PULMICORT 1 mg/2 ml Suspension for Inhalation/Nebulization in Unit-Dose Container 20 Units

VIDAL
Medicines
Update of 31/07/2025

PULMICORT^® suspension for inhalation by nebuliser
budesonide

Forms and presentations

Suspension for inhalation by nebuliser at 0,5 mg/2 ml and at 1 mg/2 ml:  Single-dose containers of 2 ml, box of 20.

Composition

	per container
Budesonide (INN) micronised	0,5 mg
or	1 mg

Excipients (common): disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate, water for injection.

Indications

Pulmicort, suspension for inhalation by nebuliser in single-dose container, is indicated:

• As maintenance treatment of asthma in adults, adolescents and children when pressurised or dry powder inhalers cannot be used or are unsuitable.
  

Dosage and administration

Dosage

The initial dose will be determined according to the severity of asthma before treatment and will then be adjusted according to individual results:

Adult : 0,5 mg to 4 mg per day.

Child : 0,25 mg to 2 mg per day. The dose of 2 mg is reserved for the treatment of severe asthma.

Administrations are usually divided into 2 nebulisation sessions per day. A daily dose of up to 1 mg may be administered in a single nebulisation session per day.

The suspension contained in the single-dose container is sterile. The unused quantity remaining in the opened single-dose container must be discarded.

After several days (or weeks) of initial treatment, when the clinical condition has improved, symptoms have regressed and asthma is controlled, the minimum effective dose should be sought. To this end, the daily dose may be administered as one nebulisation session per day, if this dosing schedule promotes treatment compliance.

In case of destabilisation of asthma, the dose and number of administrations should be increased again.

In children under 5 years presenting with recurrent episodes of bronchial wheezing, administration of inhaled budesonide in a course of 2 to 3 months may be considered in order to determine whether it is asthma. A significant improvement in symptoms under corticosteroid treatment and their reappearance upon discontinuation of treatment should suggest the diagnosis of asthma. Treatment with Pulmicort, nebulisation should be stopped if no clinical benefit is observed within 2-3 months. Unless the diagnosis of asthma is confirmed, budesonide treatment should not be continued for more than 3 months to avoid unjustified prolonged exposure (see Warnings and Precautions for UseAdverse effects).

Cost of daily treatment: 0,85 to 6,83 euro(s) (Pulmicort 0,5 mg/2 ml); 1,21 to 4,84 euro(s) (Pulmicort 1 mg/2 ml).


Method of administration:

This budesonide suspension must be administered by inhalation using a compressed air (or pneumatic) nebulisation device (nebuliser). Ultrasonic generators are not recommended, as they may not be suitable for correct administration of Pulmicort.

Do not inject. Do not swallow.

The Pulmicort suspension is ready to use.

Patients should be informed that they must carefully follow the manufacturer's instructions for the use and maintenance of the nebulisation device.

A filling volume of 2 to 4 ml is suitable for most nebulizers. If necessary, make up to the recommended volume with sterile physiological saline.

The resulting mixture is delivered by an air or oxygen flow (6 to 8 liters per minute) for approximately 10 to 15 minutes, during which the patient breathes at their usual rate.

The technique of use by the patient must be checked regularly.

After inhalation, the unused suspension remaining in the nebulizer chamber must be discarded.

The patient should be advised to rinse their mouth after each nebulisation session in order to reduce the risk of oropharyngeal candidiasis, and to rinse their face with water when using a face mask in order to reduce the risk of local skin irritation on the face.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Warnings and precautions

• Inform the patient that this medicine is not intended to abort an established asthma attack, but is a continuous maintenance treatment of asthma to be continued regularly, daily and at the prescribed doses, and whose effects on asthma symptoms will only be felt after a few days to a few weeks.
  
• If, despite a well-conducted treatment, paroxysmal dyspnea occurs, a fast-acting, short-acting inhaled beta-2 agonist bronchodilator should be used to treat acute symptoms. The patient should be informed and told that an immediate medical consultation is necessary if, in this case, the relief usually obtained is not rapidly observed after inhalation of the beta-2 agonist bronchodilator.
  
• If a patient develops, over a few days, a rapid increase in their consumption of fast-acting, short-acting inhaled beta-2 agonist bronchodilators, a decompensation of their disease and the possibility of progression to severe acute asthma (status asthmaticus) should be feared (especially if peak flow values decrease and/or become irregular). The physician should also inform the patient of the need, in this case, for an immediate consultation. The therapeutic management should then be reassessed.
  
