BUDENTE STERI NEB AMPOULES 0.5 MG/ML 2 ML

Indications

- treatment of bronchial asthma (as basic therapy; with insufficient efficacy of beta2-adrenomimetics; to reduce the dose of oral GCS) in case of inefficiency or inability to use Budesonide in the inhaler forcing the drug into the respiratory tract, or inhaler containing the drug in powder form;

- treatment of chronic obstructive pulmonary disease (COPD);

- stenosing laryngotracheitis (false croup).

Dosage and administration

Budenit Steri Neb is administered by inhalation using nebulizer inhalers.

The recommended doses of Budenit Steri Neb in the case of the start of inhaled GCS therapy for severe bronchial asthma, as well as on the background of dose reduction or discontinuation of oral GCS for adults (including the elderly) and children over 12 years old - 1-2 mg 2 times / day, maintenance dose - 0.5-4 mg / day; for children from 6 months to 12 years old - 0.25-0.5 mg 2 times / day, maintenance dose - 0.25-2 mg / day. In the event that the recommended dose does not exceed 1 mg / day, the entire dose of Budenit Steri Neb can be taken at one time (at a time).

Maintenance dose of Budenit Steri Neb is to be selected individually. When a therapeutic effect is achieved, the maintenance dose of Budenit Steri Neb is to be reduced to the lowest dose.wherein the patient has no symptoms of the disease: for adults (including the elderly) and children over 12 years old - 0.5-1 mg 2 times / day; for children from 6 months to 12 years old - 0.25-0.5 mg 2 times / day.

Table of recalculation of doses for patients receiving oral GCS in terms of budesonide.

If it is necessary to achieve an additional therapeutic effect, an increase in the dose of Budenit Steri Neb can be recommended instead of a combination with oral GCS (to reduce the risk of systemic effects).

When stenosing laryngotracheitis (false croup) for children aged 6 months and older, the recommended dose is 2 mg / day at a time or in 2 doses of 1 mg with an interval of 30 minutes.

Technique of using the drug Budenit Steri Neb

Ultrasonic nebulizers are not suitable for use with Budenit Steri Neby. The patient's dose of Budenit Steri Neb may vary depending on the nebulizer used. The time of inhalation and the dose of Budenit Steri Neb are dependent on the speed of the air flow, the volume of the nebulizer chamber and the volume of the filling. Therefore, for inhalation of the drug Budenit Steri Neb need to use the appropriate nebulizer, as well as a mouthpiece and a special mask for the face. The nebulizer must be connected to the air compressor to create the appropriate air flow. Before using the drug Budenit Steri Neb must read the instructions of the manufacturer of the nebulizer.

one.Prepare a nebulizer according to the manufacturer's instructions.

2. Separate Budenit Steri Neb (ampoule with a sterile solution) from the unit, for this, turn and pull it.

3. Holding the ampoule of Budenit Steri Heaven drug vertically upside down with a cap, break off the cap.

4. Squeeze the solution into the nebulizer tank.

5. Use the nebulizer according to the manufacturer's instructions.

Rinse mouth after inhalation. If a mask was used, wash the skin of the face.

The solution remaining unused in the nebulizer chamber should be poured. Thoroughly wash the nebulizer.

When using the drug Budenit Steri Neb, avoid contact with the solution in the eyes.

Side effect of the drug Budenit Steri Neb

Often (≥1 / 100, <1/10): irritation and dryness of the pharyngeal mucosa, candidal stomatitis, hoarseness, cough, dryness of the oral mucosa, unpleasant taste sensations.

Rarely (≥1 / 10,000, <1/1000): nervousness, excitability, depression, behavioral disturbances, immediate and delayed type hypersensitivity reactions (including rash, contact dermatitis, urticaria, angioedema and bronchospasm), the appearance of skin bruising or thinning of the skin, headache, nausea, esophageal candidiasis.

With inhalation treatment of corticosteroids, systemic effects may occur, especially with long-term treatment with high doses. The probability of occurrence of such effects is much less than in the treatment of GCS for oral administration.Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, reduced bone mineral density, cataracts, and glaucoma.

The drug Budenit Steri Neb contains 0.1 mg / ml disodium edetate, which can cause bronchospasm at concentrations above 1.2 mg / ml.

As in the case of other inhalation therapy, paradoxical bronchospasm may occur with a rapid increase in shortness of breath after a dose. In the event of a severe reaction, it is necessary to prescribe an alternative therapy.

In some cases, skin irritation occurs when using a mask nebulizer. To prevent irritation after applying the mask, the skin of the face should be washed with water.

Contraindications Budenit Steri Neb

- age up to 6 months;

- Hypersensitivity to the components of the drug Budenit Steri Neb.

Precautions should be prescribed the drug Budenit Steri Neb with pulmonary tuberculosis, fungal, bacterial, parasitic and viral infections of the respiratory system, liver cirrhosis, pregnancy, during lactation.

