Budesonide isiciler, for inhalation 200 mcg/dose 200 doses

Budesonide Isicheiler is a GKS for inhalation, intranasal and topical use. It has anti-inflammatory, anti-allergic and anti-exudative effect, which when administered by inhalation leads to a reduction of bronchial obstruction.

The mechanism of action consists in inhibition of release of mediators of inflammation and allergy, and reduction of respiratory tract reactivity to their action. During treatment, respiratory function improves, the severity and frequency of dyspnea, attacks of choking, coughing significantly decrease. The maximal clinical effect develops after 1-2 weeks of therapy.

Pharmacokinetics

Inhalation administration penetrates 30-35% of the dose into the bronchioles. The bioavailability upon entry into the lungs is about 73%. 25-30% enter the gastrointestinal tract. Bioavailability by oral route of administration is 10.7%.

The C_max of budesonide in plasma is reached after 1.5-2 hours.

Budesonide is rapidly excreted from the body. T_1/2 when administered by inhalation is 2-3 hours. Plasma clearance is 55-85 l/h.

Indications

Bronchial asthma requiring maintenance therapy with glucocorticoids.

Pharmacological effect

Budesonide Easyhaler – GCS for inhalation, intranasal and local use. It has an anti-inflammatory, anti-allergic and anti-exudative effect, which, when used in inhalation, leads to a reduction 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 airways to their action. During the treatment, respiratory function improves, the severity and frequency of shortness of breath, attacks of suffocation, and cough are significantly reduced. The maximum clinical effect develops after 1-2 weeks of therapy.

Pharmacokinetics

When administered by inhalation, 30-35% of the dose penetrates the bronchioles. Bioavailability when entering the lungs is about 73%. 25-30% enter the gastrointestinal tract. Bioavailability by oral route is 10.7%.

Cmax of budesonide in plasma is achieved after 1.5-2 hours.

Budesonide is quickly eliminated from the body. T1/2 for inhalation administration is 2-3 hours. Plasma clearance – 55-85 l/h.

Special instructions

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

The replacement of systemic corticosteroids with inhalations is carried out gradually.

The effectiveness and safety of budesonide in children under 7 years of age have not been studied.

Impact on the ability to drive vehicles and operate machinery

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

Active ingredient

Budesonide

Composition

1 dose of powder for inhalation contains:

Pregnancy

Use during pregnancy is possible when the expected benefit to the mother outweighs the potential risk to the fetus.

If use is necessary 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

From the respiratory system: when used in inhalation, irritation of the mucous membranes of the pharynx, oral cavity, nose, and candidiasis is possible; with increased sensitivity – bronchospasm.

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, the metabolism of budesonide in the liver may slow down.

Storage conditions

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

Shelf life

3 years.

Manufacturer

Orion Corporation, Finland