Budesonide Easyhaler, inhalation powder 200 µg/dose, 200 doses

Composition

1 dose of powder for inhalation contains: Active ingredient: budezonide 200 mcg.

Pharmacological action

Budesonide Izihaler is a corticosteroid for inhalation, intranasal and topical use. It has an anti-inflammatory, anti-allergic and anti-exudative effect, which, when inhaled, leads to a decrease in bronchial obstruction.

The mechanism of action is to inhibit the release of inflammatory and allergic mediators, as well as to reduce the reactivity of the respiratory tract to their action. During treatment, the respiratory function improves, the severity and frequency of shortness of breath, suffocation attacks, and coughing significantly decreases. The maximum clinical effect develops after 1-2 weeks of therapy.

Pharmacokinetics

When inhaled,30-35% of the dose penetrates the bronchioles. Bioavailability at entry into the lungs is about 73%.25-30% enter the gastrointestinal tract. Oral bioavailability is 10.7%.

_Cmax of budesonide in plasma is reached in 1.5-2 hours.

Budesonide is rapidly eliminated from the body. T_1/2 for inhalation use is 2-3 hours. Plasma clearance is 55-85 l/h.

Indications

Bronchial asthma requiring maintenance therapy with glucocorticoids.

Use during pregnancy and lactation

Use during pregnancy is possible when the intended benefit to the mother exceeds the potential risk to the fetus.

If necessary, use during lactation, breastfeeding should be discontinued, due to the lack of data on the excretion of budesonide in breast milk.

Contraindications

Hypersensitivity to budesonide.

Side effects

Respiratory system disorders:  when inhaled, irritation of the mucous membranes of the pharynx, mouth, nose, candidiasis is possible; with hypersensitivity, bronchospasm is possible.

Interaction

Cimetidine and omeprazole do not have a clinically significant effect on the pharmacokinetic parameters of budesonide when taken orally. However, under the influence of cimetidine, it is possible to slow down the metabolism of budesonide in the liver.

How to take, course of use and dosage

When inhaled, the dose is set depending on the indications, age, and method of inhalation.

Special instructions

Use with caution in patients with pulmonary tuberculosis, as well as in chickenpox. Budesonide is not intended for the relief of acute attacks of suffocation in bronchial asthma. It is not recommended for use in the intermittent course of the disease.

Replacement of systemic corticosteroids by inhalation is carried out gradually.

The efficacy and safety of budesonide in children under 7 years of age has not been studied.

Influence on the ability to drive motor vehicles and manage mechanisms

Budesonide does not affect the ability to engage in potentially dangerous activities that require increased attention and high speed of psychomotor reactions.

Product form

Metered dose powder for inhalation

Storage conditions

In a dry place, at a temperature not exceeding 30 °C.

Shelf

life is 3 years.

Active ingredient

Budesonide

Conditions of release from pharmacies

By prescription

Dosage form

powder for inhalation

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children over 16 years of age

Indications

Chronic obstructive pulmonary disease, Bronchial asthma