Modern drug for inhalation for children Pulmicort: instructions, dosage and rules for medical procedures. Pulmicort: instructions for use

As part of drugs Pulmicort and Pulmicort Turbuhaler contains a substance budesonide .

Besides suspension for inhalation Pulmicort also includes Excipients: sodium citrate , sodium chloride , polysorbate 80 , sodium salt EDTA , purified water and anhydrous lemon acid.

Release form

Pulmicort is available in two versions: dosed suspension for may contain 0.25 mg/ml or 0.5 mg/ml budesonide . Produced in cardboard packs, which contain 20 containers of 2 ml.

Powder for inhalation Pulmicort Turbuhaler also has two forms of release: 200 doses of 100mcg of budesonide or 100 doses of 200mcg of budesonide in a metered dose inhaler. The inhaler itself consists of reservoirs for desiccant and storage of powder, cap and mouthpiece. The drug is packed in a cardboard box.

pharmachologic effect

The drug has glucocorticoid , anti-inflammatory , and also antiallergic actions.

Indications for use

Pharmacodynamics and pharmacokinetics

absorption

Budesonide, which enters the body through inhalation, is rapidly absorbed. Approximately 25-30% of the dose of the drug enters the lungs. After half an hour, the highest concentration of the drug is reached in . The systemic bioavailability of Pulmicort is approximately 38% of the administered dose.

Metabolism and distribution

The binding of the drug to plasma proteins is at the level of 90%. The distribution of budesonide by volume is about 3 liters per kilogram. At the end of absorption, an intense biotransformation of budesonide , which results in the formation with low glucocorticosteroid activity .

breeding

The substance budesonide INN is mainly metabolized with the participation CYP3A4. Then in conjugated form or simply with urine unchanged metabolites are excreted from the body. Pharmacokinetics of the substance budesonide in patients with impaired renal function and in children is unknown. And in patients with liver disease, the time spent in the body of budesonide may increase.

Contraindications

Side effects

For respiratory organs: dry mouth, cough, mucosal irritation respiratory tract, carious lesions of the oropharynx . Given the possibility of carious damage to the oropharynx, taking the drug should carefully monitor oral hygiene.

For endocrine system: hypofunction of the adrenal cortex , as well as symptoms of systemic action of glucocorticosteroids.

For central nervous system: excitability, inappropriate behavior, nervousness, depression, clouding of consciousness.

Allergic reactions: contact , rash , . In the case of using a nebulizer with a mask, irritation of the skin of the face may occur.

Instructions for use (Method and dosage)

Preparations Pulmicort and Pulmicort Turbuhaler used as prophylactic in case, while using these medicines when acute attacks this disease is not appropriate. Given the small likelihood that systemic effects will develop, the daily dosage of these drugs can be increased to achieve improved therapeutic effect up to 1000 mcg instead of combining medication with others oral glucocorticosteroids .

Stop taking oral glucocorticosteroids to switch to the drug Pulmicort or Pulmicort Turbuhaler it is necessary for ten days, taking previously selected doses of oral corticosteroids, while adding a high dose of Pulmicort. After ten days, gradually reduce the intake of the oral drug to the minimum effective dose (over a month, with a reduction step in terms of prednisolone 2.5 mg). Thanks to this scheme, in some cases, you can even completely abandon oral corticosteroids.

The dosage of 250 micrograms of budesonide should be slightly diluted. How to dilute such a dose: you need to dilute the medicine with a 0.9% solution sodium chloride . Before diluting with saline, you need to take 1 ml of the drug, so that in the end you get 2 ml.

Instructions for use Pulmicort for inhalation

The dosage of the drug should be selected by the doctor in individually for each patient. If the daily dose is within 1000 mcg, then you can take the entire dose of the drug at a time. If a larger dose is required, then it is better to take it several times.

The initial daily dose of Pulmicort for children from 6 months is 250-500mcg. The daily dosage for adults is from 1000 to 2000 mcg.

supportive daily dosage for children from 6 months - 250-2000 mcg. Adults should take 500-4000 mcg per day. In case of severe obstructive conditions, the dosage may be increased on the recommendation of the attending physician.

A prerequisite for therapy with Pulmicort is the selection of the minimum maintenance dose on an individual basis.

Suspension of the drug Pulmicort is used for inhalation with the help of compressor nebulizer , which is equipped with a special mask and mouthpiece. The nebulizer is connected to a compressor that creates the required air flow (approximately 5-8 liters per minute), must be filled by volume at 2-4 ml. Please note that ultrasonic nebulizers not suitable for Pulmicort suspension!

