Beclomethasone hormonal. Form, composition, packaging. Instructions for the patient to use the inhaler

Name:

Beclomethasone (Beclometasonum)

Pharmacological
action:

GCS for inhalation use.
It has anti-inflammatory and anti-allergic effect.
It inhibits the release of inflammatory mediators, increases the production of lipomodulin, an inhibitor of phospholipase A, reduces the release of arachidonic acid, and inhibits the synthesis of prostaglandins. Prevents marginal accumulation of neutrophils, reducing the formation of inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, which leads to slower infiltration processes and granulation.
Increases the number of active β-adrenergic receptors, neutralizes their desensitization, restores the patient's response to bronchodilators, allowing to reduce the frequency of their use.

Beclomethasone reduces the amount mast cells in the mucous membrane of the bronchi, the swelling of the epithelium and the secretion of mucus by the bronchial glands decrease.
Causes relaxation smooth muscle bronchi, reduces their hyperreactivity and improves performance external respiration.
Does not have mineralocorticoid activity.
AT therapeutic doses does not cause side effects characteristic of systemic corticosteroids.
When applied intranasally, it eliminates edema, hyperemia of the nasal mucosa.
The therapeutic effect usually develops after 5-7 days of course use of beclomethasone.
When applied externally and locally, it has an anti-allergic and anti-inflammatory effect.

Pharmacokinetics
After inhalation, part of the dose that enters the respiratory tract is absorbed in the lungs. AT lung tissue beclomethasone dipropionate is rapidly hydrolyzed to beclomethasone monopropionate, which in turn is hydrolyzed to beclomethasone.
The portion of the dose that is inadvertently swallowed largely inactivated during the "first pass" through the liver.
In the liver, the process of converting beclomethasone dipropionate to beclomethasone monopropionate and then to polar metabolites occurs.
Plasma protein binding active substance, located in the systemic circulation, is 87%.
With the on / in the introduction of T1 / 2 of beclomethasone 17,21-dipropionate and beclomethasone are approximately 30 minutes. Excreted up to 64% with feces and up to 14% with urine within 96 hours, mainly in the form of free and conjugated metabolites.

Indications for
application:

For inhalation use: treatment bronchial asthma(including with insufficient effectiveness of bronchodilators and / or sodium cromoglycate, as well as hormone-dependent bronchial asthma severe course in adults and children).
For intranasal use: prevention and treatment of year-round and seasonal allergic rhinitis, including rhinitis hay fever vasomotor rhinitis.
For outdoor and local application : in combination with antimicrobial agents- infectious and inflammatory diseases of the skin and ear.

Mode of application:

When administered by inhalation the average dose for adults is 400 mcg / day, the frequency of use is 2-4 times / day.
If necessary, the dose can be increased to 1 g / day.
For kids single dose- 50-100 mcg, frequency of use - 2-4 times / day.
When administered intranasally the dose is 400 mcg / day, the frequency of use is 1-4 times / day.
For external and topical application The dose depends on the indication and the dosage form drug.

Side effects:

From the side respiratory system : hoarseness, feeling of irritation in the throat, sneezing; rarely - cough; in isolated cases - eosinophilic pneumonia, paradoxical bronchospasm, with intranasal use - perforation of the nasal septum. Possibility of oral candidiasis upper divisions respiratory tract, especially long-term use, passing with local antifungal therapy without stopping treatment.
allergic reactions: rash, urticaria, itching, erythema and swelling of the eyes, face, lips and larynx.
Effects due systemic action : decreased function of the adrenal cortex, osteoporosis, cataracts, glaucoma, growth retardation in children.

Contraindications:

For inhalation and intranasal use:
- severe attacks of bronchial asthma, requiring intensive care;
- tuberculosis;
- Candidiasis of the upper respiratory tract;
- I trimester of pregnancy;
- hypersensitivity to beclomethasone.

beclomethasone not intended for relief of acute asthmatic attacks.
It should also not be used in severe asthma attacks requiring intensive care.
Should be strictly observed the recommended route of administration for the dosage form used.
With extreme caution and under the close supervision of a physician, beclomethasone should be used in patients with adrenal insufficiency.
The transfer of patients who are constantly taking GCS orally to inhaled forms can only be done when the condition is stable.

In the event of the likelihood of developing paradoxical bronchospasm, bronchodilators (for example, salbutamol) are inhaled 10-15 minutes before the administration of beclomethasone.
With the development of candidiasis of the oral cavity and upper respiratory tract, local antifungal therapy is indicated without stopping treatment with beclomethasone.
Infectious and inflammatory diseases of the nasal cavity and paranasal sinuses when appropriate therapy is prescribed, they are not a contraindication for treatment with beclomethasone.
Preparations for inhalation use containing 250 mcg of beclomethasone in 1 dose, not intended for children under 12 years of age.

Interaction
other medicinal
by other means:

With the simultaneous use of beclomethasone with other GCS for systemic or intranasal use, it is possible to increase the suppression of the function of the adrenal cortex.
Prior inhalation use of beta-agonists may increase the clinical efficacy of beclomethasone.

Pregnancy:

Contraindicated in the first trimester pregnancy.
Application in II and in III trimesters pregnancy is possible only when the expected benefit to the mother outweighs potential risk for the fetus.
Newborns whose mothers received beclomethasone during pregnancy should be carefully examined for adrenal insufficiency.
If necessary, use during lactation should decide on the termination of breastfeeding.

