Budenit Steri-Neb, 0.5mg/ml ampoules, 1 dose, 2ml, 20pcs

Composition

1 ml contains budesonide 0.5 mg;

excipients:

polysorbate 80;

sodium chloride;

sodium citrate dihydrate;

citric acid monohydrate;

disodium edetate;

water for injection.

Pharmacological action

Budenit Sterib has anti-inflammatory, anti-allergic, and anti-exudative effects.

Indications

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

Use during pregnancy and lactation

The use of budesonide during pregnancy is possible only if the benefit to the mother exceeds the possible risk to the fetus.

If necessary, the drug is used in the minimum effective dose.

There are no data on the excretion of budesonide in breast milk.

Prescribing the drug during lactation is possible only under the supervision of a doctor if the expected benefit to the mother exceeds the possible risk to the child.

Contraindications

• hypersensitivity to budesonide or any other component of Budenit Sterib;
• children (up to 12 months).

With caution:  tuberculosis of the lungs, fungal, bacterial, parasitic and viral infections of the respiratory system, cirrhosis of the liver, pregnancy, lactation.

Composition

Pharmaceutical Interaction:  Budenit Steri-Neb can be mixed with 0.9% sodium chloride solution and other solutions intended for use with nebulizers, such as sterbutalin, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide.

Pharmacological:  budesonide is mainly metabolized by the CYP3A4 isoenzyme. Taking 100 mg ketoconazole 2 times a day increases the plasma concentration of orally administered budesonide 10 mg once by an average of 7.8 times. There is no information about this interaction with inhaled budesonide dosage forms, but a significant increase in the drug’s plasma concentration should be expected, therefore, such inhibitors of the CYP3A4 isoenzyme as ketoconazole and itraconazole may increase the systemic effect of budesonide. Other potent CYP3A4 inhibitors are also likely to significantly increase the concentration of budesonide in plasma.

How to take, course of use and dosage

by inhalation using nebulizer inhalers. Recommended doses of Budenit Steri-Neb in case of initiation of inhaled corticosteroid therapy in severe asthma, as well as against the background of dose reduction or discontinuation of oral corticosteroids, are as follows: :

• Adults (including the elderly) and children over 12 years of age: usually 1-2 mg 2 times a day. The maintenance dose is 0.5-4 mg / day.
• Children from 12 months to 12 years: 0.25-0.5 mg 2 times a day. The maintenance dose is 0.25-2 mg / day.
• The maintenance dose should be selected individually. When a therapeutic effect is achieved, the maintenance dose should be reduced to the lowest effective dose.
• Adults (including the elderly) and children over 12 years of age: 0.5-1 mg 2 times a day.
• Children from 12 months to 12 years: 0.25-0.5 mg 2 times a day.

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

Overdose

In acute overdose with budesonide, clinical manifestations usually do not occur.

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

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

Special instructions

Budenit Steri-Neb is not intended for rapid relief of asthma attacks.

To stop acute bronchospasm, it is recommended to use short-acting inhaled bronchodilators.

Form of production

Suspension for inhalation

Storage conditions

At a temperature not exceeding 25 °C.

Shelf

life is 2 years.

Active ingredient

Budesonide

Conditions of release from pharmacies

By prescription

Dosage form

suspension for inhalation

Description

Nursing mothers as prescribed by a doctor, Adults as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children over 1 year old, Children as prescribed by a doctor

Indications

Chronic obstructive pulmonary disease, Bronchitis, Bronchial asthma