Pulmicort
Pulmicort: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Pulmicort
ATX code: R03BA02
Active ingredient: budesonide (budesonide)
Manufacturer: AstraZeneca AB (Sweden)
Description and photo update: 2019-20-08
Prices in pharmacies: from 328 rubles.
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Pulmicort is an inhaled glucocorticosteroid (GCS) with anti-inflammatory activity in the bronchi, which reduces the frequency of exacerbations and the severity of symptoms of bronchial asthma.
Release form and composition
The dosage form of Pulmicort is a dosed suspension for inhalation: an almost white or white liquid, easy to resuspend (2 ml in single-dose polyethylene containers, 5 containers in a laminated foil envelope, 4 envelopes in a cardboard box).
1 ml of suspension Pulmicort contains:
- Active ingredient: budesonide (micronized) - 0.25 mg or 0.5 mg;
- Auxiliary components: sodium citrate, citric acid (anhydrous), sodium chloride, polysorbate 80, disodium edetate (disubstituted sodium salt of ethylenediaminetetraacetic acid), purified water.
Pharmacological properties
Pharmacodynamics
Pulmicort is a drug that has a glucocorticoid, anti-inflammatory and anti-allergic effect.
Its active ingredient is budesonide, an inhaled GCS, which, when used in therapeutic doses, has an anti-inflammatory effect on the bronchi, thereby reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. Moreover, it causes fewer side effects than systemic corticosteroids.
Budesonide reduces the edema of the bronchial mucosa, the formation of sputum and mucus production, reduces airway hyperresponsiveness. Does not possess mineralocorticosteroid activity. Well tolerated even with prolonged use.
After inhalation of one dose of Pulmicort, the therapeutic effect develops in a few hours. The maximum effect is achieved after 1–2 weeks of regular treatment.
A dose-dependent effect of budesonide on urinary and plasma cortisol levels was noted. On adrenal function, budesonide at therapeutic doses has a significantly less effect than prednisone at a dose of 10 mg.
Budesonide does not affect the acute manifestations of the disease, but has a preventive effect on the course of bronchial asthma.
Pharmacokinetics
Budesonide is rapidly absorbed by inhalation. In adult patients, after inhalation of the Pulmicort suspension through a nebulizer, the systemic bioavailability is approximately 15% of the total applied dose and about 40–70% of the delivered dose. The maximum plasma concentration is reached 30 minutes after inhalation.
It is characterized by a high bond with plasma proteins - about 90%. The volume of distribution is about 3 l / kg.
After absorption, budesonide is intensively biotransformed (more than 90%) in the liver with the formation of metabolites with low glucocorticosteroid activity (the activity of the main metabolites 16α-hydroxyprednisolone and 6β-hydroxy-budesonide is less than 1% of the activity of budesonide).
The CYP3A4 isoenzyme is predominantly involved in the metabolism of budesonide. Metabolites are excreted unchanged in the urine or in conjugated form.
The systemic clearance of the drug is approximately 1.2 L / min. Its pharmacokinetics are proportional to the size of the applied dose.
The pharmacokinetic parameters of budesonide in patients with impaired renal function and in children have not been studied. In the presence of concomitant liver diseases, it is possible to slow down the excretion of budesonide from the body.
Indications for use
- Bronchial asthma (as maintenance therapy);
- Chronic obstructive pulmonary disease (COPD).
Contraindications
- Age up to 6 months;
- Hypersensitivity to budesonide and excipients.
According to the instructions, Pulmicort for inhalation is used with caution and under more careful supervision in the active form of pulmonary tuberculosis, cirrhosis of the liver, as well as in fungal, bacterial and viral infections of the respiratory system.
In the course of therapy, the possibility of manifestation of the systemic action of GCS should be considered.
Instructions for use Pulmicort: method and dosage
Pulmicort for inhalation is applied using a special apparatus - a nebulizer that converts the suspension into an aerosol. With a calm and even inhalation through the mouthpiece, the drug in the form of an aerosol enters the patient's lungs. For young children, the procedure is performed through a special mask.
Ultrasonic nebulizers are not suitable for using Pulmicort in the form of a suspension!
They start using the nebulizer after carefully studying the instructions, strictly following all the recommendations.
After each inhalation, rinse your mouth thoroughly with water, this will reduce the risk of developing candidiasis of the oropharynx, you also need to rinse your face with water to prevent skin irritation. The diluted suspension is used within the next half hour.
The nebulizer chamber should be cleaned after each procedure.