Before using the drug in nebulas, gently shake the container with the suspension contained inside. Open the container and carefully squeeze the contents into the nebulizer. If only 1 ml of suspension is needed for use, then squeeze out the contents of the container until the liquid level reaches the indicated line. Before using the remaining liquid, the liquid contained in the container must be shaken with a twisting motion. Considering that Pulmicort enters the lungs of the patient with the help of a nebulizer when inhaling, it is imperative to instruct the patient to inhale the drug evenly and carefully.

If, during inhalation, children cannot inhale on their own using a nebulizer, then a special mask should be used, after making sure that it fits snugly against the face.
Mouthpiece, nebulizer chamber and mask should be cleaned after each use by rinsing them warm water using a detergent or according to the manufacturer's instructions. The nebulizer itself must be thoroughly rinsed and then dried by connecting the inlet air valve or compressor to the chamber.

Instructions for use Pulmicort Turbuhaler

The dosage of the drug is selected for each patient individually.

The daily dose for children from 6 years old is 100-800mcg. As a rule, the daily dose is taken as 2-4 inhalations. In this case, the daily dose, which does not exceed 400 mcg, can be taken at a time. The transition to taking the drug once a day must be made under the supervision of a pediatrician.

The daily norm for adults is 200-800 mcg. If the dose is not more than 400 mcg, then it can be taken at a time, and for larger doses, it can be broken down into several doses. In the treatment of severe exacerbations, the daily dose may be increased to 1600mcg. In the event of a patient switching from using an aerosol form to Pulmicort Turbuhaler, the daily dose may be reduced. When choosing a maintenance dose of the drug, one should strive to ensure that the minimum effective dose is prescribed.

There are some rules for using the Turbuhaler inhaler. The drug enters the respiratory tract when performing an active breath through the mouthpiece. Turbuhaler is a reusable inhaler that allows you to inhale and dose the drug in small doses.
Turbuhaler is quite easy to use, you just need to follow simple instructions:

• It is required to unscrew and then remove the cap.
• The inhaler should be held vertically so that the dispenser is at the bottom. Load the dose into the inhaler by turning the dispenser all the way counterclockwise, then return the dispenser to its original position until you hear a click.
• Exhale after removing the inhaler from your mouth.
• In order to get the required dose into the lungs, inhale deeply through the mouth, after clenching the mouthpiece with your teeth and clasping it with your lips. If more than one inhalation is required, then repeat steps 2, 3 and 4 as many times as required.
• Close the inhaler tightly with the cap.
• Be sure to rinse your mouth with water, which will minimize the risk of infection of the oropharynx with a fungus.

Given the small amount of powder you inhale while inhaling, you may not be able to taste it. But if you did everything according to the instructions, you can be sure that you received the necessary dose of the drug when you inhale.

Once a week, the outside of the mouthpiece should be cleaned using a dry cloth. Cleaning liquids must not be used.

When a red mark appears in the inhaler, it means that there are about twenty doses left in it. And when the red mark is at the bottom of the dose window, it means that the inhaler is empty.

Overdose

In case of acute overdose, clinical manifestations do not occur. If the overdose is chronic, then effects may occur hypercortisolism , as well as the occurrence of suppression adrenal function .

In addition, there may be clinical manifestations hypercortisolism: arterial hypertension , muscle weakness, weight gain, hyperpigmentation . Also at chronic overdose in order to treat hypercortisolism, the drug is gradually canceled, systematically reducing the dosage.

Interaction

The systemic action of Pulmicort can be increased and , which increase the plasma concentration of this drug. The therapeutic effect of the drug is enhanced by pre-inhalation beta-agonists dilating the bronchi.

Terms of sale

The drug is available by prescription.

Storage conditions

Preparations Pulmicort and Pulmicort Turbuhaler should be stored in a cool dry place with an ambient temperature not exceeding 30 degrees Celsius.

Containers with the suspension inside should be stored only in the original envelope, which protects the drug from light.

Best before date

The drug is stored for 2 years.

After opening the envelope with containers, the time of using the drug is reduced to 3 months.

The opened container must be used up within 12 hours.

special instructions

To minimize the risk of fungal infection of the oropharynx, the patient should be instructed to rinse the mouth with water with particular care after each inhalation of this medicine.

Preparations Pulmicort and Pulmicort Turbuhaler should be avoided in conjunction with , ketonazole , as well as other substances that retain in the body CYP3A4 . If these substances were nevertheless prescribed to the patient at the same time as budesonide (basic active substance drug), then you need to maximize the time between doses of these drugs.

Due to the risks that pituitary-adrenal function may be weakened, required to be given Special attention those patients who are transferred to the reception Pulmicorta and Pulmicorta Turbuhaler with oral glucocorticosteroids. In addition, special attention should be paid to those patients who long time received the maximum recommended dose of glucocorticosteroids. In such patients, stressful situations possible symptoms and signs adrenal insufficiency . Also in cases surgical intervention or recommended for stress complementary therapy with systemic glucocorticosteroids.

