Pulmicort Turbuhaler - instructions for use, doses, side effects, contraindications

Description:Plastic inhaler for 100 mcg / dose: the rotating part of the inhaler is a light brown color, on the underside it is squeezed out BUDESONIDE 100; for 200 μg / dose: the rotating part of the inhaler is brown, on the underside it is squeezed out BUDESONIDE 200. The inhaler contains round granules from white to almost white color, easily destroyed at the slightest mechanical effect. An insignificant part of the substance can be present in the form of a powder.

Pharmacotherapeutic group:glucocorticosteroid for topical application

ATX: & nbsp

R.03.B.A.02 Budesonide

Pharmacodynamics:

Budesonide is a glucocorticosteroid with a strong local anti-inflammatory effect.

The exact mechanism of action of glucocorticosteroids in the treatment of bronchial asthma is not fully understood. An anti-inflammatory effect, such as inhibiting the release of inflammatory mediators and a cytokine-mediated immune response, is perhaps the most important. The affinity of budesonide to the receptors of glucocorticosteroids is 15 times higher than that of prednisolone. The anti-inflammatory effect of budesonide is mediated by a decrease in the degree of airway obstruction during an early and late allergic response. Budesonide reduces the reactivity of the respiratory tract in response to inhalation of histamine and methacholine.

The sooner the bronchial asthma of the persistent current is started with treatment with budesonide, the greater the improvement in lung function should be expected.

The dose-dependent effect on the cortisol content in plasma and urine is shown on the background of Pulmicort turbuhaler intake. In recommended doses, the drug has a significantly lower effect on adrenal function than prednisone in a dose of 10 mg, as was shown in ACTH tests.

The use of budesoid in a dose of up to 400 micrograms per day in children older than 3 years did not lead to systemic effects. Biochemical signs of the systemic effect of the drug may occur when taking the drug at a dose of 400 to 800 micrograms per day. When the dose exceeds 800 mcg per day, the systemic effects of the drug are often encountered.

The use of glucocorticosteroids for the treatment of bronchial asthma can cause a slowdown in growth.

Initially, a small, usually transient growth retardation (approximately 1 cm) was noted, usually during the first year of treatment. Long-term studies in clinical practice have shown that children and adolescents who received inhaled budesonide therapy,on average, the estimated growth for adults. However, in a long-term double-blind trial with predominantly no titration of dose budesonide to minimal effective, the growth of children and adolescents taking inhalation budesonide, on reaching adulthood, on average, was 1.2 cm less than in the placebo group (see the recommendations for dosing and growth control in the sections "Dosing and Administration" and "Special instructions"). Therapy with inhaled budesonide once or twice a day showed efficacy for the prevention of asthma physical effort.

Therapy with inhaled budesonide once or twice a day showed efficacy for the prevention of asthma physical effort.

Pharmacokinetics:

Absorption

Inhalable budesonide quickly absorbed. After inhalation using Turbuhaler about 25-35% of the measured dose of 1 falls into the lungs. The maximum concentration in the blood plasma is reached 30 minutes after inhalation. Systemic bioavailability of the drug is about 38% of the dose.

Metabolism and distribution

The binding to plasma proteins is on average 90%.The volume of budesonide distribution is approximately 3 l / kg. After suction budesonide is subjected to intensive (more than 90%) biotransformation in the liver with the formation of metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites of β-hydroxybuddesonide and 16 α-hydroxy-prednisolone is less than 1% of the glucocorticosteroid activity of budesonide.

Excretion

Budesonide is metabolized mainly with the participation of the enzyme CYP3A4. Metabolites are excreted unchanged in urine or in conjugated form. A small amount of unmodified budesonide is excreted in the urine. Budesonide has a high system clearance (about 1.2 l / min). The pharmacokinetics of budesonide is proportional to the magnitude of the administered dose of the drug.