• Instructions for use BECLOMETASONE
• Ingredients of BECLOMETASONE
• Indications for beclomethasone
• Storage conditions of the drug BECLOMETASONE
• Shelf life of the drug BECLOMETASONE

ATC code: Respiratory system (R) > Nasal preparations (R01) > Decongestants and other topical preparations (R01A) > Corticosteroids (R01AD) > Beclometasone (R01AD01)

Release form, composition and packaging

Excipients: anhydrous ethanol, 1,1,1,2-tetrafluorodichloroethane

Excipients: anhydrous ethanol, propylene glycol, 1,1,1,2-tetrafluorodichloroethane

200 doses - aluminum cans (1) with a dosing device and a spray nozzle - cardboard boxes.
400 doses - aluminum cans (1) with a dosing device and a spray nozzle - cardboard boxes.

Excipients: anhydrous ethanol, isopropyl alcohol, 1,1,1,2-tetrafluorodichloroethane

200 doses - aluminum cans (1) with a dosing device and a spray nozzle - cardboard boxes.
400 doses - aluminum cans (1) with a dosing device and a spray nozzle - cardboard boxes.

Description medicinal product BECLOMETASONE was created in 2012 on the basis of instructions posted on the official website of the Ministry of Health of the Republic of Belarus.

pharmachologic effect

It has anti-inflammatory and anti-allergic effect.

It inhibits the release of inflammatory mediators, increases the production of lipomodulin, an inhibitor of phospholipase A, reduces the release of arachidonic acid, and inhibits the synthesis of prostaglandins. It prevents the marginal accumulation of neutrophils, reducing the formation of inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, which leads to a slowdown in the processes of infiltration and granulation. Increases the number of active β-adrenergic receptors, restores the patient's response to bronchodilators, allowing to reduce the frequency of their use. Under the action of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema and mucus secretion by the bronchial glands decrease. It causes relaxation of the smooth muscles of the bronchi, reduces their hyperreactivity and improves the performance of external respiration. Does not have mineralocorticoid activity. In therapeutic doses, it does not cause side effects characteristic of systemic glucocorticosteroids.

Pharmacokinetics

After inhalation, part of the dose that enters the respiratory tract is absorbed in the lungs. More than 25% of the inhaled dose is deposited in respiratory tract, the remaining amount - in the mouth, throat and swallowed. The part of the dose that is inadvertently swallowed is largely inactivated during the "first pass" through the liver. In the liver, the process of converting beclomethasone dipropionate to beclomethasone monopropionate and then to polar metabolites occurs. In the lungs, before absorption of beclomethasone, dipropionate is extensively metabolized to the active metabolite of beclomethasone-17-monopropionate. Its systemic absorption occurs in the lungs (36% lung fraction), in the gastrointestinal tract (26% of the swallowed dose). Beclomethasone dipropionate is rapidly absorbed (Tmax - 0.3 h), beclomethasone-17-monopropionate is absorbed more slowly (Tmax - 1 h). Communication with blood plasma proteins is relatively high - 87%. Beclomethasone dipropionate and beclomethasone-17-monopropionate have high plasma clearance (150 and 120 l/h, respectively). T 1/2 is 0.5 and 2.7 h, respectively. Excreted up to 64% with feces and up to 14% with urine, mainly in the form of free and conjugated metabolites.

Indications for use

Basic therapy bronchial asthma.

Adults and children:

• asthma mild degree(patients requiring periodic symptomatic treatment bronchodilators more often than occasionally);
• asthma moderate(patients requiring regular asthma treatment and patients with unstable or worsening asthma due to existing preventive therapy or therapy with bronchodilators alone);
• severe asthma (patients with severe chronic asthma. After starting beclomethasone aerosol, most patients who were dependent on systemic steroids for adequate control of asthma symptoms will be able to significantly reduce or completely stop oral administration corticosteroids).

Dosing regimen

The drug Beclomethasone aerosol for inhalation is used only by inhalation. Patients should be aware that Beclomethasone inhalation aerosol is used to prevent disease and therefore should be taken regularly, even in the absence of asthma attacks. The dose of the drug is adjusted, depending on individual reaction. If improvement after the use of short-acting bronchodilators becomes less effective or requires large quantity inhalations than usual, control treatment under the supervision of a specialist is necessary. For patients who find it difficult to synchronize breathing with the use of an inhaler, it is recommended to additionally use a spacer - a device to facilitate the inhalation of inhaled drugs. Children may also be advised to use a special baby spacer.

Application

The starting dose of inhaled beclomethasone dipropionate should be adjusted according to the severity of the disease. The dose may be adjusted until control is achieved and then should be titrated to the lowest dose that maintains effective control over asthma.

Adults (including the elderly):

Beclomethasone 50 mcg/dose:

The usual initial dose is 200 mcg 2 times / day. AT severe cases it can be increased to 600-800 mcg / day (in this case, it is recommended to use the drug form with high content active ingredient). The dose of the drug can then be adjusted to achieve control over the symptoms of asthma or reduced to the minimum effective, depending on the individual response of the patient. General daily dose should be administered two to four times a day.

Beclomethasone 250 mcg/dose:

The usual dose is 1000 mcg / day, which can be increased to 2000 mcg. It can be reduced if the patient's asthma has stabilized. The total daily dose should be administered two to four times a day. The Spacer device should always be used when administered to adults and adolescents 16 years of age and older at a total daily dose of 1000 micrograms or more.

