Pulmikort ®.
Trade name of the drug
International non-proprietary title
Budesonide
Dosage form
Suspension for inhalation dosage 0.25 mg / ml and 0.5 mg / ml
Structure
1 ML suspension contains
active substance -budesonide micronized 0.25 and 0.5 mg,
excipients:dinatariya Edetat, sodium chloride, polysorbate 80, acidic acid anhydrous, sodium citrate, water for injection.
Description
Suspension from white to almost white, easily resuspended when forming a precipitate
Pharmacotherapeutic group
Preparations for the treatment of obstructive diseases of the respiratory tract. Other inhalation preparations for the treatment of obstructive respiratory diseases. Glucocorticosteroids. Budesonide.
ATH code R03V02.
Pharmacological properties
Pharmacokinetics
Inhaled budesonide is quickly absorbed. In adults, the systemic bioavailability of budesonide after the inhalation of the pulmicort ® suspension through the nebulizer is approximately 15% of the total prescribed dose and about 40-70% of the delivered. The maximum concentration in the blood plasma is reached 60 minutes after the start of inhalation.
Communication with plasma proteins is an average of 90%. The volume of budesonide distribution is approximately 3l / kg. After suction, budesonide is subjected to intensive biotransformation (more than 90%) in the liver to form metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the main metabolites 6B-hydroxy-budesonide and 16a-hydroxyprednisolone is less than 1% of the glucocorticosteroid activity of the budesonide.
Budesonide is metabolized mainly with the participation of the CYP3A4 enzyme. Metabolites are removed unchanged or in a conjugated form with urine. Budesonide has a high systemic clearance (about 1.2 l / min), the half-life of the drug is an average of 4 hours. Pharmacokinetics of budesonide is proportional to the value of the administered dose of the drug.
Pharmacokinetics of budesonide in children and patients with impaired kidney function has not been studied. Patients with liver disease may increase the time of finding budesonide in the body.
Pharmacodynamics
Pulmikort ®, inhaled glucocorticosteroid, in the recommended doses has an anti-inflammatory effect in bronchi, reducing the severity of symptoms and the frequency of aggravation of bronchial asthma with a lower frequency of side effects than when using systemic glucocorticosteroids. Reduces the severity of edema of mucous membranes, mucus products, sputum formation and respiratory hypereactivity. It is well tolerated with long-term treatment, does not have mineralocorticosteroidal activity.
The start time of the therapeutic effect after the inhalation of one dose of the drug is several hours. The maximum therapeutic effect is achieved in 1-2 2 weeks after treatment. Pulmikort ® has a prophylactic effect on a bronchial asthma and does not affect the acute manifestations of the disease.
The dose-dependent impact on the content of the cortisol in plasma and the urine on the background of the pulmicorti ® reception is shown. In the recommended doses, the drug has a significantly less effect on the adrenal function than the prednone in a dose of 10 mg as shown in the ACTG tests.
Therapy inhalation bulvikart ® 1 or 2 times a day showed the effectiveness for the prevention of asthma of physical effort.
Indications for use
Bronchial asthma, requiring maintenance therapy with glucocorticosteroids to control the inflammatory process
Standing laryngotrachite (false croup)
Method of application and dose
Bronchial asthma
The dose of the drug is selected individually. In the event that the recommended dose does not exceed 1 mg / day, the entire dose of the drug can be taken at a time (one time). If the dose is required more, it is better to take it several times.
: 0.5 - 1 mg twice a day.
: 1-2 mg twice a day. In very severe cases, the dose can be increased.
Dose with supporting treatment :
Children aged 3 months to 12 years: 0.25-0.5 mg twice a day.
Children aged 12 years and older, adults / Elderly patients: 0.5-1 mg per day. In the case of severe exacerbations, the dose can be increased.
Table for dose definition
*) It should be diluted with a 0.9% sodium solution of chloride or a nebulizer solution to a volume of 2 ml
For all patients, it is desirable to determine the minimum efficient supportive dose.
If it is necessary to achieve an additional therapeutic effect, it is possible to recommend an increase in the daily dose (up to 1 mg / day) bulvikort ® instead of a combination of the drug with oral glucocorticosteroids, thanks to the lower risk of system effects.
Croup
For the treatment of babies and children with a crop, the recommended dose of budesonide when using the nebulizer is 2 mg. The dose is administered immediately or divided by 2 times (1 mg) with an interval of 30 minutes. The next dose can be administered after 12 hours. The treatment continues not more than 36 hours or before improving clinical symptoms.
Patients receiving oral glucocorticosteroids:
Cancellation of oral glucocorticosteroids should be started against the background of a stable state of patient health. For 10 days, it is necessary to take a high dose of pulmikort ® against the background of receiving oral glucocorticosteroids in the usual dosage. In the future, during the month, the dose of oral glucocorticosteroids should be gradually reduced (for example, 2.5 mg of prednisolone or analog) to a minimum effective dose. In many cases, it is possible to completely abandon the reception of oral glucocorticosteroids.
Since the pulmicort ®, used in the form of a suspension using a nebulizer, gets into the lungs when inhaling it is important to instruct the patient inhaling the drug through the nebulizer mouthpiece calmly and smoothly.
There is no data on the use of budesonide in patients with renal failure or impaired liver function. Taking into account the fact that budesonide is derived by biotransformation in the liver, one can expect an increase in the duration of the drug in patients with severe liver cirrhosis.
Application of bulvikorta ® Suspension for inhalations with nebulizer
Pulmikort ® Suspension is used for inhalation using an appropriate nebulizer equipped with mouthpiece and / or a special mask. The nebulizer is connected to the compressor to create the necessary air flow (5-8l / min), the volume of filling the nebulizer should be 2-4ml.
It is important to inform the patient:
Ultrasound nebulizers are not suitable for the use of bulvikort ® suspension;
Pulmikorti ® Suspension is mixed with a 0.9% sodium solution chloride or thermobutaline solutions, salbutulol, phenooterol, acetylcysteine, sodium chromiumlicate and bromide ipratropium; Diluted suspension should be used for 30 minutes;
After inhalation, we should rinse with water to reduce the risk of infectious damage to the rotogling;
To prevent skin irritation after using the mask you should rinse the skin with water;
In cases where the child cannot independently draw through the nebulizer, a special mask is applied.
