Pulmicort - instructions for use, analogs, reviews and release forms (suspension or powder for inhalation dosed Turbuhaler) hormonal medication for the treatment of bronchial asthma in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Pulmicort. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Pulmicort in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Pulmicort in the presence of existing structural analogues. Use for the treatment of bronchial asthma and chronic obstructive pulmonary disease in adults, children, as well as during pregnancy and lactation.

Pulmicort - Glucocorticosteroid (GCS) for inhalation. Budesonide (the active substance of the drug Pulmicort) at recommended doses has anti-inflammatory effect in the bronchi, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma with a lower incidence of side effects than with systemic GCS. Reduces the severity of the bronchial mucosa edema, mucus production, sputum formation and airway hyperreactivity. Well tolerated with long-term treatment, does not have mineralocorticoid activity.

The time to start 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.

Pulmicort 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 cortisol content in plasma and urine is shown on the background of 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.

Composition

Budesonide (in micronized form) + auxiliary substances.

Pharmacokinetics

After inhalation, the Pulmicort is rapidly absorbed. In adults, the systemic bioavailability of budesonide, after inhalation of Pulmicort through the nebulizer, is approximately 15% of the total prescribed dose and about 40-70% of the delivered dose. Budesonide undergoes intensive biotransformation (more than 90%) in the liver with the formation of metabolites with low glucocorticoid activity. Budesonide is excreted in the urine in the form of unchanged or conjugated metabolites. The pharmacokinetics of budesonide is proportional to the magnitude of the administered dose of the drug.

Indications

• A bronchial asthma requiring maintenance therapy for SCS;
• chronic obstructive pulmonary disease (COPD).

Forms of release

Suspension for inhalations dosed with 250 μg and 500 μg.

Powder for inhalation dosed with 100 μg and 200 μg (Pulmicort Turbuhaler).

Instructions for use and dosage

Suspension

The dose of Pulmicort is set individually. In the event that the recommended dose does not exceed 1 mg per day, the entire dose of the drug is administered once (at a time).In case of taking a higher dose, it is recommended to divide it into 2 doses.

The initial dose for adults (including elderly patients) is 1-2 mg per day. The maintenance dose is 0.5-4 mg per day. In case of severe exacerbations, the dose may be increased.

Children at the age of 6 months and older, the recommended initial dose is 0.25-0.5 mg per day. If necessary, the dose may be increased to 1 mg per day. The maintenance dose is 0.25-2 mg per day.

For all patients, it is desirable to determine the minimum effective maintenance dose.

If it is necessary to achieve an additional therapeutic effect, an increase in the daily dose (up to 1 mg per day) of Pulicicort can be recommended instead of the combination of the drug with GCS for oral administration, due to a lower risk of systemic effects.

Patients receiving glucocorticosteroids (HSC) for oral administration

Cancellation of GCS for oral administration should be started against a background of stable patient health. Within 10 days, high doses of Pulmicort are prescribed on the background of taking GCS inside at the usual dose. In the future, during the month should gradually reduce the dose of GCS taken internally (for example, 2.5 mg Prednisolone or its analog), to the minimum effective dose.In many cases, it is possible to completely refuse from taking GCS inside.

There is no data on the use of budesonide in patients with renal insufficiency or liver dysfunction. Taking into account the fact that budesonide is biotransformed in the liver, an increase in the duration of action of the drug in patients with severe hepatic cirrhosis can be expected.

Using a Pulcicort with a Nebulizer

The pulmicort is used for inhalations using an appropriate nebulizer equipped with a mouthpiece and a special mask. The nebulizer is connected to the compressor to create the required air flow (5-8 l / min), the nebulizer filling volume should be 2-4 ml.

Because Pulmicort, used in the form of a suspension with the help of a nebulizer, gets into the lungs during inspiration, it is important to instruct the patient to inhale the drug through the nebulizer mouthpiece calmly and smoothly.

In cases where a child can not independently inhale through a nebulizer, a special mask is used.

The patient should be informed of the need to carefully read the instructions for using the drug, and that ultrasonic nebulizers are not suitable for the use of Pulmicort in the form of a suspension.The suspension is mixed with 0.9% sodium chloride solution or with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglicate and ipratropium bromide. The patient should remember that after inhalation, rinse the mouth with water to reduce the risk of developing candidiasis of the oropharynx and that, to prevent skin irritation after using the mask, you should wash your face with water. You should also know that a dilute Pulmicort suspension should be used within 30 minutes.

It is recommended that the nebulizer be cleaned regularly according to the manufacturer's instructions.

The nebulizer chamber should be cleaned after each use.

The nebulizer chamber and the 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 the compressor or the inlet air valve.