Children:

Beclomethasone 50 mcg/dose:

The usual initial dose is 100 mcg 2 times / day. Depending on the severity of bronchial asthma, the daily dose can be increased to 400 mcg, which is taken in 2-4 doses.

Beclomethasone 250 mcg/dose:

In patients with hepatic or renal insufficiency: there is no need for dose adjustment in patients with hepatic or renal insufficiency.

The sprayed aerosol is inhaled through the mouth into the lungs. Proper management has importance for successful therapy. The patient should be instructed on how to use beclomethasone correctly and it is recommended that you read and follow the instructions printed on the package insert.

Instructions for use (rules for using the inhaler)

As with other inhalation drugs, therapeutic effect may decrease as the balloon cools. Cylinders must not be broken, pierced or incinerated, even if they are empty. If the inhaler is new or has not been used for three days or more, remove the mouthpiece cap by lightly pressing on the sides, shake the inhaler well and spray once into the air to ensure adequate operation.

1. Remove the mouthpiece cap by slightly pressing on the sides.

2. Make sure that there are no foreign objects inside and outside the inhaler, including the mouthpiece.

3. Shake the inhaler thoroughly to ensure that any foreign object is removed from the inhaler and to ensure that the contents of the inhaler are evenly mixed.

4. Take the inhaler vertically between the thumb and all other fingers, and thumb should be at the base of the inhaler, below the mouthpiece.

5. Exhale as deeply as possible, then place the mouthpiece in your mouth between your teeth and cover it with your lips without biting.

6. Starting to inhale through the mouth, press the top of the inhaler to spray the drug, while continuing to inhale slowly and deeply (this releases one dose of aerosol).

7. Hold your breath, remove the inhaler from your mouth and remove your finger from the top of the inhaler. Continue to hold your breath for as long as possible.

8. If you need to perform further sprays, you should wait about 30 seconds, holding the inhaler vertically. Then follow steps 3-7.

9. Place the mouthpiece cap in place by pushing and clicking in the desired direction.

• follow steps 5, 6 and 7 slowly. It is important to start inhaling as slowly as possible just before spraying. The first few times you should practice in front of a mirror. If a “cloud” appears at the top of the inhaler or from the sides of the mouth, you must start again from point 2.

Small children may need help, it may be necessary for adults to carry out inhalations. Ask the child to exhale and spray immediately after the child begins to inhale. It is recommended to master the technique together. Older children or debilitated adults may hold the inhaler with both hands. Both should be placed index fingers on the top of the inhaler, and both thumbs- on the base below the mouthpiece.

Cleaning

The inhaler should be cleaned at least once a week:

1. Remove the metal container from the plastic case of the inhaler and remove the mouthpiece cap.

2. Wipe the plastic case and mouthpiece with a damp cloth.

Z. Let dry in a warm place. Avoid excessive heat.

4. Place the metal bottle and mouthpiece cap back in place. It is necessary to advise the patient about the importance of rinsing the mouth and throat with water or brushing the teeth immediately after using the inhaler. The patient should be informed of the importance of cleaning the inhaler at least once a week to prevent blockage, and of carefully following the instructions for cleaning the inhaler printed on the package insert. The inhaler must not be washed or placed in water.

Side effect

The following side effects systematized by organs and systems depending on the frequency of occurrence:

• very often (1/10), often (1/100 and<1/10), нечасто (1/1000 и <1/100), редко (1/10000 и <1/1000) и очень редко (<1/10000), включая отдельные сообщения. Данные о побочных действиях, возникающих очень часто, часто и нечасто, главным образом базируются на клинических исследованиях. Данные о побочных действиях, возникающих редко и очень редко, получают главным образом спонтанно.

Infections and infestations: very often - candidiasis of the oral cavity and pharynx. Some patients may develop candidiasis of the oral cavity and pharynx, the frequency of which increases at high doses (more than 400 mcg of beclomethasone dipropionate per day). This complication occurs more often in patients with high blood levels of Candida precipitins, which indicates a previous infection. In this case, it is useful to rinse the mouth after inhalation. If necessary, during the entire period of treatment, an antifungal drug is prescribed, while continuing the use of beclomethasone.

The immune system: hypersensitivity reactions have been reported with the following manifestations:

• infrequently - skin rash, urticaria, itching, erythema;
• very rarely - angioedema of the eyes, face, lips and oropharynx, respiratory symptoms (shortness of breath and / or bronchospasm) and anaphylactoid / anaphylactic reactions.

Endocrine system: possible systemic action, including:

• very rarely - Cushing's syndrome, cushingoid signs, adrenal suppression, growth retardation in children and adolescents, decreased bone mineralization, cataracts and glaucoma.

Mental disorders: very rarely - a feeling of anxiety, sleep disturbance, behavioral changes, including hyperactivity and excitability (mainly in children).

Respiratory system and chest: often - hoarseness of voice, sore throat. In some patients, inhaled beclomethasone dipropionate may cause hoarseness or throat irritation, in which case it is useful to gargle with water immediately after inhalation .;

As with other inhaled drugs, paradoxical bronchospasm may develop with rapidly increasing dyspnea after inhalation. In this case, fast-acting inhaled bronchodilators are immediately applied, inhaled beclomethasone is immediately stopped, the patient is examined and, if necessary, alternative therapy is prescribed.

Use during pregnancy and lactation

Contraindicated in the first trimester of pregnancy.

