Pulmicort: how and where to store the drug after opening

Pulmicort suspension for nebulizer - official instructions for use

Registration number:

Tradename:

International nonproprietary name:

Dosage form:

dosed suspension for inhalation

1 ml of suspension contains: Active ingredient: budesonide (micronized budesonide) 0.25 mg or 0.5 mg. Excipients: sodium chloride 8.5 mg, sodium citrate 0.5 mg, disodium edetate (sodium ethylenediaminetetraacetic acid (disubstituted) (disodium EDTA)) 0.1 g, polysorbate 80 0.2 mg, citric acid (anhydrous) 0.28 mg, purified water to 1 ml.

Description

An easily resuspended, white or off-white, sterile suspension in low-density polyethylene containers containing a single dose.

Pharmacotherapeutic group

Glucocorticosteroid for local use.

ATX code : R03BA02

Pharmacological properties

Pharmacodynamics Budesonide, an inhaled glucocorticosteroid, 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 frequency of side effects than when using systemic glucocorticosteroids. 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. The maximum concentration in blood plasma is reached 30 minutes after the start of inhalation. Metabolism and distribution The binding to plasma proteins averages 90%. The volume of distribution 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. Elimination 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

• Bronchial asthma requiring maintenance therapy with glucocorticosteroids. • Chronic obstructive pulmonary disease (COPD). • Stenosing laryngotracheitis (false croup)

Contraindications

• Hypersensitivity to budesonide. • Children up to 6 months.

With caution (more careful monitoring of patients is required): in patients with fungal, viral, bacterial infections of the respiratory system, cirrhosis of the liver; when prescribing, the possible manifestation of the systemic effect of glucocorticosteroids should be taken into account.

Use during pregnancy and lactation

Pregnancy: 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. Lactation: 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.

Directions for use and doses

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 one time). If you take a higher dose, it is recommended to divide it into two doses. Recommended starting dose: Children 6 months and older: 0.25-0.5 mg per day. If necessary, the dose can be increased to 1 mg/day. Adults/elderly patients: 1-2 mg per day. Maintenance dose: Children 6 months and older: 0.25-2 mg per day. Adults: 0.5-4 mg per day. In case of severe exacerbations, the dose may be increased.

Dose table

*) 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 (up to 1 mg/day) of Pulmicort instead of combining the drug with oral glucocorticosteroids, due to the lower risk of developing systemic effects. Patients receiving oral glucocorticosteroids Cancellation of oral glucocorticosteroids should begin when the patient's health is stable. For 10 days, it is necessary to take a high dose of Pulmicort while taking oral glucocorticosteroids in the usual dose. Subsequently, over the course of a month, the dose of oral glucocorticosteroids (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 glucocorticosteroids. 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 per day. The dose of the drug can be taken at one time (at a time) or divided into two doses of 1 mg each with an interval of 30 minutes.

Side effect

The incidence of undesirable effects is presented as follows: Often (>1/100, 1/1000, 1/10000,

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.

Interaction with other drugs

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 about 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, such as 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.

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 glucocorticosteroids to taking Pulmicort. Also, special attention should be paid to patients taking high doses of glucocorticosteroids, or who have been receiving the highest recommended doses of inhaled glucocorticosteroids 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, additional therapy with systemic glucocorticosteroids is recommended. Particular attention should be paid to patients who are transferred from systemic to inhaled glucocorticosteroids (Pulmicort) or in cases where a violation of the pituitary-adrenal function can be expected. In such patients, the dose of systemic glucocorticosteroids should be reduced with extreme caution and hypothalamic-pituitary-adrenal function should be monitored. Patients may also require the addition of oral corticosteroids during stressful situations such as trauma, surgery, etc. When switching from oral glucocorticosteroids 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 glucocorticosteroid deficiency. Replacing oral glucocorticosteroids with inhaled ones sometimes leads to the development of concomitant allergies, for example, rhinitis and eczema, which were previously treated with systemic drugs. In children and adolescents receiving treatment with glucocorticosteroids (regardless of the method of delivery) for an extended period, it is recommended to regularly monitor growth parameters. When prescribing glucocorticosteroids, 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 per 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 per day. When the dose exceeds 800 mcg per day, systemic effects of the drug are common. The use of glucocorticosteroids 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.

Effect on the ability to drive a car or use other machinery

Pulmicort does not affect the ability to drive a car or use other machinery.

Using Pulmicort using a nebulizer

Pulmicort is used for inhalation using an appropriate nebulizer equipped with a mouthpiece and a special mask. The nebulizer is connected to a compressor to create the required air flow (5-8 l/min), the filling volume of the nebulizer should be 2-4 ml. It is important to inform the patient: - 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 should be 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 (as shown in the picture) and open it by twisting 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, the contents of the container are squeezed out until the surface of the liquid reaches the level indicated by the line. The open container is stored 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 you use a mask, make sure that the mask fits tightly to your 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 according to the manufacturer's instructions. Rinse and dry the nebulizer well by connecting the chamber to the compressor or air inlet valve.

Release form

Suspension for inhalation dosed 0.25 mg/ml and 0.5 mg/ml. 2 ml of the drug in a low-density polyethylene container. 5 containers are connected into one sheet. A sheet of 5 containers is packaged in a laminated foil envelope. 4 envelopes in a cardboard box with instructions for use.

Storage conditions

At temperatures below 30°C. Keep out of the reach of children. The drug in containers must be used within 3 months after opening the envelope. An opened container must be used within 12 hours. Containers should be stored in an envelope to protect them from light.

Vacation conditions

Best before date

2 years. Do not use after the expiration date stated on the package.

(information is provided only when packaging at AstraZeneca AB, Sweden):

Name and address of the manufacturer

AstraZeneca AB, SE-151 85 Sodertalje. Sweden

Additional information is available upon request : Representative office of AstraZeneca UK Limited, UK, in Moscow and AstraZeneca Pharmaceuticals LLC: 125284 Moscow, st. Begovaya no. 3, building 1

Or (information is indicated only when packaging at ZiO-Zdorovye CJSC, Russia):

Company manufacturer

AstraZeneca AB, SE-151 85 Sodertalje, Sweden

Release quality control of ZiO-Zdorovye CJSC, Russia, 142103, Moscow region, Podolsk, st. Zheleznodorozhnaya, 2

Additional information is available upon request : Representative office of AstraZeneca UK Limited, UK, in Moscow and AstraZeneca Pharmaceuticals LLC: 125284 Moscow, st. Begovaya 3, building 1

Is it better to use Berodual instead of Pulmicort?

Pulmicort and Berodual have the ability to alleviate the patient's condition with bronchospasm. But it is worth noting that the first drug is a steroid type, it should be used with caution for a disease of unknown etiology. For any viral or bacterial infection, you must adhere to the doctor's prescription.

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Berodual also has a bronchodilator property, which manifests itself locally, in contrast to the previous drug, which has a systemic effect. The therapeutic effect is achieved much faster, within 15 minutes from the moment of administration. No negative effects of this drug on mucus production in the respiratory tract have been noted.

Only the doctor decides whether to use medications for coronavirus or not. Self-medication can be dangerous in the presence of dangerous infectious diseases.