Pulmicort suspension for inhalation doses. 0.25 mg/ml 2ml No. 20 buy in Moscow at a price of 612.5 rubles

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.

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.

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

Dose (mg)	Volume of Pulmicort (suspension for inhalation)
Dose (mg)	0.25 mg/ml	0.5 mg/ml
0,25	1 ml*	–
0,5	2 ml	–
0,75	3 ml	–
1	4 ml	2 ml
1,5	–	3 ml
2	–	4 ml

*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.

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.

Side effects of the drug Pulmicort

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

Common (1/100)	Airways	Candidal infection of the mouth and throat, mild throat irritation, cough, hoarseness
Single (≤1/1000)	Are common	Angioedema
	CNS	Nervousness, anxiety, depression, behavior disorder
	Leather	Urticaria, rashes, dermatitis, subcutaneous hemorrhages
	Airways	Bronchospasm

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.

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.

Special instructions for the use of the drug Pulmicort

When using inhaled steroids, patients should rinse their mouths with water after each dose, as there is a risk of infection of the oropharynx with fungal microflora. Concomitant treatment with ketoconazole, itraconazole or other strong CYP3A4 inhibitors should be avoided. If cancellation is not possible, the interval between the use of these drugs should be increased as much as possible. Special monitoring is required in patients who have used oral steroids, since the risk of developing adrenal insufficiency may persist over a long period of time. Patients who require acute treatment with high-dose corticosteroids or long-term treatment with inhaled corticosteroids at the highest recommended doses may also be considered at risk. These patients may develop signs and symptoms of adrenal insufficiency when under extreme stress. During periods of stress or planned surgical interventions in this group of patients, the possibility of using additional systemic corticosteroids should be considered. When switching from oral steroid therapy to inhaled corticosteroids, patients may experience symptoms such as muscle and joint pain. In such cases, a temporary increase in the dose of the oral steroid may be possible. In isolated cases, symptoms such as fatigue, headache, nausea, vomiting are noted, indicating systemic insufficiency of GCS. Replacing systemic steroid therapy with inhaled corticosteroids sometimes results in allergic manifestations such as rhinitis and eczema, which were previously controlled by systemic medications. In children and adolescents receiving long-term treatment with corticosteroids, regular growth monitoring is recommended, regardless of the form of the drug used. The benefits of GCS therapy should be considered in comparison with the possible risk of growth inhibition. As with other types of inhaled therapy, paradoxical bronchospasm may occur immediately after dosing. If severe reactions occur, treatment should be reconsidered and alternative therapy initiated if necessary. Patients should be advised to contact their physician if the effect of treatment decreases, as repeated inhalations to control severe asthma attacks should not delay the start of other important therapy. In case of sudden deterioration of the patient's condition, therapy must be supplemented with a course of short-acting oral steroids. Decreased liver function may affect the ability to eliminate budesonide. When using Pulmicort in children over 3 years of age at doses up to 400 mcg/day, no systemic effects were observed. Within the dose range of 400–800 mcg/day, biochemical signs of a systemic effect may occur. At daily doses exceeding 800 mcg, such signs are common. The asthma disease itself, as well as the use of inhaled corticosteroids, can slow down the patient’s growth. However, studies of children and adolescents treated with budesonide for an extended period of time (≤13 years) have shown that these patients achieve expected adult height. During pregnancy and breastfeeding. Data obtained from a study of approximately 2000 women during pregnancy did not reveal an increased risk of developmental disorders that would result from budesonide therapy. Results from animal studies have demonstrated that corticosteroids may cause developmental disorders, however, these data are not considered significant in humans at recommended doses. During pregnancy, it is necessary to use the least effective dose of budesonide, taking into account the risk of worsening the course of asthma. It is not known whether budesonide passes into breast milk. The use of budesonide during breastfeeding should only be considered if the expected benefit to the mother outweighs any likely risk to the baby. The drug does not affect the ability to drive vehicles or operate other machinery.

Buy Pulmicort suspension for inhalation doses. 0.25 mg/ml 2ml No. 20 in pharmacies

Pulmicort Susp. d/inhal. doses 0.25 mg/ml 2ml No. 20

Pulmicort suspension for inhalation 0.25 mg/ml, 1 dose, 2 ml

Release form, composition and packaging Dosed suspension for inhalation, white or almost white, easily resuspended.