Application in the II and III trimesters of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. Newborns whose mothers received beclomethasone during pregnancy should be carefully examined for adrenal insufficiency.

If necessary, use during lactation should decide on the termination of breastfeeding.

Use in children

Small children may need help, it may be necessary for adults to carry out inhalations. Ask the child to exhale and spray immediately after the child begins to inhale. It is recommended to master the technique together. Older children can hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs on the base below the mouthpiece.

special instructions

Beclomethasone does not provide relief from acute asthma symptoms that require short-acting inhaled bronchodilators. Patients should have the means to stop the attack. Severe asthma requires regular medical examination, including lung function testing, as there is a risk of severe attacks and even death. Patients should be instructed to seek medical attention if short-acting bronchodilators become less effective and more inhalations than usual are required, as this may indicate worsening asthma control. If this occurs, patients should be evaluated and the need for increased anti-inflammatory therapy (eg, higher doses of inhaled corticosteroids or a course of oral corticosteroids) should be considered. Treatment of exacerbations of severe asthma should be carried out in the usual manner, i.e. by increasing the dose of inhaled beclomethasone dipropionate, giving systemic steroids if necessary and/or an appropriate antibiotic if infection is present, along with β-agonist therapy. Treatment with beclomethasone should not be abruptly stopped. Systemic effects of inhaled corticosteroids may occur, especially when given in high doses for a long time. These effects are much less likely than with oral corticosteroids. Possible systemic effects include:

• adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma, a range of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (especially in children). It is important that doses of inhaled corticosteroids be titrated to the lowest dose at which effective asthma control is maintained. It is recommended to monitor the growth of children receiving long-term treatment with inhaled corticosteroids. If growth slows, therapy should be re-evaluated to reduce the dose of inhaled corticosteroids, if possible, to the lowest dose that maintains effective asthma control.

Long-term treatment with high doses of inhaled corticosteroids can lead to clinically significant adrenal suppression. Additional administration of systemic corticosteroids should be considered during periods of stress or elective surgery.

Patients treated with systemic steroids for a long period of time or in high doses, who are prescribed beclomethasone, need special care, since recovery from possible suppression of the adrenal cortex can take a long time. Dose reduction of systemic steroids may be initiated approximately one week after the start of treatment with beclomethasone. The size of the dose reduction should correspond to the maintenance dose of systemic steroids. For patients receiving maintenance doses of prednisolone 10 mg per day (or equivalent), reduce the dose to no more than 1 mg per week. For higher doses, longer dose reduction intervals may be appropriate. The functions of the adrenal cortex should be monitored regularly with a gradual decrease in the dose of systemic steroids.

Some patients do not feel well during the withdrawal of systemic steroids, despite the preservation or even improvement of respiratory function. Persistent intake of inhaled beclomethasone dipropionate should be encouraged and systemic steroid withdrawal should be continued if there are objective signs of adrenal insufficiency. Patients weaned off oral steroids whose adrenal function is impaired should have a steroid warning card, information from which may be required if additional systemic steroids are required during periods of stress, eg, worsening asthma attacks, thoracic infection, serious intercurrent illness, surgery, trauma etc.

Changing from systemic steroid therapy to inhaled therapy sometimes exposes allergies, such as allergic rhinitis or eczema, previously treated with a systemic drug. These allergies require symptomatic treatment with antihistamines and/or topical agents, including topical steroids.

As with all inhaled corticosteroids, special attention is needed in patients with active or quiescent pulmonary tuberculosis.

Patients should be informed that this product contains a small amount of ethanol (approximately 9 mg per dose). At normal doses, the amount of ethanol is negligible and poses no risk to patients.

Overdose

Acute overdose can lead to a temporary decrease in adrenal function, which does not require emergency treatment, since the function of the adrenal cortex is restored within a few days, as evidenced by plasma cortisol levels.

In chronic overdose, there may be a persistent suppression of the function of the adrenal cortex.

drug interaction

With the simultaneous use of beclomethasone with other GCS for systemic or intranasal use, it is possible to increase the suppression of the function of the adrenal cortex. Prior inhalation use of beta-agonists may increase the clinical efficacy of beclomethasone. Phenobarbital, phenytoin, rifampicin, and other inducers of microsomal oxidation reduce efficacy. Due to the content of a small amount of ethanol, an interaction may occur in patients with hypersensitivity taking disulfiram or metronidazole.

Terms and conditions of storage

Store the drug at a temperature not exceeding 25 ° C, out of the reach of children. Do not freeze.

Shelf life - 3 years. Do not use after the expiry date stated on the package.

Beclomethasone: instructions for use

Compound

Description

pharmachologic effect

Indications for use

Adults and children:

Mild asthma (patients requiring intermittent symptomatic treatment with bronchodilators more frequently than occasionally);

Moderate asthma (patients requiring regular asthma treatment and patients with unstable asthma or worsening on existing prophylactic or bronchodilator therapy);

Severe asthma (patients with severe chronic asthma. After starting beclomethasone aerosol, most patients who have been dependent on systemic steroids for adequate control of asthma symptoms will be able to significantly reduce or completely eliminate oral corticosteroid use).