Side effects
Up to 10% of patients receiving the drug may experience the following side effects.
Circuit and lymphatic systems:
Defeat of cervical lymph nodes
Head organs
Earache
Middle Otitis
Inflammatory diseases of the ear
Gastrointestinal tract:
Gastroenteritis
Abdominal pain
General:
Tired
Influencing syndrome
The immune system:
Allergic reactions
Inflammatory diseases of the eye
Simple herpes
Outdoor Ear Shell Infections
Viral infection
Injuries, poisoning and complications of procedures:
Fracture bone
Metabolism:
Anorexia
Skeletal and muscular and connecting fabrics:
Malgy
Nervous system:
Hyperkinesia.
Airways:
Rotoglot Candidiasis
Irritation of the mucous pharynx
Bronchospasm
Dysphonia
Chest pain
Vision:
Glaucoma
Cataract
Conjunctivitis
Leather:
Urticaria, rash, contact dermatitis
Pustile rash, hemorogic rash
Skin itch
Hematoma
Angioedema swelling and anaphylactic reactions
The reactions of the hypersensitivity of immediate and slow-type
Endocrine system:
Symptoms and symptoms of systemic effects of corticosteroids, including the suppression of the function of the adrenal cortex and growth delay.
Psychoneurological symptoms may also be observed, such as nervousness, excitability, anxiety, anxiety, depression, sleep disorder, aggression, psychosis, irritability, emotional instability, psychomotor hyperactivity, violation of behavior.
Taking into account the risk of the development of the chipped candidiasis, the patient should carefully rinse with water after each inhalation of the drug.
In rare cases, symptoms caused by the systemic action of glucocorticosteroids can occur, including hypofunction of adrenal glands.
In rare cases, the appearance of bruises on the skin was observed.
There were cases of irritation of the skin of the face when using nebulizer with a mask. To prevent irritation after using the mask, the person should be washed with water.
Contraindications
Increased sensitivity to budesonide or other components
drug
Active form of pulmonary tuberculosis
Children's age up to 3 months
Primary treatment of asthmatic status or other urgent episodes of asthma, where intensive therapy is needed
Medicinal interactions
The interaction of budesonide was not observed with other drugs used in the treatment of bronchial asthma.
Ketoconazole (200 mg once a day) increases the plasma concentration of oral budesonide (3 mg once a day) on average 6 times with joint admission. When taking ketoconazole 12 hours after the Budesonide reception, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information about such interaction when adhere to budesonide in the form of inhalation is absent, however, it is assumed that in this case an increase in the concentration of budesonide in the blood plasma should be expected. In case of the need to receive ketoconazole and budesonide, it should be increased between the reception of drugs to the maximum possible. It should also be considered to reduce the dose of budesonide. Another potential CYP3A4 inhibitor, for example, itraconazole, also significantly increases the plasma concentration of budesonide.
Preliminary inhalation of beta-adrenostimulants expands bronchi, improves budesonide admission to the respiratory tract and strengthens its therapeutic effect.
Phenobarbital, phenytoin, rifampicin reduce efficiency (induction of microsomal oxidation enzymes) Budesonide.
Methandrottenolon, estrogens enhance the action of budesonide.
special instructions
To minimize the risk of fungal lesions of the o'clock, instruct the patient about the need to carefully rinse the mouth with water after each drug inhalation.
Share appointment of bulvikort ® with ketoconazole, itraconazole or other potential CYP3A4 potential inhibitors should be avoided. If the pulmicort is ® and ketoconazole or other potential CYP3A4 inhibitors were assigned to increase the time between the reception of drugs to the maximum possible.
Patients who do not have steroid dependence: the therapeutic effect is usually achieved within 10 days. Patients with excessive secretion of mucus in bronchi can be pre-assigned a short (about 2 weeks) additional course of therapy with oral glucocorticosteroids, after which the monotherapy of budesonide must be sufficient.
Patients having steroid dependence: when switching from oral glucocorticosteroids on the pulmicort ®, the patient must be in a relatively stable state. During the first 10 days, the patient is prescribed a high dose of the drug pulmicort ® in combination with a previously used dose of oral GKS.
Due to the possible risk of weakening the adrenal function, special attention should be paid to patients who are translated from oral glucocorticosteroids on inhalation glucocorticosteroids (pulmicort ®) or in the case when the function of the pituitary and adrenal system can be distinguished. Also, special attention should be paid to patients who have taken high doses of glucocorticosteroids or long received the highest recommended doses of inhalation glucocorticosteroids. In such patients, it is necessary to reduce the dose of systemic glucocorticosteroids with extreme caution and control the hypothalamic-pituitary-adrenal function. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. In stress or in cases of surgical intervention, it is recommended to carry out additional therapy with systemic glucocorticosteroids.
When moving from oral glucocorticosteroids on the pulmicort ® patients may feel previously observed symptoms, such as muscle pain or joint pain. In such cases, a temporary increase in dose of oral glucocorticosteroids may be needed. In rare cases, such symptoms may be observed as a sense of fatigue, headache, nausea and vomiting, indicating the systemic insufficiency of glucocorticosteroids.
Replacing oral glucocorticosteroids on inhalation sometimes leads to a manifestation of concomitant allergies, for example, rhinitis and eczema, which previously stopped with systemic drugs.
In children and adolescents, receiving glucocorticosteroids (regardless of the delivery method) for a long period, it is recommended to regularly monitor growth rates due to the fact that the use of glucocorticosteroids for the treatment of bronchial asthma may cause a height violation. When prescribing glucocorticosteroids, it follows when, in account, the ratio of use of the drug and the possible risk of growth retardation. Nevertheless, the results of the observations of children and adolescents obtained by bulvikort ® for a long period (up to 13 years) showed that the growth of patients reaches the expected regulators for adults.
