Budesonide

Pharmacologic Category

Corticosteroid, Inhalant (Oral)

Dosing: Adult

Note: Titrate to lowest effective dose once asthma is stable.

Asthma: Oral inhalation: Note: To decrease the severity or duration of an asthma exacerbation, may consider temporarily quadrupling the dose (early in the course of illness) in patients with mild to moderate asthma with a mild flare in symptoms. Reserve this approach for patients with no prior history of life-threatening asthma exacerbations, and in those with good self-management skills; return to baseline dose after normalization of symptoms or at a maximum of 14 days of the quadrupled dose (GINA 2020; McKeever 2018).

Pulmicort Flexhaler: Dry powder inhaler: Initial: 360 mcg twice daily (selected patients may be initiated at 180 mcg twice daily); maximum: 720 mcg twice daily; Note: May increase dose after 1 to 2 weeks of therapy in patients who are not adequately controlled

Pulmicort Nebuamp [Canadian product]: Nebulization suspension: Initial: 1 to 2 mg twice daily; dose may be increased if needed.

Pulmicort Turbuhaler [Canadian product]: Dry powder inhaler:

Initial (or during periods of severe asthma or when switching from oral corticosteroid therapy): 400 to 2,400 mcg daily in 2 to 4 divided doses.

Maintenance: 200 to 400 mcg twice daily (higher doses may be needed for some patients). Patients taking 400 mcg/day may take as a single daily dose.

Asthma guidelines:

Global Initiative for Asthma and National Asthma Education and Prevention Program guidelines (GINA 2020; NAEPP 2007): Dry powder inhaler: Note: Administer in 1 to 4 inhalations/day depending on strength of inhaler.

Low-dose therapy: 180 to 400 mcg/day.

Medium-dose therapy: >400 to 800 mcg/day.

High-dose therapy: >800 mcg/day.

Chronic obstructive pulmonary disease (acute exacerbation) (off-label use): Nebulization solution: 2 mg every 6 hours (Maltais 2002).

Chronic obstructive pulmonary disease (stable) (off-label use): Inhalation: 100, 200, or 400 mcg daily (dry powder inhaler) or 0.2, 0.25, or 0.5 mg/mL/day (nebulization suspension) as a component of dual or triple combination therapy (GOLD 2014; GOLD 2019).

Eosinophilic esophagitis (off-label use): Oral:

Note: Individualize dose. Optimal dosing has not been established. Swallow oral budesonide viscous liquid/suspension slowly over 5 to 10 minutes (ACG [Dellon 2013], AGA/NASPGHAN [Furuta 2007]; Contreras 2014; Dellon 2017; Dohil 2010).

Induction therapy: 2 mg/day as an oral budesonide viscous liquid/suspension; may divide into 2 doses (ACG [Dellon 2013]; Liacouras 2011; Straumann 2010). Note: Duration of induction therapy is up to 12 weeks followed by assessment of symptomatic response (eg, dysphagia). Once remission is achieved, the dose may be gradually lowered to an individualized maintenance dose (Dellon 2014; Dellon 2017).

Maintenance therapy: 0.5 to 1 mg/day; may divide into 2 doses (ACG [Dellon 2013]; Hirano 2020; Straumann 2011).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, budesonide undergoes hepatic metabolism; drug may accumulate with hepatic impairment; use with caution and monitor closely.

Dosing: Pediatric

Asthma, maintenance therapy: Note: Doses should be titrated to the lowest effective dose once asthma is controlled; dosing is presented in mg and mcg; additional precautions should be taken.

US labeling:

Pulmicort Respules: Nebulization solution: Oral inhalation:

Infants ≥6 months: Limited data available: Initial: 0.25 mg twice daily or 0.5 mg once daily; maximum daily dose: 1 mg/day (Baker 1999).

Children and Adolescents:

Symptomatic children not responding to nonsteroidal asthma medications: Initial: 0.25 mg once daily may be considered.

