Pulmicort, 20 pcs., 2 ml, 0.5 mg/ml, dosed suspension for inhalation

Release form

Pulmicort is available in two versions: dosed suspension for inhalation may contain 0.25 mg/ml or 0.5 mg/ml budesonide . Available in cardboard packs containing 20 containers of 2 ml each.

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

Use of the drug Pulmicort

Dosing is individual. If the daily dose does not exceed 1 mg, the entire dose can be administered simultaneously. If a higher daily dose is required, it should be divided into 2 doses per day. The initial dose is: in children over 6 months of age : 0.25–0.5 mg/day. If necessary, the dose can be increased to 1 mg/day; in adults : 1–2 mg/day. For maintenance treatment: in children over 6 months of age : 0.25–2 mg/day; in adults : 0.5–4 mg/day. In severe cases, the dose can be increased. Dosage table

*It is necessary to increase the volume to 2 ml using 0.9% saline solution or aerosol solution (Pulmicort suspension for inhalation can be mixed with sodium chloride solution 9 mg/ml (0.9%) and/or aerosol solutions containing terbutaline, salbutamol, fenoterol, acetylcysteine, cromoglycic acid or ipratropium bromide.

The mixture should be used within 30 minutes). After using a single dose, the effect occurs within a few hours. The full therapeutic effect is achieved only after several weeks of treatment. The maintenance dose should be as low as possible. Patients using oral steroids When replacing therapy with oral steroids, the patient should be in a relatively stable condition. For 10 days, Pulmicort suspension is used in a high dose in combination with the dose of an oral steroid that was used previously. Thereafter, the oral dose should be gradually reduced to the maximum possible level, for example by 2.5 mg of prednisolone or equivalent per month. Often, the use of an oral steroid can be stopped completely. Because budesonide enters the lungs through inhalation, it is important that the patient inhales the drug slowly and evenly through the nebulizer nozzle. There is no experience in treating patients with impaired hepatic and renal function. Since budesonide is eliminated primarily by hepatic metabolism, caution is required when used in patients with severe liver cirrhosis. Children who cannot inhale the drug through the nozzle can use a breathing mask. Using Pulmicort using a nebulizer Pulmicort is inhaled using a jet nebulizer with a nozzle or an appropriate breathing mask. Ultrasonic nebulizers should not be used because they provide a very low dose of budesonide to the patient. The nebulizer and compressor (propellant) should be adjusted so that most of the supplied liquid droplets are within 3–5 microns. in vitro study showed that the Pari Inhalierboy, Pari Master and Ailos nebulizers provided comparable doses of budesonide. The amount of budesonide delivered to the patient varies between 11-22% of the nebulizer dose and depends on factors such as: nebulization time; filling volume; technical characteristics of the compressor (propellant) and nebulizer; the volume of air that the patient inhales; use of a breathing mask or nozzle. The speed of air flow through the nebulizer also matters. To obtain the maximum possible dose of budesonide, the flow rate should be 5–8 L/min. The filling volume should be 2–4 ml. The available dose for small children is maximized by using a breathing mask that fits tightly to the face.

Pharmacodynamics and pharmacokinetics

Budesonide, which enters the body by inhalation, is quickly absorbed. Approximately 25-30% of the drug dose reaches the lungs. After half an hour, the highest concentration of the drug in the blood plasma . The systemic bioavailability of Pulmicort is approximately 38% of the dose taken.

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. Upon completion of absorption, intense biotransformation of budesonide occurs in the liver, resulting in the formation of metabolites that have low glucocorticosteroid activity.

The substance budesonide INN is mainly metabolized with the participation of the enzyme CYP 3A4. Then, in conjugated form or simply with urine, unchanged metabolites are excreted from the body.

The pharmacokinetics of budesonide in patients with impaired renal function and in children is unknown. And in patients with liver disease, the time budesonide remains in the body may increase.