As well as when using other inhalation therapy, immediately after the use of the drug may be observed paradoxical bronchospasm. In the case of pronounced bronchospasm, it is necessary to revise the treatment applied and, if necessary, appoint alternative methods of treatment.
When using any inhalation corticosteroids, especially for a long time and in high doses, system effects are possible, although the probability of this is significantly lower than when using oral glucocorticosteroids. Possible systemic effects include: Cushing syndrome, Kushingoid symptoms, suppression of adrenal cortex function, growth delay in children and adolescents, reducing the mineral density of bone tissue, cataract, glaucoma and, in more rare cases, mental and behavioral disorders, including psychomotor hyperactivity, disorder Sleep, anxiety, depression and aggressive behavior (especially in children). Therefore, it is very important to use the minimum dose of inhalation corticosteroid, allowing to ensure effective control of asthma symptoms.
Patients may have a hypersensitivity reaction, including anaphylaxis, rash, contact dermatitis, urticule, angioedema swelling. The use of bulvikort ® should be discontinued in the event of such reactions.
Patients with a high risk of reducing the mineral density of bone tissue must be warned that the use of corticosteroids can lead to complications.
The long-term use of inhalation corticosteroids can increase the risk of eye disease (cataract, glaucoma), it is necessary to regularly inspect the doctor.
Pulmikort ® drug is not intended for rapid removal of symptoms of asthma exacerbations; To this end, the bronighting means of quick action is used. If the treatment of a quick-acting brutantor is ineffective, or a larger number of inhalation is required than usual, the patient should consult a doctor. In this situation, it may be necessary to increase the doses of regularly accepted drugs (for example, inhalation budesonide) or the addition of long-term beta-agonist therapy and conducting the treatment of therapy with oral glucocorticosteroids.
Carefullyprescribed (needed more careful observation of patients): Patients with fungal, viral and bacterial infections of respiratory organs, liver cirrhosis. When prescribed, a possible manifestation of the system action of glucocorticosteroids should be taken into account.
Pregnancy and lactation period
In research on animal glucocorticosteroids led to the development of congenital defects. It is unlikely that these results are relevant in relation to people. Against the background of the reception of pregnant women, the pulmicort ® was not revealed to increase the risk of development anomalies in the fetus, however, it is impossible to completely exclude the risk of their development, so during pregnancy, the minimum effective dose of pulmicorti ® should be used, not forgetting the possibility of deterioration of bronchial asthma.
When prescribing the drug, the ratio of the intended benefits for mother and potential risk for the child should be taken into account.
Pulmikort ® is highlighted with breast milk. When prescribing the drug, the ratio of the intended benefits for mother and potential risk for the child should be taken into account.
Features of the influence of the medicinal product on the ability to control the vehicle or potentially hazardous mechanisms
Pulmikort ® does not affect patient ability to manage vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Under the overdose of bulvikart ® in doses, significantly exceeding the recommended, clinical manifestations does not occur. With long-term use of the drug in doses, significantly exceeding the recommended, systemic glucocorticosteroid effect in the form of hypercorticism and suppressing the adrenal function can develop.
2 ml of the drug in ampoules from low-density polyethylene with an extruded line for opening.
5 ampoules are connected by heatmaking into one set, which is packed in an envelope from the multilayer foil.
4 envelopes are placed along with the instructions for use in state and Russian in a cardboard pack.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children!
Storage term
Conditions of vacation from pharmacies
On prescription
Manufacturer
Astraseneca AB, SE- 151 85 Kontej, Sweden
Pulmikort - Trading Mark, Property of the Astrasenec Group of Companies.
Address of the organization of the host claims from consumers with test products (goods) in the territory of the Republic of Kazakhstan
Representation Zak "Astrasenek Yu-Kay Limited"
Phone: +7 727 226 25 30
e-mail: [Email Protected]
Are you a hospital leaf due to back pain?
How often do you encounter a back pain?
Can you carry pain without receiving painful agents?
Learn more as quickly as possible to cope with the back pain
Registration Certificate Owner:
Astrazeneca AB
R03BA02 (Budesonide)
Before using the drug bulvikort you should consult with your doctor. This application instruction is intended exclusively for familiarization. For more information, please contact the manufacturer's annotation.
04.005 (GKS for inhalations)
Suspension for inhalations dosed white or almost white, easily resuspended.
Auxiliary substances: sodium chloride, sodium citrate, Dinatarium Edetat (sodium salt of ethylenediaminetetraacetic acid (double-sufficient)), polysorbate 80, citric acid (anhydrous), purified water.
2 ml (1 dose) - single-window polyethylene containers (5) - laminated foil envelopes (4) - Cardboard packs.
GKS for inhalation. Budesonide in the recommended doses has an anti-inflammatory effect in bronchi, reducing the severity of symptoms and the frequency of aggravation of bronchial asthma with a lower frequency of side effects than when using systemic GKS. Reduces the severity of edema of mucous membranes, mucus products, sputum formation and respiratory hypereactivity. It is well tolerated with long-term treatment, does not have mineralocorticoid activity.
The start time of the therapeutic effect after the inhalation of one dose of the drug is several hours. The maximum therapeutic effect is achieved 1-2 weeks after treatment.
Budesonide has a prophylactic effect on a bronchial asthma and does not affect the acute manifestations of the disease.
The dose-dependent effect on the content of the cortisol in plasma and the urine on the background of receiving the bulvikort is shown. In the recommended doses, the drug has a significantly smaller effect on the function of adrenal glands than at a dose of 10 mg, as was shown in the ACTG tests.
Suction
After inhalation, budesonide is quickly absorbed. In adults, the systemic bioavailability of budesonide, after inhalation of bulvikorts through the nebulizer, is approximately 15% of the total dose and about 40-70% of the delivered. Cmax in blood plasma is reached 30 minutes after the start of inhalation.
Distribution and metabolism
Binding with plasma proteins is an average of 90%. VD Budesonide is about 3 l / kg.
