Pulmicort inhalation suspension 0.5mg/ml 1 dose 2ml, 20pcs

Composition

Active ingredient:

budesonide (micronized) 0.5 mg;

Auxiliary substances:

sodium chloride-8.5 mg;

sodium citrate-0.5 mg;

disodium edetate (sodium salt of ethylenediaminetetraacetic acid, two-substituted, disodium salt of EDTA) – 0.1 mg;

polysorbate 80-0.2 mg;

citric acid (anhydrous) – 0.28 mg;

purified water-up to 1 ml

Pharmacological action

Pulmicort – glucocorticoid, anti-allergic, anti-inflammatory.

Pharmacodynamics

Budesonide, an inhaled corticosteroid, in recommended doses has an anti-inflammatory effect in the bronchi, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma with a lower frequency of side effects than with the use of systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and hyperreactivity of the respiratory tract. It is well tolerated during long-term treatment, does not have mineralocorticosteroid activity.

The start time of 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 has a preventive effect on the course of bronchial asthma and does not affect the acute manifestations of the disease.

A dose-dependent effect on plasma and urinary cortisol levels has been shown when taking Pulmicort®. At recommended doses, the drug has a significantly lower effect on adrenal function than prednisone at a dose of 10 mg, as shown in ACTH tests.

Pharmacokinetics

Absorption. Inhaled budesonide is rapidly absorbed. In adults, the systemic bioavailability of budesonide after inhalation of Pulmicort® suspension through a nebulizer is approximately 15% of the total prescribed dose and about 40-70% of the delivered dose. Cmax in blood plasma is reached 30 minutes after the start of inhalation.

Metabolism and distribution. Binding to plasma proteins is on average 90%. The_{vd of}budesonide is approximately 3 l / kg. After absorption, budesonide undergoes intensive biotransformation (more than 90%) in the liver with the formation of metabolites with low glucocorticoid activity. The glucocorticosteroid activity of the main metabolites 6β-hydroxy-budesonide and 16α-hydroxyprednisolone is less than 1% of the glucocorticosteroid activity of budesonide.

Output.

Budesonide is mainly metabolized by the enzyme CYP3A4. Metabolites are excreted unchanged in the urine or in conjugated form. Budesonide has a high systemic clearance (about 1.2 l / min). The pharmacokinetics of budesonide are proportional to the amount of the administered dose of the drug.

The pharmacokinetics of budesonide in children and patients with impaired renal function have not been studied. In patients with liver diseases, the time spent in the body of budesonide may increase.

Indications

• bronchial asthma requiring maintenance therapy with corticosteroids;
• chronic obstructive pulmonary disease (COPD);
• stenosing laryngotracheitis (false croup).

Use during pregnancy and lactation

Monitoring of pregnant women taking budesonide did not reveal any abnormalities in the fetus, however, the risk of their development cannot be completely excluded, so during pregnancy, due to the possibility of worsening the course of bronchial asthma, the minimum effective dose of budesonide should be used.

Budesonide penetrates into breast milk, but when using Pulmicort® in therapeutic doses, the effect on the child was not observed. Pulmicort® can be used during breastfeeding.

Contraindications

• hypersensitivity to budesonide;
• children under 6 months of age.

With caution (more careful monitoring of patients is required): in patients with an active form of pulmonary tuberculosis; fungal, viral, bacterial infections of the respiratory system, cirrhosis of the liver; when prescribing, the possible manifestation of the systemic effect of corticosteroids should be taken into account.

Side effects

From the respiratory tract:  often-oropharyngeal candidiasis, irritation of the mucous membrane of the throat, cough, hoarseness of voice, dry mouth; rarely-bronchospasm.

Common:  rarely-angioedema, headache.

From the side of the skin:  rarely-bruising on the skin, rash, contact dermatitis, urticaria.

From the central nervous system:  rarely — nervousness, excitability, depression, behavioral disorders.

Interaction

There is no clinically significant interaction of budesonide with other drugs used in the treatment of bronchial asthma. When taken together, ketoconazole (at a dose of 200 mg 1 time/day) increases the plasma concentration of budesonide (taken orally at a dose of 3 mg 1 time/day) by an average of 6 times. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in blood plasma increased by an average of 3 times. It is likely that other potential inhibitors of the CYP3A4 enzyme will cause a significant increase in the plasma level of budesonide.

Pharmaceutical interaction

Pulmicort can be diluted with 0.9% sodium chloride solution or mixed with solutions of terbutaline, salbutamol, sodium cromoglycate and ipratropium bromide.

How to take, course of use and dosage

By inhalation. The dose of the drug is selected individually. If the recommended dose does not exceed 1 mg / day, the entire dose of the drug can be taken at one time (at a time). In case of taking a higher dose, it is recommended to divide it into 2 doses.

Recommended starting dose

Children from 6 months and older — 0.25-0.5 mg/day. If necessary, the dose can be increased to 1 mg / day.

Adults/elderly patients — 1-2 mg / day.

Maintenance dose

Children from 6 months and older — 0.25-2 mg / day.

Adults — 0.5-4 mg / day. In case of severe exacerbations, the dose may be increased.

Overdose

With an acute overdose of Pulmicort in the form of a suspension for inhalation, even when using very high doses, there are no clinical problems.

With prolonged use of the drug in doses significantly higher than recommended, the development of systemic effects of corticosteroids may occur.

Special instructions

Co-use of budesonide and ketoconazole or other potential CYP3A4 inhibitors should be avoided. If such a combination is necessary, increase the time between drug use to the maximum possible or consider reducing the dose of budesonide.

Special attention should be paid to patients who are transferred from systemic to inhaled corticosteroids (Pulmicort) in cases where pituitary-adrenal insufficiency can be expected. In such patients, special care should be taken to reduce the dose of corticosteroids for systemic use and monitor the function of the hypothalamic-pituitary-adrenal system. This category of patients may require additional use of corticosteroids for oral use during stressful situations, injuries, and surgical interventions.

When switching from oral corticosteroids to Pulmicort, pain in the muscles and joints may develop, which sometimes leads to the need for a temporary increase in the dose of corticosteroids for oral use. In rare cases, there is a feeling of fatigue, headache, nausea and vomiting, indicating systemic insufficiency of corticosteroids.

When switching from corticosteroids for oral use to inhaled ones, it is sometimes possible to exacerbate existing allergic reactions, rhinitis and eczema, which were previously stopped by systemic medications.

To reduce the risk of oral and pharyngeal candidiasis, the patient should rinse his mouth with water after each inhalation of Pulmicort.

To prevent skin irritation, wash your face after using the nebulizer with a mask.

The nebulizer chamber and mouthpiece or mask are washed with warm water using a mild detergent (according to the manufacturer’s instructions). The nebulizer should be thoroughly rinsed and dried by connecting the chamber to a compressor or air inlet valve.

The nebulizer chamber should be cleaned after each use.

Use in pediatrics

In children and adolescents who receive corticosteroids (any form) for an extended period of time, it is recommended to regularly monitor their growth indicators. When prescribing corticosteroids, the ratio of the expected benefit of the drug and the potential risk of growth retardation should be evaluated.

Influence on the ability to drive motor vehicles and manage mechanisms

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

Form of production

Metered dose suspension for inhalation

Storage conditions

At a temperature not exceeding 30 °C.

Shelf life

2 years

Active ingredient

Budesonide

Conditions of release from pharmacies

By prescription

Dosage form

suspension for inhalation

Purpose

For adults as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Children as prescribed by a doctor, Pregnant women as prescribed by a doctor

Indications

Bronchitis, Chronic obstructive pulmonary disease, Bronchial asthma