Rules for using Pulmicort with a nebulizer

1. Before use, shake the container gently with a slight rotational movement.

2. Hold the container straight upright and open it, turning and tearing off the "wing".

3.Gently place the container open end into the nebulizer and slowly squeeze out the contents of the container.

A container containing a single dose is marked with a line. If the container is turned over, this line will show a volume equal to 1 ml.

If it is necessary to use only 1 ml of the suspension, the contents of the container are squeezed out until the surface of the liquid reaches the level indicated by the line.

The open container is stored in a place protected from light. The open container should be used within 12 hours.

Before using the remainder of the liquid, the contents of the container are gently shaken by rotational movement.

Powder Turbuhaler

The dose of Pulmicorta Turbuhaler is selected individually. Recommended doses of the drug in the case of the onset of inhaled glucocorticosteroid therapy in the period of severe exacerbations of bronchial asthma, as well as against a dose reduction or withdrawal of oral GCS, are as follows:

Children older than 6 years: 100-800 mcg per day (the total daily intake of the drug can be divided into 2-4 inhalations). In the event that the recommended dose does not exceed 400 mcg per day, the entire dose of the drug can be taken at a time (one time).

In children, the transition to a single dose should be performed under the supervision of a pediatrician.

Adults: the usual dose is 200-800 μg per day (the total daily dose of the drug can be divided into 2-4 inhalations). For the treatment of severe exacerbation of bronchial asthma, the daily dose can be increased to 1600 μg. If the recommended dose does not exceed 400 mcg per day, the entire dose of the drug can be applied at a time (once).

When selecting a maintenance dose, it is necessary to strive to prescribe the minimum effective dose.

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

The best efficacy of budesonide was demonstrated when using Turbuhaler compared with a similar dose of budesonide in the form of a dosed aerosol. In the case of the transfer of a patient in a stable condition from Pulmicort in aerosol form to Pulmicort Turbuhaler,should consider the possibility of reducing the daily dose of budesonide To enhance the therapeutic effect, an increase in the daily dose of Pulmicort turbuhaler may be recommended instead of the combination of the drug with oral glucocorticosteroids, due to a lower risk of systemic effects.

The drug contained in the Turbuhaler, enters the patient's airways along with the air streams while performing an active inspiration through the Turbuhaler mouthpiece.

It is important to convince the patient to carefully read the instructions for using Pulmicort Turbuhaler.

To be sure that the optimal dose of the drug has entered the lungs, take a deep and strong breath through Turbuhaler's mouthpiece.

Under no circumstances exhale through the mouthpiece.

After inhalation of the required dose of the drug, rinse the mouth with water in order to minimize the risk of fungal infection of the oropharynx.

How to use Pulmicort Turbuhaler

Turbuhaler - multi-dose inhaler, which allows you to dose and inhale the drug in very small doses. When you inhale, the powder from Turbuhaler is delivered and the lungs. Therefore, it is important that you take a deep and deep breath through the mouthpiece.

Turbuhaler is very simple to use. Just follow the instructions below:

1. Unscrew and remove the cap.

2. Hold the inhaler vertically with the dispenser down. Load the dose into the inhaler by turning the dispenser counter-clockwise until it stops, and then turn the dispenser to its original position until it clicks.

3. Exhale. Do not exhale through the mouthpiece. Before exhaling, remove the inhaler from the mouth.

4 Gently squeeze the mouthpiece with your teeth, squeeze your lips and inhale deeply and strongly through your mouth. The mouthpiece can not be chewed and strongly compressed with teeth.

If more than one dose is required, repeat steps 2-5.

5. Close the inhaler cap.

6. Rinse your mouth with water.

Important! Never exhale through the mouthpiece. Always close the inhaler cap tightly after use.

Since the amount of inhaled powder is very small, you may not feel the taste of the powder after inhalation. However, if you followed the instructions, you can be sure. that they inhaled the necessary dose of the drug.

Cleaning. Regularly (once a week), clean the mouthpiece from the outside with a dry cloth. Do not use water or other liquids to clean the mouthpiece.

How do you know that the inhaler is empty?

The appearance of a red mark in the dose window means that approximately 20 doses remain in the inhaler. The inhaler is empty when the red mark reaches the bottom edge of the indicator dose window.

The sound that you hear when you shake the inhaler is produced by a dehumidifying agent, not a medicine.

Side effect

• candidiasis of the oropharynx;
• irritation of the pharyngeal mucosa;
• cough;
• hoarseness of voice;
• dry mouth;
• allergic reactions;
• angioedema;
• headache;
• hives;
• rash;
• contact dermatitis;
• bronchospasm;
• nervousness;
• excitability;
• depression;
• behavioral disorders;
• the appearance of bruising on the skin;
• irritation of the skin of the face when using a nebulizer with a mask.

