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Budesonide (oral inhalation): Drug information

Budesonide (oral inhalation): Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Budesonide (oral inhalation): Patient drug information" and "Budesonide (oral inhalation): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Pulmicort;
  • Pulmicort Flexhaler
Brand Names: Canada
  • Pulmicort Nebuamp;
  • Pulmicort Turbuhaler;
  • TARO-Budesonide;
  • TEVA-Budesonide
Pharmacologic Category
  • Corticosteroid, Inhalant (Oral)
Dosing: Adult

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

Asthma, maintenance/controller

Asthma , maintenance/controller (alternative agent): Note: Product selection: Individualize daily budesonide dose based on severity of symptoms, typically as follows: low doses for mild persistent asthma; low to medium doses for moderate persistent asthma; and medium to high doses for severe persistent asthma. Select a product with a favorable dosage per actuation to improve convenience and adherence (Ref).

Dosage Classification for Budesonide Preparations (GINA 2023)

Low dose

Medium dose

High dose

Budesonide

200 to 400 mcg/day

>400 to 800 mcg/day

>800 mcg/day

Usual dosage ranges, mild to moderate:

Pulmicort Flexhaler (90 mcg/actuation or 180 mcg/actuation): Dry powder inhaler: Oral inhalation: 90 to 720 mcg twice daily (Ref). Note: There is limited evidence for additional improvement with dose increases >1,000 mcg/day (Ref).

Pulmicort Turbuhaler (Canadian product): Dry powder inhaler (100 mcg/actuation, 200 mcg/actuation, or 400 mcg/actuation): Oral inhalation: 200 to 2,400 mcg/day; doses ≤400 mcg/day may be administered once daily; doses >400 mcg/day should be administered in 2 to 4 (usually 2) divided doses (Ref). Note: There is limited evidence for additional improvement with dose increases >1,000 mcg/day (Ref).

Pulmicort Nebuamp (Canadian product): Nebulization suspension: Oral inhalation: 1 to 2 mg twice daily.

Titration: For patients whose symptoms are not adequately controlled after 2 to 4 weeks of therapy, may increase controller therapy in a step-wise fashion. For patients whose symptoms are well controlled for 3 to 6 months on a stable regimen, may reduce controller therapy in a step-wise fashion (Ref).

Chronic obstructive pulmonary disease, maintenance

Chronic obstructive pulmonary disease, maintenance (off-label use):

Note: In patients with persistent exacerbations on dual long-acting bronchodilator therapy or elevated eosinophil count (Group E), consider triple therapy (inhaled corticosteroid, long-acting beta agonist, and long-acting muscarinic antagonist). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).

Nebulization suspension (0.25 mg per 2 mL or 0.5 mg per 2 mL): Oral inhalation: 0.25 to 1 mg twice daily; reserve higher doses for patients with concomitant features of chronic obstructive pulmonary disease and asthma (Ref).

Eosinophilic esophagitis

Eosinophilic esophagitis:

Nebulization suspension: An oral suspension (prepared with nebulizer inhalation product) has been used for treatment of eosinophilic esophagitis. An oral suspension (Eohilia) is also commercially available. Detailed information is available in the Budesonide: Systemic monograph.

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

Dosing: Kidney 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: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Budesonide (oral inhalation): Pediatric drug information")

Asthma, maintenance therapy

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 (Ref).

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 (Ref): 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 (Ref):

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 (Ref): 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 (Ref):

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

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 (Ref). 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 (Ref). 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) (Ref).

Eosinophilic esophagitis

Eosinophilic esophagitis: Nebulization (Pulmicort Respules): An oral suspension (prepared with nebulizer inhalation product) has been used for treatment of eosinophilic esophagitis. An oral suspension (Eohilia) is also commercially available; detailed information is available in Budesonide: Systemic monograph.

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

Dosing: Kidney 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.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

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

Canadian labeling: Additional contraindications (not in US labeling): Moderate to severe bronchiectasis, pulmonary tuberculosis (TB) (disease [active TB] or infection [latent TB]), 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, respiratory tuberculosis (TB) disease (active TB) or infection (latent TB), 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, antiseizure medications 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.

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).

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)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Aerosol powder (Pulmicort Flexhaler Inhalation)

90 mcg/ACT (per each): $237.12

180 mcg/ACT (per each): $317.52

Suspension (Budesonide Inhalation)

0.25 mg/2 mL (per mL): $1.31 - $5.20

0.5 mg/2 mL (per mL): $1.30 - $6.10

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.