The pharmacokinetics of budesonide in children and patients with impaired renal function is unknown. In patients with liver disease, budesonide can be longer in the body.

Indications for use

- bronchial asthma, requiring maintenance therapy with glucocorticosteroids to control the inflammatory process.

- chronic obstructive pulmonary disease (COPD).

Indications:

- bronchial asthma, requiring maintenance therapy with glucocorticosteroids to control the inflammatory process.

- chronic obstructive pulmonary disease (COPD).

Contraindications:

Hypersensitivity to budesonide.

Children under 6 years.

Carefully:Caution should be exercised when treating inhaled glucocorticosteroids in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system; cirrhosis of the liver, glaucoma, hypothyroidism.

Pregnancy and lactation:

Pregnancy

Animal studies have shown that glucocorticosteroids can cause fetal abnormalities, but these data can not be extrapolated to people receiving glucocorticosteroids at the recommended doses. While taking budesonide, pregnant women did not have an increased risk of fetal development anomalies, nevertheless, the risk of their development can not be ruled out completely, therefore, during pregnancy, the minimum effective dose of budesonide should be used, without forgetting the possibility of worsening of the course of bronchial asthma.When prescribing the drug should take into account the ratio of expected benefits for the mother and the potential risk to the child.

Breastfeeding period

Budesonide is excreted in breast milk, but with the use of the drug Pulmicort Turbuhaler in therapeutic doses of exposure to an infant is not expected. When prescribing the drug should take into account the ratio of expected benefits for the mother and the potential risk to the child.

Dosing and Administration:

The dose of Pulmicorta Turbuhaler is selected individually.

The recommended dose of the drug in the case of the onset of inhaled glucocorticosteroid therapy during the period of severe exacerbations of bronchial asthma, as well as against a reduction in dose or withdrawal of oral glucocorticosteroids, are as follows:

Children older than 6 years: 100-800 mcg / day (total daily dose of the drug can be divided into 2-4 inhalations). In the event that the recommended dose does not exceed 400 mcg / day, the entire dose of the drug can be taken at a time (one time).

At children transition to single reception of a preparation should be spent under observation of the pediatrist.

Adults: The usual dose is 200-800 μg / day (the total daily dose of the drug can be divided into 2-4 inhalations).For the treatment of severe exacerbation of bronchial asthma, the daily dose can be increased to 1600 μg.

If the recommended dose does not exceed 400 mcg / day, the entire dose of the drug can be taken at a time (one time).

When selecting a maintenance dose, it is necessary to strive to prescribe the minimum effective dose.

The time to start the therapeutic effect after inhalation of a single dose of the drug is several hours. The maximum therapeutic effect is achieved 1-2 weeks after treatment. Pulmicort Turbuhaler has a preventive effect on the course of bronchial asthma and does not affect the acute manifestations of the disease.

The best efficacy of budesonide was demonstrated when using Turbuhaler compared with a similar dose of budesonide in the form of a dosed aerosol. In the case of a patient who is in a stable condition from Pulmicort in aerosol form to Pulmicort Turbuhaler, the possibility of reducing the daily dose of budesonide should be considered.

To enhance the therapeutic effect, an increase in the daily dose of Pulmicort turbuhaler may be recommended instead of the combination of the drug with oral glucocorticosteroids, due to a lower risk of systemic effects.

Patients receiving oral glucocorticosteroids

Abolition of oral glucocorticosteroids should be performed against a background of stable patient health. Within 10 days it is recommended to take a high dose of Pulmicort while taking oral glucocorticosteroids in a selected dose. In the future, the dose of oral glucocorticosteroids should be gradually reduced (for example, 2.5 mg prednisolone or its analog) to the lowest possible level. In many cases it is possible to completely stop taking oral glucocorticosteroids.

There is no data on the use of budesonide in patients with renal insufficiency or liver dysfunction. Taking into account the excretion of budesonide due to biotransformation in the liver, an increase in the duration of action of the drug in patients with severe cirrhosis of the liver can be expected.