Particular attention should be paid to those patients who are transferred from systemic to inhaled glucocorticosteroids, as well as in cases where a violation is expected. pituitary-adrenal function . In these cases, it is necessary to carefully reduce the dose of systemic glucocorticosteroids, as well as control adrenal hormonal function.

If the patient switches from taking oral corticosteroids to drugs Pulmicort or Pulmicort Turbuhaler, he may experience symptoms such as joint pain or muscle pain . In this case, it may be necessary to temporarily increase the dose of oral corticosteroids. In some cases, there may also be nausea and vomit , headache , a feeling of fatigue, indicating a systemic insufficiency of glucocorticosteroids.

If oral corticosteroids were replaced with inhaled ones, then sometimes, in connection with this, a concomitant allergy (or) appears, which was previously stopped with the help of systemic drugs.

In addition, patients should be instructed that if the effectiveness of therapy with , Budoster, Budesonide-Nativ, Budiair, Novopulmon E Novolizer, Tafen Novolizer .

Animal studies have shown the results of the development of abnormalities in the fetus when taking corticosteroids, but these data cannot be transferred to people who receive the recommended doses of glucocorticosteroids.

For breastfeeding mothers, the following information will be useful: evidence that budesonide can get into breast milk- have not been identified. But still, when prescribing this drug, it is necessary to take into account the potential risks for the child, comparing them with the intended benefits.

Catad_pgroup Anti-asthma drugs

Pulmicort suspension for nebulizer - official instruction by application

Registration number:

P N013826/01-140907

Tradename:

Pulmicort (Pulmicort)

International non-proprietary name:

Dosage form:

Compound

1 ml suspension contains:
Active ingredient: budesonide (budesonide micronized) 0.25 mg or 0.5 mg.
Auxiliary ingredients: sodium chloride 8.5 mg, sodium citrate 0.5 mg, disodium edetate (ethylenediaminetetraacetic acid sodium salt (disubstituted) (EDTA disodium salt)) 0.1 g, polysorbate 80 0.2 mg, citric acid (anhydrous) 0.28 mg, purified water up to 1 ml.

Description

Easily resuspendable, sterile suspension of white or nearly white color in containers made of low density polyethylene containing a single dose.

Pharmacotherapeutic group

ATX code: R03BA02

Pharmacological properties

Indications for use

Contraindications

Carefully(more careful monitoring of patients is required): in patients with fungal, viral, bacterial infections of the respiratory system, cirrhosis of the liver; appointment should take into account possible manifestation systemic action of glucocorticosteroids.

Use during pregnancy and lactation

Dosage and administration

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 at a time - (at a time). In case of taking a higher dose, it is recommended to divide it into two doses.
Recommended starting dose:
Children 6 months and older: 0.25-0.5 mg per day. If necessary, the dose can be increased to 1 mg / day.
Adult/Elderly Patients: 1-2 mg per day.
Dose for maintenance treatment:
Children 6 months and older: 0.25-2 mg per day.
Adults: 0.5-4 mg per day. In case of severe exacerbations, the dose may be increased.

Dose Table

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 daily dose(up to 1 mg / day) Pulmicorta instead of a combination of the drug with oral glucocorticosteroids, due to more low risk development of systemic effects.
Patients receiving oral glucocorticosteroids
Cancellation of oral glucocorticosteroids should be started against the background of a stable state of health of the patient. Within 10 days it is necessary to take a high dose of Pulmicort while taking oral glucocorticosteroids at the usual dose. In the future, within a month, the dose of oral glucocorticosteroids (for example, 2.5 mg of prednisolone or its analogue) should be gradually reduced to the minimum effective dose. In many cases, it is possible: to completely refuse to take oral glucocorticosteroids.
Since Pulmicort administered as a suspension via a nebulizer enters the lungs during inhalation, it is important to instruct the patient to inhale the drug calmly and evenly through the nebulizer mouthpiece.
There are no data on the use of budesonide in patients with kidney failure or impaired liver function. Taking into account the fact that budesonide is excreted by biotransformation in the liver, one can expect an increase in the duration of action of the drug in patients with severe liver cirrhosis.
Stenosing laryngotracheitis (false croup):
Children aged 6 months and older: 2 mg per day. The dose of the drug can be taken at a time (at a time) or divided into two doses of 1 mg with an interval of 30 minutes.

