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth). Use budesonide with extreme caution in patients with respiratory tuberculosis; untreated bacterial, fungal, systemic viral or parasitic infections; or ocular herpes simplex. Localized Candida infections of the nose and pharynx have been reported rarely; interruption of therapy may be necessary while antifungal therapy is employed. Corticosteroids impair wound healing; avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma; allow healing to occur before use. Use of nasal budesonide in place of systemic corticosteroids may unmask allergies (eg, eczema, rhinitis) that were previously controlled by the systemic corticosteroids. Rare cases of immediate hypersensitivity reactions, nasal septum perforation, increased IOP, glaucoma, or cataracts may occur with intranasal corticosteroids. Warnings HPA suppression or hypercorticism (Cushing's syndrome) may occur with use of higher than recommended doses or at typical doses in susceptible patients. Acute adrenal insufficiency may occur with abrupt withdrawal after long-term use, with stress, or when converting from systemic to topical corticosteroid therapy; withdrawal or discontinuation of corticosteroids should be done carefully; patients with HPA axis suppression may require doses of systemic glucocorticosteroids prior to, during, and after unusual stress (eg, surgery). Immunosuppression may occur; patients may be more susceptible to infections; avoid exposure to chickenpox and measles. Epistaxis may occur.

Warnings HPA suppression or hypercorticism (Cushing's syndrome) may occur with use of higher than recommended doses or at typical doses in susceptible patients. Acute adrenal insufficiency may occur with abrupt withdrawal after long-term use, with stress, or when converting from systemic to topical corticosteroid therapy; withdrawal or discontinuation of corticosteroids should be done carefully; patients with HPA axis suppression may require doses of systemic glucocorticosteroids prior to, during, and after unusual stress (eg, surgery). Immunosuppression may occur; patients may be more susceptible to infections; avoid exposure to chickenpox and measles. Epistaxis may occur. Potent inhibitors of cytochrome P450 isoenzyme CYP3A4 (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin) may significantly increase budesonide serum concentrations and result in systemic corticosteroid effects. Metabolism/Transport Effects

Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Nasal). Risk C: Monitor therapy Telaprevir: May increase the serum concentration of Budesonide (Nasal). Management: Concurrent use of telaprevir with inhaled budesonide is not recommended, unless the risk for excessive systemic corticosteroid effects is outweighed by the potential benefits. Risk D: Consider therapy modification Pregnancy Risk Factor B ( show table ) Pregnancy Implications Adverse events have been observed with corticosteroids in animal reproduction studies. Studies of pregnant women using intranasal budesonide have not demonstrated an increased risk of abnormalities. Intranasal corticosteroids may be used in the treatment of rhinitis during pregnancy; budesonide is preferred (Wallace, 2008) Monitoring Parameters Monitor growth in pediatric patients; check mucous membranes for signs of fungal infection Mechanism of Action Controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes and fibroblasts, reverses capillary permeability, and stabilizes lysosomal membranes at the cellular level to prevent or control inflammation Pharmacodynamics Clinical effects are due to direct local effect, rather than systemic absorption. Onset of action: Within 10 hours Maximum effect: 2 weeks Duration after discontinuation: Several days Pharmacokinetics (Adult data unless noted) Absorption: 34% of dose delivered reaches systemic circulation Protein binding: 85% to 90% Metabolism: Extensively metabolized by the liver via cytochrome P450 CYP3A isoenzyme to 2 major metabolites: 16α-hydroxyprednisolone and 6β-hydroxybudesonide; both are <1% as active as parent Half-life: Children 10-14 years: 1.5 hours Adults: 2-3.6 hours Elimination: 60% to 66% of dose renally excreted as metabolites; no unchanged drug found in urine Clearance: Children 4-6 years: 0.5 L/minute (~50% greater than healthy adults after weight adjustment) Adults: 0.9-1.8 L/minute Patient Information (For additional information see "Budesonide (nasal): Patient drug information" )

Adults: 2-3.6 hours Elimination: 60% to 66% of dose renally excreted as metabolites; no unchanged drug found in urine Clearance: Children 4-6 years: 0.5 L/minute (~50% greater than healthy adults after weight adjustment) Adults: 0.9-1.8 L/minute Patient Information (For additional information see "Budesonide (nasal): Patient drug information" ) Full response to this medication may not be seen for 2-5 weeks. Use regularly. Do not stop treatment, even if feeling better. Notify physician if condition being treated persists or worsens; do not decrease dose or discontinue without physician approval. Avoid exposure to chicken pox or measles; if exposed, seek medical advice without delay. Report sore mouth or mouth lesions, persistent headache, or nosebleeds to physician; carefully read and follow the patient instructions for use leaflet that accompanies the product. Use of UpToDate is subject to the Subscription and License Agreement . Topic 15945 Version 25.0 © 2013 UpToDate, Inc. All rights reserved. | Subscription and License Agreement | Release: 21.4 - C21.36 Licensed to: Southeast Alabama Med Ctr | Support Tag: [1104-122.72.76.133-F9050627AA-S244013.14]