Budesonide is intensive biotransformation (more than 90%) in the liver to form metabolites with low glucocorticoid activity. The glucocorticoid activity of the main metabolites (6β-hydroxy-budesonide and 16α-hydroxyprednisolone) is less than 1% of the glucocorticosteroid activity of budesonide. Budesonide is metabolized mainly with the participation of the CYP3A4 enzyme.
Election
Budesonide is excreted with urine in the form of unchanged or conjugated metabolites. Budesonide has a high systemic clearance (about 1.2 l / min). Pharmacokinetics of budesonide is proportional to the value of the administered dose of the drug.
Pharmacokinetics in special clinical cases
Pharmacokinetics of budesonide in children and patients with impaired kidney function has not been studied.
In patients with liver disease, it is possible to increase the time of being budesonide in the body.
The dose of the drug Pulmikort® is established individually. In the event that the recommended dose does not exceed 1 mg / day, the entire dose of the drug is introduced at a time (at a time). In the case of a higher dose, it is recommended to divide it into 2 receptions.
The initial dose for adults (incl. Older patients) is 1-2 mg / day. Supporting dose is 0.5-4 mg / day. In the case of severe exacerbations, the dose can be increased.
Determination of the dose of drug
* You should dilute a 0.9% sodium solution of chloride to a volume of 2 ml.
For all patients, it is desirable to determine the minimum efficient supportive dose.
If it is necessary to achieve an additional therapeutic effect, it is possible to recommend an increase in the daily dose (up to 1 mg / day) bulvikort instead of a combination of the drug with GCS for intake, due to the lower risk of system effects.
Patients receiving HSC for intake
Cancellation of GCS for receiving inside it is necessary to start against the background of a stable state of patient health. For 10 days, high doses of the Pulmikort® drug are prescribed against the background of GCS intake in the usual dose. In the future, during the month, it should be gradually reduced by the GCS dose, taken inward (for example, 2.5 mg of prednisolone or its analog), to a minimum effective dose. In many cases, it is possible to completely refuse to receive GKS inside.
There is no data on the use of budesonide in patients with renal failure or impaired liver function. Taking into account the fact that budesonide is biotransformed in the liver, it is possible to expect an increase in the duration of the drug in patients with severe liver cirrhosis.
Using a bulvikort with a nebulizer
Pulmikort® is used for inhalation using the appropriate nebulizer equipped with mouthpiece and a special mask. The nebulizer is connected to the compressor to create the necessary airflow (5-8 l / min), the volume of the nebulizer filling must be 2-4 ml.
Since the pulmicort® applied in the form of a suspension using a nebulizer falls into the lungs when inhaling, it is important to instruct the patient to inhale the drug through the nebulizer mouthpiece calmly and smoothly.
In cases where the child cannot independently draw through the nebulizer, a special mask is applied.
The patient should be informed about the need to carefully read the instructions for the use of the drug, as well as that ultrasound nebulizers are not suitable for the use of bulvikort in the form of a suspension. The suspension is mixed with a 0.9% sodium solution of chloride or with thermoputaline solutions, salbutamola, acetylcysteine, sodium chromaglicate and. The patient must remember that after inhalation, it should rinse with water to reduce the risk of developing the Kandidosis of the o'clock and that to prevent skin irritation after using the mask should be rinsed with the skin of the face with water. You should also know that the diluted Pulmikort® suspension should be used for 30 minutes.
The nebulizer chamber should be cleaned after each use.
The nebulizer and mouthpiece or mask washed with warm water using a soft detergent (in accordance with the manufacturer's instructions). The nebulizer should rinse well and dry, connecting the chamber with a compressor or an inlet air valve.
Rules for using a bulvikort with a nebulizer
1. Before use, you should gently shake the container with a light rotational motion.
2. Keep the container directly vertically and open it, turning and taking off the "wing".
3. Gently put the container with an open end into the nebulizer and slowly squeeze the contents of the container.
The container containing a one-time dose marked with a line. If the container is turned over, then this line will show a volume equal to 1 ml.
If only 1 ml of suspension is necessary, the contents of the container are squeezed until the surface of the fluid reaches the level indicated by the line.
The open container is stored in a place protected from light. The open container must be used for 12 hours.
Before using the residue of the liquid, the contents of the container are gently shaken by rotational motion.
Dose (mg)
Treatment of drug
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
In case of acute overdose, the drug pulmicort® clinical manifestations do not occur.
With prolonged use of the drug in doses, significantly exceeding the recommended, the development of system effects of GCS in the form of hypercorticism and suppressing adrenal function is possible.
The interaction of budesonide was not observed with other drugs used in the treatment of bronchial asthma.
With a joint taking ketoconazole (at a dose of 200 mg 1 time / day) increases the plasma concentration of budesonide (taken inside at a dose of 3 mg 1 time / day) on average 6 times. When taking ketoconazole 12 hours after receiving the budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information about such interaction of NPI, but there is no information in the form of inhalation, however, it is assumed that in this case an increase in the concentration of budesonide in the blood plasma should be expected. If it is necessary to receive ketoconazole and budesonide, it should be increased between the receptions of drugs to the maximum possible. It should also be considered to reduce the dose of budesonide.
Another potential CYP3A4 inhibitor, itraconazole, also significantly increases the plasma concentration of budesonide
Preliminary inhalation of beta-adrenostimulants expands bronchi, improves budesonide admission to the respiratory tract and strengthens its therapeutic effect.
Phenobarbital, phenytoin, rifampicin, while simultaneously use, reduce the effectiveness of the bulvikort (due to the induction of microsomal oxidation enzymes).
Methandrottenolon, estrogens enhance the action of budesonide.
Observation of pregnant women who took Budesonide did not reveal the abnormalities of the fetus, nevertheless it is impossible to completely exclude the risk of their development, so during pregnancy due to the possibility of deteriorating the flow of bronchial asthma, the minimum effective dose of the drug should be used.
Budesonide is distinguished with breast milk, however, when using bulvikort in therapeutic doses, the impact on the child is not marked. Pulmikort® can be used with breast insillium.
Up to 10% of patients receiving the drug may experience the following side effects:
From the CNS side: nervousness, excitability, depression, behavior impairment are possible.
