Beclometasone
The drug is intended for inhalation administration using an inhalation device (see “Patient Instructions for Using an Inhalation Device”). After each inhalation, you must thoroughly rinse your mouth and throat with water.
Use regularly (even in the absence of symptoms of the disease). The dose is selected taking into account individual clinical effectiveness, increasing until a clinical effect appears or decreasing to the minimum effective dose. When switching to a high dose of inhaled beclomethasone, many patients receiving systemic corticosteroids will be able to reduce their dose or stop them altogether.
The initial dose is determined by the severity of bronchial asthma.
In mild cases of bronchial asthma, the forced expiratory volume (FEV) or peak expiratory flow (PEF) is more than 80% of the expected values, with a spread of PEF values of less than 20%.
In case of moderate bronchial asthma, FEV or PEF is 60-80% of the required values, the daily spread of PEF indicators is 20-30%.
In severe bronchial asthma, FEV or PEF is 60% of the expected values, the daily variation in PEF is more than 30%. The daily dose is divided into several doses (2-4 inhalations per day).
Adults and children over 12 years old
Recommended initial daily doses:
- mild bronchial asthma - 200-600 mcg/day (for 2 inhalations per day);
- moderate bronchial asthma 600-1000 mcg/day (for 2-4 inhalations per day);
- severe bronchial asthma 1000-2000 mcg/day (for 2-4 inhalations per day).
The standard maximum daily dose is 1000 mcg. In some very severe cases, the daily dose can be increased to 1500-2000 mcg (for 2-4 inhalations per day). Treatment of bronchial asthma is based on a stepwise approach - therapy begins according to the step corresponding to the severity of the disease.
Inhaled corticosteroids are prescribed at the second stage of therapy.
Stage 2. Basic therapy.
100-400 mcg 2 times a day.
Stage 3. Basic therapy.
Inhaled corticosteroids are used in a high daily dose or in a standard daily dose, but in combination with inhaled long-acting beta2-agonists.
The recommended daily dose is 800-1600 mcg; in some cases, the daily dose can be increased to 2000 mcg.
Stage 4. Severe bronchial asthma.
The recommended daily dose is 800-1600 mcg; in some cases, the daily dose can be increased to 2000 mcg.
Stage 5. Severe bronchial asthma.
The recommended daily dose is 800-1600 mcg; in some cases, the daily dose can be increased to 2000 mcg.
Children from 4 to 12 years old
The recommended initial daily dose is 100-200 mcg (for 2 inhalations per day). The standard maximum daily dose is 200 mcg. In some very severe cases, the daily dose can be increased to 400 mcg (for 2-4 inhalations per day).
The drug containing 250 mcg of beclomethasone per dose is not intended for use in this group of patients.
Special patient groups
There is no need to adjust the dose in the elderly or in patients with renal or hepatic insufficiency.
Skipping one dose of the drug
If you accidentally miss an inhalation, the next dose must be taken at the scheduled time in accordance with the treatment regimen.
Administration can be carried out using special dispensers (spacers). improving the distribution of the drug in the lungs and reducing the risk of side effects.
Rules for using the drug:
Preparation for first use
:
Before using the drug for the first time, you should: put the inhaler nozzle, equipped with a protective cap, on the cylinder and valve stem, remove the protective cap from the inhaler nozzle. Then shake the canister vigorously with vertical movements, turn the canister over with the inhaler nozzle facing down and spray two times into the air to make sure the valve is working properly. When taking a break from using the drug for several days, you should spray one spray into the air after thoroughly shaking the container.
Application:
1. Remove the protective cap from the inhaler nozzle and make sure that the outlet tube of the inhaler nozzle is clean. Turn the canister over with the inhaler nozzle down, hold the inhalation device between your index finger and thumb in a vertical position, with your thumb under the inhaler nozzle and your index finger on the bottom of the aluminum canister.
2. Shake the aluminum can vigorously up and down.
3. Exhale deeply through your mouth. Pinch the outlet tube of the inhalation device tightly with your lips.
4. Take a slow and deep breath. As you inhale, press the top of the balloon to release the dose and continue to inhale slowly.
5. Remove the inhalation device from your mouth and hold your breath for 10 seconds or as long as does not cause discomfort. Exhale slowly.
6. After inhalation, rinse your mouth with water, being careful not to swallow the aerosol that came into contact with the oral mucosa during inhalation.
7. If you need to administer more than one dose of the drug, wait 1 minute and repeat all steps from step 2 to step 6.
8. Close the inhaler nozzle with the protective cap.
Take your time when performing steps 3 and 4. When releasing a dose of medication, it is important to inhale as slowly as possible. Before use, practice in front of a mirror.
If you notice "steam" coming from the top of the can or from the corners of your mouth, start again at step 2.
Cleaning
:
The inhaler nozzle should be cleaned at least once a week.