Contraindications

Pregnancy and lactation

Dosage and administration

The drug Beclomethasone aerosol for inhalation is used only by inhalation. Patients should be aware that Beclomethasone inhalation aerosol is used to prevent disease and therefore should be taken regularly, even in the absence of asthma attacks. The dose of the drug is adjusted, depending on the individual response. If the improvement after the use of short-acting bronchodilators becomes less effective or more inhalations than usual are required, follow-up treatment under the supervision of a specialist is necessary. For patients who find it difficult to synchronize breathing with the use of an inhaler, it is recommended to additionally use a spacer - a device to facilitate the inhalation of inhaled drugs. Children may also be advised to use a special baby spacer.

Application

The starting dose of inhaled beclomethasone dipropionate should be adjusted according to the severity of the disease. The dose may be adjusted until control is achieved and then titrated to the lowest dose at which effective asthma control is maintained.

Adults (including the elderly):

Beclomethasone 50 mcg/dose:

The usual initial dose is 200 mcg 2 times / day. In severe cases, it can be increased to 600-800 mcg / day (in this case, it is recommended to use a formulation with a high content of the active substance). The dose of the drug can then be adjusted to achieve control over the symptoms of asthma or reduced to the minimum effective, depending on the individual response of the patient. The total daily dose should be administered two to four times a day.

Beclomethasone 250 mcg/dose:

The usual dose is 1000 mcg / day, which can be increased to 2000 mcg. It can be reduced if the patient's asthma has stabilized. The total daily dose should be administered two to four times a day. The Spacer device should always be used when administered to adults and adolescents 16 years of age and older at a total daily dose of 1000 micrograms or more.

Children:

Beclomethasone 50 mcg/dose:

The usual initial dose is 100 mcg 2 times / day. Depending on the severity of bronchial asthma, the daily dose can be increased to 400 mcg, which is taken in 2-4 doses.

Beclomethasone 250 mcg/dose:

In patients with hepatic or renal insufficiency: there is no need for dose adjustment in patients with hepatic or renal insufficiency.

The sprayed aerosol is inhaled through the mouth into the lungs. Proper administration is essential for successful therapy. The patient should be instructed on how to use beclomethasone correctly and it is recommended that you read and follow the instructions printed on the package insert.

Instructions for use (rules for using the inhaler)

As with the use of other inhalation drugs, the therapeutic effect may decrease when the balloon is cooled. Cylinders must not be broken, pierced or incinerated, even if they are empty. If the inhaler is new or has not been used for three days or more, remove the mouthpiece cap by lightly pressing on the sides, shake the inhaler well and spray once into the air to ensure adequate operation.

1. Remove the mouthpiece cap by slightly pressing on the sides.

2. Make sure that there are no foreign objects inside and outside the inhaler, including the mouthpiece.

3. Shake the inhaler thoroughly to ensure that any foreign object is removed from the inhaler and to ensure that the contents of the inhaler are evenly mixed.

4. Take the inhaler vertically between the thumb and all other fingers, and the thumb should be at the base of the inhaler, below the mouthpiece.

5. Exhale as deeply as possible, then place the mouthpiece in your mouth between your teeth and cover it with your lips without biting.

6. Starting to inhale through the mouth, press the top of the inhaler to spray the drug, while continuing to inhale slowly and deeply (this releases one dose of aerosol).

7. Hold your breath, remove the inhaler from your mouth and remove your finger from the top of the inhaler. Continue to hold your breath for as long as possible.

8. If you need to perform further sprays, you should wait about 30 seconds, holding the inhaler vertically. Then follow steps 3-7.

9. Place the mouthpiece cap in place by pushing and clicking in the desired direction.

Important: follow steps 5, 6 and 7 slowly. It is important to start inhaling as slowly as possible just before spraying. The first few times you should practice in front of a mirror. If a “cloud” appears at the top of the inhaler or from the sides of the mouth, you must start again from point 2.

Small children may need help, it may be necessary for adults to carry out inhalations. Ask the child to exhale and spray immediately after the child begins to inhale. It is recommended to master the technique together. Older children or debilitated adults may hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs on the base below the mouthpiece.

Cleaning

The inhaler should be cleaned at least once a week:

1. Remove the metal container from the plastic case of the inhaler and remove the mouthpiece cap.

2. Wipe the plastic case and mouthpiece with a damp cloth.

Z. Let dry in a warm place. Avoid excessive heat.

4. Place the metal bottle and mouthpiece cap back in place. It is necessary to advise the patient about the importance of rinsing the mouth and throat with water or brushing the teeth immediately after using the inhaler. The patient should be informed of the importance of cleaning the inhaler at least once a week to prevent blockage, and of carefully following the instructions for cleaning the inhaler printed on the package insert. The inhaler must not be washed or placed in water.

Side effect

The following side effects are systematized by organs and systems depending on the frequency of occurrence: very often (1/10), often (1/100 and<1/10), нечасто (1/1000 и <1/100), редко (1/10000 и <1/1000) и очень редко (<1/10000), включая отдельные сообщения. Данные о побочных действиях, возникающих очень часто, часто и нечасто, главным образом базируются на клинических исследованиях. Данные о побочных действиях, возникающих редко и очень редко, получают главным образом спонтанно.

Infections and infestations: very often - candidiasis of the oral cavity and pharynx. Some patients may develop candidiasis of the oral cavity and pharynx, the frequency of which increases at high doses (more than 400 mcg of beclomethasone dipropionate per day). This complication occurs more often in patients with high blood levels of Candida precipitins, which indicates a previous infection. In this case, it is useful to rinse the mouth after inhalation. If necessary, during the entire period of treatment, an antifungal drug is prescribed, while continuing the use of beclomethasone.