In some cases, symptoms caused by the system action of GCS may arise (including adrenal hypofunction).
Others: rarely - the appearance of bruises on the skin, irritation of the skin of the face when using nebulizer with a mask.
Frequency of detection
Organism / reaction system
Type of side effects
Often (\u003e 1/100)
Airways
Candidiasis of rotogling, irritation of the mucous membrane of the pharynx, cough, hoarseness of the voice, dry mouth
Rarely (allergic reactions
Angioedema swelling
CNS.
Headache
Dermatological reactions
Urticaria, rash, contact dermatitis
Airways
Bronchospasm
The drug should be stored in an inaccessible place at temperatures below 30 ° C. Shelf life - 2 years. Do not apply after the expiration date indicated on the package.
After opening the envelope, the containers contained in it should be used for 3 months. Containers should be stored in an envelope to protect them from light.
The open container must be used for 12 hours.
With caution (needed more careful observation of patients) It is necessary to prescribe a drug to patients with an active form of pulmonary tuberculosis, fungal, viral, bacterial infections of respiratory organs, liver cirrhosis.
When prescribed, a possible manifestation of the system action of GCS should be taken into account.
To minimize the risk of fungal lesions of the o'clock, instruct the patient about the need to carefully rinse the mouth with water after each drug inhalation.
To prevent skin irritation after using a nebulizer with a mask, a person should be washed.
To avoid sharing budesonide with ketoconazole, itraconazole or other potential CYP3A4 inhibitors. If such a combination is necessary, you should increase the time between the receptions of the drugs to the maximum possible.
Due to the possible risk of weakening the adrenal function, special attention must be paid to patients who are translated from the system GKS to the reception of the bulvikort. Also, special attention should be paid to patients who have taken high doses of GCS or long received the highest recommended doses of inhalation GKS. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. In stress or in cases of surgical intervention, it is recommended to carry out additional therapy with system GKS.
Particular attention should be paid to patients who are translated from the system on inhalation GCS (Pulmikort®) or in the case when you can expect a violation of the pituitary and adrenal function. In such patients, it is necessary to reduce the GCS dose for systemic use and control the indicators of the function of the hypothalamic-pituitary-adrenal system. This category of patients may require additional appointment of GCS for intakes in the period of stressful situations, such as injury, surgical intervention.
When moving from oral GKS on the pulmicort® patients may feel previously observed symptoms, such as muscle pain or joint pain. In such cases, a temporary increase in the dose of GKS for receiving inside is required. In rare cases, such symptoms may be observed as a sense of fatigue, headache, nausea and vomiting, indicating the system deficiency of GKS.
When switching from GCS to receive inside into inhalation, it is sometimes possible to exacerbate existing allergic reactions, rhinitis and eczema, which previously stopped with systemic drugs.
Therapy with a bulvikort when applying 1 or 2 times / day showed the effectiveness for the prevention of asthma of physical effort.
Use in pediatrics
In children and adolescents that receive the treatment of GCS (any forms) over a long period, it is recommended to regularly monitor growth rates. When appointing GCS, it should be estimated to estimate the ratio of the intended benefits from the use of the drug and the potential risk of growth slowdown.
The use of budesonide in a dose of up to 400 μg / day in children over 3 years has not led to the emergence of system effects. The biochemical signs of the systemic effect of the drug may occur when applying the drug at a dose from 400 to 800 μg / day. Upon exceeding the dose of 800 μg / day, the systemic effects of the drug are often found.
The use of GCS for the treatment of bronchial asthma may cause a height violation. The results of observations of children and adolescents that have received budesonide for a long period (up to 11 years) have shown that the growth of patients reaches the expected regulatory indicators for adults.
Impact on the ability to driving vehicles and control mechanisms
Pulmikort® does not affect the ability to drive a car or other mechanisms.
There is no data on the use of budesonide in patients with renal failure.
There is no data on the use of budesonide in patients with impaired liver function. Taking into account the fact that budesonide is biotransformed in the liver, it is possible to expect an increase in the duration of the drug in patients with severe liver cirrhosis.
Approved
Order of the Chair
Monitoring committee medical and
pharmaceutical activity
Ministry of Health
Republic of Kazakhstan
From "____" ______________ 20
№ ______________
Medical Instructions
drug
Pulmikort
Trade name of the drug
Pulmikort
International non-proprietary title
Budesonide
Dosage form
Suspension for inhalations dosed 0.25 mg and 0.5 mg
Structure
1 ML suspension contains:
active substance- budesonide (budesonide micronized) 0.25 and 0.5 mg
excipients:dinatariya Edetat, sodium chloride, polysorbate 80, acidic acid anhydrous, sodium citrate, water for injection.
Description
Easily resuspended suspension of white or almost white.
Pharmacotherapeutic group
Glucocorticosteroids for inhalation applications.
ATH code R03V02.
Pharmacological properties
Pharmacokinetics
Inhaled budesonide is quickly absorbed. In adults, the systemic bioavailability of budesonide after the inhalation of the suspension bulvikort through the nebulizer is approximately 15% of the total prescribed dose and about 40-70% of the delivered. The maximum concentration in the blood plasma is reached 60 minutes after the start of inhalation.
Communication with plasma proteins is an average of 90%. The volume of budesonide distribution is approximately 3l / kg. After suction, budesonide is subjected to intensive biotransformation (more than 90%) in the liver to form metabolites with low glucocorticosteroid activity. Glucocorticosteroidal activity of the main metabolites 6? -Hidroxy-Budesonida and 16? - Hydroxyprednisolone is less than 1% glucocorticosteroidal activity of budesonide.
Budesonide is metabolized mainly with the participation of the CYP3A4 enzyme. Metabolites are removed unchanged or in a conjugated form with urine. Budesonide has a high systemic clearance (about 1.2 l / min), the half-life of the drug is an average of 4 hours. Pharmacokinetics of budesonide is proportional to the value of the administered dose of the drug.
Pharmacokinetics of budesonide in children and patients with impaired kidney function has not been studied. Patients with liver disease may increase the time of finding budesonide in the body.