The compressor creates an air flow rate (5-8 liters per minute) required to fill the nebulizer with a volume of 2-4 ml. The device is equipped with a special mask and mouthpiece.
The doctor sets the dose of Pulmicort individually.
When prescribing a daily dose of 1 mg, it is administered at a time, if the dose is higher, it is divided into 2 doses.
To mix the suspension, use 0.9% sodium chloride solution or solutions of acetylcysteine, salbutamol, terbutaline, fenoterol, sodium cromoglycate, ipratropium bromide.
Recommended daily dosage:
- Adults, including elderly patients: the initial dose is 1-2 mg, the maintenance dose is 0.5-4 mg. To achieve the desired effect in severe exacerbation of the disease, the dose can be increased;
- Children over the age of 6 months: the initial dose is 0.25-0.5 mg, if necessary, an increase to 1 mg is allowed. The maintenance dose is 0.25-2 mg.
For each patient, the minimum effective maintenance dose is determined, providing a clinical effect.
Due to the lower risk of developing unwanted systemic effects, in some cases it is recommended to increase the daily dose of Pulmicort to 1 mg as monotherapy, instead of a combination with GCS for oral administration.
Patients who are on the treatment of oral corticosteroids should start discontinuing therapy during a period of stable condition. Against the background of the usual dose of oral corticosteroids, the patient receives high doses of Pulmicort for 10 days. Then, within a month, the dose of oral corticosteroids is gradually reduced to the minimum effective. Very often it is possible to completely cancel the intake of GCS inside.
With severe cirrhosis of the liver, the duration of action of Pulmicort increases.
Side effects
- Respiratory system: often - dry mouth, cough, oropharyngeal candidiasis, hoarseness, irritation of the pharyngeal mucosa; rarely - bronchospasm;
- Nervous system: rarely - headache; possibly - depression, nervousness, behavior disorders; excitability;
- Dermatological reactions: rarely - skin rash, urticaria, contact dermatitis;
- Allergic reactions: rarely - angioedema;
- Other reactions: rarely - facial skin irritation (from using a nebulizer with a mask), bruising on the skin; in some cases - hypofunction of the adrenal glands and symptoms of other pathologies caused by the systemic action of GCS.
Overdose
In acute overdose, clinical symptoms were not observed.
In the case of long-term use of Pulmicort in doses significantly exceeding the recommended therapeutic ones, systemic effects characteristic of glucocorticosteroids may develop, manifested by hypercortisolism and suppression of adrenal function.
special instructions
It is recommended to avoid the appointment of budesonide while the use of ketoconazole, itraconazole or other potential CYP3A4 inhibitors. If this combination is necessary, the period between taking the drugs should be increased to the maximum possible.
Control over the condition of patients is required when switching to taking Pulmicort from systemic corticosteroids, since the risk of weakening of adrenal function increases. It is necessary to pay special attention to patients with oral administration of high doses of GCS or long-term receipt of the highest recommended doses of inhaled GCS. Since stressful situations in this category of patients can cause symptoms of adrenal insufficiency, additional therapy with systemic GCS is recommended during surgery and other stresses.
The transition from systemic GCS to Pulmicort is carried out with caution.
If there is a risk of impaired pituitary-adrenal function, the dose of systemic corticosteroids should be reduced with special attention to the patient's condition and control of the parameters of the function of the hypothalamic-pituitary-adrenal system. In case of trauma, surgery and other stresses of this category of patients, additional intake of GCS inside may be required.
With the appearance of pain in joints or muscles in the case of switching from oral corticosteroids to inhalation, a temporary increase in the dose of corticosteroids for oral administration is possible. The development during the transition period of feelings of fatigue, headache, nausea, vomiting is evidence of systemic insufficiency of GCS.
Due to the cessation of the action of systemic drugs during the transition, the risk of exacerbation of existing eczema, allergic pathologies, rhinitis increases.
For the prevention of physical exertion asthma, the use of Pulmicort 1-2 times a day is effective.
During pregnancy, it is recommended to use the minimum effective dose of the drug.
The use of therapeutic doses of Pulmicort during breastfeeding does not affect the child.
GCS in pediatrics is used after a careful assessment of comparing the expected therapeutic effect and the potential threat in slowing the growth of the child. With prolonged use of Pulmicort in children and adolescents, regular monitoring of the growth rate should be carried out.
The observation results showed that the use of budesonide for 11 years in children and adolescents did not affect their achievement of standard growth rates.