Side effect

Frequency of occurrence unwanted effects presented as follows:
Often (>1/100,<1/10); Нечасто (>1/1000, <1/100); Редко (>1/10000, <1/1000); Очень редко (<1/10000), включая отдельные сообщения.
Up to 10% of patients taking the drug may experience the following side effects:

Taking into account the risk of developing oropharyngeal candidiasis, the patient should thoroughly rinse his mouth with water after each inhalation of the drug.
In rare cases, symptoms caused by systemic action of glucocorticosteroids may occur, including adrenal hypofunction and growth retardation in children. The severity of these symptoms probably depends on the dose of the drug, the duration of therapy, concomitant or previous therapy with glucocorticosteroids, as well as individual sensitivity.
There have been cases of facial skin irritation when using a nebulizer with a mask. To prevent irritation after using the mask, the face should be washed with water.

Overdose

Interaction with other drugs

There was no interaction of budesonide with other drugs used in the treatment of bronchial asthma.
Ketoconazole (200 mg once a day) increases the plasma concentration of oral budesonide (3 mg once a day) by an average of 6 times when taken together. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. Information on such an interaction when taking budesonide in the form of inhalation is not available, however, it is assumed that in this case, too, an increase in the concentration of budesonide in the blood plasma should be expected. If it is necessary to take ketoconazole and budesonide, the time between taking the drugs should be increased to the maximum possible. You should also consider reducing the dose of budesonide. Another potential inhibitor of CYP3A4, for example, itraconazole, also significantly increases the plasma concentration of budesonide.
Pre-inhalation of beta-agonists dilates the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.
Phenobarbital, phenytoin, rifampicin reduce the effectiveness (induction of microsomal oxidation enzymes) of budesonide.
Methandrostenolone, estrogens enhance the effect of budesonide.

special instructions

Influence on the ability to drive a car or other mechanisms

Pulmicort does not affect the ability to drive a car or other mechanisms.

Application of Pulmicort with a nebulizer

Pulmicort is used for inhalation using an appropriate nebulizer equipped with a mouthpiece and a special mask. The nebulizer is connected to a compressor to create the required air flow (5-8 l/min), the filling volume of the nebulizer should be 2-4 ml.
It is important to inform the patient:
- carefully read the instructions for use of the drug;
- ultrasonic nebulizers are not suitable for the use of Pulmicort suspension;
- Pulmicort suspension is mixed with 0.9% sodium chloride solution or with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium bromide; the diluted suspension should be used within 30 minutes.
- after inhalation, rinse your mouth with water to reduce the development of oropharyngeal candidiasis;
- to prevent skin irritation after using the mask, rinse your face with water;
- it is recommended to regularly clean the nebulizer in accordance with the manufacturer's instructions;
In cases where the child cannot breathe on his own through the nebulizer, a special mask is used.

How to use Pulmicort ® with a nebulizer

1. Shake the container gently with a slight swirling motion before use.
2. Hold the container straight upright (as shown in the picture) and open it by turning and prying off the "wing".
3. Carefully place the container with the open end into the nebulizer and slowly squeeze out the contents of the container.
The container containing the single dose is marked with a line. If the container is turned upside down, this line will show a volume of 1 ml.
If only 1 ml of suspension is to be used, the contents of the container are squeezed out until the surface of the liquid reaches the level indicated by the line.
The opened container is stored in a place protected from light. An open container must be used within 12 hours.
Before using the rest of the liquid, the contents of the container are gently shaken with a rotary motion.
Note
1. Rinse your mouth with water after each inhalation.
2. If you use a mask, make sure that the mask fits snugly against your face when inhaling. Wash your face after inhalation.
cleaning
The nebulizer chamber, mouthpiece or mask should be cleaned after each use.
Clean the nebulizer chamber, mouthpiece or mask with warm water using a mild detergent or according to the manufacturer's instructions. Rinse well and dry the nebulizer by connecting the chamber to a compressor or air inlet valve.

Release form

Storage conditions

At temperatures below 30°C. Keep out of the reach of children.
The drug in containers should be used within 3 months after opening the envelope. An open container must be used within 12 hours. Containers should be stored in an envelope to protect them from light.

Holiday conditions

On prescription.

Best before date

2 years. Do not use after the expiry date stated on the packaging.

(information is indicated only when packaging at AstraZeneca AB, Sweden):

Name and address of the manufacturer

Or (information is indicated only when packing at ZiO-Zdorovye CJSC, Russia):

Manufacturing firm

Description of the dosage form

Easily resuspendable, sterile white or off-white suspension in single dose LDPE containers.

pharmachologic effect

Pharmacodynamics

Budesonide, an inhaled corticosteroid, at 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 incidence of side effects than when using systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperreactivity. It is well tolerated during long-term treatment, does not have mineralocorticosteroid activity.

The time of onset 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 was shown while taking Pulmicort ® . At recommended doses, the drug has significantly less 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. C max in blood plasma is achieved 30 minutes after the start of inhalation.