Pharmacodynamics
The pulmicort is an inhalation glucocorticosteroid, in the recommended doses, has an anti-inflammatory effect in bronchi, reducing the severity of symptoms and the frequency of thermal asthma exacerbations with a lower frequency of side effects than when using systemic glucocorticosteroids. Reduces the severity of edema of mucous membranes, mucus products, sputum formation and respiratory hypereactivity. It is well tolerated with long-term treatment, does not have mineralocorticosteroidal activity.
The start time of the therapeutic effect after the inhalation of one dose of the drug is several hours. The maximum therapeutic effect is achieved in 1-2 2 weeks after treatment. Pulmikort® has a prophylactic effect on a bronchial asthma and does not affect the acute manifestations of the disease.
A dose-dependent effect on the content of the cortisol in plasma and the urine on the background of the pulmikart reception is shown. In the recommended doses, the drug has a significantly less effect on the adrenal function than the prednone in a dose of 10 mg as shown in the ACTG tests.
Indications for use
Bronchial asthma requiring supporting therapy
Glucocorticosteroids to control the inflammatory process.
Method of application and dose
Children from 6 months and older: 0.25- 0.5mg per day. If necessary, the dose can be increased to 1 mg / day.
Adults / Elderly Patients: 1-2 mg per day.
Dose with supporting treatment:
Children from 6 months and older: 0.25- 2 mg per day.
Adults: 0.5- 4 mg per day. In the case of severe exacerbations, the dose can be increased.
Table for dose definition
* You should dilute with a 0.9% sodium solution of chloride or a nebulizer solution to a volume of 2 ml
For all patients, it is desirable to determine the minimum efficient supportive dose.
If you need to achieve an additional therapeutic effect, it is possible to recommend an increase in the daily dose (up to 1 mg / day) pulmicort® instead of a combination of the drug with oral glucocorticosteroids, thanks to the lower risk of system effects.
Patients receiving oral glucocorticosteroids:
Cancellation of oral glucocorticosteroids should be started against the background of a stable state of patient health. Within 10 days, it is necessary to take a high dose of pulmicort® on the background of receiving oral glucocorticosteroids in the usual dosage. In the future, during the month, the dose of oral glucocorticosteroids should be gradually reduced (for example, 2.5 mg of prednisolone or analog) to a minimum effective dose. In many cases, it is possible to completely abandon the reception of oral glucocorticosteroids.
Since the pulmicort® applied in the form of a suspension using a nebulizer falls into the lungs when inhaling it is important to instruct the patient to inhale the drug through the nebulizer mouthpiece calmly and smoothly.
There is no data on the use of budesonide in patients with renal failure or impaired liver function. Taking into account the fact that budesonide is derived by biotransformation in the liver, one can expect an increase in the duration of the drug in patients with severe liver cirrhosis.
Application of pulmicort® suspension for inhalations using nebulizer
Pulmikort® suspension is used for inhalation using an appropriate nebulizer equipped with mouthpiece and / or a special mask. The nebulizer is connected to the compressor to create the necessary air flow (5-8l / min), the volume of filling the nebulizer should be 2-4ml.
It is important to inform the patient:
Ultrasound nebulizers are not suitable for use of pulmicorta® suspension;
Pulmikort® suspension is mixed with a 0.9% sodium chloride solution or thermobutaline solutions, salbutamola, phenotherol, acetylcysteine, chromiumlicate sodium and bromide ipratropium; Diluted suspension should be used for 30 minutes.
After inhalation, we should rinse with water to reduce the risk of infectious damage to the rotogling;
To prevent skin irritation after using the mask you should rinse the skin with water;
In cases where the child cannot independently draw through the nebulizer, a special mask is applied.
Side effects
Up to 10% of patients receiving the drug may experience the following side effects:
Airways:
Rotoglot Candidiasis
Irritation of the mucous pharynx
Bronchospasm
Angioedema
Urticaria, rash, contact dermatitis
Psychoneurological symptoms may also be observed, such as nervousness, excitability, depression, violation of behavior. Taking into account the risk of the development of the chipped candidiasis, the patient should carefully rinse with water after each inhalation of the drug.
In rare cases, symptoms caused by the systemic action of glucocorticosteroids can occur, including hypofunction of adrenal glands.
In rare cases, the appearance of bruises on the skin was observed.
There were cases of irritation of the skin of the face when using nebulizer with a mask. To prevent irritation after using the mask, the person should be washed with water.
Contraindications
Increased sensitivity to budesonide or other components
Drug
Active form of pulmonary tuberculosis
Children's age up to 6 months.
Medicinal interactions
The interaction of budesonide was not observed with other drugs used in the treatment of bronchial asthma.
Ketoconazole (200 mg once a day) increases the plasma concentration of oral budesonide (3 mg once a day) on average 6 times with joint admission. When taking ketoconazole 12 hours after the Budesonide reception, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information about such interaction when adhere to budesonide in the form of inhalation is absent, however, it is assumed that in this case an increase in the concentration of budesonide in the blood plasma should be expected. In case of the need to receive ketoconazole and budesonide, it should be increased between the reception of drugs to the maximum possible. It should also be considered to reduce the dose of budesonide. Another potential CYP3A4 inhibitor, for example, itraconazole, also significantly increases the plasma concentration of budesonide.
Preliminary inhalation of beta-adrenostimulants expands bronchi, improves budesonide admission to the respiratory tract and strengthens its therapeutic effect.
Phenobarbital, phenytoin, rifampicin reduce efficiency (induction of microsomal oxidation enzymes) Budesonide.
Methandrottenolon, estrogens enhance the action of budesonide.
special instructions
To minimize the risk of fungal lesions of the o'clock, instruct the patient about the need to carefully rinse the mouth with water after each drug inhalation.
Share Pulmikort® shared appointment with ketoconazole, itraconazole or other potential CYP3A4 inhibitors. In case the pulmicort® and ketoconazole or other potential CYP3A4 inhibitors have been assigned, you should increase the time between the reception of drugs to the maximum possible.