Previously treated with bronchodilators alone: Initial: 0.25 mg twice daily or 0.5 mg once daily; maximum daily dose: 0.5 mg/day.

Previously treated with inhaled corticosteroids: Initial: 0.25 mg twice daily or 0.5 mg once daily; maximum daily dose: 1 mg/day.

Previously treated with oral corticosteroids: Initial: 0.5 mg twice daily or 1 mg once daily; maximum daily dose: 1 mg/day.

Pulmicort Flexhaler: Dry powder inhaler: Oral inhalation:

Children ≥6 years and Adolescents <18 years: Initial: 180 mcg twice daily (some patients may be initiated at 360 mcg twice daily); maximum dose: 360 mcg/dose.

Adolescents ≥18 years: Initial: 360 mcg twice daily (some patients may be initiated at 180 mcg twice daily); maximum dose: 720 mcg/dose.

Canadian labeling:

Pulmicort Nebuamp [Canadian Product]: Nebulization solution: Oral inhalation:

Infants ≥3 months and Children: Initial: 0.25 to 0.5 mg twice daily; may increase to 1 mg twice daily.

Adolescents: Initial: 1 to 2 mg twice daily; further dose increases may be necessary.

Pulmicort Turbuhaler [Canadian product]: Dry powder inhaler: Oral inhalation:

Children 6 to 11 years: Initial (or during periods of severe asthma or when switching from oral corticosteroid therapy): 200 to 400 mcg daily in 2 divided doses; once symptoms are controlled, decrease dose to lowest effective maintenance dose.

Children ≥12 years and Adolescents:

Initial (or during periods of severe asthma or when switching from oral corticosteroid therapy): 400 to 2,400 mcg/day in 2 to 4 divided doses.

Maintenance: 200 to 400 mcg twice daily (higher doses may be needed for some patients). Note: Patients taking 400 mcg/day may take as a single daily dose.

Asthma guidelines:

Nebulization solution: Oral inhalation:

NIH Asthma Guidelines (NAEPP 2007): Administer once daily or in divided doses twice daily.

Children ≤4 years:

"Low" dose: 0.25 to 0.5 mg/day.

"Medium" dose: >0.5 to 1 mg/day.

"High" dose: >1 mg/day.

Children 5 to 11 years:

"Low" dose: 0.5 mg/day.

"Medium" dose: 1 mg/day.

"High" dose: 2 mg/day.

Global Initiative for Asthma Guidelines (GINA 2018):

Children ≤5 years:

"Low" dose: 500 mcg/day.

Children 6 to 11 years:

"Low" dose: 250 to 500 mcg/day.

"Medium" dose: >500 to 1,000 mcg/day.

"High" dose: >1,000 mcg/day.

Dry powder: Oral inhalation:

NIH Asthma Guidelines (NAEPP 2007): Administer in divided doses twice daily.

Children 5 to 11 years:

"Low" dose: 180 to 400 mcg/day.

"Medium" dose: >400 to 800 mcg/day.

"High" dose: >800 mcg/day.

Children ≥12 years and Adolescents:

"Low" dose: 180 to 600 mcg/day.

"Medium" dose: >600 to 1,200 mcg/day.

"High" dose: >1,200 mcg/day.

Global Initiative for Asthma Guidelines (GINA 2018):

Children 6 to 11 years:

"Low" dose: 100 to 200 mcg/day.

"Medium" dose: >200 to 400 mcg/day.

"High" dose: >400 mcg/day.

Children ≥12 years and Adolescents:

"Low" dose: 200 to 400 mcg/day.

"Medium" dose: >400 to 800 mcg/day.

"High" dose: >800 mcg/day.

