In the article, we will consider in detail the composition of Pulmicort and the instructions for it. This is a Swedish anti-inflammatory drug used for inhalation. The medicine is often used not only in accordance with direct medical indications, but also for coughs of various origins in adults and children from 6 months.
Composition of "Pulmicort" and release form
This medication is available in the form of a white metered suspension that is easily resuspendable. The main active element is budesonide (micronized) at a dosage of 500 mcg per 1 ml.
Auxiliary substances in the composition of "Pulmicort" for inhalation are: disodium edetate, sodium chloride, polysorbate 80, sodium citrate, anhydrous citric acid, purified water.
Medical packaged in single-dose polyethylene containers and foil envelopes, as well as in cartons.
The composition of Pulmicort is described in detail in the instructions.
Pharmacological properties of the drug
This is a glucocorticosteroid for inhalation. Budesonide as part of "Pulmicort" in the recommended dosages has an anti-inflammatory effect on the bronchi, reduces the severity of symptoms and the frequency of asthma attacks with the lowest frequency of side effects than during the use of systemic corticosteroids. In addition, this medicine reduces the severity of edema of the mucous membrane of the bronchi, mucus production, sputum formation and high reactivity of the respiratory channels. The drug is well tolerated in long-term treatment, has no mineralocorticoid activity.
The therapeutic effect after inhalation of a single dose of this drug occurs almost immediately and lasts for several hours. The maximum result is achieved 1-2 weeks after the treatment. The main substance in the composition of the medicine "Pulmicort" has a preventive effect on the course of the disease and does not affect its acute symptoms.
Shows a dose-dependent effect on the content of cortisol in the urine and plasma while taking the drug. At recommended levels, it has significantly less effect on adrenal function than prednisone, as shown in ACTH tests.
Pharmacokinetic indicators
Budesonide as part of Pulmicort is rapidly absorbed after inhalation. In adult patients, systemic bioavailability after inhalation through a nebulizer is approximately 15% of the total prescribed dosage and about 40-70% of that received. Maximum level inplasma is achieved 30 minutes after inhalation administration.
Plasma protein binding averages 90%. Budesonide in the liver undergoes intensive biotransformation with the formation of metabolites with low hormonal activity. The glucocorticoid activity of these substances (16α-hydroxyprednisolone and 6β-hydroxy-budesonide) is less than 1% of the activity of budesonide, which is excreted in the urine in the form of conjugated or unchanged metabolites. The substance has a high clearance (1.2 l/min).
Pharmacokinetic characteristics of budesonide as part of Pulmicort for inhalation in childhood and in people with impaired renal function have not been studied.
Indications for prescription
The medicine is prescribed in such cases:
- for bronchial asthma requiring maintenance treatment with corticosteroids;
- for chronic obstructive pulmonary disease (COPD).
What is the dosage of Pulmicort for inhalation? The instruction will help us to understand this issue.
Dosing rules
The dosage of the drug is set individually. If the dose recommended by the doctor is not more than 1 mg / day, it is administered at a time. In the case of the introduction of larger doses of the drug, it is recommended to divide them into 2 inhalation injections.
The initial dosage for adult patients is 1-2 mg per day. The maintenance dose is 0.5-4 mg per day. During exacerbations, the volume of the drug administered may be increased.
At the age of 6 months and more, the initial dosage is0.25-0.5 mg per day. If necessary, it is increased to 1 mg per day.
Before using Pulmicort for inhalation, the medication should be diluted with 0.9% sodium chloride solution so that the total volume of the drug is 2 ml.
If it is necessary to obtain an additional therapeutic result, an increase in the dose of the drug can be recommended instead of its combination with GCS for internal use, due to the low risk of developing systemic adverse reactions.
This confirms the instructions for "Pulmicort" for inhalation for adults.
Advice for patients receiving oral HSCs
Cancellation of oral corticosteroids should be started after stabilization of the patient's state of he alth. Within 10 days, high doses of Pulmicort are prescribed against the background of the use of GCS in the usual doses. In the future, over the course of a month, the dose of GCS should be gradually reduced to a minimum volume. In many cases, patients manage to completely stop using these medications.
Using with a nebulizer
The use of "Pulmicort" is carried out by inhalation, using a nebulizer equipped with a special mask and mouthpiece. The device is connected to a compressor to obtain the required air flow, the filling volume of the nebulizer container must be at least 2-4 ml. Since the drug is inhaled into the lungs, it is important to instruct the patient to inhale the drug through the mouthpiece evenly and calmly. If the procedure is performed on a child, and he cannot do it on his ownbreath, a special mask is used.
