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

"Pulmicort" for inhalation: description of the drug

The drug belongs to the group of glucocorticosteroids. It is produced in 2 forms:

1. Solution.
2. Powder.

Used by children and adults in the form of inhalations. The active ingredient of this medication is budesonide. It is used to relieve bronchospasms and acts as an anti-inflammatory agent. Medicinal components are quickly absorbed and then excreted from the body, dissolved in the urine. Therefore, the effect occurs within a few minutes. The maximum degree of exposure is observed several hours after inhalation.

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.

Indications for use of Pulmicort

This remedy is used to treat and relieve symptoms of such pathologies:

• laryngitis (in children);
• chronic bronchitis (obstructive type);
• bronchial asthma (if its treatment requires the use of hormonal medications);
• persistent, prolonged cough, accompanied by bronchospasms.

The medication is also used for complications of asthma when symptoms occur. Inhalation can eliminate bronchospasm and normalize breathing.

Symptoms of tracheitis

In the acute form of the disease, the main symptom is a severe cough, which is almost not accompanied by sputum production. Cough attacks most often occur during sleep at night or in the morning after waking up. Deep breathing can also provoke such an attack.

After an attack, patients often complain of pain in the throat and behind the sternum when inhaling, and therefore try to breathe shallowly for some time. This is one of the characteristic symptoms of how to distinguish tracheitis from inflammatory processes in other parts of the respiratory system.

In the initial period of the disease there is almost no sputum, and what is released consists of mucus and has a very viscous and thick consistency. On the 3rd–4th day, the amount of sputum increases, impurities of pus appear in it, but it comes off more easily, which alleviates the patient’s condition during coughing attacks.

In the chronic form of tracheitis, all of the above symptoms are also present, but have a less pronounced, smoothed character. The course of this pathology is always long, wave-like, with periods of exacerbation and remission. If inflammation is caused by allergic reactions, then it is often seasonal.

It must also be said that isolated damage to the trachea is quite rare, and therefore signs of tracheitis in adults and children are almost always combined with both manifestations of inflammation of other parts of the respiratory system, and with general symptoms:

• hoarseness of voice; increase in body temperature - in adults up to 37–38 0C, in children - up to 39 0C in the acute period;
• general weakness and headaches;
• various respiratory disorders;
• difficulty swallowing, etc.

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

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.

Instructions for use of "Pulmicort"

The drug is used as an inhaler. To do this, rinse the mouthpiece with warm water, wipe it, and place it upside down to the mouth (canister upside down). Then you need to take a deep breath and press once. Next, rinse your mouth with warm water.

The dosage depends on the category of the patient:

1. For children, the norm is calculated by the doctor. In this case, the recommended dosage is 0.25-0.5 mg per day.
2. Adults carry out inhalations based on the maximum daily amount of 1.0 mg.

Attention!

Before each inhalation, shake the can well.

Prevention of tracheitis

In order to reduce the likelihood of this pathology occurring, you need to:

• completely stop smoking;
• limit alcohol consumption;
• exclude too cold or too hot foods from the diet;
• reduce the consumption of spicy foods and carbonated drinks; maintain a room temperature of 22–230C and air humidity of about 50%;
• periodically ventilate the rooms and carry out wet cleaning in them;
• promptly contact specialists for the treatment of upper respiratory tract diseases.

List of scientific literature used:

1. Blot M., Bonniaud-Blot P., Favrolt N., Chavanet P., Piroth L. Update on childhood and adult infectious tracheitis. Médecine et Maladies Infectieuses. 2022 Nov; 47(7):443-452.
2. Casazza G., Graham M.E., Nelson D., Chaulk D., Sandweiss D., Meier J. Pediatric Bacterial Tracheitis—A Variable Entity: Case Series with Literature Review. Otolaryngology–Head and Neck Surgery. Mar 2022; 160(3):546-549.
3. Lauren V. Burton, Michael Silberman. Bacterial Tracheitis. StatPearls Publishing. 2022, Jan.
4. Russell CJ, Shiroishi MS, Siantz E., Wu BW, Patino CM The use of inhaled antibiotic therapy in the treatment of ventilator-associated pneumonia and tracheobronchitis: a systematic review. BMC Pulmonary Medicine. 2016, Mar. 08;16:40.
5. Orlova N.V., Suranova T.G. Acute respiratory diseases: clinical features, drug therapy. Medical Council, 2018, No. 15, p. 82-88.
6. Pechkareva A.V. All about ENT diseases. To help a specialist. Publisher: Phoenix. Series: Medicine, 2013, 219 pp.
7. Sakhatarova O.V., Levchenko N.P. Diagnostics in otorhinolaryngology and ophthalmology. MDK.01.01 Propaedeutics of clinical disciplines. Publisher: Phoenix, 2015, 206 pp.

"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.

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.

"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.

Diagnosis when symptoms of tracheitis appear in children and adults

Typically, identifying this disease does not cause any particular problems. SM-Clinic specialists establish a preliminary diagnosis after an initial examination and interview with the patient. In addition, to clarify the form and extent of the disease, the doctor may prescribe additional examinations:

• Laryngo- and tracheobronchoscopy - direct visualization of the mucous membrane of the upper respiratory tract using an endoscope;
• X-ray of the chest organs;
• culture of sputum for bacteriological examination and identification of the infectious agent that caused the inflammation;
• general and biochemical urine and blood tests;
• tests with allergenic substances if the allergic nature of the disease is suspected.

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.