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

Withdrawal. Budesonide is metabolized mainly by the CYP3A4 enzyme. 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 is proportional to 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 for Pulmicort ®

bronchial asthma requiring maintenance therapy with corticosteroids;

chronic obstructive pulmonary disease (COPD);

stenosing laryngotracheitis (false croup).

Contraindications

hypersensitivity to budesonide;

children's age up to 6 months.

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

Use during pregnancy and lactation

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

Budesonide passes into breast milk, however, when using Pulmicort ® in therapeutic doses, no effect on the child was noted. Pulmicort ® can be used during breastfeeding.

Side effects

The frequency of occurrence of undesirable effects is presented as follows: often (> 1/100,<1/10); нечасто (>1/1000, <1/100); редко (>1/10000, <1/1000); очень редко (<1/10000), включая отдельные сообщения.

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

General: rarely - angioedema, headache.

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

From the side of the central nervous system: rarely - nervousness, irritability, depression, behavioral disorders.

Taking into account the risk of developing oropharyngeal candidiasis, the patient should thoroughly rinse his mouth with water after each inhalation of the drug.

In rare cases, there may be symptoms caused by the systemic action of corticosteroids, including adrenal hypofunction.

There have been cases of facial skin irritation when using a nebulizer with a mask. To prevent irritation after using the mask, the face should be washed with water.

Interaction

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

Ketoconazole (at a dose of 200 mg 1 time per day) increases the plasma concentration of oral budesonide (at a dose of 3 mg 1 time per day) by an average of 6 times when taken together. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. Information on such an interaction when taking budesonide in the form of inhalation is not available, however, it is assumed that in this case, too, an increase in the concentration of budesonide in the blood plasma should be expected. If it is necessary to take ketoconazole and budesonide, the time between taking the drugs should be increased to the maximum possible. You should also consider reducing the dose of budesonide. Another potential inhibitor of CYP3A4 (eg itraconazole) also significantly increases the plasma concentration of budesonide.

Pre-inhalation of beta-agonists dilates the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.

Phenobarbital, phenytoin, rifampicin reduce the effectiveness (induction of microsomal oxidation enzymes) of budesonide.

Methandrostenolone, estrogens enhance the effect of budesonide.

Dosage and administration

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 a time (at a time). In case of taking a higher dose, it is recommended to divide it into 2 doses.

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 for 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.

Dose Table

* Should be diluted with 0.9% sodium chloride solution to a volume of 2 ml.

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 of Pulmicort ® (up to 1 mg / day) can be recommended instead of a combination of the drug with oral corticosteroids, due to a lower risk of developing systemic effects.

Patients receiving oral corticosteroids

Cancellation of oral corticosteroids should be started against the background of a stable state of health of the patient. Within 10 days it is necessary to take a high dose of Pulmicort ® while taking oral corticosteroids at the usual dose. In the future, within 1 month, the dose of oral corticosteroids (for example, 2.5 mg of prednisolone or its analogue) should be gradually reduced to the minimum effective dose. In many cases, it is possible to completely refuse to take oral GCS.

Since Pulmicort ® administered as a suspension via a nebulizer enters the lungs during inhalation, it is important to instruct the patient to inhale the drug calmly and evenly through the nebulizer mouthpiece.

There are no data on the use of budesonide in patients with renal insufficiency or impaired liver function. Taking into account the fact that budesonide is excreted by biotransformation in the liver, an increase in the duration of action of the drug in patients with severe liver cirrhosis can be expected.

Stenosing laryngotracheitis (false croup)

Children aged 6 months and older - 2 mg / day. The dose of the drug can be taken at a time (at a time) or divided into 2 doses of 1 mg with an interval of 30 minutes.

Overdose

Symptoms: in acute overdose, clinical manifestations do not occur. With prolonged use of the drug in doses significantly higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercorticism and suppression of adrenal function.

special instructions

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

Co-administration of budesonide with ketoconazole, itraconazole, or other potential CYP3A4 inhibitors should be avoided. In the event that budesonide and ketoconazole or other potential inhibitors of CYP3A4 have been prescribed, the time between taking the drugs should be increased to the maximum possible.

Due to the possible risk of weakening the function of the adrenal glands, special attention should be paid to patients who are transferred from oral corticosteroids to taking Pulmicort ® . Also, special attention should be paid to patients who have taken high doses of corticosteroids or who have received the highest recommended doses of inhaled corticosteroids for a long time. In stressful situations, these patients may show signs and symptoms of adrenal insufficiency. In case of stress or in cases of surgical intervention, additional therapy with systemic corticosteroids is recommended.