INSTRUCTION FOR USE OF TURBUCHALER

Turbuhaler - multi-dose inhaler, which allows you to dose and inhale the drug in very small doses (Figure 1). When you inhale, the powder from Turbuhaler is delivered to the lungs. Therefore, it is important that you take a deep and deep breath through the mouthpiece.

Preparing the Turbuhaler for first use:

Before the first use of Turbuhaler it must be prepared for work.

1. Unscrew and remove the cap.

2. Hold the inhaler vertically with the dispenser down (Fig. 2). Do not hold the inhaler for the mouthpiece when you turn the dispenser.

Turn the dispenser all the way in one direction (no matter, clockwise or counterclockwise), and then also against the stop in the opposite direction. During the rotation of the dispenser, you will hear a click. Follow the procedure twice.

Now the inhaler is ready for use, and you should not repeat this procedure of preparing Turbuhaler for work before each use. In order to take the drug, follow the instructions below.

how use Pulmicort® Turbuhaler®

To take one dose of the drug, follow the procedure described below.

1. Unscrew and remove the cap.

2. Hold the inhaler vertically with the dispenser down (Fig. 2). Do not hold the inhaler for the mouthpiece when you turn the dispenser. To measure the dose of the drug, turn the dispenser all the way in one

direction (no matter, clockwise or counterclockwise), and then also to emphasis in

the opposite direction. During the rotation of the dispenser, you will hear a click.

3. Do not hold the inhaler at the mouth. Exhale. Do not exhale through the mouthpiece.

4. Carefully place the mouthpiece between the teeth, compress the lips and draw a strong and deep breath through the inhaler (Figure 3). The mouthpiece should not be chewed or compressed with teeth.

5. Before exhaling, remove the inhaler from the mouth.

6.If inhalation of more than one dose is required, repeat steps 2-5.

7.Close the inhaler cap, check that the inhaler cap has been carefully screwed.

8. Rinse your mouth with water.

IMPORTANT!

Never exhale through the mouthpiece.

Always close the inhaler cap tightly after use.

Since the amount of inhaled powder is very small, you may not feel the taste of the powder after inhalation. However, if you followed the instructions, you can be sure that you inhaled the necessary dose of the drug.

Cleaning

Regularly (once a week), clean the mouthpiece from the outside with a dry cloth.

Do not use water or other liquids to clean the mouthpiece.

How do you know that the inhaler is empty?

The appearance of a red mark in the indicator window means that approximately 20 doses remain in the inhaler (Figure 4). When the red mark reaches the bottom edge of the dose indicator window (Figure 5), the inhaler is empty and must be replaced with a new one.

Note that even when the inhaler is empty, the dispenser continues to rotate. The sound that you hear when you shake the inhaler is produced by a dehumidifying agent, not a medicine.

Recycling

Be careful with the inhaler used, remember that some amount of the drug may remain inside the inhaler.

Side effects:

Up to 10% of patients taking the drug may experience the following side effects:

Frequent (> 1/100)

Airways:

Candidiasis of the oropharynx, irritation of the mucous pharynx, cough,

hoarseness

Rare (<1/1000)

Are common:

Leather:

Airways:

Angioedema

Urticaria, rash, contact dermatitis

Bronchospasm

There may also be neuropsychiatric symptoms, such as nervousness, excitability, depression, behavioral disorders. Taking into account the risk of development of the oropharyngeal kididosis, the patient should thoroughly rinse the mouth with water after each inhalation of the drug.

In rare cases, symptoms can occur due to systemic effects of glucocorticosteroids, including adrenal hypofunction. There may also be nausea, changes in taste, hypercorticism, hypokorticism,cataract, glaucoma, difficulty swallowing, slowing growth (in children and adolescents), decreased bone density.

In rare cases, bruises appeared on the skin.