Due to the possible risk of weakening the adrenal function, special attention should be paid to patients who are translated from oral glucocorticosteroids on inhalation glucocorticosteroids (pulmicort®) or in the case when you can expect a violation of the pituitary and adrenal function. Also, special attention should be paid to patients who have taken high doses of glucocorticosteroids or long received the highest recommended doses of inhalation glucocorticosteroids. In such patients, it is necessary to reduce the dose of systemic glucocorticosteroids with extreme caution and control the hypothalamic-pituitary-adrenal function. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. In stress or in cases of surgical intervention, it is recommended to carry out additional therapy with systemic glucocorticosteroids.
When moving from oral glucocorticosteroids on pulmicort® patients may experience previously observed symptoms, such as muscle pain or joint pain. In such cases, a temporary increase in dose of oral glucocorticosteroids may be needed. In rare cases, such symptoms may be observed as a sense of fatigue, headache, nausea and vomiting, indicating the systemic insufficiency of glucocorticosteroids.
Replacing oral glucocorticosteroids on inhalation sometimes leads to a manifestation of concomitant allergies, for example, rhinitis and eczema, which previously stopped with systemic drugs.
In children and adolescents, receiving glucocorticosteroids (regardless of the delivery method) for a long period, it is recommended to regularly monitor growth rates due to the fact that the use of glucocorticosteroids for the treatment of bronchial asthma may cause a height violation. When prescribing glucocorticosteroids, the relationship of the use of the drug and the possible risk of growth retardation should be taken into account. Nevertheless, the results of the observations of children and adolescents received by Pulmikort® for a long period (up to 13 years) showed that the growth of patients reaches the expected regulatory indicators for adults.
Pulmikort for inhalation is an effective glucocorticoid drug that is successfully used to treat diseases of the respiratory organs, including children.
Available in powder form, there is also a suspension for the inhalation, which must be breeding with saline. The effect of the drug occurs immediately during the procedure.
The active ingredient of this drug is budesonide. After the inhalation, the substance is quickly absorbed into the body and after the urine is displayed. Its specific sensitivity is 15 times more than that of prednisone.
GKS for inhalations.
You can buy a doctor's prescription.
How much does the pulmikart cost in pharmacies? The average price is at the level of 800 rubles.
Pulmikort for inhalations is produced in the form of powder and suspension. White suspension is placed in 1 or 2 ml containers. The drug is implemented in two dosages - 0.25 mg / ml and 0.5 mg / ml. The first option is mainly used for the treatment of children from 6 months to 12 years. Flimicort for inhalations 0.5 mg is most often used for adult patient therapy. The price of the drug varies from 900 to 1300 rubles.
The preparation is one active ingredient and several auxiliary. The basis of the drug is a micronized budesonide, which turns out to be a complex therapeutic effect: relieves inflammation and swelling, stops an allergic reaction.
This medicinal product is hormonal. But you should not be afraid and categorically refuse to treat with a bulvikort. Yes, hormonal drugs can increase weight. Yes, there are cases of addictive to hormones contained in medication.
But some of the diseases, for example, bronchial asthma are being treated only by hormonal drugs. A bulvikort allows you to achieve a stealing remission and significantly improve well-being and health.
Like any other glucocorticosteroid, the bulvikort has pronounced anti-inflammatory, anti-allergic and mineralactricity effects.
The mechanism of action is based on a decrease in the synthesis in the cells of the organism of prostaglandins, leukotrienes, prostacyclines, which have an irritant effect and damage tissues by activating inflammatory processes. Also, during the exudation phase, a large number of interleukins are distinguished - these are mediators of inflammation, damaging cell walls and causing fluid yield into the intercellular space.
Basic effects from reception:
Pulmikort Suspension for inhalation is prescribed for the following diseases and conditions:
Inhalation with a bulvikort reduce the production of mucus and simplify its retreat. Another excellent action has an aggregate with the addition of a suspension against dry cough and with severe inflammatory rotting cavity processes. How to use the means is indicated in the instructions for the drug.
Pulmikort is contraindicated to use:
When taking pregnant substances, Budesonide did not find any increased risks of development of anomalies from the fetus. However, it is not necessary to completely exclude these risks, so when taking the drug during pregnancy, you need to use the minimum efficient dosage of the drug to avoid the deterioration of bronchial asthma.
Animal studies have shown the results of the development of anomalies in the fetus when taking GKS, but these data cannot be transferred to people who receive recommended doses of glucocorticosteroids.
For nursing mothers, the following information will be useful: the data that budesonide can get into breast milk - not detected. But still, when appointing this drug, you need to take potential risks for a child, comparing them with the alleged benefit.
In children and adolescents that receive the treatment of GCS (any forms) over a long period, it is recommended to regularly monitor growth rates. When appointing GCS, it should be estimated to estimate the ratio of the intended benefits from the use of the drug and the potential risk of growth slowdown.
The use of budesonide in a dose of up to 400 μg / day in children over 3 years has not led to the emergence of system effects. The biochemical signs of the systemic effect of the drug may occur when applying the drug at a dose from 400 to 800 μg / day. Upon exceeding the dose of 800 μg / day, the systemic effects of the drug are often found.
The use of GCS for the treatment of bronchial asthma may cause a height violation. The results of observations of children and adolescents that have received budesonide for a long period (up to 11 years) have shown that the growth of patients reaches the expected regulatory indicators for adults.
As indicated in the instructions for use, the pulmicort is used using a special inhalation apparatus - a nebulizer that converts suspension into an aerosol. With a calm and even breathtaking through the mouthpiece, the drug in the form of an aerosol enters the lungs of the patient. In young children, the procedure is performed through a special mask.
For the use of bulvikort in the form of suspension, ultrasound nebulizers are not suitable! The use of nebulizer is proceeded after attentive examination of the instruction, strictly observing all the recommendations.
After each inhalation, it is necessary to carefully rinse the mouth with water, this will reduce the risk of the development of the chipped candidiasis, also need to wash the face with water to prevent skin irritation. The diluted suspension is used in the next half hour.
After each procedure, clean the nebulizer chamber should be cleaned.