Pharmacological properties of the drug Pulmicort

budesonide (INN - budesonidum - budesonide) is a corticosteroid that has a pronounced local anti-inflammatory effect. The affinity of budesonide for GCS receptors is approximately 15 times higher than that of prednisolone. The anti-inflammatory effect causes a decrease in bronchial obstruction both at the early and late stages of the allergic reaction. Budesonide reduces the activity of histamine and methacholine. Absorption. After inhaled administration, budesonide is rapidly absorbed. The maximum plasma concentration is reached within 60 minutes after the start of nebulization and is approximately 4 nmol/l after a dose of 2 mg. In adults, pulmonary distribution of nebulized budesonide is approximately 15% of the nominal dose. Systemic availability via a jet nebulizer is also approximately 15% of the nominal dose, a small portion of which is due to absorption of the drug that has been ingested. Distribution and metabolism. Plasma protein binding is approximately 90%. The volume of distribution is approximately 3 l/kg. Budesonide undergoes significant (≈90%) first-pass metabolism in the liver to metabolites with low GCS activity. The GCS activity of the main metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is ≤1% of the activity of budesonide. Removal . Budesonide is eliminated by metabolism catalyzed primarily by the CYP3A4 enzyme. Metabolites are excreted in the urine in unchanged or conjugated form. Only a small amount of unchanged budesonide is detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 l/min), its plasma half-life after intravenous administration averages 4 hours. The pharmacokinetic parameters of budesonide are dose proportional at clinically significant doses. Children. In children aged 4-6 years with asthma, the maximum plasma concentration is reached within 20 minutes after the start of nebulization and is approximately 2.4 nmol/l after taking a dose of 1 mg. In patients with asthma aged 4-6 years, the pulmonary distribution of budesonide administered by nebulizer is 6% of the nominal dose, and the systemic availability of budesonide after inhalation with a jet nebulizer (Pari LC Jet Plus with Pari Master compressor) is approximately 6% of the nominal dose. In children aged 4 to 6 years with asthma, the systemic clearance of budesonide is approximately 0.5 l/min. In children (per 1 kg of body weight), the clearance is approximately 50% higher than the clearance in adults. In children with asthma, the terminal half-life of budesonide after inhalation is about 2 hours, as in healthy adults. The maximum concentration and AUC following a single dose of 1 mg nebulized budesonide in children aged 4 to 6 years are comparable to those in healthy adults receiving the same dose of budesonide using the same nebulization system. The pharmacokinetics of budesonide in patients with impaired renal function is not known. The effect of budesonide may be increased in patients with liver disease.

Side effects

For the respiratory system: dry mouth, cough, irritation of the mucous membranes of the respiratory tract, carious lesions of the oropharynx. Considering the possibility of carious lesions of the oropharynx, those taking the drug should carefully monitor oral hygiene.

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

For the central nervous system: excitability, inappropriate behavior, nervousness, depression, fog.

Allergic reactions: contact dermatitis , rash, angioedema , urticaria . If you use a nebulizer with a mask, facial skin irritation may occur.

Side effects of the drug Pulmicort

The number of local side effects that were noted in patients using the drug is up to 10%.

When using inhaled corticosteroids, in order to minimize the risk of candidal infections of the oropharynx, the patient should rinse his mouth with water after each procedure. In isolated cases, signs or symptoms of systemic glucocorticoid effects, including adrenal hypofunction, may appear. Facial skin irritation has been reported in some cases where a breathing mask has been used. To prevent irritation, you should wash your face after using the mask.

Instructions for use of Pulmicort (Method and dosage)

The drugs Pulmicort and Pulmicort Turbuhaler are used as prophylactic agents in the case of bronchial asthma , while the use of these drugs during acute attacks of this disease is not advisable. Given the low likelihood that systemic effects will develop, the daily dosage of these drugs can be increased to achieve an improved therapeutic effect up to 1000 mcg instead of combining the drug with other oral corticosteroids.

To switch to Pulmicort or Pulmicort Turbuhaler, you need to stop taking oral glucocorticosteroids 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 the course of a month, in increments of reduction in terms of prednisolone of 2.5 mg). Thanks to this scheme, in some cases it is even possible to completely abandon oral corticosteroids.

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

Instructions for use of Pulmicort for inhalation

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

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

Maintenance daily dosage for children from 6 months is 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 the drug Pulmicort is the selection of the minimum maintenance dose on an individual basis.

A suspension of the drug Pulmicort is used for inhalation using a compressor nebulizer , which is equipped with a special mask and mouthpiece. The nebulizer is connected to a compressor, which creates the required air flow (approximately 5-8 liters per minute), should be filled in volume by 2-4 ml. Please note that ultrasonic nebulizers are 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 marked line. Before using the remaining liquid, the liquid contained in the container must be shaken using a rotational motion. Considering that Pulmicort, using a nebulizer, enters the patient’s lungs when inhaled, it is necessary to instruct the patient to inhale the drug evenly and carefully.