Particular attention should be paid to patients who are transferred from systemic to inhaled corticosteroids (Pulmicort ®), or in the case when a violation of the pituitary-adrenal function can be expected. In such patients, the dose of systemic corticosteroids should be reduced with extreme caution and hypothalamic-pituitary-adrenal function should be monitored. Also, patients may need to add oral corticosteroids during stressful situations, such as trauma, surgery.

When switching from oral corticosteroids 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 oral corticosteroids may be necessary. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may be observed, indicating systemic insufficiency of corticosteroids.

Replacing oral corticosteroids with inhaled ones sometimes leads to the manifestation of concomitant allergies (for example, rhinitis and eczema), which were previously stopped by systemic drugs.

In children and adolescents receiving corticosteroid treatment (regardless of the method of delivery) for an extended period, it is recommended to regularly monitor growth rates. When prescribing GCS, the ratio of the benefits of using the drug and the possible risk of growth retardation should be taken into account.

The use of budesonide at a dose of up to 400 mcg / day in children older than 3 years did not lead to systemic effects. Biochemical signs of a systemic effect of the drug may occur when taking the drug at a dose of 400 to 800 mcg / day. When exceeding a dose of 800 mcg / day, systemic effects of the drug are common.

The use of corticosteroids for the treatment of bronchial asthma can cause growth disorders. 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 indicators for adults.

Therapy with inhaled budesonide 1 or 2 times a day has shown effectiveness in the prevention of exercise-induced bronchial asthma.

Influence on the ability to drive a car or other mechanisms. Pulmicort ® does not affect the ability to drive a car or other mechanisms.

Application of Pulmicort ® with a nebulizer

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

It is important to inform the patient about the following:

Ultrasonic nebulizers are not suitable for the use of Pulmicort ® Suspension;

Pulmicort ® suspension is mixed with 0.9% sodium chloride solution or with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium bromide; the diluted suspension is used within 30 minutes;

After inhalation, rinse your mouth with water to reduce the development of oropharyngeal candidiasis;

To prevent skin irritation after using the mask, rinse your face with water;

In cases where the child cannot breathe on his own through the nebulizer, a special mask is used.

How to use Pulmicort ® with a nebulizer

1. Shake the container gently with a slight swirling motion before use.

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

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

The container containing the single dose is marked with a line. If the container is turned upside down, this line will show a volume of 1 ml.

If only 1 ml of suspension is to be used, squeeze out the contents of the container until the surface of the liquid reaches the level indicated by the line.

Store open container in a place protected from light. An open container must be used within 12 hours.

Shake the contents of the container gently with a twisting motion before using the rest of the liquid.

Note

Name:

Pulmicort (Pulmicort)

Pharmacological
action:

GCS for inhalation use. Budesonide at 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 incidence of side effects than when using systemic corticosteroids. Reduces the severity of edema of the bronchial mucosa, mucus production, sputum formation and airway hyperreactivity.
It is well tolerated during long-term treatment, does not have mineralocorticoid activity.
The time of onset 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 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 was shown while taking Pulmicort. At recommended doses, the drug has significantly less effect on adrenal function than prednisone at a dose of 10 mg, as shown in ACTH tests.

Pharmacokinetics
Suction
After inhalation, budesonide is rapidly absorbed. In adults, the systemic bioavailability of budesonide, after inhalation of Pulmicort through a nebulizer, is approximately 15% of the total administered dose and about 40-70% of the delivered dose. Cmax in blood plasma is reached 30 minutes after the start of inhalation.
Distribution and metabolism
Plasma protein binding averages 90%. Vd of budesonide is approximately 3 l / kg.
Budesonide undergoes intensive biotransformation (more than 90%) in the liver with the formation of metabolites with low glucocorticoid activity.
The glucocorticoid activity of the main metabolites (6β-hydroxy-budesonide and 16α-hydroxyprednisolone) is less than 1% of the glucocorticoid activity of budesonide.
Budesonide is metabolized mainly with the participation of the CYP3A4 enzyme.

breeding
Budesonide is excreted in the urine as unchanged or conjugated metabolites. Budesonide has a high systemic clearance (about 1.2 l/min). The pharmacokinetics of budesonide is proportional to the administered dose of the drug.
Pharmacokinetics in special clinical situations
The pharmacokinetics of budesonide in children and patients with impaired renal function has not been studied.
In patients with liver disease, an increase in the residence time of budesonide in the body is possible.

Indications for
application:

Bronchial asthma requiring maintenance therapy with corticosteroids;
- chronic obstructive pulmonary disease (COPD).

