Version May 2024
Note: For patients with mucous crusting, rinsing with saline nasal spray before budesonide administration can remove mucous crusting and improve nasal coating (deShazo 2022). If nasal obstruction is so severe that sprays cannot penetrate when treating rhinitis, consider concomitant use of an intranasal decongestant for up to 5 days (Dykewicz 2020).
Nasal polyps (Canadian labeling ; formulations not available in the United States): Note: Discontinue therapy if significant improvement is not observed within 3 weeks.
Rhinocort Aqua: Intranasal: 1 spray (64 mcg) in each nostril twice daily; total daily dose: 256 mcg/day.
Rhinocort Turbuhaler: Intranasal: 1 application (100 mcg) in each nostril twice daily; total daily dose: 400 mcg/day.
Nonallergic rhinitis :
OTC 32 mcg/spray formulation (off label): Intranasal: 1 spray (32 mcg) in each nostril once daily (total daily dose: 64 mcg/day) or 2 sprays (64 mcg) in each nostril once daily (total daily dosage: 128 mcg/day) (Lieberman 2022).
Rhinocort Aqua [Canadian product]: Intranasal: Initial: 2 sprays (128 mcg) in each nostril once daily or 1 spray (64 mcg) in each nostril twice daily (total daily dose: 256 mcg/day); Maintenance: Individualize; use lowest effective dose.
Rhinocort Turbuhaler [Canadian product]: Intranasal: Initial: 2 applications (200 mcg) in each nostril once daily (total daily dose: 400 mcg/day); Maintenance: Individualize; use lowest effective dose.
Rhinosinusitis, c hronic (off label use): Intranasal: 2 sprays (64 mcg) in each nostril twice daily (total daily dose: 256 mcg/day) (Lund 2004).
Patients with nasal polyps: Intranasal: 2 sprays (64 mcg) in each nostril once or twice daily (total daily dose: 128 to 256 mcg/day) or 4 sprays (128 mcg) in each nostril once daily (total daily dose: 256 mcg/day) (Jankowski 2001; Joe 2008).
Upper respiratory symptoms (OTC 32 mcg/spray formulation): Intranasal: 2 sprays (64 mcg) in each nostril once daily (total daily dosage: 128 mcg/day); once symptoms improve, reduce to 1 spray (32 mcg) in each nostril once daily (total daily dosage: 64 mcg/day). Maximum dose: 128 mcg/day (2 sprays in each nostril once daily).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied). Systemic availability of budesonide may be increased in patients with hepatic impairment; monitor closely for signs and symptoms of hypercortisolism.
Refer to adult dosing.
(For additional information see "Budesonide (nasal): Pediatric drug information")
Allergic rhinitis, hayfever; relief of nasal symptoms: OTC formulation (32 mcg/spray):
Children 6 to <12 years: Intranasal: Initial: 1 spray (32 mcg) per nostril once daily; dose may be increased if needed to 2 sprays (64 mcg) per nostril once daily; after improvement of symptoms, decrease dose to 1 spray (32 mcg) per nostril once daily. If duration of therapy exceeds 2 months, consider additional monitoring parameters (eg, growth). Maximum daily dose: 128 mcg/day.
Children ≥12 years and Adolescents: Intranasal: Initial: 2 sprays (64 mcg) per nostril once daily; after improvement of symptoms, decrease dose to 1 spray (32 mcg) per nostril once daily. Usual maximum daily dose: 128 mcg/day. Note: Based on previous FDA-approved manufacturer labeling (Rhinocort Aqua prescribing information 2010), some patients who do not achieve adequate control may benefit from increased dosage of 4 sprays (128 mcg) per nostril once daily; a reduced dosage may be effective after initial control is achieved.
Canadian labeling: Children ≥6 years and Adolescents: Intranasal:
Rhinocort Aqua 64 mcg/spray [Canadian product]: Initial: 2 sprays (128 mcg) in each nostril once daily or 1 spray (64 mcg) in each nostril twice daily (total daily dose: 256 mcg/day). Once symptoms are controlled, decrease dose to lowest effective dose.
Rhinocort Turbuhaler 100 mcg/spray [Canadian product]: Initial: 2 sprays (200 mcg) in each nostril once daily (total daily dose: 400 mcg/day). Once symptoms are controlled, decrease dose to lowest effective dose.