Remove the inhaler nozzle from the aluminum cylinder. Gently rinse the inhaler nozzle and protective cap with warm water.
Do not use hot water!
Shake the inhaler nozzle and protective cap to remove any remaining water and dry them without using heating devices.
Do not allow the aluminum cylinder to come into contact with water!
Beclomethasone, 1 piece, 250 mcg/dose, dosed aerosol for inhalation
Before prescribing inhaled drugs, it is necessary to instruct the patient on the rules for their use, ensuring the most complete delivery of the drug to the desired areas of the lungs. The development of oral candidiasis is most likely in patients with high levels of precipitating antibodies in the blood against the Candida fungus, which indicates a previous fungal infection. After inhalation, you should rinse your mouth and throat with water. To treat candidiasis, topical antifungal drugs can be used while continuing Beclomethasone therapy.
If patients take GCS orally, then Beclomethasone is prescribed while taking the previous dose of GCS, and the patients should be in a relatively stable condition. After about 1–2 weeks, the daily dose of oral corticosteroids begins to be gradually reduced. The dose reduction scheme depends on the duration of previous therapy and the size of the initial dose of GCS. Regular use of inhaled corticosteroids allows, in most cases, to cancel oral corticosteroids (patients who need to take no more than 15 mg of prednisolone can be completely transferred to inhaled therapy). However, in the first months after the transition, the patient's condition should be carefully monitored until his pituitary-adrenal system has recovered sufficiently to ensure an adequate response to stressful situations (for example, injury, surgery or infection).
When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema) that were previously suppressed by systemic drugs may occur.
Patients with reduced function of the adrenal cortex who are transferred to inhalation treatment should have a supply of GCS and always carry a warning card with them, which should indicate that in stressful situations they need additional systemic administration of GCS (after eliminating the stressful situation, the dose of GCS can be repeated reduce). A sudden and progressive worsening of asthma symptoms is a potentially dangerous condition, often life-threatening for the patient, and requires an increase in the dose of GCS. An indirect indicator of the ineffectiveness of therapy is the more frequent use of short-acting β2-agonists than before.
Beclomethasone dipropionate for inhalation is not intended for the relief of attacks, but for regular daily use. Short-acting β2-adrenergic agonists (for example, salbutamol) are used to relieve attacks. In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, the dose of inhaled beclomethasone dipropionate should be increased and, if necessary, a systemic corticosteroid and an antibiotic should be prescribed if the infection develops.
If paradoxical bronchospasm develops, you should immediately stop using Beclomethasone, assess the patient's condition, conduct an examination and, if necessary, prescribe therapy with other drugs. With long-term use of any inhaled corticosteroids, especially in high doses, systemic effects may be observed (see “Side effects”), but the likelihood of their development is much lower than when taking corticosteroids orally. Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids is reduced to the minimum effective dose that controls the course of the disease. At a dose of 1500 mcg/day, the drug does not cause significant suppression of adrenal function in most patients. Due to possible adrenal insufficiency, special care should be taken and regular monitoring of adrenal function indicators when transferring patients taking oral corticosteroids to treatment with beclomethasone.
It is recommended to regularly monitor the growth dynamics of children receiving inhaled corticosteroids for a long time.
Administration can be carried out using special dispensers (spacers), which improve the distribution of the drug in the lungs and reduce the risk of side effects.
Abrupt withdrawal of Beclomethasone aerosol is not recommended.
It is necessary to protect the eyes from contact with the drug. By washing after inhalation you can prevent damage to the skin of the eyelids and nose.
The Beclomethasone canister should not be pierced, disassembled or thrown into fire, even if it is empty. Like most other inhalation aerosol products, Beclomethasone may be less effective at low temperatures. When cooling the cylinder, it is recommended to remove the inhaler nozzle from it and warm it with your hands for a few minutes.
Information about the possible effect of the drug on the ability to drive vehicles and machinery
No data.
Side effects of the drug Beclomethasone
Dysphonia, throat irritation, cough, sneezing, paradoxical bronchospasm, eosinophilic pneumonia, allergic reactions, candidiasis of the oral cavity and upper respiratory tract (with long-term use and/or when used in high doses). With long-term use in doses of more than 1.5 mg/day, systemic side effects of GCS, headache, dizziness, cataracts, increased intraocular pressure, leukocytosis, lymphopenia, eosinopenia are possible. With a single inhalation of beclomethasone dipropionate in high doses (more than 1 mg), there may be a slight decrease in the function of the hypothalamic-pituitary-adrenal system, which does not require any emergency measures, and treatment should be continued. The function of the hypothalamic-pituitary-adrenal system is restored after 1-2 days.