The immune system: hypersensitivity reactions have been reported with the following manifestations: infrequently - skin rash, urticaria, itching, erythema; very rarely - angioedema of the eyes, face, lips and oropharynx, respiratory symptoms (shortness of breath and / or bronchospasm) and anaphylactoid / anaphylactic reactions.

Endocrine system: possible systemic effects, including: very rarely - Cushing's syndrome, cushingoid signs, adrenal suppression, growth retardation in children and adolescents, decreased bone mineralization, cataracts and glaucoma.

Mental disorders: very rarely - a feeling of anxiety, sleep disturbance, behavioral changes, including hyperactivity and excitability (mainly in children).

Respiratory system and chest: often - hoarseness of voice, sore throat. In some patients, inhaled beclomethasone dipropionate may cause hoarseness or throat irritation, in which case it is useful to gargle with water immediately after inhalation .; very rarely - paradoxical bronchospasm.

As with other inhaled drugs, paradoxical bronchospasm may develop with rapidly increasing dyspnea after inhalation. In this case, fast-acting inhaled bronchodilators are immediately applied, inhaled beclomethasone is immediately stopped, the patient is examined and, if necessary, alternative therapy is prescribed.

Overdose

Acute overdose can lead to a temporary decrease in adrenal function, which does not require emergency treatment, since the function of the adrenal cortex is restored within a few days, as evidenced by plasma cortisol levels.

In chronic overdose, there may be a persistent suppression of the function of the adrenal cortex.

Interaction with other drugs

With the simultaneous use of beclomethasone with other GCS for systemic or intranasal use, it is possible to increase the suppression of the function of the adrenal cortex. Prior inhalation use of beta-agonists may increase the clinical efficacy of beclomethasone. Phenobarbital, phenytoin, rifampicin, and other inducers of microsomal oxidation reduce efficacy. Due to the content of a small amount of ethanol, an interaction may occur in patients with hypersensitivity taking disulfiram or metronidazole.

Application features

Beclomethasone does not provide relief from acute asthma symptoms that require short-acting inhaled bronchodilators. Patients should have the means to stop the attack. Severe asthma requires regular medical examination, including lung function testing, as there is a risk of severe attacks and even death. Patients should be instructed to seek medical attention if short-acting bronchodilators become less effective and more inhalations than usual are required, as this may indicate worsening asthma control. If this occurs, patients should be evaluated and the need for increased anti-inflammatory therapy (eg, higher doses of inhaled corticosteroids or a course of oral corticosteroids) should be considered. Treatment of exacerbations of severe asthma should be carried out in the usual manner, i.e. by increasing the dose of inhaled beclomethasone dipropionate, giving systemic steroids if necessary and/or an appropriate antibiotic if infection is present, along with β-agonist therapy. Treatment with beclomethasone should not be abruptly stopped. Systemic effects of inhaled corticosteroids may occur, especially when given in high doses for a long time. These effects are much less likely than with oral corticosteroids. Possible systemic effects include: adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (especially in children). It is important that doses of inhaled corticosteroids be titrated to the lowest dose at which effective asthma control is maintained. It is recommended to monitor the growth of children receiving long-term treatment with inhaled corticosteroids. If growth slows, therapy should be re-evaluated to reduce the dose of inhaled corticosteroids, if possible, to the lowest dose that maintains effective asthma control.

Long-term treatment with high doses of inhaled corticosteroids can lead to clinically significant adrenal suppression. Additional administration of systemic corticosteroids should be considered during periods of stress or elective surgery.

Patients treated with systemic steroids for a long period of time or in high doses, who are prescribed beclomethasone, need special care, since recovery from possible suppression of the adrenal cortex can take a long time. Dose reduction of systemic steroids may be initiated approximately one week after the start of treatment with beclomethasone. The size of the dose reduction should correspond to the maintenance dose of systemic steroids. For patients receiving maintenance doses of prednisolone 10 mg per day (or equivalent), reduce the dose to no more than 1 mg per week. For higher doses, longer dose reduction intervals may be appropriate. The functions of the adrenal cortex should be monitored regularly with a gradual decrease in the dose of systemic steroids.

Some patients do not feel well during the withdrawal of systemic steroids, despite the preservation or even improvement of respiratory function. Persistent intake of inhaled beclomethasone dipropionate should be encouraged and systemic steroid withdrawal should be continued if there are objective signs of adrenal insufficiency. Patients weaned off oral steroids whose adrenal function is impaired should have a steroid warning card, information from which may be required if additional systemic steroids are required during periods of stress, eg, worsening asthma attacks, thoracic infection, serious intercurrent illness, surgery, trauma etc.

Changing from systemic steroid therapy to inhaled therapy sometimes exposes allergies, such as allergic rhinitis or eczema, previously treated with a systemic drug. These allergies require symptomatic treatment with antihistamines and/or topical agents, including topical steroids.

As with all inhaled corticosteroids, special attention is needed in patients with active or quiescent pulmonary tuberculosis.

Patients should be informed that this product contains a small amount of ethanol (approximately 9 mg per dose). At normal doses, the amount of ethanol is negligible and poses no risk to patients.

Release form

Storage conditions

Best before date

Terms of dispensing from pharmacies

Beclomethasone analogues, synonyms and drugs of the group

Self-medication can be harmful to your health.
It is necessary to consult a doctor, and also read the instructions before use.

