Budenite Steri-Neb - Instructions For Use For Inhalation, Reviews, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Budenite Steri-Neb

Budenite Steri-Neb: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Budenit Steri-Neb

ATX code: R03BA02

Active ingredient: budesonide (budesonide)

Producer: IVAX Pharmaceuticals UK Limited (Great Britain)

Description and photo update: 2019-10-09

Prices in pharmacies: from 399 rubles.

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Budenite Steri-Neb is a glucocorticosteroid preparation for inhalation of anti-inflammatory, anti-exudative and anti-allergic action.

Release form and composition

The drug is produced in the form of a metered suspension for inhalation: finely dispersed, almost white, practically odorless (2 ml each in polyethylene ampoules, soldered together in the form of a block, 5 sealed ampoules each in laminated foil, in a cardboard box of 4 or 12 blocks and instructions for use of Budenite Steri-Neb).

Composition for 1 ml of suspension:

• active substance: budesonide - 250 mcg or 500 mcg;
• auxiliary components: sodium chloride, citric acid monohydrate, polysorbate 80, disodium edetate, sodium citrate dihydrate, water for injection.

Pharmacological properties

Pharmacodynamics

Budesonide - the active substance of Budenite Steri-Neb, is a glucocorticosteroid that has a pronounced local anti-inflammatory and anti-allergic effect.

The main effects of budesonide:

• increased production of lipocortin, which is an inhibitor of phospholipase A ₂;
• inhibition of the release of arachidonic acid;
• inhibition of the synthesis of prostaglandins and leukotrienes;
• reduction of inflammatory exudation and cytokine production;
• inhibition of macrophage migration;
• decrease in the severity of the processes of infiltration and granulation;
• inhibition of the release of inflammatory mediators from mast cells (immediate-type hypersensitivity reaction);
• the formation of a chemotaxis substance (this explains the effectiveness of Budenite Steri-Neb in delayed-type hypersensitivity reactions);
• restoration of the patient's sensitivity to bronchodilators, which reduces the frequency of their use;
• reduction of edema of the bronchial mucosa, mucus production, sputum formation;
• reduction of airway hyperresponsiveness;
• increased mucociliary transport.

With long-term treatment, budesonide is well tolerated and has no mineralocorticoid activity.

After inhalation of one dose of the drug, the onset of the therapeutic effect is noted in a few hours. The therapeutic effect reaches its maximum in 1–2 weeks.

Budesonide effectively prevents the appearance of attacks of bronchial asthma of physical exertion, but it does not stop an acute attack of bronchospasm.

Pharmacokinetics

Budesonide is rapidly absorbed after inhalation. In adults, the systemic bioavailability after administration of the substance through a nebulizer is approximately 15% of the total prescribed dose. The maximum plasma concentration in the blood is 3.5 nmol / l, the time to reach it is 30 minutes after the start of inhalation.

The substance binds to plasma proteins at a level of 85–90%. The volume of distribution is 3 l / kg.

Biotransformation of budesonide occurs in the liver with the participation of microsomal enzymes, mainly the isoenzyme CYP3A4. The main metabolites are 16-α-hydroxyprednisolone and 6-β-hydroxybudesonide. They are practically devoid of biological activity (in comparison with budesonide, 100 times less).

It is excreted in the form of metabolites: by the kidneys - 70%, through the intestines - 10%. The systemic clearance of inhaled budesonide and metabolites is 0.5 and 1.4 l / min, respectively. The half-life is 2-2.8 hours.

Indications for use

• bronchial asthma: as a basic therapy, to reduce the dose of oral glucocorticosteroids, in case of insufficient effectiveness of beta ₂ -adrenomimetics (Budenit Steri-Neb is used if it is impossible or ineffective to use budesonide in an inhaler that contains the drug in powder form, or an inhaler that pumps the drug into the respiratory tract);
• stenosing laryngotracheitis;
• chronic obstructive pulmonary disease.

Contraindications

Absolute:

• children up to 6 months old;
• hypersensitivity to certain ingredients of the drug.

Relative (Budenite Steri-Neb for inhalation is used with caution):

• pulmonary tuberculosis;
• cirrhosis of the liver;
• viral, bacterial, fungal and parasitic infections;
• the period of pregnancy and breastfeeding.

