Universal reference book for medicines
Product name: BUDENIT STERI-NEB (BUDENIT STERI-NEB)

Active substance: budesonide

Type: GCS for inhalation

Manufacturer: NORTON HEALTHCARE (UK), acting under the trademark IVAX Pharmaceuticals UK (UK) manufactured by IVAX Pharmaceuticals UK (UK)

Suspension for inhalations dosed almost white, finely dispersed, practically odorless.

1 ml

budesonide 250 μg

- "500 μg

Excipients: polysorbate 80 - 0.2 mg, sodium chloride - 8.5 mg, sodium citrate dihydrate - 0.5 mg, citric acid monohydrate - 0.31 mg, disodium edetate - 0.1 mg, water d / and - up to 1 ml.

2 ml - polyethylene ampoules, welded together in the form of a block (5) - foil laminated (4) - packs cardboard.

2 ml - polyethylene ampoules, welded together in the form of a block (5) - foil laminated (12) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

SCS with a pronounced local anti-inflammatory and antiallergic effect.
Budesonide increases the production of lipocortin, an inhibitor of phospholipase A 2 , inhibits the release of arachidonic acid, inhibits the synthesis of leukotrienes and prostaglandins, reduces inflammatory exudation and production of cytokines, inhibits the migration of macrophages, reduces the severity of infiltration and granulation processes, the formation of a chemotaxis substance (which explains the effectiveness of hypersensitivity reactions delayed type), inhibits the release of mast cells from inflammatory mediators (the reaction is hypersensitive ty of immediate type).Budesonide restores the sensitivity of the patient to bronchodilators, allowing to reduce the frequency of their use, reduces edema of the bronchial mucosa, mucus production, sputum formation and reduces airway hyperreactivity. Increases mucociliary transport. Well tolerated with long-term treatment, does not have mineralocorticoid activity.
The time to start the therapeutic effect after inhalation of a single dose of the drug is several hours.
The maximum therapeutic effect is achieved 1-2 weeks after treatment. Budesonide effectively prevents attacks of bronchial asthma of physical stress, but does not arrest an acute attack of bronchospasm.
PHARMACOKINETICS

Suction

After inhalation budesonide is quickly absorbed.
In adults, systemic bioavailability after inhalation of budesonide through the nebulizer is approximately 15% of the total prescribed dose. C max in blood plasma is 3.5 nmol / l and is reached 30 minutes after the start of inhalation.
Distribution

Binding to plasma proteins is 85-90%.
V d - 3 l / kg.
Metabolism

Budesonide undergoes biotransformation involving microsomal liver enzymes, primarily the isoenzyme CYP3A4.
The main metabolites - 6 -? - hydroxybuddesonide and 16 -? - hydroxyprednisolone are practically devoid of biological activity (100 times less than budesonide).
Excretion

It is excreted by the kidneys in the form of metabolites - 70%, through the intestine - 10%.
The systemic clearance of the inhaled drug is 0.5 l / min. The systemic clearance of metabolites is 1.4 l / min. T 1/2 - 2-2.8 hours.
INDICATIONS

- treatment of bronchial asthma (as a basic therapy, with insufficient effectiveness of beta 2 -adrenomimetics, to reduce the dose of oral glucocorticosteroids) in case of ineffectiveness or impossibility of using budesonide in an inhaler injecting the drug into the respiratory tract or inhaler containing the drug in the form of a powder;

- treatment of chronic obstructive pulmonary disease (COPD);

- stenosing laryngotracheitis (false croup).

DOSING MODE

Budenit Steri-Neb is administered by inhalation with nebulizer inhalers.

Recommended doses of the drug in the case of the onset of inhaled GCS therapy in severe bronchial asthma, as well as against a dose reduction or withdrawal of oral GCS for adults (including the elderly) and children over 12 years of age - 1-2 mg 2 times / day, maintenance dose - 0.5-4 mg / day;
for children from 6 months to 12 years - 0.25-0.5 mg 2 times / day, maintaining a dose of 0.25-2 mg / day. In the event that the recommended dose does not exceed 1 mg / day, the entire dose of the drug can be taken at a time (one time).
The maintenance dose should be selected individually.
When the therapeutic effect is achieved, the maintenance dose should be reduced to the lowest dose at which the patient has no symptoms: for adults (including the elderly) and children over 12 years of age - 0.5-1 mg 2 times / day; for children from 6 months to 12 years- 0.25-0.5 mg 2 times / day.
Dose conversion table for patients receiving oral GCS in terms of budesonide.

The dose (mg) of budesonide taken orally Budenit Steri-Neb 0.5 mg / 2 ml (0.25 mg / ml) volume (ml) Budenit Steri-Neb 1 mg / 2 ml (0.5 mg / ml) volume (ml)

0.25 1 -

0.5 2 1

0.75 3 -

1 4 2

1.5 6 3

2 8 4

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

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

Technique of use

Ultrasonic nebulizers are not suitable for use with the drug Budenit Steri-Neb.
The dose required by the patient may vary depending on the nebulizer used. The time of inhalation and the dose of the drug depend on the speed of the air flow, the volume of the nebulizer chamber and the filling volume. Therefore, for inhalation of Budenit Steri-Neb it is necessary to use the appropriate nebulizer, as well as a mouthpiece and a special face mask. The nebulizer must be connected to an air compressor to create an appropriate airflow. Before using the medication, it is necessary to read the instructions of the nebulizer manufacturer.
1. Prepare the nebulizer according to the instructions of its manufacturer.

