Pulmicort

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Pulmicort on Prescriptsy

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Pulmicort is a brand of budesonide, an inhaled corticosteroid (ICS) used for the regular prevention and long-term management of asthma.

Budesonide works by reducing chronic inflammation in the airways, decreasing bronchial hyperresponsiveness, mucus production, and the frequency and severity of asthma symptoms and exacerbations.

Pulmicort is available in several formulations: Pulmicort Turbohaler (a dry powder inhaler delivering 100, 200, or 400 micrograms per dose), Pulmicort Inhaler (a pressurised metered-dose inhaler), and Pulmicort Respules (a nebuliser suspension available in 0.25 mg/mL, 0.5 mg/mL, and 1 mg/mL strengths).

Pulmicort is a prescription-only medicine (POM) in the United Kingdom, manufactured by AstraZeneca.

Asthma is a chronic inflammatory disease of the airways that affects approximately 5.4 million people in the UK, including 1.1 million children.

It is characterised by variable and recurring symptoms of wheeze, breathlessness, chest tightness, and cough, together with variable expiratory airflow limitation.

The underlying pathology involves chronic airway inflammation driven by eosinophils, mast cells, T lymphocytes, and other inflammatory cells, which leads to structural changes in the airway wall (airway remodelling) over time.

Inhaled corticosteroids are the cornerstone of asthma management and are recommended at Step 2 and above in both the BTS/SIGN British Guideline on the Management of Asthma and NICE guideline NG80.

This page provides a comprehensive clinical guide to Pulmicort, including how it works, dosage instructions, side effects, safety warnings, and how to obtain it in the United Kingdom.

Important safety information about Pulmicort

Before reading further, please note these essential safety points.

• Pulmicort is a preventer inhaler for regular daily use. It does not relieve acute asthma symptoms. Always carry your reliever inhaler (usually salbutamol).
• Rinse your mouth with water and spit out after every dose to reduce the risk of oral thrush and hoarseness.
• Do not stop Pulmicort suddenly without medical advice, especially if you have been using high doses.
• If your asthma symptoms worsen despite regular use, or if you are using your reliever inhaler more than three times a week, seek medical review.
• Call 999 in a severe asthma attack: unable to speak in sentences, blue lips, reliever not helping.

Understanding asthma and the role of inhaled corticosteroids

Asthma involves chronic inflammation of the bronchial airways.

In susceptible individuals, exposure to triggers such as allergens (house dust mite, pollen, pet dander), respiratory infections, cold air, exercise, and air pollution causes an exaggerated inflammatory response.

The inflamed airways become swollen, produce excess mucus, and the surrounding smooth muscle contracts, narrowing the airway lumen and restricting airflow.

Over time, repeated inflammatory episodes can cause permanent structural changes (airway remodelling), including thickening of the basement membrane, smooth muscle hypertrophy, and goblet cell hyperplasia.

Inhaled corticosteroids are the most effective anti-inflammatory treatment for asthma. They suppress the chronic inflammatory process at multiple levels, reducing eosinophilic infiltration, cytokine production, and mucus hypersecretion.

Regular use of ICS decreases the frequency of asthma symptoms, reduces the risk of exacerbations, prevents hospitalisations, and decreases asthma-related mortality.

The BTS/SIGN guideline and NICE NG80 both recommend ICS as first-line maintenance therapy for patients whose asthma is not adequately controlled by short-acting beta-2 agonists (SABA) alone.

What Pulmicort contains and how it works

Budesonide is a non-halogenated synthetic glucocorticoid with potent topical anti-inflammatory activity and a favourable ratio of local to systemic effect.

When inhaled, budesonide is deposited on the airway mucosa, where it is absorbed into epithelial cells and binds to intracellular glucocorticoid receptors.

The activated budesonide-receptor complex translocates to the cell nucleus and modifies gene transcription.

It upregulates anti-inflammatory proteins (such as lipocortin-1, which inhibits phospholipase A2) and downregulates pro-inflammatory mediators (including interleukins, tumour necrosis factor, and granulocyte-macrophage colony-stimulating factor).

This results in reduced recruitment of inflammatory cells, decreased vascular permeability, and diminished mucus secretion.

A key pharmacokinetic advantage of budesonide is its high first-pass hepatic metabolism.

Approximately 90% of any budesonide that is swallowed (as opposed to inhaled into the lungs) is inactivated during first-pass metabolism by CYP3A4 enzymes in the liver, producing metabolites with negligible glucocorticoid activity.

This means that the swallowed fraction contributes very little to systemic exposure, reducing the risk of side effects compared with older ICS agents.

The fraction deposited in the lungs (which varies by device and technique from 15% to 40%) exerts its therapeutic effect locally, and any that is absorbed into the systemic circulation is also rapidly metabolised.

Clinical evidence and UK prescribing guidance

Budesonide is one of the most extensively studied ICS, with a clinical evidence base spanning more than 40 years.