Contraindications

• children up to 6 months (up to 6 years old at Turbuhaler);
• hypersensitivity to budesonide.

Application in pregnancy and lactation

Observation of pregnant women taking budesonide did not reveal fetal development abnormalities, nevertheless, the risk of their development can not be completely excluded, therefore, in pregnancy, the minimum effective dose of the drug should be used in connection with the possibility of worsening of the course of bronchial asthma.

Budesonide excreted in breast milk, however, when applying Pulmicort in therapeutic doses, no effect was observed on the baby. Pulmicort can be used for breastfeeding.

Use in children

In children and adolescents receiving treatment with GCS (any form) for an extended period, it is recommended to monitor growth rates on a regular basis. When appointing GCS, it is necessary to evaluate the ratio of the prospective benefit from the use of the drug and the potential risk of slowing growth.

The use of budesonide in a dose of up to 400 micrograms per day in children older than 3 years did not lead to systemic effects. Biochemical signs of the systemic effect of the drug may occur when the drug is used at a dose of 400 to 800 micrograms per day. When the dose exceeds 800 mcg per day, the systemic effects of the drug are often encountered.

The use of GCS to treat bronchial asthma can cause dysplasia. The results of observations of children and adolescents who received budesonide for a long period (up to 11 years) showed that the growth of patients reaches the expected normative indices for adults.

special instructions

To minimize the risk of fungal oropharyngeal injury, the patient should be instructed to thoroughly rinse the mouth with water after each inhalation of the drug.

To prevent skin irritation after using a nebulizer with a mask, the face should be washed.

Joint administration of budesonide with ketoconazole, Itraconazole or other potential inhibitors of CYP3A4 should be avoided. If such a combination is necessary, you should increase the time between doses of the drugs to the maximum possible.

Because of the possible risk of weakening adrenal function, special attention should be paid to patients who are transferred from systemic SCS to Pulmicort. Also, special attention should be paid to patients taking high doses of GCS or who received long-term recommended maximum doses of inhaled glucocorticosteroids. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. When stress or in cases of surgical intervention, additional therapy with systemic GCS is recommended.

Particular attention should be given to patients who are transferred from systemic to inhaled glucocorticosteroids (Pulmicort) or in the case where a disorder of the pituitary-adrenal function can be expected. In such patients, it is necessary with special care to reduce the dose of GCS for systemic use and monitor the performance of the hypothalamic-pituitary-adrenal system. This category of patients may require an additional appointment of GCS for oral administration during periods of stressful situations, such as trauma, surgery.

When switching from oral GCS to Pulmicort, patients may experience previously observed symptoms, such as muscle pain or joint pain. In such cases, a temporary increase in the dose of GCS for oral administration may be required. In rare cases, symptoms such as a feeling of fatigue, headache, nausea and vomiting, indicating a systemic failure of GCS, can be observed.

When switching from GCS for oral ingestion to inhalation, it is sometimes possible to exacerbate existing allergic reactions, rhinitis and eczema, which were previously treated with systemic drugs.

Pulmicort therapy when applied 1 or 2 times a day has shown efficacy for the prevention of asthma physical effort.

Impact on the ability to drive vehicles and manage mechanisms

The pulmicort does not affect the ability to drive a car or other machinery.

Drug Interactions

There was no interaction of budesonide with other drugs used in the treatment of bronchial asthma.

When combined, Ketoconazole (200 mg once a day) increases the plasma concentration of budesonide (ingested at a dose of 3 mg once a day), on average, 6-fold. When taking ketoconazole 12 hours after the administration of budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. Information on this interaction with budesonide in the form of inhalation is not available, but it is expected that in this case an increase in the concentration of budesonide in the blood plasma should be expected. If it is necessary to take ketoconazole and budesonide, you should increase the time between doses of the drugs to the maximum possible. You should also consider the possibility of reducing the dose of budesonide.

Another potential inhibitor of CYP3A4, itraconazole, also significantly increases the plasma concentration of budesonide

Preliminary inhalation of beta-adrenostimulants expands bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.

Phenobarbital, phenytoin, rifampicin when used simultaneously reduces the effectiveness of Pulmicort (due to the induction of microsomal oxidation enzymes).

Methandrostenolone, estrogens strengthen the action of budesonide.

Analogues of the drug Pulmicort

Structural analogs for the active substance:

• Apulein;
• Benacorte;
• Benarin;
• Budenit Steri Neb;
• Budenofalk;
• Budesonide;
• Budesonid Ishihyler;
• Budiere;
• Budostere;
• Novopulmon E Novolayzer;
• Pulmicort Turbuhaler;
• Tafen nasal;
• Tafen Novolayzer.

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