2. Separate the Steri-Neb (ampoule with sterile solution) from the block, to do this, turn and pull it.

3. Holding the ampoule vertically upside down with a cap, break off the cap.

4. Extract the solution into the nebulizer reservoir.

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

Rinse mouth after inhalation.
If a mask is used, it is necessary to wash the skin of the face.
The solution left unused in the nebulizer chamber should be poured.
Wash the nebulizer thoroughly.
When using the drug, avoid contact with the solution in the eyes.

SIDE EFFECT

Often (? 1/100, <1/10): irritation and dryness of the mucous membrane of the pharynx, candidal stomatitis, hoarseness of the voice, coughing, dryness of the oral mucosa, unpleasant taste sensations.

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

With inhaled treatment of SCS, systemic effects can occur, especially in 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 preparation Budenit Steri-Neb contains 0.1 mg / ml of disodium edetate, which can cause bronchospasm at concentrations above 1.2 mg / ml.

As with other inhalation therapies, paradoxical bronchospasm may occur with a rapid increase in dyspnea after a dose.
In case of a severe reaction, alternative therapy should be prescribed.
In some cases, irritation of the facial skin occurs when using a nebulizer with a mask.
To prevent irritation after applying the mask, the face skin should be rinsed with water.
CONTRAINDICATIONS

- age up to 6 months;

- Hypersensitivity to the components of the drug.

With caution should prescribe the drug for pulmonary tuberculosis, fungal, bacterial, parasitic and viral infections of the respiratory system, liver cirrhosis, pregnancy, lactation.

PREGNANCY AND LACTATION

The use of budesonide in pregnancy is possible only if the benefit to the mother exceeds the possible risk to the fetus.
If necessary, use the drug in the lowest effective dose.
Data on the isolation of budesonide with breast milk are absent.
The purpose of the drug during lactation is possible only under the supervision of a doctor in the case when the expected benefit for the mother exceeds the possible risk for the child.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for cirrhosis.

APPLICATION FOR CHILDREN

Contraindicated in children under the age of 6 months.

SPECIAL INSTRUCTIONS

The drug Budenit Steri-Neb is not intended for the rapid removal of asthma attacks, for the relief of acute bronchospasm it is recommended to use short-acting inhaled bronchodilators.

Patients who do not receive SCS

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

Before transferring the patient from oral GCS to treatment with Budenit Steri-Neb, the patient's condition should be relatively stable.
Then 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 GCS should be gradually reduced (for example, 2.5 mg prednisolone or its equivalent every month) as far as possible to the lowest level. In most cases, oral GCS can be completely replaced by the preparation Budenit Steri-Neb.
Sometimes during the transfer from treatment with SCS for oral administration for treatment with the drug Budenit Steri-Neb, symptoms that were previously blocked by systemic drugs such as rhinitis, eczema, muscle and joint pain are observed.
The occurrence of such symptoms as fatigue, headache, nausea and vomiting, may indicate the development of systemic failure of GCS. In such cases, it may even be necessary to temporarily increase the dose of oral GCS.
The systemic side effect of inhaled glucocorticosteroids may be manifested, first of all, with the administration of high doses for an extended period of time.
The likelihood of this effect is significantly lower than when treated with 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 glucocorticosteroids to the lowest dose at which effective control of the disease remains. It is recommended to regularly monitor the growth in children receiving inhaled glucocorticosteroids for an extended period of time. In the case of growth retardation, treatment should be adjusted to reduce the dose of GCS for inhalation to the lowest dose at which effective control of bronchial asthma remains.
Oral administration of ketoconazole and itraconazole or other inhibitors of the CYP3A4 isoenzyme causes an increase in the systemic effect of budesonide.
Therefore, in case of need of joint application it is necessary to take them with the maximum interval. One should also consider the possibility of reducing the dose of budesonide.
To minimize the risk of fungal stomatitis, the patient and / or the child's parents should be informed of the need to rinse the mouth with water after each inhalation of the drug.

Impact on the ability to drive vehicles and manage mechanisms

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

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

Treatment: cancellation of the drug, inhalation of short-acting bronchodilators.

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

DRUG INTERACTION

The metabolism of budesonide is mainly carried out with the participation of the CYP3A4 isoenzyme.
Admission ketoconazole at a dose of 100 mg 2 times / day increases the concentration in the plasma of orally administered budesonide at a dose of 10 mg once, on average, 7.8 times. There is no information on such interaction with inhaled dosage forms of budesonide, but a noticeable increase in plasma concentration in the plasma should be expected, therefore, such inhibitors of the CYP3A4 isoenzyme as ketoconazole and itraconazole may increase the systemic effect of budesonide. Other potent inhibitors of CYP3A4 probably also can significantly increase the concentration of budesonide in plasma.
Preliminary inhalation of beta-adrenomimetics expands bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.

Phenobarbital, phenytoin, rifampicin decrease efficiency (induction of microsomal liver enzymes).

Methandienone, estrogens strengthen the action of budesonide.

Pharmaceutical interaction

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

BUDN-RU-00081-DOK

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.

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