Instructions for use BEKLOMETASONE
The drug Beclomethasone aerosol for inhalation is used only by inhalation. Patients should be aware that Beclomethasone inhalation aerosol is used to prevent the disease and should therefore be taken regularly, even when there are no asthma attacks. The dose of the drug is adjusted depending on the individual reaction. If improvement after the use of short-acting bronchodilators becomes less effective or more inhalations are required 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 inhalation of inhaled drugs. For children, the use of a special pediatric spacer may also be recommended.
Application
The initial dose of inhaled beclomethasone dipropionate should be adjusted based on the severity of the disease. The dose may be adjusted until control is achieved and then titrated to the lowest dose that maintains effective asthma control.
Adults (including older people):
Beclomethasone 50 mcg/dose:
The usual starting 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 form of the drug with a high content of the active substance). The dose of the drug can then be adjusted to achieve control of asthma symptoms or reduced to the minimally effective dose, depending on the individual patient's response. The total daily dose should be administered two to four times daily.
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 daily. The Spacer device should always be used when administered to adults and adolescents 16 years of age or older at a total daily dose of 1000 mcg or more.
Children:
Beclomethasone 50 mcg/dose:
The usual starting dose is 100 mcg 2 times a day. Depending on the severity of bronchial asthma, the daily dose can be increased to 400 mcg, which is administered in 2-4 doses.
Beclomethasone 250 mcg/dose:
Beclomethasone 250 mcg/dose is not recommended for children.
In patients with liver or kidney failure:
There is no need for dose adjustment in patients with hepatic or renal impairment.
The sprayed aerosol is inhaled through the mouth into the lungs. Proper management is essential for successful therapy. The patient should be instructed on how to use beclomethasone correctly and is advised to read and follow the instructions printed in the package insert.
Instructions for use (rules for using the inhaler)
As with other inhaled medications, the therapeutic effect may decrease as the balloon cools. Cylinders must not be broken, punctured or burned, even if empty. If the inhaler is new or has not been used for three days or more, remove the mouthpiece cap by pressing lightly on the sides, shake the inhaler well and spray one spray into the air to ensure adequate operation.
1. Remove the mouthpiece cap by lightly 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 matter is removed from the inhaler and to ensure that the contents of the inhaler are evenly mixed.
4. Hold the inhaler vertically between your thumb and all other fingers, with your thumb on 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 your mouth, press the top of the inhaler to spray the drug, while continuing to inhale slowly and deeply (this releases one dose of the 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 as long as possible.
8. If further sprays are necessary, wait approximately 30 seconds, holding the inhaler vertically. After this, follow steps 3-7.
9. Place the mouthpiece cap into place by pressing and clicking in the desired direction.
Important:
- follow steps 5, 6 and 7, slowly. It is important to start inhaling as slowly as possible 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 on the sides of your mouth, you must start again from step 2.
Young children may need assistance, and it may be necessary for adults to administer the inhalations. The child should be asked to exhale and spray immediately after the child begins to inhale. It is recommended to master the technique together. Older children or frail adults 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.
Cleaning
The inhaler should be cleaned at least once a week:
- 1. Remove the metal canister from the plastic case of the inhaler and remove the mouthpiece cap.
2. Wipe the plastic case and mouthpiece with a damp cloth.
H. Allow to dry in a warm place. Avoid excessive heat.
4. Place the metal balloon and mouthpiece cap in place. The patient should be counseled about the importance of rinsing the mouth and throat with water or brushing 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 in the package insert. The inhaler must not be washed or placed in water.
Pharmacological properties of the drug Beclomethasone
Locally acting GCS is used as a basic therapy for asthma and has anti-inflammatory and antiallergic effects. Inhibits the release of inflammatory mediators, increases the production of lipomodulin - an inhibitor of phospholipase A, reduces the formation of arachidonic acid and its metabolic products - cyclic endoperoxides, prostaglandins. Under the influence of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema decreases, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and lymphokine production, macrophage migration is inhibited, the intensity of infiltration and granulation processes decreases, which ultimately improves indicators of external respiration function. Increases the number of active β-adrenergic receptors, restores the patient’s response to bronchodilators, and allows to reduce the frequency of their use. It has virtually no mineralocorticosteroid activity and no resorptive effect after inhalation administration. In therapeutic doses, it has an active local effect without the development of side effects characteristic of systemic corticosteroids. It does not relieve bronchospasm; the therapeutic effect develops gradually, usually after 5–7 days of course use of beclomethasone dipropionate. Absorption is low; when administered by inhalation in recommended doses, it does not have significant systemic activity. 10–20% of the dose enters the lungs, where beclomethasone dipropionate is hydrolyzed into its active metabolite, beclomethasone monopropionate. Most of the beclomethasone that enters the digestive tract is inactivated during its first passage through the liver. Connection with blood plasma proteins - 87%. The main part (35–76%) is excreted within 96 hours in feces, mainly in the form of polar metabolites, 10–15% in urine.