Asthma; mild flare, exacerbation: Limited data available:

Children ≥12 years and Adolescents with mild to moderate asthma, no prior history of life-threatening asthma exacerbations, and with good self-management skills:

It is recommended to temporarily quadruple the inhaled corticosteroid dose early in the course of a mild flare to decrease the severity of an asthma exacerbation. After symptoms stabilize or after a maximum of 14 days of quadrupled dose, whichever occurs first, patients should be returned to their baseline dose (GINA 2019). Quadrupling the inhaled corticosteroid dose has been shown to decrease the severity of an asthma exacerbation in select patients. In a randomized trial of adolescents ≥16 years and adults (n=1,871), temporarily quadrupling the inhaled corticosteroid dose when asthma control began to deteriorate resulted in fewer severe asthma exacerbations (ie, less treatment with systemic glucocorticoids or unscheduled appointments for asthma) compared to patients who maintained their inhaled corticosteroid dose (McKeever 2018). No data for quadrupling the dose in patients <16 years of age has been published. Quintupling the dose of inhaled corticosteroids (fluticasone) in children 5 to 11 years of age was not shown to reduce the rate of severe exacerbations and may have been associated adverse effects (decreased linear growth, particularly in patients <8 years of age) (GINA 2019; Jackson 2018).

Eosinophilic esophagitis: Nebulization (Pulmicort Respules): An oral suspension (prepared with nebulizer inhalation product) has been used for treatment of eosinophilic esophagitis (see Budesonide: Systemic monograph for details on dosing and administration).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, budesonide undergoes hepatic metabolism; drug may accumulate with hepatic impairment; use with caution; monitor closely.

Use: Labeled Indications

Asthma: Maintenance and prophylactic treatment of asthma in patients ≥6 years of age (dry powder inhaler) or 12 months to 8 years of age (nebulization suspension).

Limitations of use: Not for relief of acute bronchospasm.

Use: Off-Label: Adult

​Chronic obstructive pulmonary disease (acute exacerbation)Level of Evidence [B, G]

Data from a multicenter, double-blind, randomized, placebo-controlled trial supports the use of budesonide in the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD). Additional trials may be necessary to further define the role of budesonide in this condition Ref.

Based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for the management of COPD, nebulized budesonide may be an alternative to oral corticosteroids for the treatment of acute exacerbations.

​Chronic obstructive pulmonary disease (stable)Level of Evidence [G]

Based on the GOLD guidelines for the management of COPD, inhaled corticosteroids (ICS) may be considered as part of dual or triple combination therapy (with a long acting beta agonist [LABA] or with a LABA and long-acting muscarinic antagonist), respectively) in patients with moderate to very severe COPD. However, regular treatment with ICS has been shown to increase the risk of pneumonia, especially in those with severe disease. Combination therapy is recommended in patients with a history of hospitalization(s) for exacerbations of COPD, ≥2 moderate exacerbations of COPD per year, blood eosinophils >300 cells/microliter, and concomitant or history of asthma. Combination therapy may also be considered in patients with 1 moderate exacerbation of COPD per year and blood eosinophils of 100 to 300 cells/microliter.

​Eosinophilic esophagitis (oral)Level of Evidence [B, G]

Data from controlled trials and meta-analyses indicate that budesonide inhalational suspension, compounded into a viscous suspension and swallowed rather than inhaled, is effective at improving the clinicopathologic features of eosinophilic esophagitis Ref.

Guidelines from the American College of Gastroenterology and consensus recommendations from the American Gastroenterological Association (AGA) Institute/North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition on the management of eosinophilic esophagitis recommend oral administration of inhalational corticosteroids (eg, fluticasone, budesonide) as first-line therapy in adults and children with eosinophilic esophagitis and that the corticosteroid type and duration of therapy be individualized. They note that symptoms often recur upon discontinuation, and steroid resistance has been reported Ref. AGA Institute/Joint Task Force on Allergy-Immunology Practice Parameters guidelines also recommend oral administration of inhalational corticosteroids over oral glucocorticosteroid therapy or no treatment for patients with eosinophilic esophagitis Ref. Access Full Off-Label Monograph

Level of Evidence Definitions

​Level of Evidence Scale

Class and Related Monographs

Corticosteroids

Clinical Practice Guidelines

Asthma:

Canadian Thoracic Society, “Asthma Management Continuum - 2010 Consensus Summary for Children Six Years of Age and over, and Adults,” January/February 2010

ERS/ATS, "Management of Severe Asthma," September 2019

GINA, "Global Strategy for Asthma Management and Prevention," 2020 Update

NHLBI/NAEPP The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007

Chronic Cough:

CHEST, "Managing Chronic Cough due to Asthma and NAEB in Adults and Adolescents," January 2020

COPD:

"Canadian Thoracic Society Recommendations for Management of Chronic Obstructive Pulmonary Disease," 2007 Update

GOLD, "Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease," 2019

Exercise-induced Bronchoconstriction:

AAAAI/ACAAI, “Exercise-induced Bronchoconstriction,” Update - 2016

Administration: Oral

Oral: Treatment of eosinophilic esophagitis (off-label use): Swallow viscous liquid/suspension (oral inhalation preparation) slowly over 5 to 10 minutes immediately after preparation. Avoid ingesting any solid or liquid food, brushing teeth, or rinsing mouth for 30 minutes after budesonide administration. (ACG [Dellon 2013]; Contreras 2014; Dellon 2017; Dohil 2010; Furuta 2007; Rubinstein 2014). When administering twice daily, preferably take after breakfast and before bedtime (Richter 2016).

Administration: Inhalation

Dry powder inhaler:

Pulmicort Flexhaler: Do not shake prior to use. Unit should be primed prior to first use only; will not need primed again, even if not used for a long time. Hold inhaler in upright position (mouthpiece up) to load dose. Discard when dose indicator reads “0”. Rinse mouth with water (without swallowing) after each use. Keep inhaler dry; do not place in water to determine if it is empty. Clean mouthpiece once a week with dry tissue.

Pulmicort Turbuhaler [Canadian product]: Hold inhaler in upright position (mouthpiece up) to load dose. Do not shake inhaler after dose is loaded. Unit should be primed prior to first use. Place mouthpiece between lips and inhale forcefully and deeply; mouthpiece should face up. Do not exhale through inhaler; do not use a spacer. 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. Rinse mouth with water after use to reduce incidence of candidiasis.

Nebulization suspension: Shake well before using; do not swallow suspension. Use with jet nebulizer connected to an air compressor; administer with mouthpiece or facemask. Do not use ultrasonic nebulizer. Compatibility with other medications (eg, albuterol, ipratropium) in nebulizer has been reported (Burchett 2010; Kamin 2014); also refer to institution-specific policies. Rinse mouth with water (without swallowing) following each treatment; wash face if using face mask.

Administration: Pediatric

Inhalation:

Nebulization: Shake gently with a circular motion before use. Administer only with a compressed air driven jet nebulizer connected to an air compressor; do not use an ultrasonic nebulizer; use adequate flow rates and administer via appropriate size face mask or mouthpiece. Compatibility with other medications (eg, albuterol, levalbuterol, ipratropium) in nebulizer has been reported (Burchett 2010; Kamin 2014); also refer to institutional policy. Avoid exposure of nebulized medication to eyes. Rinse mouth following treatments to decrease risk of oral candidiasis (wash face if using face mask).

Nebuamp [Canadian Product]: Each ampule contains 2 mL of product; if a partial ampule is necessary to achieve appropriate dose, add enough normal saline for meet fill volume in nebulizer cup.

Oral inhaler:

Pulmicort Flexhaler: Hold inhaler in upright position (mouthpiece up) to load dose. Do not shake prior to use. Unit should be primed prior to first use. It will not need to be primed again, even if not used for a long time. Place mouthpiece between lips and inhale forcefully and deeply. Do not exhale through inhaler; do not use a spacer. Dose indicator does not move with every dose, usually only after 5 doses. Discard when dose indicator reads "0". Rinse mouth with water after use to reduce incidence of candidiasis.