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

Instructions for use of Pulmicort Turbuhaler

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

The daily dose for children from 6 years of age is 100-800 mcg. As a rule, the daily dose is taken for 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 done under the supervision of a pediatrician.

The daily norm for adults is 200-800 mcg. If the dose is no more than 400 mcg, then it can be taken at a time, and for larger doses it can be divided into several doses. When treating severe exacerbations, the daily dose can be increased to 1600 mcg. If a patient switches from using the aerosol form to Pulmicort Turbuhaler, the daily dose may be reduced. When selecting a maintenance dose of the drug, you 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 during active inhalation through the mouthpiece. Turbuhaler is a reusable inhaler that allows you to inhale and dose the drug in small doses.

The drug Turbuhaler is quite easy to use, you just need to follow simple instructions:

• You need to unscrew and then remove the cap.
• The inhaler should be held vertically with the dispenser 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 for the required dose to reach the lungs, inhale deeply through your mouth, first squeezing the mouthpiece with your teeth and wrapping your lips around it. If not one, but several inhalations are required, then repeat steps 2, 3 and 4 the required number of times.
• Close the inhaler tightly with the cap.
• Be sure to rinse your mouth with water, which will reduce the risk of oropharyngeal fungal infection to a minimum.

Given the small amount of powder you inhale during inhalation, 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 required dose of the drug when you inhale.

Once a week, you should clean the outside of the mouthpiece using a dry cloth. Do not use liquids for cleaning.

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

"Pulmicort" in the form of a suspension: instructions

Also for inhalation, a suspension is used, which is prepared from powder. In this form, the drug is used to treat laryngotracheitis in children. For preparation, use a physiological solution of table salt with a concentration of 0.9%.

When diluting 1 ml, the medicine is diluted in 1 ml of saline, resulting in a single dosage of 2 ml. The prepared suspension is mainly given to children under 11 years of age, inclusive, 2 times a day. If the child is under 5 years of age inclusive, use 0.5 ml of suspension 2 times a day. Moreover, the solution is prepared fresh so that it can be used immediately.

Overdose

In case of acute overdose, no clinical manifestations occur. If the overdose is chronic, the effects of hypercortisolism , as well as suppression of adrenal function.

In addition, clinical manifestations of hypercortisolism may be observed: arterial hypertension , muscle weakness, weight gain, amenorrhea , hyperpigmentation . Also, in case of chronic overdose for the treatment of hypercortisolism, the drug is gradually discontinued, systematically reducing the dosage.

special instructions

To minimize the risk of oropharyngeal fungal infection, the patient should be instructed to rinse the mouth with water after each inhalation of this medication.

The drugs Pulmicort and Pulmicort Turbuhaler should not be taken together with Itraconazole , Ketoconazole , as well as other substances that retain CYP 3A4 in the body. If these substances were nevertheless prescribed to the patient simultaneously with budesonide (the main active ingredient of the drug), then the time between doses of these drugs should be maximized.

Due to the risks that pituitary-adrenal function may be weakened, special attention is required to those patients who are transferred to Pulmicort and Pulmicort Turbuhaler from oral glucocorticosteroids. In addition, special attention should be paid to those patients who have received the maximum recommended doses of glucocorticosteroids for a long time. Such patients may experience symptoms and signs of adrenal insufficiency . Also, in cases of surgery or stress, additional therapy with systemic glucocorticosteroids is recommended.

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

If a patient switches from taking oral corticosteroids to 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, nausea and vomiting, headache, and fatigue may also occur, which indicates a systemic deficiency of glucocorticosteroids.

If oral corticosteroids have been replaced by inhaled ones, then sometimes a concomitant allergy ( eczema or rhinitis ) appears, which was previously treated with systemic medications.

In addition, patients should be instructed that if the effectiveness of therapy with short-acting bronchodilators is reduced, they should consult a doctor, since an unauthorized increase in the frequency of use of the drug may delay the prescription of an adequate dosage for treatment. If there is a sudden deterioration in the condition, then the possibility of treatment with oral corticosteroids should be considered.