Mode of application:

The dose of the drug Pulmicort is set individually.
In the event that the recommended dose does not exceed 1 mg / day, the entire dose of the drug is administered at a time (at one time).
In case of taking a higher dose, it is recommended to divide it into 2 doses.
Starting dose for adults(including elderly patients) is 1-2 mg / day. The maintenance dose is 0.5-4 mg / day.
In case of severe exacerbations, the dose may be increased.
Children aged 6 months and older the recommended initial dose is 0.25-0.5 mg / day. If necessary, the dose can be increased to 1 mg / day. The maintenance dose is 0.25-2 mg / 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 / day) of Pulmicort can be recommended instead of a combination of the drug with GCS for oral administration, due to a lower risk of developing systemic effects.
Patients receiving oral HSC
Cancellation of GCS for oral administration should be started against the background of a stable state of health of the patient.
Within 10 days, high doses of Pulmicort are prescribed while taking GCS orally at the usual dose. In the future, within a month, the dose of corticosteroids taken orally (for example, 2.5 mg of prednisolone or its analogue) should be gradually reduced to the minimum effective dose. In many cases, it is possible to completely refuse to take GCS orally.
There are no data on the use of budesonide in patients with renal or hepatic impairment. 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 liver cirrhosis can be expected.

Application of Pulmicort with a nebulizer
Pulmicort is used for inhalation using an appropriate nebulizer equipped with a mouthpiece and a special mask. The nebulizer is connected to a compressor to create the required air flow (5-8 l/min), the filling volume of the nebulizer should be 2-4 ml.
Since Pulmicort administered in the form of a suspension via a nebulizer enters the lungs during inhalation, it is important to instruct the patient to inhale the drug calmly and evenly through the nebulizer mouthpiece.
In cases where the child cannot breathe on his own through the nebulizer, a special mask is used.
The patient should be informed about the need to carefully read the instructions for use of 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 a 0.9% solution of sodium chloride or with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium bromide.

The patient must remember that after inhalation, rinse your mouth with water to reduce the risk of developing oropharyngeal candidiasis and that to prevent skin irritation after using the mask, rinse the face with water. You should also be aware that the diluted Pulmicort suspension should be used within 30 minutes.
It is recommended to clean the nebulizer 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 rinsed well and dried by connecting the chamber to a compressor or air inlet valve.

Rules for using Pulmicort with a nebulizer:
- before use, gently shake the container with a slight rotational movement;
- hold the container straight upright and open it by turning and tearing off the "wing";
- carefully place the container with the open end into the nebulizer and slowly squeeze out the contents of the container.
The container containing the single dose is marked with a line. If the container is turned upside down, this line will show a volume of 1 ml.
If only 1 ml of suspension is to be used, the contents of the container are squeezed out until the surface of the liquid reaches the level indicated by the line.
The opened container is stored in a place protected from light. An open container must be used within 12 hours.
Before using the rest of the liquid, the contents of the container are gently shaken with a rotary motion.

How to use Pulmicort Turbuhaler
The dose of the drug is selected individually. Children over 6 years old: 100-800 mcg per day. The total daily dose is usually divided into several doses (2-4 inhalations).
By decision of the attending physician, a dose not exceeding 400 mcg / day may not be divided, but included in one dose.
The transition to a single dose should be carried out under the supervision of a pediatrician.
Adults: 200-800 micrograms per day. The dose can be divided into several doses, if the dose does not exceed 400 mcg per day, a single dose is allowed.
In the case of treatment of severe exacerbations, it is possible to increase the daily dose to 1600 mcg.
When transferring a patient from an aerosol form of the drug to Pulmicort Turbuhaler, a decrease in the daily dose of the drug is possible.

Side effects:

The drug is well tolerated.
Possible side effects:
- on the part of the respiratory system: candidal lesions of the oropharynx, irritation of the mucous membranes of the respiratory tract, cough, dry mouth. In view of the risk of developing candidal lesions of the oropharynx, the patient should carefully monitor oral hygiene;
- from the side of the central nervous system: nervousness, excitability, depression, inappropriate behavior, clouding of consciousness;
- from the endocrine system: symptoms of systemic action of glucocorticosteroids, hypofunction of the adrenal cortex;
- allergic reactions: rash, urticaria, contact dermatitis, angioedema, possibly irritation of the skin of the face when using a nebulizer with a mask.

Contraindications:

Age up to 6 years (Pulmicort Turbuhaler);
- age up to 6 months (Pulmicort suspension for inhalation);
- hypersensitivity to budesonide.

Carefully(more careful monitoring of patients is required) the drug should be prescribed to patients with an active form of pulmonary tuberculosis, fungal, viral, bacterial infections of the respiratory system, cirrhosis of the liver.
When prescribing, one should take into account the possible manifestation of the systemic action of GCS.