Landmark trials including the START study (Steroid Treatment As Regular Therapy) demonstrated that early introduction of low-dose budesonide in patients with mild persistent asthma significantly reduced the risk of severe exacerbations and improved lung function compared with placebo.

The study also showed that delaying ICS treatment was associated with a greater decline in lung function over time, supporting the current recommendation for early initiation of ICS therapy.

The BTS/SIGN guideline (2019, updated) recommends starting ICS at a dose appropriate to the severity of asthma.

Low-dose ICS (budesonide 200 to 400 micrograms per day) is recommended at Step 2.

If control remains inadequate, options at Step 3 include adding a long-acting beta-2 agonist (LABA) before increasing the ICS dose.

Medium-dose ICS (budesonide 400 to 800 micrograms per day) and high-dose ICS (above 800 micrograms per day) are reserved for Steps 3 to 5.

NICE NG80 follows a similar stepwise approach but recommends a LABA plus low-dose ICS combination as an option before moving to medium-dose ICS.

NICE recommends reviewing asthma control at every consultation and stepping down treatment when control has been maintained for at least 3 months.

The goal is always to find the lowest effective ICS dose that maintains good symptom control, preserves lung function, and prevents exacerbations.

Pulmicort compared with other ICS options

Several ICS preparations are available in the UK. Beclometasone dipropionate (Qvar, Clenil Modulite) is the most commonly prescribed ICS in the UK.

Fluticasone propionate (Flixotide) is approximately twice as potent as budesonide and beclometasone on a microgram-for-microgram basis.

Ciclesonide (Alvesco) is a prodrug activated in the lungs with very low systemic bioavailability. Mometasone furoate (Asmanex) is another potent ICS option.

When comparing ICS, dose equivalences are important: 200 micrograms of budesonide is broadly equivalent to 200 micrograms of beclometasone dipropionate (standard particle) or 100 micrograms of fluticasone propionate.

The choice of ICS depends on factors including dose requirements, device preference, inspiratory flow rate, side-effect profile, and cost.

Pulmicort Turbohaler is a breath-actuated device that does not require coordination between actuation and inhalation, making it suitable for patients who find pressurised metered-dose inhalers difficult to use.

Pulmicort Respules are the preferred choice for infants and young children who cannot use handheld inhalers and require nebulised therapy.

Dosage and administration

Pulmicort Turbohaler: Adults and adolescents over 12 years: start at 200 to 400 micrograms twice daily.

Maintenance dose may be reduced to as low as 200 micrograms once daily in well-controlled patients. Maximum 1,600 micrograms per day.

Children aged 5 to 12 years: 100 to 400 micrograms twice daily, adjusted to the lowest effective dose.

To use the Turbohaler, remove the cap, hold the device upright, twist the grip at the base one full turn in one direction and back again until you hear a click, exhale gently away from the mouthpiece, seal your lips around the mouthpiece, and inhale steadily and deeply.

Hold your breath for 5 to 10 seconds and exhale slowly. If a second dose is prescribed, repeat the process.

Pulmicort Respules (nebuliser suspension): Adults: 1 to 2 mg twice daily initially, reduced to 0.5 to 1 mg twice daily for maintenance.

Children aged 3 months to 12 years: 0.25 to 0.5 mg twice daily, up to 1 mg twice daily in severe cases.

Respules are designed for use with a jet nebuliser equipped with a mouthpiece or a well-fitting face mask. Ultrasonic nebulisers are not suitable for budesonide suspension.

After nebulisation, wash the face if a mask was used, and rinse the mouth.

After every inhalation, rinse your mouth with water and spit it out. This simple step significantly reduces the risk of oropharyngeal candidiasis and hoarseness.

Using a spacer device with a pressurised MDI formulation also helps reduce oropharyngeal deposition and improves drug delivery to the lungs.

Side effects of Pulmicort

Common side effects

Oropharyngeal candidiasis (oral thrush) is the most characteristic side effect of ICS therapy, reported in approximately 5% to 10% of users.

It occurs because the deposited corticosteroid suppresses local immune defences, allowing overgrowth of Candida species.

Symptoms include white patches on the tongue, inner cheeks, or palate, and a sore or burning sensation. Rinsing the mouth after inhalation is the most effective preventive measure.

Oral thrush can usually be treated with nystatin or miconazole oral gel without needing to stop the ICS.

Hoarseness (dysphonia) affects a similar proportion of users and is caused by corticosteroid-induced myopathy of the vocal cord muscles. It is usually mild and improves with dose reduction.

Throat irritation and cough on inhalation may also occur, particularly when starting treatment or using a new device.

Systemic side effects at high doses

At doses exceeding 800 micrograms per day in adults (or 400 micrograms per day in children), the risk of systemic effects increases.

These may include adrenal suppression, reduced bone mineral density (increasing fracture risk with long-term use), posterior subcapsular cataracts, glaucoma, skin thinning, and easy bruising.