Interactions of the drug Pulmicort

There are no data on clinically significant cases of interaction of inhaled corticosteroids with drugs used for asthma. Ketoconazole at a dose of 200 mg 1 time per day increases the plasma concentration of oral budesonide (3 mg 1 time per day) by an average of 6 times when taken simultaneously. When ketoconazole was administered 12 hours after budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information about such an interaction regarding inhaled budesonide, however, in this case, a significant increase in its level in the blood plasma is expected. Since there are no data to make dosage recommendations, combinations of these drugs should be avoided. If this is not possible, the interval between the use of ketoconazole and budesonide should be increased if possible. The possibility of reducing the dose of budesonide should also be considered. Other potent CYP3A4 inhibitors, such as itraconazole, also lead to significant increases in budesonide plasma levels.

Analogues of Pulmicort

Level 4 ATX code matches:
Alvesco

Budenit Steri-Neb

Asmanex

Beclazon

Budesonide

Flixotide

Aldecin

The drugs Pulmicort in nebulas and Pulmicort Turbuhaler have the following analogues:

• Apulein
• Benacort
• Benacap
• Budenit Steri-Neb
• Budesonide
• Benarin
• Budesonide Easyhaler
• Tafen nasal
• Budoster
• Budesonide-Nativ
• Budiair
• Novopulmon E Novolizer
• Tafen Novolizer

Which is better: Berodual or Pulmicort?

You can often find this question among reviews. These are slightly different drugs: Berodual relieve spasms from the bronchi and help relieve shortness of breath, and Pulmicort is used to relieve swelling from inflammation. For obstructive bronchitis in children, some were prescribed Berodual along with Pulmicort.

"Pulmicort" and "Berodual": comparison

Both medications are often taken together - on the recommendation of a pediatrician. Moreover, “Berodual” is used for prevention, and “Pulmicort” is used to relieve asthma symptoms.

The difference between the drugs is that Berodual, unlike Pulmicort, is not a hormonal drug. It blocks prescriptions that help relieve bronchial spasm. In this case, the effect occurs within a few minutes. At the same time, Berodual does not allow a complete cure for asthma. Therefore, complex therapy is necessary on the recommendation of a pediatrician and pulmonologist.

“Pulmicort” is classified as a hormonal drug, which scares many parents. It is believed, for example, that it will lead to growth and metabolic problems. In fact, the medication is safe if the dosage is followed. In addition, it is available only by prescription - a preliminary consultation with a doctor is required.

During pregnancy and lactation

When pregnant women take the substance budesonide, no increased risk of developing abnormalities in the fetus has been found. However, these risks should not be completely excluded, therefore, when taking the drug during pregnancy , you should use the minimum effective dosage of the drug to avoid worsening bronchial asthma .

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

The following information will be useful for nursing mothers: there is no evidence that budesonide can pass into breast milk. But still, when prescribing this drug, you need to take into account the potential risks for the child, comparing them with the expected benefits.

Contraindications

In some cases, Pulmicort cannot be used:

• children up to 6 months inclusive;
• hypersensitivity to the active substance.

The drug can be used during pregnancy - no problems with fetal development have been identified. Although the active ingredient passes into breast milk, no harmful effects on the baby have been established. This allows you to use the product at any stage of breastfeeding. But it is better to reduce the dosage after consulting a doctor.

"Pulmicort" is used with caution in the presence of the following disorders:

• open tuberculosis;
• respiratory infections of various origins (viral, fungal, bacterial):
• cirrhosis of the liver.

Reviews for Pulmicort

On the Internet you can find a variety of, sometimes even opposing, reviews. As a rule, among the negative ones, the most common are those in which we are talking about allergic reactions that occurred after using the drug, the appearance of problems with the adrenal glands, as well as general disorders of the body associated with hormonal changes. At the same time, many do not know for sure whether the drug is hormonal or not, although this is stated in the instructions.

Various forums also had reports that some complained of a sharp deterioration in health that occurred after stopping use of the drug. As a rule, such reviews are written by those people who gave up the drug too abruptly, and did not gradually reduce the dosage, as should be done. Reviews for Pulmicort Turbuhaler are similar.