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/actuation (1 ea); 200 mcg/actuation (1 ea); 400 mcg/actuation (1 ea)

Suspension, Inhalation:

Pulmicort Nebuamp: 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)

Administration: Adult

Oral (swallowed): Treatment of eosinophilic esophagitis (off-label route): An oral suspension (prepared with nebulizer inhalation product) has been used for treatment of eosinophilic esophagitis. An oral suspension (Eohilia) is also commercially available. Detailed information is available in the Budesonide: Systemic monograph.

Oral 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 (Ref); 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 (Ref); 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 to 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.

Use: Labeled Indications

Asthma, maintenance/controller: 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, maintenance

Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

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). Management: Consider alternatives to this combination when possible. If combined, monitor for increased corticosteroid adverse effects during coadministration of inhaled budesonide and strong CYP3A4 inhibitors. Risk D: Consider therapy modification

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

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider therapy modification

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

Nirmatrelvir and Ritonavir: May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy

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

Reproductive Considerations

Uncontrolled asthma may negatively affect fertility by increasing time to pregnancy and reducing birth rate. Fertility may be improved in patients adequately treated with inhaled corticosteroids (Couillard 2021; ERS/TSANZ [Middleton 2020]). Inhaled corticosteroids used for the treatment of asthma should not be discontinued in patients planning to become pregnant (GINA 2023). The lowest dose that maintains asthma control should be continued (ERS/TSANZ [Middleton 2020]).

Pregnancy Considerations

Studies of pregnant patients 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 2023).

ICS are recommended for the treatment of asthma during pregnancy. Due to the risk of exacerbations, stepping down or stopping ICS should not be done during pregnancy (GINA 2023). Budesonide is one of the preferred agents. The lowest dose that maintains asthma control should be continued (ERS/TSANZ [Middleton 2020]). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).

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 patients 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.

Breastfeeding 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.

Budesonide inhalation is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).

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 [Churg-Strauss]); hepatic impairment; signs/symptoms of oral candidiasis; asthma symptoms; glaucoma/cataracts

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.

Pharmacokinetics (Adult Data Unless Noted)

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

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Aerovial | Budeson nebu | Budesonida df | Exudrol Bude | Kerpet | Neumotex bronquial | Neumotex nebu;
  • (AT) Austria: Novolizer budesonid meda;
  • (CH) Switzerland: Pulmicort;
  • (CI) Côte d'Ivoire: Pulmicort;
  • (CL) Chile: Pulmicort;
  • (CN) China: Pulmicort | Tian qing su chang;
  • (CO) Colombia: Budemar-Hfa | Budesonida;
  • (CZ) Czech Republic: Pulmax;
  • (DE) Germany: Budepur e | Larbex steri neb;
  • (EC) Ecuador: Inflabon;
  • (EE) Estonia: Pulmicort;
  • (ES) Spain: Budesonida;
  • (ET) Ethiopia: Pulmicort;
  • (FI) Finland: Budesonid easyhaler;
  • (HR) Croatia: Pulmicort | Tafen;
  • (IE) Ireland: Budesitan;
  • (IL) Israel: Budesonide sterinebs teva;
  • (IN) India: Foresp | Ibinide r nexpule;
  • (KE) Kenya: Budecort respules | Pulmicort;
  • (KR) Korea, Republic of: Pulmicort;
  • (LU) Luxembourg: Pulmicort;
  • (LV) Latvia: Neplit | Pulmicort;
  • (MX) Mexico: Budenova | Budzyd | Pulmicort;
  • (NL) Netherlands: Budesonide clickhaler kr | Pulmicort;
  • (NO) Norway: Giona | Pulmicort;
  • (PH) Philippines: Primavent;
  • (PL) Poland: Budelin | Budixon neb | Nebbud;
  • (PR) Puerto Rico: Pulmicort | Pulmicort flexhaler;
  • (PT) Portugal: Budesonida Mylan;
  • (PY) Paraguay: Budecort | Butibel | Nebucort;
  • (QA) Qatar: Bumicort | Pulmicort Respules | Pulmicort Turbuhaler;
  • (RO) Romania: Bodinet;
  • (RU) Russian Federation: Budesonide native | Pulmicort;
  • (SI) Slovenia: Pulmicort;
  • (TR) Turkey: Budenosin Discair;
  • (TW) Taiwan: Inflammide | Pulmicort;
  • (UA) Ukraine: Budixon neb | Pulmicort;
  • (UG) Uganda: Pulmicort;
  • (VE) Venezuela, Bolivarian Republic of: Bronklast | Budecort | Budesonida;
  • (VN) Viet Nam: Zensonid
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