Beclomethasone is a metered-dose aerosol spray for inhalation (through the mouth) and intranasal (through the nose) use, which is part of the group of glucocorticosteroids. The main active ingredient of beclomethasone dipropionate is a cream or white powder, which is practically insoluble in water, odorless.

Beclomethasone has an anti-allergic effect on the patient's body. The drug fights against inflammatory processes in the respiratory tract, eliminates edema and significantly reduces the amount of secretions produced by the mucous membranes of the human nasopharynx. The drug can be used as a nasal spray, as well as a preparation for inhalation.

With inhalation use of an aerosol, beclomethasone dipropionate, which enters the respiratory tract, is absorbed by the lungs.

The effect of the drug is especially well manifested individually after 4-7 days of treatment.

Store the drug at a temperature not exceeding 25 degrees Celsius. Subject to these requirements, the shelf life of the drug is 3 years.

Indications for use

• bronchial asthma;
• allergic rhinitis (seasonal and year-round);
• vasomotor rhinitis;
• nasal polyposis.

The drug is taken by inhalation for bronchial asthma.

For rhinitis and nasal polyps, the medicine is used as a nasal spray. As prescribed by the attending physician, it can be used for hay fever or.

Release form

The medicine is produced in the form of a metered aerosol.

Produced in polyethylene bottles of 9 ml, 10 ml and 23 ml. Each vial has a dispenser. Each package includes a spray nozzle.

There are release forms according to the amount of active substance contained in 1 dose of the drug. So, 1 dose of the drug may contain 50 micrograms, 100 micrograms or 250 micrograms of beclomethasone dipropionate.

Instructions for use of the drug Beclomethasone contains the exact dosages in which it should be taken.

Intranasal use

The medicine used as a nasal spray is prescribed for children aged 6 years and older.

Children aged 6 to 12 should irrigate each nasal passage 2 to 4 times a day. 50 mcg is injected into each nostril. The maximum amount of the drug consumed per day should not exceed 400 mcg.

Children aged 12 years and older, as well as adult patients, should irrigate each nasal passage 2 to 4 times a day. 100 mcg is injected into each nostril. The maximum amount of the drug consumed per day should not exceed 1000 mcg.

Inhalation use

The drug, used as an aerosol for inhalation, is prescribed for children aged 6 years and older.

Children aged 6 to 12 years old take 50 micrograms twice a day. The maximum amount of the drug consumed per day should not exceed 400 mcg.

Children aged 12 years and older, as well as adult patients, take 100-400 mcg 2 to 4 times a day. The maximum amount of the drug consumed per day should not exceed 2000 mcg.

Remember that the exact dosage of the drug can only be set by a doctor.

Contraindications

First of all, it must be said about the individual intolerance of the active substance (beclomethasone dipropionate).

It is also necessary to highlight:

• age up to 6 years;
• non-asthmatic bronchitis;
• pregnancy and lactation;
• severe attacks of bronchial asthma.

Use with caution when:

• cirrhosis of the liver;
• glaucoma;
• hypothyroidism.

Side effects

Subject to the requirements of the instructions, Beclomethasone, as a rule, is well tolerated by patients. However, some patients have experienced the following side effects:

• sore throat;
• hoarseness of voice;
• sneezing and coughing;
• candidiasis (a type of fungal infection) of the respiratory tract;
• dryness and irritation of the nasal mucosa;
• nosebleeds;
• pain in the throat and nasal cavity (the appearance of ulcers);
• dizziness and headache;
• drowsiness;
• Pain in the eyes;
• allergic reaction;
• loss of taste;
• increase in intraocular pressure.

Analogues

There are a large number of analogues (sprays, aerosols, etc.) of Beclomethasone, similar to it in terms of indications for use, as well as pharmacological effects on the human body. Prices for these pharmacological agents vary quite a lot.

Analogues of Beclomethasone include: Berodual, Ketotifen, Travisil, Ribomunil, Amoxicillin, Ambroxol, Foradil, Epinephrine, Solvin, Aldecin, Altemix, Salbroxol, Lincomycin and many others.

Price

The retail price of Beclomethasone on pharmacy shelves ranges from 110 to 250 rubles.

Bronchial asthma is a serious disease that can lead to complications such as pneumosclerosis, pulmonary insufficiency. And in especially severe cases, a person may experience ruptures in the lungs. To prevent the occurrence of such dangerous complications, it is important to start therapy correctly and on time. For the treatment of bronchial asthma, doctors recommend the drug Beclomethasone. Today we will find out what this medicine is, how to use it correctly. We will also determine which analogues of this medication can be purchased at a pharmacy.

Pharmacological properties

The drug "Beclomethasone" is a hormonal drug that is intended for inhalation use. This medicine affects the lungs of a person. The drug has anti-allergic, anti-inflammatory, anti-edematous effect. The drug is usually prescribed for the treatment of bronchial asthma. At the same time, the components of the drug help to reduce epithelial edema, bronchial hyperactivity, and they also improve. Due to this, asthma attacks disappear.

The composition of the tool. Implementation form

The drug "Beclomethasone", instructions for the use of which are necessarily included in the package, is sold in the form of a metered aerosol, as well as a powder for inhalation. The product contains the following ingredients: the main substance is beclomethasone dipropionate; additional elements - dextose, purified water, polysorbate, sodium hydroxide solution, hydrochloric acid,

In what cases is it prescribed?

"Beclomethasone" is an aerosol that can be prescribed to patients with such problems:

Bronchial asthma.

