Suspension for nebulization "Budesonide-Intel Neb" contains a potent non-halogenated corticosteroid - budesonide, intended for the treatment of bronchial asthma in patients for whom the use of inhalers with compressed air spraying of medicinal substances or in the form of a dry powder dosage form is ineffective or inappropriate. "Budesonide-Intel Neb" is also recommended for use in infants and children with croup (a complication of an acute viral infection of the upper respiratory tract, also known as laryngotracheobronchitis or subconjunctival laryngitis), which is an indication for hospitalization.
Composition
The active substance is budesonide (0.25 mg/ml). One single-dose container contains 0.5 mg of budesonide.
Excipients: sodium chloride, sodium citrate, disodium edetate, polysorbate 80, citric acid anhydrous, water for injections.
Contraindication
Hypersensitivity to budesonide or any other ingredient of the drug.
Method of application
The dosage of Budesonide-Intel Neb should be adjusted depending on the individual needs of the patient.
The dose administered to the patient depends on the nebulization equipment used. The nebulization time and the dose delivered depend on the flow rate, the volume of the nebulizer chamber and the filling volume. The air flow rate through the device used for nebulization should be 6-8 liters per minute. The appropriate filling volume for most nebulizers is 2-4 ml. The dose should be reduced to the minimum necessary to maintain adequate control of bronchial asthma. The highest dose (2 mg per day) in children under 12 years of age 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 when reducing or stopping oral glucocorticosteroids, the recommended dose is:
Adults (including elderly patients): usually 1-2 mg twice a day (in severe cases, the dose can be further increased); Children over 12 years of age: the dosage is the same as for adults; Children aged 6 months to 12 years - 0.5-1 mg twice a day.
Bronchial asthma (maintenance therapy)
The maintenance dose should be selected individually and should be equal to the lowest dose at which the patient is free of symptoms of the disease.
Adults (including elderly patients) and children over 12 years of age: 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
"Budesonide-Intel Neb" makes it possible to cancel or significantly reduce the dose of glucocorticosteroids for oral use while maintaining control of bronchial asthma. To begin the transition from oral steroids, the patient should be in a relatively stable condition. For about 10 days, a high dose of budesonide in nebules should be used in combination with the dose of steroid used previously. After this, the dose of oral steroids should be gradually reduced to the lowest possible level, for example, by 2.5 mg of prednisolone or equivalent per month. Often, the use of oral steroids can be completely stopped by replacing it with the drug "Budesonide-Intel Neb".
Dosage features
The drug can be mixed with 0.9% saline and with nebulizer solutions containing terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide. The mixture should be used within 30 minutes.
Dosage recommendations:
0.25 - 1 ml; 0.5 - 2 ml; 0.75 - 3 ml; 1.0 - 4 ml; 1.5 - 6 ml; 2.0 - 8 ml.
For patients for whom it is desirable to increase the therapeutic effect, especially patients without a large amount of mucus in the respiratory tract, it is recommended to increase the dose of budesonide instead of combination treatment with oral corticosteroids, which is associated with a lower risk of systemic side effects.
Croup
For children with croup, the usual dose is 2 mg of nebulized budesonide. This dose should be administered as a single dose or as two 1 mg doses 30 minutes apart. The dose may be repeated every 12 hours for a maximum of 36 hours or until clinical improvement.
Method of use
The drug "Budesonide-Intel Neb" should only be used with nebulizers suitable for this purpose.
The container must be detached from the strip, shaken gently and opened by breaking off the tip tab. Carefully squeeze the contents of the container into the nebulizer chamber. Discard the empty container and cover the nebulizer chamber with the cap.
Budesonide-Intel Neb should be administered using a jet nebulizer with a nozzle or a suitable breathing mask. The nebulizer should be connected to an air compressor that provides sufficient air flow (6-8 l/minute), and the fill volume should be 2-4 ml.
Application features
Pregnant women
Budesonide passes into breast milk. However, when using therapeutic doses of budesonide, no effect on the breast-fed child is expected. "Budesonide-Intel Neb" can be used during breastfeeding.
Children
The drug should be used in children according to indications.
Drivers
Budesonide has no or negligible influence on the ability to drive and use machines.
Overdose
Budesonide-Intel Neb contains 0.1 mg/ml disodium edetate, which has been shown to cause bronchoconstriction at levels exceeding 1.2 mg/ml. Acute overdose of budesonide, even at excessive doses, is unlikely to be a clinically significant problem.
Side effects
Infections and infestations: common (≥ 1/100 to < 1/10) - oropharyngeal candidiasis.
On the part of the digestive system: often (from ≥ 1/100 to <1/10) - nausea, mental disorders.
Respiratory, thoracic and mediastinal disorders: common (≥ 1/100 to < 1/10) - cough, hoarseness, throat irritation.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, protected from light and out of the reach of children. Keep containers in an envelope to protect from light.
Shelf life - 3 years.
After opening the envelope, the containers contained therein should be used within 3 months. After this period, the remaining product must be disposed of. The contents of an opened container must be used within 12 hours. After this period, the remaining product must be disposed of.
