Budesonide inhalers

Generic Name

Budesonide

Brand Names (Inhalation Formulations)

Pulmicort Turbohaler

Pulmicort Flexhaler

Pulmicort Respules (nebuliser suspension)

Pulmicort Inhaler

Symbicort (combination with formoterol)

DuoResp Spiromax (budesonide + formoterol)

Generic dry powder and pressurised metered-dose inhalers (pMDIs) available

Drug Class

Inhaled corticosteroid (ICS)

Anti-inflammatory agent for respiratory use

Mechanism of Action

Budesonide exerts potent glucocorticoid activity at the site of airway inflammation

It binds to intracellular glucocorticoid receptors in respiratory epithelial cells, suppressing transcription of pro-inflammatory genes

This leads to reduced synthesis of inflammatory cytokines (e.g., IL-4, IL-5, TNF-α), decreased eosinophilic infiltration, suppression of mast cell activity, and decreased mucus production

Regular use reduces airway hyperresponsiveness, prevents asthma exacerbations, and improves pulmonary function

Low oral bioavailability and high first-pass metabolism ensure minimal systemic exposure

Indications

Approved Respiratory Uses

Asthma (mild, moderate, or severe persistent asthma)

Maintenance therapy in chronic asthma

Maintenance treatment of chronic obstructive pulmonary disease (COPD) in combination with long-acting beta-agonists (LABAs)

Acute asthma exacerbation prevention

Croup in children (via nebulised form)

Off-label or Investigational Uses

Chronic cough associated with upper airway inflammation

Bronchopulmonary dysplasia (BPD) in preterm infants (in select protocols)

Inflammatory airway disease in select rare syndromes

Formulations and Delivery Devices

Dry Powder Inhalers (DPI)

Pulmicort Turbohaler (Europe, Asia)

Pulmicort Flexhaler (US)

Delivers 100 mcg, 200 mcg, or 400 mcg per actuation depending on device

Breath-actuated; requires sufficient inspiratory flow

Contains no propellants or preservatives

Pressurised Metered-Dose Inhalers (pMDI)

Less commonly used for budesonide monotherapy

Available in combination formulations with formoterol

Nebuliser Suspension (Pulmicort Respules)

0.25 mg/mL, 0.5 mg/mL, 1 mg/mL

Used especially in children and elderly who cannot coordinate inhaler use

Administered via jet nebuliser with mouthpiece or tightly fitting face mask

Combination Inhalers

Symbicort (budesonide + formoterol fumarate dihydrate)

Available as Turbohaler or Spiromax

Contains both anti-inflammatory and bronchodilator activity

Used in asthma and COPD maintenance and reliever therapy (MART)

Dosing and Administration

Asthma (Adults and Adolescents ≥12 years)

Initial dose: 200–800 mcg per day

Maintenance dose: 200–1600 mcg/day (divided twice daily)

Max dose: 1600 mcg/day in severe asthma

Low dose: ≤400 mcg/day

Medium dose: 401–800 mcg/day

High dose: >800 mcg/day

Asthma (Children 6–11 years)

Usual dose: 100–400 mcg/day

Severe asthma: up to 800 mcg/day

Administered twice daily; once-daily dosing possible for mild asthma

Asthma (Children <6 years)

Nebulised budesonide preferred

0.25–1 mg/day via nebuliser in divided doses

COPD (Maintenance Therapy, combination inhalers)

Typically 160–320 mcg budesonide with 4.5–9 mcg formoterol twice daily

Used in symptomatic COPD patients with frequent exacerbations despite bronchodilators

Croup (Nebulised)

2 mg budesonide via nebulisation in a single dose

Can be repeated once after 12 hours if needed

Administration Technique

Dry Powder Inhalers

Breathe out fully (not into device), place mouthpiece between lips, and inhale forcefully and deeply

Hold breath for 10 seconds then exhale slowly

Rinse mouth with water and spit after each use to prevent oral candidiasis

Do not shake device

Nebuliser Use

Use only with jet nebulisers

Nebulise over 5–10 minutes

Ensure face mask fits well if used in children

Clean and dry equipment after use

Contraindications

Hypersensitivity to budesonide or any components of the formulation

Use for acute bronchospasm as monotherapy (not a rescue inhaler)

Precautions

Not for relief of acute asthma attacks

Do not discontinue suddenly in patients on high doses

Adrenal suppression risk with prolonged high-dose use

Monitor for growth suppression in children

Caution in patients with active or latent tuberculosis, herpes simplex ocular infection, or untreated fungal/viral infections

Monitor intraocular pressure in patients at risk for glaucoma

May mask signs of infection

Adverse Effects

Local Effects

Oral candidiasis (thrush)

Hoarseness or dysphonia

Sore throat

Cough or throat irritation

Dry mouth

Systemic Effects (especially at high doses or prolonged use)

Adrenal suppression

Growth retardation in children

Hyperglycemia

Osteopenia or osteoporosis

Cataracts

Glaucoma

Mood changes (irritability, anxiety, insomnia)

Rare/Serious Effects

Paradoxical bronchospasm

Hypersensitivity reactions

Suppressed immunity

HPA axis dysfunction

Pregnancy and Lactation

Pregnancy

Considered relatively safe

Used widely in pregnant women with asthma

Inhaled route limits fetal exposure

Lactation

Excreted in breast milk in very low quantities

No adverse effects expected in breastfed infants

Use in Special Populations

Pediatrics

Used widely in children with asthma

Growth should be monitored periodically

Use lowest effective dose for maintenance

Elderly

Generally well tolerated

Monitor for osteoporosis, glaucoma, and systemic effects with prolonged use

Hepatic Impairment

Systemic exposure may increase due to impaired metabolism

Monitor for signs of adrenal suppression or systemic corticosteroid effects

Drug Interactions

CYP3A4 Inhibitors (e.g. ketoconazole, itraconazole, ritonavir)

May significantly increase systemic budesonide levels

Avoid concurrent use or adjust dose

Beta-agonists and Anticholinergics

Often used concomitantly in asthma/COPD

Complementary bronchodilatory effect

Live Vaccines

Use caution in immunocompromised individuals

Monitoring Parameters

Symptom control and peak expiratory flow (PEF)

Lung function tests (spirometry)

Signs of oral candidiasis

HPA axis function in long-term high-dose users

Growth rate in children

Intraocular pressure and bone mineral density in long-term use

Patient Counseling Points

Do not use for sudden asthma attacks

Use regularly at same times daily

Rinse mouth thoroughly after use

Monitor for white patches in mouth or persistent hoarseness

Do not shake dry powder inhalers

Ensure correct inhalation technique

Do not stop suddenly unless instructed

Keep device clean and dry

Do not exceed prescribed dose

Seek medical attention if symptoms worsen despite regular use

Storage

Store at room temperature

Protect from moisture and extreme heat

Keep inhaler tightly closed when not in use

Nebules should be protected from light and used promptly after opening