Growth retardation in children may occur at high doses; studies suggest budesonide may cause a small reduction in growth velocity (approximately 0.5 to 1 cm) during the first 1 to 2 years of use, though final adult height does not appear to be significantly affected.

The BTS/SIGN guideline recommends issuing a steroid card to patients on high-dose ICS and monitoring for adrenal insufficiency.

Rare side effects

Paradoxical bronchospasm (sudden worsening of wheeze immediately after inhalation) is rare but requires immediate treatment with a reliever inhaler and discontinuation of the ICS.

Allergic reactions including rash, urticaria, and angioedema are very rare. Behavioural disturbances (hyperactivity, sleep disturbance, anxiety, aggression) have been reported rarely in children.

Contact your prescriber if you notice personality or behavioural changes in your child.

When to seek medical advice

Contact your GP or asthma nurse if you develop persistent oral thrush, troublesome hoarseness, or worsening asthma symptoms despite regular use.

Call 999 if you experience signs of a severe asthma attack (unable to complete sentences, blue lips, exhaustion, reliever inhaler not working), severe allergic reaction (facial swelling, throat swelling, difficulty breathing), or symptoms of adrenal crisis (collapse, confusion, severe nausea, abdominal pain).

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Preventer, not reliever

Pulmicort is for regular preventive use only. It has a slow onset of action and provides no immediate bronchodilation.

Always carry a separate reliever inhaler (salbutamol or terbutaline) for acute symptoms.

If you find yourself needing your reliever inhaler on most days, or waking at night with asthma symptoms, your asthma is not well controlled.

Seek a review with your prescriber or asthma nurse.

Contraindications

Pulmicort is contraindicated in patients with known hypersensitivity to budesonide or any excipient. Pulmicort Turbohaler contains no propellants or excipients other than budesonide.

Pulmicort Respules contain polysorbate 80, sodium chloride, sodium citrate, citric acid, and disodium edetate; check for excipient sensitivities if relevant.

Steroid transfer and adrenal insufficiency

Patients transferring from oral corticosteroids (prednisolone) to inhaled budesonide are at risk of adrenal insufficiency during and after the transition.

Oral steroid doses should be reduced gradually under medical supervision.

Patients may experience symptoms of steroid withdrawal (fatigue, joint pain, muscle aches, depression) even if their asthma remains well controlled.

The MHRA has issued safety advice reminding prescribers that adrenal crisis can be fatal if unrecognised. A steroid emergency card should be issued to all patients at risk.

Infections

ICS may mask symptoms of respiratory infection. Active or quiescent pulmonary tuberculosis requires caution. Patients with untreated fungal, viral, or bacterial respiratory infections should be treated for the infection before relying solely on ICS for asthma control.

Drug interactions

CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, cobicistat, clarithromycin, erythromycin, nelfinavir) can substantially increase systemic budesonide exposure. Ketoconazole increased mean budesonide plasma levels approximately 6-fold in pharmacokinetic studies.

If co-prescription is unavoidable, use the lowest effective budesonide dose and monitor for Cushingoid features and adrenal suppression.

Pregnancy and breastfeeding

Budesonide is the most extensively studied ICS in pregnancy, with data from the Swedish Medical Birth Registry showing no increased risk of congenital malformations in infants exposed to budesonide during early pregnancy.

Both BTS/SIGN and NICE recommend continuing ICS during pregnancy, as uncontrolled asthma poses a greater risk to the mother and fetus than the use of ICS.

Budesonide passes into breast milk in small amounts and is considered compatible with breastfeeding.

Lifestyle advice for asthma management

Effective asthma management extends beyond medication. Identifying and avoiding triggers (house dust mites, pet dander, pollen, smoke, strong fumes) can reduce symptom burden.

All patients with asthma should have a written personalised asthma action plan, reviewed annually, that specifies daily treatment, how to recognise worsening asthma, and what to do in an emergency.

Smoking cessation is essential: smoking accelerates the decline in lung function, reduces the effectiveness of ICS, and increases the risk of exacerbations.

Annual influenza vaccination and one-off pneumococcal vaccination are recommended for all adults with asthma.

Regular exercise is beneficial for people with asthma; exercise-induced symptoms can usually be managed with a reliever inhaler taken 10 to 15 minutes before activity.

How to get Pulmicort in the UK

Pulmicort is available on NHS prescription from your GP, asthma nurse, respiratory specialist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Many patients with asthma in England may benefit from a prescription prepayment certificate, which caps costs for those needing multiple items.

Sources

• Pulmicort Turbohaler, Summary of Product Characteristics (EMC)
• Budesonide, British National Formulary (BNF)
• BTS/SIGN British Guideline on the Management of Asthma
• NICE NG80: Asthma, diagnosis, monitoring and chronic asthma management
• Asthma, NHS
• MHRA Yellow Card Scheme