Budenite Steri-Neb, instructions for use: method and dosage

Budenite Steri-Neb is used by inhalation. Inhalations are carried out using special nebulizer inhalers.

In case of severe bronchial asthma, as well as against the background of a dose reduction or cancellation of oral glucocorticosteroids, Budenit Steri-Neb is prescribed in the following doses:

• children over 12 years old and adults (including elderly patients): the initial dose is 1-2 mg twice a day, the maintenance dose is 0.5-4 mg per day;
• children aged 6 months to 12 years: the initial dose is 0.25–0.5 mg twice a day, the maintenance dose is 0.25–2 mg per day.

If the daily dose of the drug does not exceed 1 mg, it can be taken once.

The maintenance dose is selected individually. When the desired effect is achieved, it is necessary to reduce the maintenance dose to the lowest effective dose at which there are no symptoms of the disease. For adults and adolescents over 12 years of age, the lowest effective dose is 0.5-1 mg twice a day, for children aged 6 months to 12 years - 0.25-0.5 mg twice a day.

In cases where it is required to increase the therapeutic effect, it is recommended to increase the dose of Budenite Steri-Neb, and not to combine the intake of inhaled and oral glucocorticosteroids, as this reduces the risk of developing systemic side effects of budesonide.

With stenosing laryngotracheitis, Budenite Steri-Neb is prescribed to children over 6 months of age at a dose of 2 mg per day at a time or 1 mg in two divided doses with an interval of 30 minutes.

Budenite Steri-Neb should not be administered using ultrasonic nebulizers. The required dose of inhaled glucocorticosteroid and the time of inhalation may vary, depending on the type of nebulizer used (chamber volume, filling volume, air flow rate). For inhalation of the drug, use an appropriate nebulizer, mouthpiece and face mask. The required air flow is generated by an air compressor to which a nebulizer is connected. Before use, you must read the instructions for a specific nebulizer model.

Inhalation procedure:

1. Prepare the nebulizer for operation following the manufacturer's instructions.
2. Separate the ampoule with sterile solution from the common block for 5 ampoules.
3. Break off the cap while holding the ampoule in an upright position with the cap facing up.
4. Squeeze the contents of the ampoule into the nebulizer chamber.
5. Inhale according to the manufacturer's instructions for the nebulizer.

After the end of inhalation, rinse your mouth with water, and if a mask was used, then rinse your face with water. Discard the unused solution remaining in the nebulizer chamber. Rinse the nebulizer.

During inhalation, avoid contact with the eyes.

Side effects

Budenite Steri-Neb can cause the following side effects:

• often: dryness of the oral mucosa, hoarseness of voice, dryness and irritation of the pharyngeal mucosa, unpleasant taste sensations, candidal stomatitis, cough;
• rarely: nausea, thinning of the skin or the appearance of bruising, esophageal candidiasis, urticaria, rash, bronchospasm, contact dermatitis, angioedema, headache, depression, irritability, behavioral disturbances, nervousness.

With long-term treatment with large doses, systemic side effects (cataracts, glaucoma, adrenal gland suppression, decreased bone mineral density, growth retardation in adolescents and children) may occur, but the likelihood of their development is much lower than with the use of oral glucocorticosteroids.

Budenite Steri-Neb contains disodium edetate in an amount of 0.1 mg / ml. If the concentration of disodium edetate is more than 1.2 mg / ml, bronchospasm may develop.

Inhalation therapy can cause paradoxical bronchospasm and increased shortness of breath after administration of the drug. If the reaction is severe, alternative treatment should be given.

When using a nebulizer with a mask, irritation of the skin of the face sometimes occurs, therefore, after the inhalation procedure, it is necessary to rinse the skin of the face with water.

Overdose

Clinical manifestations in acute overdose are usually not observed.

Therapy: cancellation of Budenita Steri-Neb, inhalation of short-acting bronchodilators.

In the case of prolonged use in excess of the recommended doses, it is possible to develop a systemic glucocorticoid effect, manifested as hypercortisolism and suppression of adrenal function.

special instructions

Budenite Steri-Neb is not intended to relieve attacks of bronchial asthma. To relieve acute bronchospasm, it is recommended to use short-acting inhaled bronchodilator drugs.