The use of the drug Budenit Steri Neb during pregnancy and breastfeeding

The use of budesonide during pregnancy is possible only if the benefit to the mother outweighs the possible risk to the fetus. If necessary, use the drug Budenit Steri Neb is used in the minimum effective dose.

Data on the allocation of budesonide with breast milk are not available.Prescription of the drug Budenit Steri Neb in the period of lactation is possible only under the supervision of a doctor in the case when the expected benefit to the mother outweighs the possible risk to the child.

Application for violations of the liver

Precautions should be prescribed the drug Budenit Steri Neb with cirrhosis of the liver.

Use in children

Use in children under 6 months is contraindicated.

Special notes

The drug Budenit Steri Neb is not intended for quick relief of asthma attacks, it is recommended to use short-acting inhaled bronchodilator for relieving acute bronchospasm.

Patients not receiving SCS

Usually, the therapeutic effect occurs within 10 days. In patients with excessive secretion of mucus in the bronchi, a short (about 2 weeks) additional treatment with oral GCS can initially be performed. After a course of oral therapy, in many cases it is possible to completely refuse to take GCS orally.

Patients who are on the treatment of SCS

Before transferring a patient from treatment with oral corticosteroids for the treatment with Budenit Steri Neb, the patient's condition should be relatively stable. After that, the drug Budenit Steri Neb is used in combination with the previously used dose of GCS for oral administration, for about 10 days. Subsequently, the dose of oral corticosteroids should be gradually reduced (for example, by 2.5 mg of prednisone or its equivalent each month) as far as possible to the lowest level. In most cases, oral GCS can be completely replaced by Budenit Steri Neb.

Sometimes, during the transition from treatment of GCS for oral administration to the drug Budenit Steri Neb, symptoms are observed that were previously relieved by systemic drugs: for example, rhinitis, eczema, muscle and joint pain. The occurrence of symptoms such as fatigue, headache, nausea and vomiting, may indicate the development of systemic deficiency of GCS. In such cases, it may even be necessary to temporarily increase the dose of oral GCS.

Systemic side effects of inhaled corticosteroids can manifest, above all, with the introduction of high doses over an extended period of time. The likelihood of this effect is significantly less than in the treatment of oral GCS. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, reduced bone mineral density, cataracts, and glaucoma. Therefore, it is very important to titrate the dose of inhaled corticosteroids to the lowest dose, which maintains effective disease control. It is recommended to regularly monitor growth in children receiving inhaled GCS for a long period of time. If growth is delayed, treatment should be adjusted to reduce the dose of GCS for inhalation to the lowest dose, at which effective control of bronchial asthma is maintained.

Oral administration of Ketoconazole and itraconazole or other inhibitors of the isoenzyme CYP3A4 causes an increase in systemic exposure to budesonide.Therefore, if necessary, the joint use should be taken at the maximum interval. The possibility of reducing the dose of budesonide should also be considered.

To minimize the risk of fungal stomatitis, inform the patient and / or parents of the child about the need to rinse your mouth with water after each inhalation of the Budenit Steri Neb.

Influence on ability to drive motor transport and control mechanisms

The drug Budenit Steri Neb does not adversely affect the ability to drive a vehicle and work with equipment. In the case of the development of rare adverse reactions from the nervous system, it is necessary to avoid activities that require the speed of psychomotor reactions.

Overdose

With acute overdose of budesonide, clinical manifestations usually do not occur.

Treatment: the abolition of the drug Budenit Steri Neb, inhalation of short-acting bronchodilators.

With prolonged use in doses exceeding the recommended, the systemic glucocorticoid effect may develop in the form of hypercorticism and suppression of adrenal function.

Drug interaction

Metabolism of budesonide is mainly carried out with the participation of the isoenzyme CYP3A4. Reception of ketoconazole at a dose of 100 mg 2 times / day increases the plasma concentration of orally taken budesonide at a dose of 10 mg once an average of 7.8 times. Information about such interaction with inhaled dosage forms of budesonide is not available, however, a significant increase in plasma concentration should be expected, thereforeCYP3A4 isoenzyme inhibitors such as ketoconazole and itraconazole may increase the systemic effects of budesonide. Other potent CYP3A4 inhibitors are also likely to significantly increase plasma concentration of budesonide.

Pre-inhalation of beta-adrenomimetics expands the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.

Phenobarbital, phenytoin, rifampicin reduce efficacy (induction of microsomal liver enzymes).

Methandienone, estrogen enhances the effect of budesonide.

Pharmaceutical Interaction

Budenit Steri Neb can be mixed with 0.9% sodium chloride solution and other solutions designed for use with nebulizers, for example, with terbutaline, Salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide.

Terms and conditions of storage

The drug Budenit Steri Neb should be kept out of the reach of children at a temperature not exceeding 25 ° C.