Pulmicort Turbuhaler [Canadian product]: To prepare inhaler prior to use, load dose by holding inhaler in upright position and turn brown 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 mouthpiece between teeth and close lips over mouthpiece. Inhale deeply and forcefully. Do not exhale through inhaler. If the Turbuhaler is dropped, shaken, or breathed 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.

Storage/Stability

Dry powder inhaler: Store at 20°C to 25°C (68°F to 77°F). Discard when the dose counter reads “0".

Nebulization suspension: Store upright at 20°C to 25°C (68°F to 77°F). Keep in aluminum package to protect from light until ready for use. Do not refrigerate or freeze. Once aluminum package is opened, unused suspension should be used within 2 weeks. Continue to protect unopened ampules from light in foil envelope.

Pulmicort Nebuamp [Canadian product]: Store upright at 5°C to 30°C (41°F to 86°F). Keep in packaged envelope of foil laminate to protect from light. Once envelope is opened, use ampules within 3 months; opened ampules must be used within 12 hours.

Extemporaneously Prepared

Oral budesonide viscous liquid/suspension: Prepare immediately prior to ingestion from aqueous budesonide solution (1 mg per 2 mL) or nebulized solution (0.5 mg per 2 mL [Pulmicort Respules]) mixed to slurry consistency with 10 packets of Splenda or 2.5 cm3 of Neocate Nutra per milligram of budesonide. (ACG [Dellon 2013]; Dohil 2010; Rubinstein 2014)

Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693.[PubMed 23567357]

Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010;139(2):418-429.[PubMed 20457157]

Rubinstein E, Lee JJ, Fried A, et al. Comparison of 2 delivery vehicles for viscous budesonide to treat eosinophilic esophagitis in children. J Pediatr Gastroenterol Nutr. 2014;59(3):317-320.[PubMed 24821535]

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat asthma.

• It may be given to you for other reasons. Talk with the doctor.

• Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nosebleed

• Common cold symptoms

• Throat irritation

• Nose irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Cushing syndrome like weight gain in upper back or abdomen; moon face; severe headache; or slow healing

• Infection

• Chest pain

• Anxiety

• Severe diarrhea

• Severe nausea

• Vomiting

• Lack of appetite

• Severe headache

• Burning or numbness feeling

• Severe loss of strength and energy

• Bone pain

• Joint pain

• Vision changes

• Trouble breathing

• Wheezing

• Cough

• Thrush

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Contraindications

Hypersensitivity to budesonide or any component of the formulation; severe hypersensitivity to milk proteins (Pulmicort Flexhaler); primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Moderate-to-severe bronchiectasis, pulmonary tuberculosis (active or quiescent), untreated respiratory infection (bacterial, fungal, or viral)

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children, 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. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products or corticosteroids with lower systemic effect 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. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections (particularly gastroenteritis), or other conditions with severe electrolyte loss. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue budesonide and institute alternative therapy.

• Hypersensitivity reactions: Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis and urticaria) may occur; discontinue use if reaction occurs.

• 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 use, if possible, in patients with ocular herpes, active or quiescent respiratory tuberculosis, or untreated viral, fungal, parasitic or bacterial systemic infections. Exposure to chickenpox and measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered.

• Oral candidiasis: Local oropharyngeal Candida albicans infections have been reported; if this occurs, treat appropriately while continuing therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.

• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Use is contraindicated in status asthmaticus or during other acute episodes of asthma requiring intensive measures.

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Hepatic impairment: Use with caution in patients with hepatic impairment; budesonide undergoes hepatic metabolism; drug may accumulate with hepatic impairment.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; blurred vision, increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

Special populations:

• Pediatric: Orally-inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally-inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Lactose: Pulmicort Flexhaler contains lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Discontinuation of therapy: A gradual tapering of dose may be required prior to discontinuing therapy; there have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.