The patient should also be informed about the need to read the instructions for use of this medication, and that ultrasonic nebulizers are not used for its use in the form of a suspension. The suspension must be mixed with a 0.9% sodium chloride solution or with solutions of drugs such as terbutaline, salbutamol, fenoterol, sodium cromoglycate, acetylcysteine and ipratropium bromide. After inhalation, it is recommended to rinse the mouth with water to reduce the likelihood of oropharyngeal candidiasis. To reduce the risk of skin irritation after using the mask, rinse your face with water. In addition, it is important to know that the finished suspension of the Pulmicort drug should be used after a maximum of 30 minutes, after which it is considered unsuitable for administration.
It is also recommended to regularly flush the nebulizer according to the manufacturer's instructions.
Terms of Use
So, how to use "Pulmicort" when coughing? The container containing a single dose of medication is marked with a line. If you turn it upside down, then this line will mean a volume equal to 1 ml. When exactly this amount of suspension is to be applied, the contents of the package are squeezed out until the liquid reaches the level indicated by the line. An open container is stored in a dark place for no more than 12 hours. Shake the contents of the plastic container before applying the remainder of the liquid.
Side effects
Up to 10%patients who take this drug may experience these side effects:
- Respiratory tract: irritation of the mucous membrane of the pharynx, candidiasis of the oropharynx, cough, dry mouth, hoarseness, bronchospasm.
- CNS: cephalalgia, possible nervousness, depression, irritability, behavioral disturbances.
- Allergic manifestations: angioedema.
- Dermatological reactions: contact dermatitis, urticaria, rash.
- Other symptoms: there may be signs of a violation of the general condition caused by systemic exposure to corticosteroids (including increased adrenal function). In some cases, there is the appearance of hemorrhages on the skin, irritation.
Contraindications
Pharmacological preparation "Pulmicort" is contraindicated for use in such cases:
- under 6 months of age;
- high sensitivity to budesonide.
Patients require more careful monitoring (use of medication with caution) if they have an active form of pulmonary tuberculosis, fungal, viral, bacterial infections of the respiratory system, cirrhosis of the liver.
When using, the possible systemic effects of corticosteroids should be taken into account.
During pregnancy and lactation
Observation of pregnant patients who took budesonide as part of the drug "Pulmicort" did not show the occurrence of malformations in the fetus, but the risk of their occurrence cannot be ruled out. Therefore, induring pregnancy, it is recommended to use the minimum effective dosage of the drug.
Budesonide penetrates into mother's milk, however, when using Pulmicort in therapeutic doses, no effect on the child was noted, so the drug is allowed to be administered during breastfeeding.
Special Recommendations
In order to minimize the likelihood of a fungal infection of the pharynx, the patient should be instructed to thoroughly rinse the mouth after each inhalation. Wash your face to prevent skin irritation.
The concomitant use of budesonide with itraconazole, ketoconazole and other CYP3A4 inhibitors should also be avoided. If such a combination is necessary, it is recommended to increase the interval between medications to the maximum.
Due to the possible risk of decreased adrenal function, special attention should be paid to patients who are transferred from taking systemic corticosteroids to taking Pulmicort. In addition, special attention is required for patients who have taken high doses of corticosteroids or have received the highest inhaled doses of corticosteroids for a long time. When stressed, these people may show signs of adrenal insufficiency. In cases of surgical interventions, such patients are recommended to undergo additional treatment with systemic corticosteroids.
In the process of switching from oral corticosteroids to Pulmicort, patients may experience previously observed symptoms, such as joint and muscle pain. In such situations, it may be necessarytemporary increase in the dosage of corticosteroids for internal use. In some cases, symptoms such as headache, fatigue, vomiting and nausea may occur, indicating GCS deficiency. It is also possible to exacerbate existing rhinitis and eczema, allergic reactions that were previously eliminated through systemic drugs.
What is the dosage of "Pulmicort" for inhalation for children according to the instructions?
Pediatric Use
Adolescent and children receiving corticosteroid therapy (in any form) for a long period of time, regular monitoring of growth indicators is recommended. When using GCS, it is necessary to evaluate the ratio of the benefits of using this drug and the potential likelihood of growth retardation in a child.