Pharmacological action Pharmacological action - antiallergic, anti-inflammatory, glucocorticoid. 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 the drug Pulmicort® are bronchial asthma requiring maintenance therapy with GCS;

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.

Use 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.

Side effects The frequency of occurrence of undesirable effects is presented as follows: often (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.

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.

Interaction No interaction of budesonide has been observed 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.

Method of administration and dosage : 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.

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.

Overdose Symptoms: In 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.

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.

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 using 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, carefully shake the container with a gentle rotational 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.

Release form 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.

RLS > Medicines > Pulmicort® Pulmicort® (Pulmicort®) Latest update of the description by the manufacturer 10/02/2012 Packaging Active ingredient: Budesonide* (Budesonide*) Contents Composition Pharmacological action Pharmacodynamics Pharmacokinetics Indications of the drug Pulmicort Contraindications Use during pregnancy and lactation Side effects Interaction Method of administration and doses Overdose Special instructions Release form Manufacturer Terms of release from pharmacies Storage conditions of the drug Pulmicort Shelf life of the drug Pulmicort Prices in pharmacies Reviews ATX R03BA02 Budesonide Pharmacological group Glucocorticosteroid for local use [Glucocorticosteroids] Nosological classification (ICD-10) J05.0 Acute obstructive laryngitis [ croup] J44 Other chronic obstructive pulmonary disease J45 Asthma Composition Suspension for inhalation dosed 1 ml active substance: budesonide (micronized) 0.25 mg 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 Description of the dosage form An easily resuspended sterile suspension of white or almost white color in LDPE containers containing a single dose.

Pharmacological action Pharmacological action - antiallergic, anti-inflammatory, glucocorticoid. 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.

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.

Indications for the drug Pulmicort® are bronchial asthma requiring maintenance therapy with GCS;

chronic obstructive pulmonary disease (COPD);

stenosing laryngotracheitis (false croup).

Contraindications: hypersensitivity to budesonide;

children's age up to 6 months.

Use 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.

Side effects The frequency of occurrence of undesirable effects is presented as follows: often (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000), including isolated reports.

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.

Interaction No interaction of budesonide has been observed with other drugs used in the treatment of bronchial asthma.

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.

Method of administration and dosage: 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.

Dose table

Dose, mg Volume of the drug Pulmicort®, suspension for inhalation 0.25 mg/ml budesonide 0.5 mg/ml budesonide 0.25 1 ml* − 0.5 2 ml − 0.75 3 ml − 1 4 ml 2 ml 1 .5 − 3 ml 2 − 4 ml * 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.

Patients receiving oral corticosteroids

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.

Overdose Symptoms: In 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.

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.

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.

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.

Using Pulmicort® using a nebulizer

It is important to inform the patient about the following:

— you must carefully read the instructions for using the drug;

— ultrasonic nebulizers are not suitable for the use of Pulmicort® suspension;

- 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, carefully shake the container with a gentle rotational 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.

Release form 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.

Manufacturer: AstraZeneca AB, SE-151 85 Sodertalje, Sweden.

Additional information is available upon request: representative office of AstraZeneca UK Limited, UK, in Moscow and AstraZeneca Pharmaceuticals LLC.

125284, Moscow, st. Begovaya, 3, building 1.

Tel.; Fax.

Conditions for dispensing from pharmacies By prescription.

Storage conditions for the drug Pulmicort® At a temperature not exceeding 30 ° C. Keep out of the reach of children.

The shelf life of Pulmicort® is 2 years. 3 months after opening the envelope; 12 hours after opening the container. Do not use after the expiration date indicated on the package.

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.

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

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 877 RUR order

Pharmacy Dialogue

Pulmicort sachets 0.5 mg/ml 2 ml No. 20Astra Zenesa
910 rub. order
Pulmicort sachets 0.25 mg/ml 2 ml No. 20Astra Zenesa
RUR 665 order
Pulmicort Turbuhaler (portion d/ing. 200 mcg/dose 100 doses) Astra Zenesa
412 rub. order
Pulmicort Turbuhaler (portion d/ing. 100 mcg/dose 200 doses) Astra Zenesa
RUR 585 order

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

Pharmacological properties of the drug Pulmicort

Overdose

Use of the drug Pulmicort

Dose (mg)

Volume of Pulmicort (suspension for inhalation)

0.25 mg/ml

0.5 mg/ml