• The patient must be warned that improvement in their clinical condition must not lead to a change in their treatment, in particular stopping inhaled corticosteroid therapy, without medical advice.
  
• In case of bronchial infection or abundant bronchorrhea, appropriate treatment is necessary in order to promote optimal distribution of the product in the airways.
  
• In case of destabilisation of asthma, or insufficient control of asthma exacerbations despite maximum doses of inhaled corticosteroids, a short course of systemic corticosteroid therapy should be considered. It is then necessary to maintain inhaled corticosteroid therapy in association with the systemic treatment.
  
• Inhaled corticosteroid therapy may cause systemic effects, particularly with high-dose or prolonged treatment. The occurrence of these effects with the inhaled route is much less likely than during oral corticosteroid therapy. Possible systemic effects are: Cushing's syndrome or Cushingoid appearance, skin thinning, subcutaneous bruising, adrenal insufficiency, growth retardation in children and adolescents, decreased bone density, cataract and glaucoma and, more rarely, psychological and behavioural disorders including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggressiveness (particularly in children). It is important to always seek the minimum effective dose of inhaled corticosteroids that achieves control of asthma symptoms.
  
• The potential effects on bone mineral density should be kept in mind, particularly in patients receiving high doses of inhaled corticosteroids over the long term and presenting risk factors for osteoporosis. No significant effects on bone mineral density have been demonstrated in long-term clinical studies conducted in children receiving on average 400 µg/day (nominal dose) of budesonide or in adults receiving 800 µg/day (nominal dose) of budesonide. No data are available regarding the effect at higher doses.
  
• Patients who have required high doses of corticosteroids in emergencies or who have received long-term inhaled corticosteroid therapy at the maximum recommended doses may develop adrenal insufficiency. These patients are likely to present signs and symptoms of adrenal insufficiency during situations of severe stress. Signs of acute adrenal insufficiency may be non-specific: anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, loss of consciousness, convulsions, hypotension and hypoglycemia. Supplementary corticosteroid therapy should be considered in situations likely to trigger stress or in cases of scheduled surgery.
  
• Concomitant administration of inhaled corticosteroids in patients on long-term oral corticosteroid therapy (corticosteroid-dependent patients) does not remove the need for necessary precautions when reducing oral corticosteroid doses. These should be reduced very gradually, and withdrawal should be carried out under careful medical supervision (watching for the appearance of signs of acute or subacute adrenal insufficiency), which may persist for a prolonged period after cessation of systemic corticosteroid therapy.
  
• When replacing oral corticosteroid therapy with inhaled corticosteroid therapy, the systemic effect of the corticosteroid is reduced, which may lead to the reappearance of allergic symptoms (such as rhinitis, eczema) and/or rheumatological symptoms (such as muscle and joint pain). A specific treatment should be initiated. Adrenocortical insufficiency should be suspected if, in rare cases, the following symptoms occur: fatigue, headache, nausea and vomiting. A temporary increase in the dose of oral corticosteroids may then sometimes be necessary.
  
• In cases of active or quiescent pulmonary tuberculosis or pulmonary fungal infection, close monitoring and appropriate treatment are essential.
  
• Inhaled corticosteroid therapy may cause oropharyngeal candidiasis, which may require antifungal treatment and discontinuation of inhaled corticosteroid therapy (see also Dosage and administration).
  
• As with other inhaled products, bronchospasm may occur, manifesting as increased wheezing, dyspnoea and cough immediately after taking the medicine. Bronchospasm will be treated with a fast-acting bronchodilator, which must be administered immediately. Treatment with Pulmicort must be stopped immediately and the therapeutic approach will be reassessed to consider, if necessary, therapeutic alternatives.
  
• Visual disturbances may occur during systemic or local corticosteroid therapy. In case of blurred vision or the appearance of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look for, in particular, cataract, glaucoma, or a rarer lesion such as central serous chorioretinopathy, described with the administration of systemic or local corticosteroids.
  
• In case of hepatic impairment, the elimination of corticosteroids is reduced and consequently exposes patients to higher systemic concentrations and an increased risk of systemic effects. Caution is required in cases of hepatic impairment.
  
• Athletes' attention is drawn to the fact that this medicine contains an active substance that may induce a positive result in tests carried out during anti-doping controls.
  

Interactions

Drug interactions

To be taken into account:

• Ketoconazole, itraconazole, voriconazole, ritonavir-boosted protease inhibitors: increase in plasma concentrations of budesonide due to decreased hepatic metabolism by the enzyme inhibitor, with risk of onset of Cushing's syndrome.
  Budesonide is mainly metabolised by cytochrome CYP P450 3A4. A significant increase in blood levels of budesonide may be observed with potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors). Concomitant administration of these medicines should be avoided. If this combination cannot be avoided, a sufficiently long interval must be respected between administration of the CYP3A4 inhibitor and that of budesonide (see Pharmacokinetics).
  