When taken by children, reviews are rather alarming in nature, which is caused by concerns about the extensive list of side effects of the drug, as well as the fact that the drug is hormonal. However, no categorically negative reviews about inhalations for children were found. At the same time, many noted that Pulmicort was prescribed laryngitis

Among the positive reviews, you can find those that talk about the effectiveness of the drug already in the first sessions of use. Many note that the drug copes well with asthma attacks and perfectly helps in the stated indications for use, as evidenced by the majority of reviews.

Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

pharmachologic effect

Antiallergic, anti-inflammatory, glucocorticoid.

Composition and release form Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

Dosed suspension for inhalation - 1 ml:

• active substance: budesonide (micronized) - 0.25/0.5 mg;
• excipients: sodium chloride - 8.5 mg; sodium citrate - 0.5 mg; disodium edetate (sodium salt of ethylenediaminetetraacetic acid disubstituted, disodium salt EDTA) - 0.1 mg; polysorbate 80 - 0.2 mg; citric acid (anhydrous) - 0.28 mg; purified water - up to 1 ml.

Suspension for inhalation dosed, 0.25 mg/ml and 0.5 mg/ml. 2 ml of the drug in a LDPE container. 5 containers are connected into 1 sheet. A sheet of 5 containers is packaged in a laminated foil envelope. 4 envelopes in a cardboard box.

Description of the dosage form

An easily resuspended, white or off-white, sterile suspension in LDPE containers containing a single dose.

Directions for use and doses

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). If you take 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.

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

It is advisable to determine the minimum effective maintenance dose for all patients.

If it is necessary to achieve an additional therapeutic effect, it is possible to recommend increasing the daily dose of Pulmicort® (up to 1 mg/day) instead of combining the drug with oral corticosteroids, due to the lower risk of developing systemic effects.

Patients receiving oral corticosteroids

Cancellation of oral corticosteroids should begin against the background of a stable health condition of the patient. For 10 days, it is necessary to take a high dose of Pulmicort® while taking oral corticosteroids at the usual dose. Subsequently, over 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 stop taking oral corticosteroids.

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

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

Stenosing laryngotracheitis (false croup)

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

Using Pulmicort® using 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:

• you must 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 is used within 30 minutes;
• after inhalation, you should 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 a child cannot independently inhale through a nebulizer, a special mask is used.

How to use Pulmicort® using a nebulizer

1. Before use, gently shake the container with a gentle swirling motion.
2. Hold the container straight upright and open it by turning and tearing off the “wing”.
3. Carefully place the open end of the container into the nebulizer and slowly squeeze out the contents of the container.

The container containing a 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 the opened container in a place protected from light. An opened container must be used within 12 hours.

Before using the remaining liquid, carefully shake the contents of the container with a rotational motion.

Note

1. After each inhalation, rinse your mouth with water.
2. If the patient uses a mask, make sure that the mask fits tightly to the face when inhaling. Wash your face after inhalation.

Cleaning

The nebulizer chamber, mouthpiece or mask should be cleaned after each use.

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

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 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 and does not have mineralocorticosteroid activity.

The time for the onset of the therapeutic effect after inhalation of one 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 while taking Pulmicort® was shown. 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. Cmax 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 intense 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.

Excretion. Budesonide is metabolized mainly 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 is proportional to 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 disease, the residence time of budesonide in the body may increase.

Indications for use Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

• 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.

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 prescribing, the possible manifestation of the systemic effect of GCS should be taken into account.

Application Pulmicort 0.25 mg/ml 2 ml 20 pcs. suspension for inhalation, dosed during pregnancy and breastfeeding

Observation of pregnant women taking budesonide did not reveal developmental abnormalities in 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.

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. If budesonide and ketoconazole or other potential CYP3A4 inhibitors have been prescribed, the time between doses should be increased to the maximum possible.

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

Particular attention should be paid to patients who are transferred from systemic to inhaled GCS (Pulmicort®), or in cases where 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 the hypothalamic-pituitary-adrenal function should be monitored. Patients may also require the addition of oral corticosteroids during stressful situations, such as trauma or 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 occur, indicating systemic insufficiency of GCS.

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

In children and adolescents receiving treatment with corticosteroids (regardless of the method of delivery) for an extended period, it is recommended to regularly monitor growth parameters. When prescribing GCS, the balance between 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 over 3 years of age 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 the dose exceeds 800 mcg/day, systemic effects of the drug are common.

The use of corticosteroids for the treatment of bronchial asthma may cause growth impairment. The results of observations of children and adolescents receiving 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 for the prevention of bronchial asthma due to physical exertion.