Using the compressor, the speed of the air flow (5-8 l per minute) is created to fill the nebulizer with a volume of 2-4 ml. The device is equipped with a special mask and mouthpiece.
The dose of the pulmikart doctor installs individually.
When the daily dose is prescribed in the amount of 1 mg, it is administered at one time if the dose is higher - divide on 2 receptions.
To carry out inhalation, the suspension is pre-bred with saline (9% sodium chloride) in proportion 1: 1. Thus, the bulvikort is 0.25 for inhalations (the volume of one nebula - 1 ml) is divorced with 1 ml of saline. For nebules with a volume of suspension 2 ml (0.5 g of active substance) The volume of the saline required for dilution is respectively 2 ml.
Each patient is determined by the minimum efficient supportive dose, providing the clinical effect.
Due to the lower risk of developing unwanted system effects in some cases, an increase in the daily dose of the drug is recommended to 1 mg in the form of monotherapy, instead of a combination with GKS for intake.
Patients on the treatment of GCS for receiving inside, to start canceling therapy is necessary during a period of stable state. Against the background of the usual dose of GKS for oral administration for 10 days, the patient receives high doses of bulvikort. Then during the month, the dose of oral GKS is gradually decreasing, to the minimum effective. Very often, it is possible to completely cancel the GKS intake.
With pronounced cirrhosis of the liver, the duration of the drug rises.
Most often you can meet the following negative effects of the substance:
When the side effects appear, it is recommended to consult a doctor. If, with a reduction in the dosage, some of the pathogenic effects disappears, it is necessary to seriously think about finding analogs or a complete replacement course of therapy. A competent specialist usually assigns several similar drugs at once in order to select the necessary dosage.
In the case of acute overdose, clinical manifestations does not occur. If the overdose is chronic, then the effects of hypercorticism can occur, as well as suppress the adrenal function.
In addition, clinical manifestations of hypercorticism can be observed: arterial hypertension, muscle weakness, increase in body weight, amenorrhea, hyperpigmentation. Also, in chronic overdose, for the purposes of hypercorticism, the drug is gradually canceled, systematically reducing the dosage.
To prevent skin irritation after using a nebulizer with a mask, a person should be washed.
To minimize the risk of fungal lesions of the o'clock, instruct the patient about the need to carefully rinse the mouth with water after each drug inhalation.
To avoid sharing budesonide with ketoconazole, itraconazole or other potential CYP3A4 inhibitors. If such a combination is necessary, you should increase the time between the receptions of the drugs to the maximum possible.
Due to the possible risk of weakening the adrenal function, special attention must be paid to patients who are translated from the system GKS to the reception of the bulvikort. Also, special attention should be paid to patients who have taken high doses of GCS or long received the highest recommended doses of inhalation GKS. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. In stress or in cases of surgical intervention, it is recommended to carry out additional therapy with system GKS.
Special attention should be paid to patients who are translated from the system on inhalation GCS (bulvikort) or in the case when you can expect a violation of the pituitary and adrenal function. In such patients, it is necessary to reduce the GCS dose for systemic use and control the indicators of the function of the hypothalamic-pituitary-adrenal system. This category of patients may require additional appointment of GCS for intakes in the period of stressful situations, such as injury, surgical intervention.
When moving from oral GKS on the pulmicort, patients may feel previously observed symptoms, such as muscle pain or joint pain. In such cases, a temporary increase in the dose of GKS for receiving inside is required. In rare cases, such symptoms may be observed as a sense of fatigue, headache, nausea and vomiting, indicating the system deficiency of GKS.
When switching from GCS to receive inside into inhalation, it is sometimes possible to exacerbate existing allergic reactions, rhinitis and eczema, which previously stopped with systemic drugs.
Therapy with a bulvikort when applying 1 or 2 times / day showed the effectiveness for the prevention of asthma of physical effort.
When using the drug, it is necessary to take into account interaction with other drugs:
With a joint taking ketoconazole (at a dose of 200 mg 1 time / day) increases the plasma concentration of budesonide (taken inside at a dose of 3 mg 1 time / day) on average 6 times. When taking ketoconazole 12 hours after receiving the budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information about such interaction of NPI, but there is no information in the form of inhalation, however, it is assumed that in this case an increase in the concentration of budesonide in the blood plasma should be expected. If it is necessary to receive ketoconazole and budesonide, it should be increased between the receptions of drugs to the maximum possible. It should also be considered to reduce the dose of budesonide.
The pulmicort is a modern drug for inhalations with bronchial asthma, laryngotrachite and laryngitis. The tool removes the attacks of choking, warns heavy complications associated with a violation of free breathing.
The drug pulmicort is often prescribed pulmonic doctors for the treatment of kids and older children. Useful information for parents about the composition, action of an effective drug. Learn how to use bulvikort for inhalation with the use of nebulizer.
Features:
After use, doctors and patients note the positive effect of the bulvikort:
The abolition of the drug is gradually produced, with a decrease in the daily dose.
In pediatrics, the drug cannot be used in the following cases:
The preparation with caution is prescribed to young patients suffering from certain diseases:
With incorrect use, negative reactions are developing:
Note! Regular dosage excess provokes the suppression of adrenal function and hypercorticism.
Learn the rules for use and other medications for children. For example, Panadol syrup is written; On the suspension of Nurofen -. About the syrup of amboben from cough Read the address; About Lazolvan We have an article.
Dosage:
Rules for conducting inhalation:
Ultrasonic nebulizer is not suitable for using the drug bulvikort in the form of a suspension or solution. For maximum effect, high-quality spraying of the composition, use a compressor nebulizer.
Precautions:
Important information:
Take note:
The drug for removing bronchospasms is not noone, but a noticeable effect makes parents spend considerable amounts for the purchase of modern composition. The average price of the bulvikort is about 1000 rubles.
Dosage powder:
Suspension for inhalations:
Based on budesonide, several effective drugs were created:
Selection of analogs of the bulvikort produces the attending physician. For each child, the doctor will pick up an individual dosage taking into account age, frequency of attacks, severity of the disease, the degree of sensitization of the body.