Biochemical symptoms of systemic action of Pulmicort can occur when a daily dose of 0.4-0.8 mg is used; systemic effects are often found in children taking doses above 0.8 mg per day.
After each use, the nebulizer chamber, mouthpiece or mask must be washed with warm water and a mild detergent, the nebulizer must be rinsed and dried, and the chamber must be connected to an air inlet valve or compressor.
Influence on the ability to drive vehicles and complex mechanisms
Pulmicort does not affect the patient's ability to drive a car or other mechanisms.
Application during pregnancy and lactation
Observations of pregnant women who received budesonide did not reveal developmental abnormalities in the fetus, but the risk of their occurrence cannot be completely excluded. Given the possible worsening of the course of bronchial asthma, during pregnancy, Pulmicort should be used in the minimum effective dose.
Budesonide passes into breast milk, however, in therapeutic doses, the drug does not have a negative effect on an infant, therefore Pulmicort is approved for use during lactation.
Pediatric use
The appointment of Pulmicort for children under the age of 6 months is contraindicated.
With impaired renal function
There is no information on the possibility of using budesonide with concomitant renal failure.
For violations of liver function
There are no data on the use of Pulmicort in patients with concomitant hepatic impairment. However, it was found that budesonide is biotransformed in the liver, therefore it is assumed that with severe cirrhosis of the liver, the duration of the drug may increase.
Use in the elderly
No dose adjustment is required in elderly patients.
Drug interactions
The interaction of budesonide with other drugs used for the treatment of bronchial asthma was not observed.
If necessary, the simultaneous use of ketoconazole should reduce the dose of budesonide and maximize the interval between doses.
Plasma levels of budesonide significantly increase itraconazole, a potential inhibitor of CYP3A4.
The use of beta-adrenostimulants for preliminary inhalation helps to expand the bronchi, improve the flow of budesonide into the respiratory tract, and enhance its therapeutic effect.
When combined with phenytoin, phenobarbital, rifampicin, the effect of Pulmicort decreases, and in combination with estrogens, methandrostenolone, it increases.
Analogs
The analogues of Pulmicort are: Pulmicort Turbuhaler, Apulein, Benacort, Benacap, Budenit Steri-Neb, Budesonide, Benarin, Budesonide Easyheiler, Tafen nasal, Budoster, Budesonide-Nativ, Budieir, Novopulmon E Novolizer, Tafen Novolizer.
Terms and conditions of storage
Store at temperatures up to 30 ° C out of reach of children.
Shelf life is 2 years.
After breaking the tightness of the envelope, the containers are suitable for use for 3 months, protect from light. An opened container must be used within 12 hours.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Pulmicort
According to reviews, Pulmicort is an effective drug that has a pronounced anti-inflammatory and anti-edema effect, reducing airway hyperresponsiveness, sputum production and edema of the bronchial mucosa.
To its disadvantages, certain patients include:
- frequent side effects (including candidiasis of the oral mucosa);
- inconvenience of use (the drug can only be used with an appropriate nebulizer, and saline is required to dilute the suspension);
- lack of a lid (each container opens by breaking off its upper part, so it does not close back, which is inconvenient when you need to divide the dose into 2 doses);
- short shelf life (after opening each envelope, the containers that are stored in it are allowed to be used only for 3 months) and relatively high cost, especially if long-term treatment is required.
Price for Pulmicort in pharmacies
Approximate prices of Pulmicort: suspension 0.25 mg / dose - 850-1250 rubles. for 20 single-dose containers, suspension 0.5 mg / dose - 1185-1365 rubles. for 20 single-dose containers.
Pulmicort: prices in online pharmacies
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Drug name Price Pharmacy |
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Pulmicort Turbuhaler 200 mcg / dose 100 doses powder for inhalation dosed 1 pc. 328 RUB Buy |
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Pulmicort Turbuhaler powder for in. dosage. 200mcg / dose 100 doses 395 RUB Buy |
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Pulmicort Turbuhaler 100 mcg / dose 200 doses powder for inhalation dosed 1 pc. 709 r Buy |
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Pulmicort 0.25 mg / ml suspension for inhalations dosed 2 ml 20 pcs. 775 RUB Buy |
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Pulmicort suspension for in. 0.25mg / ml cont. 2ml 20 pcs. 798 r Buy |
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Pulmicort 0.5 mg / ml suspension for inhalations dosed 2 ml 20 pcs. RUB 970 Buy |
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Pulmicort suspension for in. 0.5 mg / ml cont. 2ml 20 pcs. 1041 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