Impact on the ability to drive a car or use other machinery. Pulmicort® does not affect the ability to drive a car or use other machinery.

Overdose

Symptoms: in case of acute overdose, no clinical manifestations occur. With prolonged use of the drug in doses significantly higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercortisolism and suppression of adrenal function.

Side effects Pulmicort 0.25 mg/ml 2 ml 20 pcs. dosed suspension for inhalation

The incidence of undesirable effects is presented as follows: often (>1/100.1/1000.1/10000,

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

From the side of the central nervous system: rarely - nervousness, excitability, 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, symptoms caused by the systemic effect of corticosteroids, including adrenal hypofunction, may occur.

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

Drug interactions

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

Ketoconazole (200 mg once daily) increases plasma concentrations of oral budesonide (3 mg once daily) by an average of 6-fold when administered 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. There is no information on such an interaction when taking budesonide in the form of inhalation, but it is assumed 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, the time between doses of the drugs should be increased to the maximum possible. A dose reduction of budesonide should also be considered. Another potential inhibitor of CYP3A4 (eg itraconazole) also significantly increases plasma concentrations of budesonide.

Pre-inhalation of beta-agonists dilates the bronchi, improves the entry 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 and estrogens enhance the effect of budesonide.

Price, where to buy

The price of Pulmicort for inhalation varies depending on the calculated doses. 20 pieces of 500 mcg/ml can be purchased from 1150 to 1250 rubles. Nebulas for 20 pieces of 250 mcg/ml cost from 800 to 950 rubles.

The price for Pulmicort Turbuhaler in different pharmacies is set from 700 to 800 rubles. for the 100 mcg per dose option. The option with 200 mcg per dose costs about 450 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Pulmicort Susp.
  for in. 0.5 mg/ml cont. 2ml 20 pcs AstraZeneca AB 889 RUR order

Pharmacy Dialogue

• Pulmicort sachets 0.25 mg/ml 2 ml No. 20Astra Zenesa

  RUR 645 order

• Pulmicort sachets 0.5 mg/ml 2 ml No. 20Astra Zenesa

  922 rub. order

• Pulmicort Turbuhaler (portion d/ing. 200 mcg/dose 100 doses) Astra Zenesa

  RUB 423 order

• Pulmicort Turbuhaler (portion d/ing. 100 mcg/dose 200 doses) Astra Zenesa

  RUR 585 order

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Pharmacy24

• Pulmicort Turbuhaler powder for inhalation 200 mcg/dose 100 doses Astra Zeneca AB, Sweden
  276 UAH.order
• Pulmicort Turbuhaler powder for inhalation 100 mcg/dose 200 doses Astra Zeneca AB, Sweden

  269 ​​UAH. order

• Pulmicort nebula 0.5 mg/ml 2 ml N20 suspension for inhaler Astra Zeneca AB, Sweden

  759 UAH. order

• Pulmicort nebula 0.25 mg/ml 2 ml No. 20 suspension for inhaler Astra Zeneca AB, Sweden

  526 UAH order

PaniPharmacy

• aerosol Pulmicort turbuhaler 100 mg/dose 200 doses Ukraine, AstraZeneca

  277 UAH order

• Pulmicort liquid Pulmicort suspension. d/spray 0.25 mg/ml cont. 2ml No. 20 (4x5) Sweden, AstraZeneca

  548 UAH order

• Pulmicort liquid Pulmicort suspension for spraying 0.5 mg/ml container 2 ml No. 20 (4x5) Sweden, AstraZeneca

  812 UAH order

• aerosol Pulmicort turbuhaler 200 mg/dose 100 doses Ukraine, AstraZeneca

  273 UAH order

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Storage conditions for the drug Pulmicort

At temperatures below 30 °C. Keep closed using the protective cap. An open container should be used within 12 hours. After opening the envelope, the containers it contains should be used within 3 months. Always store unopened containers in an envelope to protect them from light. If only 1 ml was used, the remainder is not sterile. Single-dose packages should be stored in an upright position to protect the suspension from settling. The 0.25 and 0.5 mg/mL dose packs have a line indicating the 1 mL level when the single-dose packs are held upside down.

List of pharmacies where you can buy Pulmicort:

• Moscow
• Saint Petersburg