Overdose:When an overdose of Pulmicort turbuhalerom in doses significantly exceeding the recommended, clinical manifestations does not arise. With prolonged use of the drug in doses much higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercorticoidism and suppression of adrenal function.

Interaction:

There was no interaction of budesonide 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) by an average of 6 times when taken together. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in the blood plasma increased by an average of 3 times. There is no information on such interaction when taking inhaled budesonide, however, it is expected that in this case an increase in the concentration of budesonide in the blood plasma should be expected.Do not prescribe these drugs at the same time due to the lack of data. If it is necessary to co-prescribe ketoconazole and budesonide, the time between taking medications should be increased to the maximum possible. You should also consider reducing the dose of budesonide. Other potential inhibitors of the CYP3A4 enzyme (eg, itraconazole) also cause a significant increase in plasma concentrations of budesonide.

Special instructions:

To minimize the risk of fungal oropharyngeal injury, the patient should be instructed to rinse the mouth thoroughly with water after each inhalation of the drug.

Joint administration of budesonide with ketoconazole, itraconazole or other potential inhibitors of CYP3A4 should be avoided. If budesonide and ketoconazole or itraconazole or other potential inhibitors of CYP3A4 have been prescribed, the time between taking the drugs to the maximum possible should be increased.

Because of the possible risk of weakening the pituitary-adrenal function, special attention should be given to patients who are transferred from oral glucocorticosteroids to Pulicicort.Also, special attention should be given to patients taking high doses of glucocorticosteroids, or who received long-term maximum recommended doses of inhaled glucocorticosteroids. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. When 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 Turbuhaler), or in the case where a disorder of the pituitary-adrenal function can be expected. In such patients, it is necessary with special care to reduce the dose of systemic glucocorticosteroids and control the hormonal function of the adrenal glands. Patients may also require the administration of oral glucocorticosteroids during periods of stressful situations such as trauma, surgery, etc.

When switching from oral glucocorticosteroids to Pulmicort Turbuhaler, patients may experience previously observed symptoms, such as muscle aches or joint pain.In such cases, a temporary increase in the dose of oral glucocorticosteroids may be necessary. In rare cases, symptoms such as fatigue, headache, nausea and vomiting can be observed, indicating a systemic insufficiency of glucocorticosteroids.

The replacement of oral glucocorticosteroids by inhalation sometimes leads to the manifestation of an existing allergy, rhinitis and eczema, which were previously stopped by systemic drugs.

For children and adolescents receiving treatment with glucocorticosteroids (regardless of the method of delivery) for an extended period, it is recommended that growth rates be regularly monitored.

Patients should be instructed about the need to consult a doctor in case of a decrease in the effectiveness of therapy with short-acting bronchodilators, as an independent increase in the frequency of use of the drug may lead to a delay in the appointment of adequate treatment. In the event of a sudden deterioration in the condition, consideration should be given to the possibility of a course of treatment with oral glucocorticosteroids.

Effect on the ability to drive transp. cf. and fur:Due with the possibility of development psychoneurological symptoms should be careful when driving vehicles and mechanisms.

Form release / dosage:Powder for inhalation dosed with 100 μg / dose, 200 μg / dose.

Packaging:200 doses (for a dosage of 100 mcg / dose), 100 or 200 doses (for a dosage of 200 mcg / dose) to a plastic inhaler consisting of a dosing device, a powder storage tank, a desiccant tank, a mouthpiece and a screw cap.
Each inhaler is placed in a cardboard box with instructions for use.

Storage conditions:Store at temperatures below 30 ° C, out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013849 / 01

Date of registration:28.09.2011

The owner of the registration certificate:AstraZeneca ABAstraZeneca AB Sweden

Manufacturer: & nbsp

ASTRAZENECA, AB Sweden

Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd.

Information update date: & nbsp2015-11-26

Illustrated instructions

Instructions

Pulmicort® Turbuhaler® (Pulmicort® Turbuhaler®)