• Transfer to oral inhaler: When transferring to oral inhalation therapy from systemic corticosteroid therapy, previously suppressed allergic conditions (rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions) may be unmasked. Withdraw systemic corticosteroid therapy by gradually tapering the dose. Monitor lung function, beta-agonist use, asthma symptoms and for signs and symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea/vomiting, hypotension) during withdrawal.

Geriatric Considerations

Ensure that patients can correctly use inhaler.

Warnings: Additional Pediatric Considerations

A 12-week study in infants (n=141; 6 to 12 months of age) receiving budesonide nebulizations (0.5 mg or 1 mg once daily) vs placebo demonstrated a budesonide dose dependent suppression of linear growth; in addition, although mean changes from baseline did not indicate budesonide-induced adrenal suppression, six infants who received budesonide had subnormal stimulated cortisol levels at week 12. Children and adolescents (n=18; 6 to 15 years) receiving budesonide nebulizations of 1 and 2 mg twice daily showed a significant reduction in urinary cortisol excretion; this reduction was not seen when patients were dosed at 1 mg/day (maximum recommended dose). Long-term effects of chronic use of budesonide nebulization on immunological or developmental processes of upper airways, mouth, and lung are unknown.

Although recommended in children ≥12 years and adolescents, using higher doses (quintupled) in children <12 years of age has not shown efficacy and may be associated with a higher risk of adverse effects. A study in children 5 to 11 years of age with mild to moderate persistent asthma evaluated quintupling the dose of the inhaled corticosteroid (fluticasone) following the early signs of decreased asthma control; results showed that quintupled fluticasone dosages did not reduce the rate of severe exacerbations and may have been associated adverse effects (decreased linear growth, particularly in patients <8 years of age) (Jackson 2018).

Pregnancy Considerations

Studies of pregnant women using inhaled budesonide have not demonstrated an increased risk of congenital abnormalities.

Maternal use of inhaled corticosteroids (ICS) in usual doses is not associated with an increased risk of fetal malformations; a small risk of malformations was observed in one study following high maternal doses of an alternative inhaled corticosteroid. Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2020).

ICS are recommended for the treatment of asthma during pregnancy (GINA 2020). Budesonide is one of the preferred agents. The lowest dose that maintains asthma control should be used. Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant females in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Breast-Feeding Considerations

Budesonide is present in breast milk.

Following use of the powder for oral inhalation, ~0.3% to 1% of the maternal dose was present in breast milk. The maximum concentration appeared within 45 minutes of dosing. Plasma budesonide levels obtained from infants ~90 minutes after breastfeeding (~140 minutes after maternal dose) were below the limit of quantification.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. However, females with asthma should be encouraged to breastfeed (GINA 2020). Budesonide inhalation is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).

Briggs' Drugs in Pregnancy & Lactation

• Budesonide

Adverse Reactions

Frequencies are for both formulations unless otherwise indicated.

>10%:

Otic: Otitis media (suspension: 12%; powder: 1%)

Respiratory: Respiratory infection (suspension: 38%; powder: ≥3%), rhinitis (5% to 12%)

1% to 10%:

Cardiovascular: Syncope (powder: 1% to 3%), chest pain (suspension: 1% to <3%)

Central nervous system: Headache (powder: ≥3%; suspension: <1%), pain (powder: ≥3%), hypertonia (powder: 1% to 3%), insomnia (powder: 1% to 3%), voice disorder (powder: 1% to 3%), emotional lability (suspension: 1% to <3%), fatigue (suspension: 1% to <3%)

Dermatologic: Skin rash (suspension: 4%; powder: <1%), contact dermatitis (suspension: 1% to <3%), eczema (suspension: 1% to <3%), pruritus (suspension: 1% to <3%), pustular rash (suspension: 1% to <3%)

Endocrine & metabolic: Weight gain (1% to 3%)

Gastrointestinal: Dyspepsia (≥5%), nausea (2% to ≥5%), gastroenteritis (suspension: 5%), diarrhea (suspension: 4%), vomiting (1% to 4%), abdominal pain (1% to 3%), dysgeusia (powder: 1% to 3%), xerostomia (powder: 1% to 3%), anorexia (suspension: 1% to <3%), viral gastroenteritis (powder: 2%), oral candidiasis (powder: 1%)