In patients who do not receive glucocorticosteroids, the therapeutic effect of Budenit Steri-Neb for inhalation occurs within 10 days. In case of excessive secretion of mucus in the bronchi, it is first recommended to undergo a 2-week additional treatment with oral glucocorticosteroids. After a course of oral treatment, in most cases, it is possible to completely avoid taking glucocorticosteroids inside.

When transferring a patient from therapy with oral glucocorticosteroids to inhaled budesonide treatment, the patient's condition should be relatively stable. For about 10 days, Budenite Steri-Neb is used in combination with oral glucocorticosteroids in usual doses, then their dose is gradually reduced to the lowest. In most cases, a complete replacement with an inhaled glucocorticosteroid is possible.

When symptoms of systemic insufficiency of glucocorticosteroids occur (nausea, vomiting, headache, fatigue), a temporary increase in the dose of oral glucocorticosteroid is sometimes required.

In children who have been receiving Budenite Steri-Neb for a long time, it is recommended to monitor growth indicators. With growth retardation, the dose of the drug is adjusted to the lowest, at which effective asthma control is observed.

Rinsing your mouth with water after each inhalation reduces the likelihood of developing fungal stomatitis.

Influence on the ability to drive vehicles and complex mechanisms

Budenit Steri-Neb does not affect the patient's ability to drive vehicles and work with potentially hazardous equipment, however, with the development of rare side effects from the nervous system, it is recommended to be careful when performing such work.

Application during pregnancy and lactation

Budenite Steri-Neb during pregnancy / lactation can only be used if the expected benefit is higher than the possible risk. The drug should be administered at the lowest effective dose.

Childhood use

Use in patients under 6 months of age is contraindicated.

For violations of liver function

With cirrhosis of the liver, Budenite Steri-Neb is prescribed with caution.

Drug interactions

Itraconazole, ketoconazole and other inhibitors of the CYP3A4 isoenzyme can increase the plasma concentration of budesonide (there is no information on this interaction with inhalation).

Inhalation beta-adrenomimetics expand the bronchi and improve the flow of Budenite Steri-Neb into the respiratory tract, which leads to an increase in the therapeutic effect of the drug.

Estrogens and methandienone increase the effect of budesonide, while rifampicin, phenobarbital, and phenytoin decrease its effectiveness.

The drug can be mixed with isotonic sodium chloride solution and other solutions administered using nebulizers (salbutamol, acetylcysteine, terbutaline, ipratropium bromide, fenoterol and sodium cromoglycate).

Analogs

The analogues of Budenite Steri-Neb are: Apulein, Buderin, Budesonide, Budiair, Budenofalk, Benarin, Benacort, Budecort, Gorakort, Tafen Nazal, Pulmicort, Cybutol Cyclocaps.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Budenite Steri-Neb

Reviews about Budenite Steri-Neb are mostly positive. It is noted that the drug has a quick therapeutic effect and has a convenient dosage. The cost is estimated from affordable to high.

Price for Budenite Steri-Neb in pharmacies

The approximate price of Budenite Steri-Neb is (20 or 60 ampoules of 2 ml): 0.25 mg / ml - 679 or 1528 rubles, 0.5 mg / ml - 939 or 2281 rubles.

Budenite Steri-Neb: prices in online pharmacies

Drug name Price Pharmacy

Budenite Steri-Neb 0.25 mg / ml suspension for inhalations dosed 2 ml 20 pcs. 399 RUB Buy

Budenite Steri-Neb suspension for in. dosage. 0.25mg / ml 2ml 20 pcs. 738 RUB Buy

Budenite Steri-Neb 0.5 mg / ml suspension for inhalation dosed 2 ml 20 pcs. 890 RUB Buy

Budenite Steri-Neb suspension for in. dosage. 0.5mg / ml 2ml 20 pcs. 1035 RUB Buy

Budenite Steri-Neb 0.25 mg / ml suspension for inhalations dosed 2 ml 60 pcs. 1249 RUB Buy

Budenite Steri-Neb suspension for in. dosage. 0.25mg / ml 2ml 60 pcs. 1436 RUB Buy

Budenite Steri-Neb 0.5 mg / ml suspension for inhalations dosed 2 ml 60 pcs. 2040 RUB Buy

Budenite Steri-Neb suspension for in. dosage. 0.5mg / ml 2ml 60 pcs. 2303 RUB Buy

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes and does not replace the official instructions. Self-medication is hazardous to health!