Pulmicort, suspension for inhalation 0.5 mg / ml, 1 dose, 2 ml,

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Product Description

Structure

Active substance:

 budesonide (micronized) 0.5 mg;

Excipients:

sodium chloride - 8.5 mg;

sodium citrate - 0.5 mg;

disodium edetate (sodium salt of ethylenediaminetetraacetic acid disubstituted, disodium salt of EDTA) - 0.1 mg;

polysorbate 80 - 0.2 mg;

citric acid (anhydrous) - 0.28 mg;

purified water - up to 1 ml

pharmachologic effect

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

Pharmacodynamics

Budesonide, an inhaled corticosteroids, 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 when using systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and respiratory tract hyperresponsiveness. It is well tolerated with prolonged 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 the content of cortisol in plasma and urine is shown with Pulmicort ® . In recommended doses, the drug has a significantly less effect on adrenal function than prednisone at a dose of 10 mg, as was shown in ACTH tests.

Pharmacokinetics

Absorption. Inhaled budesonide is rapidly absorbed. In adults systemic bioavailability after inhalation of budesonide Pulmicort ®  suspension through a nebulizer is about 15% of the total dose assignable and about 40-70% of dostavlennoy.C max  in the blood plasma is 30 minutes after the beginning of inhalation.

Metabolism and distribution. Plasma protein binding averages 90%. V d 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 glucocorticosteroid activity. The glucocorticosteroid activity of the main metabolites of 6β-hydroxy-budesonide and 16α-hydroxyprednisolone is less than 1% of the glucocorticosteroid activity of budesonide.

Breeding.

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

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

Indications

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

Pregnancy and lactation

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

Budesonide penetrates into breast milk, but the application Pulmicort ®  at therapeutic doses effects were observed in children. Pulmicort ®  can be used during breastfeeding.

Contraindications

  • hypersensitivity to budesonide;
  • children's age up to 6 months.

With caution (more careful monitoring of patients is required): in patients with active pulmonary tuberculosis; fungal, viral, bacterial infections of the respiratory system, cirrhosis of the liver; when appointing, one should take into account the possible manifestation of the systemic action of GCS.

Side effects

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

General: rarely - angioedema, headache.

On the part of the skin: rarely - the appearance of bruises on the skin, rash, contact dermatitis, urticaria.

From the side of the central nervous system: rarely - nervousness, excitability, depression, behavior disorders.

Interaction

No clinically significant interaction of budesonide with other drugs used in the treatment of bronchial asthma has been established.
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 on average by 3 times. Other potential inhibitors of the CYP3A4 enzyme are likely to cause a significant increase in plasma levels of budesonide.

Pharmaceutical interaction

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

How to take, course of administration and dosage

Inhalation. The dose of the drug is selected individually. In the event that the recommended dose does not exceed 1 mg / day, the entire dose of the drug can be taken 1 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.

Dose with maintenance treatment

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, clinical problems do not arise.

With prolonged use of the drug in doses significantly higher than recommended, the development of systemic effects of GCS is possible.

Special instructions

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

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

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

When switching from GCS for oral administration to inhalation, exacerbation of existing allergic reactions, rhinitis and eczema, which were previously stopped by systemic drugs, is sometimes possible.

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

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

The nebulizer chamber and mouthpiece or mask are washed with warm water using a mild detergent (in accordance with the manufacturer's instructions). Rinse and dry the nebulizer well by connecting the chamber to the compressor or air inlet valve.

The nebulizer chamber should be cleaned after each use.

Pediatric Use

In children and adolescents receiving corticosteroids (any form) for an extended period, it is recommended to regularly monitor growth rates. When prescribing corticosteroids, the ratio of the estimated benefits of the use of the drug and the potential risk of growth retardation should be assessed.

Influence on the ability to drive vehicles and control mechanisms

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

Release form

Suspension for inhalation, metered

Storage conditions

At a temperature not exceeding 30 ° C.

Shelf life

2 years

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