Sleep apnea/disturbances, obstructive (mild): Limited data available (Dehlink 2016; Kaditis 2016): Children ≥6 years and Adolescents: Intranasal: 1 spray (32 mcg) per nostril once daily (at bedtime) or twice daily for 6 weeks. Once daily dosing based on a double-blind, placebo-controlled, cross-over trial in 62 children (age range: 6 to 12 years) who received 1 spray (32 mcg) in each nostril once daily at bedtime; treated patients showed decreased severity of respiratory disturbance and adenoid tissue size; results also showed therapeutic effect prolonged for at least 8 weeks following discontinuation of therapy; respiratory and sleep parameters did not worsen during this time (Kheirandish-Gozal 2008). A placebo-controlled trial of 60 children with sleep disordered breathing (treatment group, n=30; age range: 4 to 10 years) who received 1 spray (32 mcg) in each nostril twice daily showed a significant improvement in quality of life and symptoms compared to placebo (Gudnadottir 2018). Consensus recommendations suggest a trial of 6 to 12 weeks of intranasal corticosteroid as one of the initial therapeutic steps in the management in treatment of obstructive sleep apnea along with weight loss (Dehlink 2016; Kaditis 2016).
Nasal polyps : Canadian labeling: Children ≥6 years and Adolescents: Intranasal:
Rhinocort Aqua 64 mcg/spray [Canadian product]: 1 spray (64 mcg) in each nostril twice daily; total daily dose: 256 mcg/day
Rhinocort Turbuhaler 100 mcg/spray [Canadian product]: One spray (100 mcg) in each nostril twice daily; total daily dose: 400 mcg/day
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (not studied).
There are no dosage adjustments provided in the manufacturer's labeling. Systemic availability of budesonide may be increased in patients with hepatic impairment; monitor closely for signs and symptoms of hypercorticism; dosage reduction may be required.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children and adults.
1% to 10%: Respiratory: Bronchospasm (2%), cough (2%), epistaxis (8%), nasal mucosa irritation (2%), pharyngitis (4%)
Frequency not defined: Respiratory: Nasal candidiasis, oropharyngeal candidiasis
Postmarketing:
Cardiovascular: Palpitations
Endocrine & metabolic: Adrenal suppression (Perry 2002), growth retardation (Perry 2002)
Hypersensitivity: Anaphylaxis, angioedema (Pitsios 2010), type 1 hypersensitivity reaction, type IV hypersensitivity reaction (Pitsios 2010)
Nervous system: Anosmia
Ophthalmic: Cataract, glaucoma, increased intraocular pressure
Respiratory: Nasal septum perforation (Cervin 1998), pharyngeal disease (pharyngeal edema, sore throat, throat irritation), wheezing
US labeling: When used for self-medication (OTC use), do not use if known hypersensitivity to budesonide or any component of the formulation or in children <6 years of age.
Canadian labeling: Hypersensitivity to budesonide or any component of the formulation; tuberculosis (TB) (disease [active TB] or infection [latent TB]); untreated bacterial, fungal, or viral infections; use in children <6 years of age.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Pediatric patients may be more susceptible to systemic toxicity. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible.
• Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery or nasal trauma until healing has occurred.
• Hypersensitivity: Hypersensitivity reactions (eg, anaphylactic reactions, angioedema, pruritus, urticaria, rash, dermatitis) may occur.
• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid exposure to chickenpox and/or measles, especially if not immunized. Avoid use or use with caution in patients with tuberculosis (TB) infection (latent TB) or disease (active TB), untreated bacterial or fungal infections (local or systemic), viral or parasitic infections, or ocular herpes simplex. The Canadian labeling contraindicates use in patients with TB infection or disease, or with untreated bacterial, fungal, or viral infections.
• Local nasal effects: Nasal septal perforation, nasal ulceration, epistaxis, and localized Candida albicans infections of the nose and/or pharynx may occur. Monitor patients periodically for adverse nasal effects; discontinuation of therapy may be necessary if an infection occurs.
Disease-related concerns:
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users or in patients who report visual changes.
Special populations:
• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing 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).
Other warnings/precautions:
• Self-medication (OTC use): Consult a health care provider before use if you have had recent nose ulcers or nose surgery; have a nose injury that has not healed; are using a steroid medicine for asthma, allergies or skin rash; have an eye infection; and/or have or had glaucoma or cataracts. When using this product, symptoms may get better on the first day of treatment; however, it may take up to 2 weeks of daily use to feel the most relief. Discontinue use and consult a health care provider if symptoms do not improve after 2 weeks, or if an infection (eg, persistent fever), changes in vision, or frequent nosebleeds occur. Do not spray into eyes or mouth or use more than directed or for the common cold.