Appointment of budesonide at a dosage of up to 400 mcg/day in children after 3 years, according to statistical information, did not lead to the development of systemic effects. Biochemical indicators of the systemic effect of the drug can occur when it is used at a dose of 400 to 800 mcg / day. With an increase in this dose, systemic effects are quite common.
The use of corticosteroids for the treatment of bronchial asthma can provoke dysplasia. The results of numerous observations of adolescents and children who received budesonide for a long time (up to 11 years) proved that growth reaches the expected norm for adults. Instructions for "Pulmicort" must be strictly observed.
Impact onability to drive vehicles and dangerous mechanisms
The drug does not affect the ability to drive a car and other complex mechanisms. The main thing is to find out in advance how much Pulmicort can be consumed per day.
Overdose symptoms
With a severe drug overdose, clinical symptoms are usually not observed.
With prolonged inhalation administration of the drug at doses significantly higher than recommended, general effects of corticosteroids may develop in the form of suppression of adrenal function and hypercortisolism.
Drug Interactions
There was no interaction of budesonide in Pulmicort for adults and children with other medications used in the treatment of bronchial asthma.
When combined with ketoconazole (at a dose of 200 mg per day), it can increase the plasma concentration of budesonide by an average of 6 times. During the use of ketoconazole 12 hours after budesonide, the level of the latter in plasma increases by an average of 3 times. If it is necessary to simultaneously take budesonide and ketoconazole, the time interval between taking these drugs should be increased to the maximum interval. Consideration should also be given to reducing the dosage of budesonide.
Itraconazole, another potential inhibitor of CYP3A4, also significantly increases plasma levels of budesonide. Preliminary inhalation of beta-adrenergic stimulants contributes to the expansion of the bronchi, improving the penetration of budesonide into the respiratory organs andenhancing its therapeutic effect.
Phenytoin, phenobarbital, rifampicin, when combined, can reduce the effectiveness of the Pulmicort medication, due to the induction of microsomal oxidation enzymes.
Estrogens and methandrostenolone enhance the effects of budesonide.
Storage rules
This pharmacological agent should be stored at a temperature not exceeding 30 ° C, out of the reach of children. The shelf life of Pulmicort is 2 years. After opening the laminated envelope, the containers contained in it must be used up within 3 months. Containers are stored in an envelope to protect from sunlight. The opened container is used within 12 hours.
When choosing analogues, it is important to understand that the instructions for use of "Pulmicort", the price and reviews for drugs of similar action do not apply. It is important to consult a doctor and do not change the drug yourself.
Price in pharmacies ranges from 812 to 1200 rubles.
Analogues
The following medications can be used as analogues of the drug "Pulmicort":
- "Benacort" - a product based on budesonide, which is available in the form of a solution and powders for inhalation. This analogue is prescribed for bronchial asthma as the main anti-inflammatory drug. Dosages are set individually by the doctor. Treatment with this agent begins at a stable period of the pathological process. First 2-3 weeksinhalations are carried out against the background of taking hormonal medications. For children, the medicine "Benacort" is contraindicated. This drug has the same effect, it can only be used from the age of sixteen.
- "Berodual" is a medicine that can be used as an analogue of "Pulmicort" in the treatment of bronchial asthma and chronic obstructive bronchitis. The main active ingredients are ipratropium bromide and fenoterol hydrobromide. The drug is produced as a liquid for inhalation. "Berodual" is a cheaper analogue of the "Pulmicort", and can be prescribed to children from 6 years old.
- Budenitis Steri-Neb is a glucocorticosteroid drug intended for inhalation procedures. This medication has anti-exudative, anti-inflammatory and anti-allergic properties. The drug is based on the active substance budesonide. The medicine is available in the form of an odorless suspension and can be used in children from 6 months.
Reviews
Doctors characterize this medicine as a good modern medicine for a wide variety of coughs. It is used not only to eliminate asthma attacks, but in the treatment of pathologies such as laryngitis, pharyngitis, when there is a threat of developing a false croup. This is especially true for young children, and the main advantage of this remedy, according to doctors, is the possibility of its use in infancy.
Patients who used Pulmicort for coughing note that this medicine helps them well, quickly stops an asthmatic attack, it is convenientin use. The drug is quite expensive, according to patients, but very effective.
We reviewed the composition of the drug for inhalation "Pulmicort" and instructions for it. We hope that the information provided will be useful to you.