Hematologic & oncologic: Ecchymosis (powder: 1% to 3%), cervical lymphadenopathy (suspension: 1% to <3%), purpura (suspension: 1% to <3%)

Hypersensitivity: Hypersensitivity reaction (1% to <3%)

Infection: Candidiasis (suspension: 4% to 5%), viral infection (suspension: 4% to 5%), infection (1% to 3%), herpes simplex infection (suspension: 1% to <3%)

Neuromuscular & skeletal: Arthralgia (≥5%), weakness (≥5%), back pain (powder: ≥3%), bone fracture (1% to 3%), myalgia (1% to 3%), neck pain (powder: 1% to 3%), hyperkinesia (suspension: 1% to <3%)

Ophthalmic: Conjunctivitis (suspension: 4%), eye infection (suspension: 1% to <3%)

Otic: Otic infection (suspension: 5%), otalgia (suspension: 1% to <3%), otitis externa (suspension: 1% to <3%)

Respiratory: Nasopharyngitis (powder: 9%), cough (5% to 9%), epistaxis (suspension: 2% to 4%), respiratory tract infection (powder: ≥3%), sinusitis (powder: ≥3%; suspension: <1%), nasal congestion (powder: 3%), pharyngitis (powder: 3%; suspension: <1%), flu-like symptoms (suspension: 1% to <3%), stridor (suspension: 1% to <3%), allergic rhinitis (powder: 2%), viral upper respiratory tract infection (powder: 2%)

Miscellaneous: Fever (≥3%)

Postmarketing and/or case reports: Adrenocortical insufficiency, aggressive behavior, anxiety, avascular necrosis of femoral head, bronchitis, bruise, cataract, depression, glaucoma, growth suppression, hypercorticoidism, increased intraocular pressure, irritability, nervousness, osteoporosis, pain, psychosis, restlessness, skin irritation (facial), throat irritation, wheezing

Allergy and Idiosyncratic Reactions

• Corticosteroid Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy

Genes of Interest

• Cytochrome P450 3A4

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; bone mineral density; growth (adolescents and children via stadiometry); signs/symptoms of HPA axis suppression/adrenal insufficiency; possible eosinophilic conditions (including eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]); hepatic impairment; signs/symptoms of oral candidiasis; asthma symptoms; glaucoma/cataracts

Advanced Practitioners Physical Assessment/Monitoring

When changing from systemic steroids to inhalational steroids, taper reduction of systemic medication slowly (may take several months). Monitor growth with long-term use in pediatric patients. Assess for signs and symptoms of HPA axis suppression/adrenal insufficiency. Assess for ocular changes. Assess for sign and symptoms of oral Candida infection with long-term use. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Obtain peak flow, FEV1 and other pulmonary function tests.

Nursing Physical Assessment/Monitoring

Check ordered pulmonary function test results and report abnormalities. Instruct patient on proper administration.

Dosage Forms Considerations

Pulmicort Flexhaler 180 mcg/actuation canisters contain 120 actuations and the 90 mcg/actuation canisters contain 60 inhalations.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Pulmicort Flexhaler: 90 mcg/actuation (1 ea); 180 mcg/actuation (1 ea) [contains milk protein]

Suspension, Inhalation:

Pulmicort: 0.25 mg/2 mL (2 mL); 0.5 mg/2 mL (2 mL); 1 mg/2 mL (2 mL) [contains disodium edta, polysorbate 80]

Generic: 0.25 mg/2 mL (2 mL); 0.5 mg/2 mL (2 mL); 1 mg/2 mL (2 mL)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Pulmicort Turbuhaler: 100 mcg/INH (1 ea); 200 mcg/INH (1 ea); 400 mcg/INH (1 ea)

Nebulization Solution, Inhalation:

Pulmicort Nebuamp: 0.125 mg/mL (2 mL); 0.25 mg/mL (2 mL); 0.5 mg/mL (2 mL) [contains edetate disodium, polysorbate 80]

Generic: 0.125 mg/mL (2 mL); 0.5 mg/mL (2 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• R03BA02

Generic Available (US)

May be product dependent

Pricing: US

Aerosol powder (Pulmicort Flexhaler Inhalation)

90 mcg/ACT (per each): $222.43

180 mcg/ACT (per each): $297.84

Suspension (Budesonide Inhalation)

0.25 mg/2 mL (per mL): $1.31 - $4.74

0.5 mg/2 mL (per mL): $1.30 - $5.58

1 mg/2 mL (per mL): $6.00 - $11.54

Suspension (Pulmicort Inhalation)

0.25 mg/2 mL (per mL): $5.23

0.5 mg/2 mL (per mL): $6.15

1 mg/2 mL (per mL): $12.31

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.

Mechanism of Action

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.

Pharmacodynamics/Kinetics

Onset of action: Nebulization: 2 to 8 days; Inhalation: 24 hours

Peak effect: Nebulization: 4 to 6 weeks; Inhalation: 1 to 2 weeks

Distribution:

Children 4 to 6 years: 3 L/kg

Adults: 2.2 to 3.9 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:

Nebulization: Children 4 to 6 years: 6%

Oral inhalation: 39% of an inhaled metered dose is available systemically

Half-life elimination:

Children 4 to 6 years: 2.3 hours (after nebulization)

Children and Adolescents 10 to 14 years: 1.5 hours

Adults: 2 to 3.6 hours

Time to peak:

Nebulization: Pulmicort Respules: Children: 20 minutes

Oral inhalation: Pulmicort Flexhaler:

Children and Adolescents: 15 to 30 minutes

Adults: 10 minutes

Excretion: Urine (60%) and feces as metabolites

Clearance:

Children 4 to 6 years: 0.5 L/minute (~50% greater than healthy adults after weight adjustment)

Adults: 0.9 to 1.8 L/minute

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Patients with cirrhosis had more than doubled systemic availability after oral ingestion.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation), dry throat, abnormal taste, and herpes simplex. Localized infections with Candida albicans or Aspergillus niger have occurred frequently in the mouth and pharynx with repetitive use of oral inhaler of corticosteroids. These infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with corticosteroid inhaler.

Effects on Bleeding

Variable effects on anticoagulant therapy are observed with glucocorticoids such as budesonide (systemic, oral inhalation).

Related Information

• Inhalant Agents

Pharmacotherapy Pearls

Effects of inhaled steroids on growth have been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally-inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with inhaled corticosteroids has not been adequately studied.

FDA Approval Date

June 24, 1997

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Brand Names: International

Aeronide (TH); Aerovent (AR); Aircort (MT); Avacort (MY); B Cort (CO); Benita (VN); Breecort (PH); Budecort (EG, MY, VN); Budenocort (NZ); Budesma (ID); Budeson (AR, BD); Budestar (TH); Budiair Jet (BG); Busonid (BR); Denecort (PH); Duasma HFA (HK); Frenolyn (SG, TR); Giona Easyhaler (SG, TH); Inflammide (PE); Miflonid (CZ); Miflonide (AT, BE, CL, DE, DK, EC, EE, ES, IL, IT, NZ, PT, TR); Neumocort (PY); Novopulmon (DE, FR); Numark (MX); Pulmax (ZA); Pulmaxan (NO); Pulmicort (AE, AT, AU, BB, BE, BG, BH, BR, CH, CL, CN, CO, CY, CZ, DK, EE, EG, FI, FR, GB, GR, HK, HU, ID, IE, IN, IS, JO, JP, KR, KW, LB, LU, LV, MX, NL, NO, NZ, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, TH, TR, TW, UA, UY, VE); Pulvisonide 200 (TH); Talgan (MY)

Last Updated 10/14/20