Therapy and prevention of allergic rhinitis, including vasomotor rhinitis and one that occurs with hay fever.

Dosage

Means "Beclomethasone" for inhalation is prescribed in the following quantity:

Men and women - 2 to 4 times a day. The daily dose can be no more than 1 g.

Children from 6 years old - 50-100 mcg 2 to 4 times a day.

The medicine "Beclomethasone", analogues of which can be found without problems in a pharmacy, is prescribed in the form of a spray in the following dosage:

Adults and children from 12 years old - 100 mcg in each nostril 3 to 4 times a day.

Children from 6 to 12 years old - 50 mcg in the right and left nostrils, also up to 4 times a day.

Despite the fact that the instructions clearly indicate the dosage of this drug, the doctor must determine the exact amount of the prescribed medication.

Medication "Beclomethasone": price

This tool has a very reasonable cost. So, for an aerosol for inhalation of 50 mcg (for 200 doses), you need to pay about 250 rubles. And for 100 micrograms for 200 doses, you need to pay 380 rubles. For 250 micrograms, you will have to pay 430 rubles.

Contraindications

The drug "Beclomethasone", analogues of which can be much more expensive in cost, it is forbidden to use the following categories of people:

People suffering from acute bronchitis.

Patients with hemorrhagic diathesis.

Patients with frequent nosebleeds.

People with systemic respiratory ailments.

Patients with pulmonary tuberculosis.

Patients with herpetic lesions of the organ of vision.

Toddlers up to 6 years old.

Women during the 1st trimester of pregnancy.

Important! If the girl is in the 2nd or 3rd trimester or she is breastfeeding, then the doctor should decide whether to use this drug.

Side effects

The drug "Beclomethasone", the use of which is necessary for people suffering from bronchial asthma, has many undesirable effects. True, rarely appearing. However, patients should be aware of the possible side effects of this medication. So, unwanted manifestations can be as follows:

Coughing, sneezing, sore throat.

Dizziness, headache.

Candidomycosis of the oral cavity.

Cataract.

Nosebleeds.

Skin rashes.

Growth retardation in children.

Myalgia.

Angioedema.

Medication "Beclomethasone": analogues

This remedy has many similar drugs with which it can be replaced. So, the analogues of this drug are such medicines: Budiair, Pulmicort, Budecort, Budesonide, Klenil, Bekotid, Beklazon, Beclomet, etc.

Means "Beklazon"

This medicine in the form of inhalation is also used for the treatment of asthma. When administered intranasally, it is prescribed for hay fever. The drug contains the following components: the main substance - beclomethasone dipropionate, as well as auxiliary elements - ethanol and hydrofluoroalkane.

The dosage of the drug "Beklazon" depends on the severity of the disease and the age of the patient and is:

For patients over 12 years old - 200-600 mcg each (with a mild degree of illness); from 600 to 1000 mcg (moderate degree of the disease), from 1000 to 2000 mcg (severe form).

For children from 4 to 12 years old, a single dose should be from 50 to 100 mcg.

In the nose, the drug can be administered from 1 to 4 times a day, 50 mcg.

The cost of the medicine "Beklazon" ranges from 210-330 rubles. If 100 mcg, then the price will be about 300 rubles. For a bottle containing 50 micrograms of a substance, you need to pay 210 rubles. This is a little cheaper than Beclomethasone, the price of which for a similar form of release is 250 rubles. Although the difference is actually insignificant.

Means "Pulmicort"

This is also an analogue of the well-known drug Beclomethasone. The medicine "Pulmicort" is also prescribed for bronchial asthma, as well as for obstruction of the lungs, stenosing laryngotracheitis.

This drug is also available in 2 versions: in the form of a metered suspension for inhalation, as well as a powder.

The composition of the drug "Pulmicort" differs from the drug "Beclomethasone". Here, the main component is the substance budesonide, and additional elements are sodium chloride, sodium citrate, disodium edatate, polysorbate, citric acid, and even purified water.

The advantage of the drug "Pulmicort" in comparison with the drug "Beclamethasone" is that it can be used in relation to children from 6 months.

The cost of this remedy in the form of a powder for inhalation ranges from 790-830 rubles. But the suspension with this medication is more expensive - about 1300 rubles.

The drug "Budiar"

This is another analogue of the drug "Beclomethasone". Budiair is intended for inhalation, local and intranasal use. The drug has anti-allergic, anti-inflammatory and anti-exudative action. Thanks to this remedy, the respiratory function improves in patients, the frequency of dyspnea and cough decreases.

The drug is sold in the following forms:

Dosed powder for inhalation.

Spray can.

Suspension.

Powder capsules.

Solution for inhalation.

It is forbidden to use the suspension with Beclamethasone in relation to children under 3 months old. Powder with this drug should not be given to boys and girls under 6 years of age. But the solution for injection can not be used in relation to children under 16 years of age.

Means "Budiar" is one of the most expensive analogues of the drug "Beclomethasone". So, for a bottle with an aerosol (200 doses) of 200 mcg, you need to pay about 3.5 thousand rubles.

Conclusion

From the article, you learned a lot of useful information about the drug Beclomethasone. Analogues, indications for use, release form, side effects, contraindications are now known to you. You also realized that this medication has many similar drugs, which, by the way, are usually much more expensive in price. But still, people should know that if the medicine "Beclomethasone" is not in the pharmacy, then it can be replaced with another without any problems.