Fertility, pregnancy and breastfeeding

Pregnancy:

Available data on a large number of pregnancies have not revealed an increased teratogenic risk associated with the use of inhaled budesonide. In animals, glucocorticoids induce malformations (see Preclinical safety). However, these observations do not appear relevant to pregnant women at therapeutic doses.

It is important for both the foetus and the mother to maintain adequate asthma treatment during pregnancy.

Pulmicort 0,50 mg/2 ml, suspension for inhalation by nebuliser in single-dose container:

This medicinal product may be prescribed during pregnancy if needed, regardless of the stage of pregnancy.

Pulmicort 1 mg/2 ml, suspension for inhalation by nebuliser in single-dose container:

Budesonide may be administered during pregnancy if the expected benefit to the mother outweighs the risks to the foetus.

Breastfeeding:

Budesonide is excreted in breast milk. However, a pharmacokinetic study showed that after administration of inhaled budesonide at doses of 200 or 400 µg twice daily, systemic exposure to budesonide in breastfed children was negligible. At therapeutic doses, no effect on the breastfed child is expected.

Budesonide may be used during breastfeeding if necessary.

Driving and using machines

Inhaled budesonide has no effect on the ability to drive vehicles and use machines.

Adverse effects

Adverse events attributable to budesonide are presented below by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1 000 and < 1/100), rare (≥ 1/10 000 and < 1/1 000), very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).

Organ class
Frequency	Adverse event
Infections and infestations
Common	Oropharyngeal candidiasis
Immune system disorders
Rare	Immediate and delayed hypersensitivity reactions, such as: skin rash, contact dermatitis, urticaria, angioedema and anaphylactic reaction
Endocrine disorders
Rare	Inhibition of adrenal function, growth retardation *
Eye disorders
Uncommon	Cataract, blurred vision (see Warnings and Precautions for Use)
Unknown	Glaucoma
Psychiatric disorders
Uncommon	Anxiety, depression
Rare	Restlessness, nervousness, behavioural disorders (mainly in children)
Unknown	Sleep disorders, psychomotor hyperactivity, aggressiveness
Nervous system disorders
Uncommon	Tremors
Respiratory, thoracic and mediastinal disorders
Common	Cough, hoarseness of voice, pharyngeal irritation
Rare	Bronchospasm
Skin and subcutaneous tissue disorders
Rare	Ecchymoses
Musculoskeletal and connective tissue disorders
Uncommon	Muscle contractures

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

Use of this medicine at doses far above the recommended doses reflects a worsening of the respiratory condition requiring prompt consultation for therapeutic reassessment.

An acute overdose of inhaled budesonide should not have any clinical impact.

Pharmacodynamics

Pharmacotherapeutic class: Inhaled glucocorticoid antiasthmatic, ATC code: R03BA02 (R: respiratory system).

Budesonide, by inhalation, exerts a marked anti-inflammatory action on the bronchial mucosa.

In adults, the suppressive effect of budesonide on the hypothalamic-pituitary-adrenal axis only occurs at a dose greater than or equal to 1600 µg/24 hours.

Pharmacokinetics

Preclinical safety

In animals, the toxicity of budesonide is related to an exacerbation of the pharmacological glucocorticoid effect.

Malformations were observed in animal reproduction studies with glucocorticoids such as budesonide (cleft palate, skeletal malformation).

However, these experimental findings observed in animals are not extrapolable to humans at the recommended doses.

Storage conditions

To be stored at a temperature not exceeding + 30 °C.

Once the protective sachet has been opened, the single-dose units must be kept protected from light in the sachet and used within 3 months.

As the suspension contained in the unit dose is sterile, any unused quantity remaining in an opened unit dose must be discarded.

Prescription, supply and reimbursement

LIST I

Marketing authorisation (AMM)	3400933727130 (1994, SmPC rev 08.01.2024) 0,5 mg/2 ml.
	3400933735692 (1994, SmPC rev 08.01.2024) 1 mg/2 ml.

Price:	17,08 euros (inhalation suspension at 0,5 mg/2 ml).
	24,20 euros (inhalation suspension at 1 mg/2 ml).
Social security reimbursement at 65% based on the TFR: 17,08 euros (20 single-dose units 0,5 mg/2 ml); 24,20 euros (20 single-dose units 1 mg/2 ml). Collect.

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