Nasal suspension: 5 mL bottles contain 60 sprays, 8.43 mL bottles contain 120 sprays
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, Nasal:
Rhinocort Allergy: 32 mcg/actuation (8.43 mL [DSC]) [contains disodium edta, polysorbate 80]
Generic: 32 mcg/actuation (8.43 mL)
Yes
Suspension (Budesonide Nasal)
32 mcg/ACT (per mL): $2.04 - $3.21
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Inhaler, Nasal:
Rhinocort Turbuhaler: 100 mcg/dose ([DSC])
Generic: 100 mcg/dose (10 mL)
Suspension, Nasal:
Rhinocort Aqua: 64 mcg/actuation (10 mL) [contains edetate (edta) disodium, polysorbate 80]
Generic: 64 mcg/actuation (10 mL)
Inhalation:
Powder for nasal inhalation: Rhinocort Turbuhaler [Canadian product]: To prepare inhaler prior to use, load dose by holding inhaler in upright position and turn grey grip as far as it will go in one direction and then turn it as far as it will go in the other direction. Prior to first use, this procedure should be done twice; with subsequent dosing, perform this procedure once. Clicking sound means inhaler is loaded with dose and ready for use. Place nasal adapter into nostril and ensure firm fit. Cover opposite nostril with finger and inhale (sniff) quickly and forcefully. Do not exhale through inhaler. If the Turbuhaler is dropped, shaken, or exhaled into after it is loaded, the dose will be lost and a new dose will need to be loaded. When a red mark appears in the dose indicator window, 20 doses are left. When the red mark reaches the bottom of the window, the inhaler should be discarded
Suspension for nasal inhalation:
OTC labeling [US product]: Shake gently before use. Prime before first use by actuating 8 times. If not used for 2 consecutive days, reprime with 1 spray or until a fine spray appears; if not used for >14 days, rinse applicator and reprime with 2 sprays or until fine spray appears. Discard after 60 or 120 sprays.
Rhinocort Aqua [Canadian product]: Invert bottle 3 to 4 times prior to use. Prime before first use by actuating 5 to 10 times until a fine mist occurs. If the spray is not used on the prior day, actuate once before administration.
Suspension for nasal inhalation: Shake gently prior to each use. Before first use, prime by pressing pump until a fine spray appears (~8 times). If ≥2 days between use, repeat priming until a fine spray appears (~1 time). If >14 days between use, rinse applicator and allow to dry, then repeat priming until a fine spray appears (~2 sprays). Blow nose to clear nostrils before each use. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose and while inhaling (sniffing), press pump to release spray. After administration lean head backward for a few seconds; avoid blowing nose for 15 minutes after use. Do not spray into eyes or mouth.
Powder for nasal inhalation: Rhinocort Turbuhaler [Canadian product]: To prepare inhaler prior to use, load dose by holding inhaler in upright position and turn grey grip as far as it will go in one direction and then turn it as far as it will go in the other direction. Prior to first use, this procedure should be done twice; with subsequent dosing, perform this procedure once. Clicking sound means inhaler is loaded with dose and ready for use. Place nasal adapter into nostril and ensure snug fit. Cover opposite nostril with finger and inhale (sniff) quickly and forcefully. Do not exhale through inhaler. If the Turbuhaler is dropped, shaken, or exhaled into after it is loaded, the dose will be lost and a new dose will need to be loaded. When a red mark appears in the dose indicator window, 20 doses are left. When the red mark reaches the bottom of the window, the inhaler should be discarded.
US labeling:
OTC: Upper respiratory symptoms: Relief of symptoms of hay fever or other upper respiratory allergies (eg, nasal congestion, runny nose, itchy nose, sneezing) in adults and children ≥6 years of age.
Canadian labeling:
Nasal polyps: Treatment of nasal polyps; prevention of nasal polyps after polypectomy.
Chronic rhinosinusitis; Nonallergic rhinitis
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Nasal). Risk C: Monitor therapy
Esketamine: Corticosteroids (Nasal) may diminish the therapeutic effect of Esketamine. Management: Patients who require a nasal corticosteroid on an esketamine dosing day should administer the nasal corticosteroid at least 1 hour before esketamine. Risk D: Consider therapy modification
Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Nasal). Risk C: Monitor therapy
Maternal use of intranasal corticosteroids (INCS) in usual doses are not associated with an increased risk of fetal malformations or preterm birth (ERS/TSANZ [Middleton 2020]). Although an agent with less systemic absorption may be considered, budesonide is one of the INCS that may be used during pregnancy (Alhussien 2018; BSACI [Scadding 2017]; ERS/TSANZ [Middleton 2020]).
Maternal use of intranasal budesonide is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).
Monitor growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular changes; signs/symptoms of Candida infection (long-term therapy)
Controls the rate of protein synthesis; depresses the migration of polymorphonuclear leukocytes, fibroblasts; reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation. Has potent glucocorticoid activity and weak mineralocorticoid activity.
Onset of action: Peak effect: Up to 2 weeks.
Distribution: ~2 to 3 L/kg.
Protein binding: 85% to 90%.
Metabolism: Hepatic via CYP3A4 to two metabolites: 16 alpha-hydroxyprednisolone and 6 beta-hydroxybudesonide; both are <1% as active as parent.
Bioavailability: Rhinocort Aqua [Canadian product]: 33%; Rhinocort Turbuhaler [Canadian product]: 22%; Oral: ~10% (limited by high first-pass effect).
Half-life elimination: 2 to 3 hours.
Time to peak, plasma: Nasal: 30 minutes.
Excretion: Urine (~66%) and feces as metabolites.
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