To minimize the risk of fungal infection of the oropharynx, 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.
Co-administration of budesonide with ketoconazole, itraconazole, or other potential inhibitors of CYP3A4 should be avoided. If such a combination is necessary, the time between doses should be increased to the maximum possible.
Due to the possible risk of weakening the function of the adrenal glands, special attention should be paid to patients who are transferred from systemic corticosteroids to taking Pulmicort.
Also, special attention should be paid to patients who have taken high doses of corticosteroids or who have received the highest recommended doses of inhaled corticosteroids for a long time.
In stressful situations, these patients may show signs and symptoms of adrenal insufficiency. In case of stress or in cases of surgical intervention, additional therapy with systemic corticosteroids is recommended.

Particular attention should be paid to patients who are transferred from systemic to inhaled corticosteroids (Pulmicort) or in the case when a violation of the pituitary-adrenal function can be expected. In such patients, it is necessary with extreme caution 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 additional administration of corticosteroids for oral administration during 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, it may be necessary to temporarily increase the dose of corticosteroids for oral administration. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may be observed, indicating systemic insufficiency of GCS.
When switching from oral GCS to inhaled ones, it is sometimes possible to exacerbate existing allergic reactions, rhinitis and eczema, which were previously stopped by systemic drugs.Therapy with Pulmicort when used 1 or 2 times / day has shown effectiveness in the prevention of exercise-induced asthma.

Pediatric use
In children and adolescents receiving treatment with corticosteroids (any form) for an extended period, it is recommended to regularly monitor growth indicators. When prescribing GCS, the ratio of the expected benefit from the use of the drug and the potential risk of growth retardation should be assessed.
The use of budesonide at a dose of up to 400 mcg / day in children older than 3 years did not lead to systemic effects. Biochemical signs of a systemic effect of the drug may occur when using the drug at a dose of 400 to 800 mcg / day. When exceeding a dose of 800 mcg / day, systemic effects of the drug are common.
The use of corticosteroids for the treatment of bronchial asthma can cause growth disorders. 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 indicators for adults.

Influence on the ability to drive vehicles and control mechanisms
Pulmicort does not affect the ability to drive a car or other mechanisms.

Interaction
other medicinal
by other means:

There was no 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 the blood plasma increased by an average of 3 times.
There is no information on such an interaction when taking budesonide in the form of inhalation, however, it is assumed that in this case, an increase in the concentration of budesonide in the blood plasma should be expected.

If necessary, taking ketoconazole and budesonide should increase the time between doses of drugs to the maximum possible. You should also consider reducing the dose of budesonide.
Another potential inhibitor of CYP3A4, itraconazole, also significantly increases the plasma concentration of budesonide.
Pre-inhalation of beta-agonists dilates the bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect.
Phenobarbital, phenytoin, rifampicin, with simultaneous use, reduce the effectiveness of Pulmicort (due to the induction of microsomal oxidation enzymes).
Methandrostenolone, estrogens enhance the effect of budesonide.

Pregnancy:

Observation of pregnant women taking budesonide did not reveal abnormalities in the development of the fetus, however, the risk of their development cannot be completely excluded, therefore, during pregnancy, due to the possibility of worsening the course of bronchial asthma, the minimum effective dose of the drug should be used.
Budesonide is excreted in breast milk, however, when using Pulmicort in therapeutic doses, no effect on the child was noted.
Pulmicort can be used for breastfeeding.

Overdose:

In acute overdose of the drug, there are no clinical manifestations.
In chronic overdose, the effects of hypercortisolism and suppression of adrenal function may occur.
Possible clinical manifestations of hypercortisolism: weight gain, striae, arterial hypertension, hyperpigmentation, muscle weakness, amenorrhea.
In case of chronic overdose for the treatment of hypercortisolism, the drug is canceled by gradually lowering the dosage.

Release form:

Suspension for inhalation Pulmicort through a nebulizer in containers of 2 ml, 20 pcs. packaged.
Powder for inhalation Pulmicort-Turbuhaler in a metered dose inhaler of 100 or 200 doses. The inhaler consists of a dosing device, a powder storage tank, a desiccant tank, a mouthpiece and a cap.

Storage conditions:

The drug should be stored out of the reach of children at temperatures below 30°C.
Shelf life - 2 years.
Do not use after the expiry date stated on the packaging.
After opening the envelope, the containers contained in it should be used within 3 months. Containers should be stored in an envelope to protect them from light.
An open container must be used within 12 hours.

1 ml suspension Pulmicort for dosed inhalation contains:
- active ingredient: budesonide (micronized) - 250 mcg or 500 mcg;
- excipients: sodium chloride, sodium citrate, disodium edetate (ethylenediaminetetraacetic acid sodium salt (disubstituted)), polysorbate 80, citric acid (anhydrous), purified water.

1 dose of Pulmicort-Turbuhaler Powder for dosed inhalation contains:
- active ingredient: budesonide - 100 mcg or 200 mcg.