Suspension for nebulization "Pulmicort" contains a powerful non-halogenated corticosteroid - budesonide, intended for the treatment of bronchial asthma in patients for whom the use of inhalers with spraying of medicinal substances with compressed air or in the form of a dosage form of a dry powder is ineffective or impractical. The preparation is also recommended for infants and children with croup (complications of acute viral upper respiratory tract infection, also known as laryngotracheobronchitis or subglottic laryngitis), which is an indication for hospitalization.
The active ingredient is budesonide (1 ml of spray suspension contains 0.25 mg of budesonide).
Excipients: sodium chloride, sodium citrate, disodium edetate, polysorbate 80, anhydrous citric acid, water for injection.
Hypersensitivity to budesonide or to any other ingredient in the preparation.
The dosage of the preparation "Pulmicort" must be adjusted depending on the individual needs of the patient.
The dose to be administered to the patient depends on the nebulization equipment used. Nebulization time and dose delivered depend on flow rate, nebulizer chamber volume and fill volume. The air flow rate through the device used for spraying should be 6-8 liters per minute. The appropriate fill volume for most nebulizers is 2-4 ml. The dosage of the preparation "Pulmicort" must be adjusted depending on the individual needs of the patient. The dose should be reduced to the minimum necessary to maintain proper control of bronchial asthma. The highest dose (2 mg per day) for children under 12 years old should be prescribed only in case of severe asthma and for a limited period of time.
Bronchial asthma
Initiation of therapy. At the beginning of treatment, during periods of exacerbation of bronchial asthma and with a decrease or discontinuation of glucocorticosteroid intake, the recommended dose of Pulmicort is:
adults (including elderly patients) - usually 1-2 mg twice a day (in severe cases, the dose can be further increased);
children over the age of 12 years - the dosage is the same as for adults;
children aged 6 months to 12 years old - 0.5-1 mg twice a day.
Supportive therapy. The maintenance dose should be selected individually and equal to the lowest dose at which the patient is asymptomatic.
adults (including elderly patients) and children over 12 years old - 0.5-1 mg twice a day;
children aged 6 months to 12 years - 0.25-0.5 mg twice a day.
Patients taking oral glucocorticosteroids as maintenance therapy
The preparation "Pulmicort" makes it possible to cancel or significantly reduce the dose of glucocorticosteroids for oral administration while maintaining control of bronchial asthma. To begin switching from oral steroids, the patient must be in a relatively stable condition. For about 10 days, a high dose of Pulmicort is used in combination with the previously used steroid dose. Thereafter, the dose of oral steroids should be gradually reduced to the lowest possible level, such as 2.5 mg prednisolone or equivalent per month. Often the use of an oral steroid can be completely discontinued by replacing it with Pulmicort.
Pulmicort can be mixed with 0.9% saline and spray solutions that contain terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglicate or ipratropium bromide. The mixture should be used within 30 minutes.
0.25 mg: the volume of the preparation is 1 ml;
0.5 mg: the volume of the preparation is 2 ml;
0.75 mg: the volume of the preparation is 3 ml;
1.0 mg: the volume of the preparation is 4 ml;
1.5 mg: the volume of the preparation is 6 ml;
2.0 mg: the volume of the preparation is 8 ml.
For patients for whom it is desirable to increase the therapeutic effect, especially patients without a large amount of mucus in the airways, it is recommended to increase the dose of Pulmicort instead of combined treatment with oral corticosteroids, which is associated with a lower risk of systemic side effects.
For children with croup, the usual dose is 2 mg of nebulized budesonide. This dose is used in one dose or twice, one mg at intervals of 30 minutes. The administration of the preparation can be repeated every 12 hours, up to a maximum of 36 hours, or until clinical improvement.
"Pulmicort" is used only with suitable nebulizers.
The container must be disconnected from the strip, gently shaken and opened by breaking off the tip of the tip. The contents of the container are gently squeezed into the nebulizer chamber. The empty container is discarded and the nebulizer chamber is covered with a lid.
Pulmicort should be administered using a jet nebulizer with a nozzle or an appropriate breathing mask. The nebulizer should be connected to an air compressor to ensure sufficient air flow (6-8 L / minute) and the filling volume should be 2-4 ml.
Pregnant
The results of a large prospective epidemiological study and the experience of international use of the preparation in the post-registration period indicate that treatment with inhaled budesonide during pregnancy did not lead to undesirable effects on the health of the fetus / newborn. Administration of budesonide during pregnancy requires careful weighing of the benefits to the woman versus the risks to the fetus. Inhaled glucocorticosteroids should be preferred over oral glucocorticosteroids, given the lower severity of systemic effects when used in doses necessary to achieve the same respiratory response.
Budesonide passes into breast milk. However, when using therapeutic doses of the preparation "Pulmicort", no effect is expected on a child who is breastfeeding. Pulmicort can be used during breastfeeding.
Children
The preparation "Pulmicort" is prescribed to children according to indications.
Drivers
The preparation does not affect or has a slight effect on the ability to drive vehicles and work with other mechanisms.
Pulmicort contains 0.1 mg / ml sodium edetate, which has been shown to cause bronchoconstriction if its level exceeds 1.2 mg / ml. Acute overdose of the preparation "Pulmicort", even with the use of excessive doses, most likely, will not present a clinically significant problem.
Infections and invasions: often (from ≥ 1/100 to <1/10) - oropharyngeal candidiasis.
Respiratory, thoracic and mediastinal disorders: often (from ≥ 1/100 to <1/10) - cough, hoarseness, throat irritation.
Store at a temperature not exceeding 30 ° C, out of the reach of children. Do not freeze. Containers should be stored upright. Store containers in an envelope to protect from light.
Shelf life is 2 years.
After opening the envelope, the containers it contains should be used within 3 months. If only 1 ml of the suspension is used, the remainder of the suspension is not sterile.
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