How does beclomethasone inhaler work for asthma. What are the potential side effects of using beclomethasone. How should beclomethasone inhaler be used correctly. When should you seek medical attention while using beclomethasone. What precautions should be taken when using beclomethasone inhaler.

Understanding Beclomethasone: A Powerful Asthma Medication

Beclomethasone is a corticosteroid medication used to prevent and manage asthma symptoms in adults and children aged 5 and older. It works by reducing inflammation and swelling in the airways, making breathing easier for those with asthma. This medication is typically prescribed as an aerosol inhaler, allowing for direct delivery to the lungs.

Beclomethasone belongs to a class of drugs known as corticosteroids, which are highly effective in controlling asthma symptoms. Unlike quick-relief inhalers, beclomethasone is a long-term control medication that needs to be used regularly to maintain its effectiveness.

How does beclomethasone differ from other asthma medications?

Beclomethasone is a preventive medication, not a rescue inhaler. It is designed for daily use to keep asthma symptoms under control, rather than for immediate relief during an asthma attack. This distinction is crucial for patients to understand in order to manage their condition effectively.

Proper Usage and Administration of Beclomethasone Inhaler

Using a beclomethasone inhaler correctly is essential for optimal asthma management. The medication is typically prescribed for twice-daily use, with specific instructions provided by your healthcare provider. It’s crucial to follow these instructions carefully to ensure you’re receiving the full benefit of the medication.

Step-by-step guide to using a beclomethasone inhaler:

1. Remove the protective cap from the inhaler.
2. If it’s your first time using the inhaler or you haven’t used it in over 10 days, prime it by releasing two test sprays into the air.
3. Exhale completely through your mouth.
4. Hold the inhaler upright or horizontally, placing the mouthpiece between your lips.
5. Tilt your head slightly back and close your lips around the mouthpiece, keeping your tongue below it.
6. Begin to inhale slowly and deeply, simultaneously pressing down on the container to release the medication.
7. Continue to inhale deeply, filling your lungs.
8. Remove the inhaler from your mouth and hold your breath for 5-10 seconds.
9. Exhale gently.
10. If prescribed multiple doses, wait at least 30 seconds before repeating the process.

Proper technique is crucial for ensuring that the medication reaches your lungs effectively. If you’re unsure about your technique, don’t hesitate to ask your healthcare provider or pharmacist for a demonstration.

Potential Side Effects and Precautions of Beclomethasone Use

While beclomethasone is generally well-tolerated, it can cause side effects in some users. It’s important to be aware of these potential effects and to report any concerning symptoms to your healthcare provider.

Common side effects of beclomethasone inhaler:

• Throat irritation or hoarseness
• Cough
• Dry mouth
• Unpleasant taste in the mouth
• Headache
• Nausea

Most of these side effects are mild and often resolve as your body adjusts to the medication. However, if they persist or worsen, it’s important to consult your healthcare provider.

Serious side effects requiring immediate medical attention:

• Signs of an allergic reaction (rash, itching, swelling, severe dizziness, difficulty breathing)
• Worsening of asthma symptoms
• Chest pain
• Irregular heartbeat
• Severe headache
• Vision problems

While rare, these serious side effects require immediate medical attention. It’s crucial to be vigilant and seek help if you experience any of these symptoms.

Maximizing the Effectiveness of Beclomethasone Treatment

To get the most benefit from your beclomethasone inhaler, it’s important to use it consistently and correctly. Here are some tips to maximize its effectiveness:

• Use the inhaler at the same times each day to maintain a consistent level of medication in your system.
• Rinse your mouth with water after each use to prevent throat irritation and oral fungal infections.
• Keep track of the number of doses you’ve used to ensure you replace the inhaler before it’s empty.
• Clean the inhaler regularly according to the manufacturer’s instructions.
• Continue using the inhaler even when you feel well, as it helps prevent asthma symptoms.

Remember, beclomethasone is a preventive medication. It may take 1-4 weeks of regular use before you experience the full benefits. Don’t discontinue use without consulting your healthcare provider, even if you feel your symptoms have improved.

Interactions and Precautions: What You Need to Know

While beclomethasone is generally safe when used as directed, there are certain precautions to keep in mind. It’s important to inform your healthcare provider about all medications you’re taking, including over-the-counter drugs and supplements, as some may interact with beclomethasone.

Special precautions for beclomethasone use:

• Inform your doctor if you have any fungal infections, as beclomethasone may worsen these conditions.
• If you’re pregnant or breastfeeding, discuss the risks and benefits with your healthcare provider.
• If you’ve recently been on oral steroids, your doctor may need to adjust your dosage gradually.
• Beclomethasone may affect growth in children, so regular monitoring is important.
• Avoid exposure to chickenpox or measles while using beclomethasone, as your immune response may be reduced.

Your healthcare provider will consider these factors when prescribing beclomethasone and may adjust your treatment plan accordingly.

Long-Term Use of Beclomethasone: What to Expect

Beclomethasone is often prescribed for long-term use in managing chronic asthma. While it’s generally safe for extended periods, it’s important to understand what to expect and how to monitor your health during long-term treatment.

Potential effects of long-term beclomethasone use:

• Increased risk of oral thrush (fungal infection in the mouth)
• Potential impact on bone density, particularly in older adults
• Possible suppression of the adrenal glands (though this is more common with oral steroids)
• Increased risk of cataracts or glaucoma in some users

Regular check-ups with your healthcare provider are crucial during long-term beclomethasone use. These visits allow for monitoring of your asthma control, adjustment of your medication if needed, and screening for potential long-term effects.

Combining Beclomethasone with Other Asthma Medications

Beclomethasone is often used in combination with other asthma medications for comprehensive asthma management. Understanding how these medications work together can help you better manage your condition.

Common combinations with beclomethasone:

• Short-acting beta-agonists (SABAs) for quick relief of acute symptoms
• Long-acting beta-agonists (LABAs) for additional long-term control
• Leukotriene modifiers to further reduce inflammation
• Anticholinergics to help open airways

Your healthcare provider will determine the most appropriate combination based on your specific asthma severity and symptoms. It’s important to use each medication as prescribed and not to adjust dosages without consulting your doctor.

Managing Asthma Beyond Medication: Lifestyle Considerations

While beclomethasone is a powerful tool in managing asthma, it’s most effective when combined with lifestyle modifications and environmental controls. Here are some additional strategies to support your asthma management:

• Identify and avoid your asthma triggers (e.g., allergens, irritants, exercise)
• Maintain a healthy weight, as excess weight can exacerbate asthma symptoms
• Exercise regularly, but be mindful of exercise-induced asthma
• Quit smoking and avoid secondhand smoke
• Use air filters and keep your living environment clean to reduce exposure to allergens
• Manage stress, as emotional factors can influence asthma symptoms
• Get vaccinated against flu and pneumonia to prevent respiratory infections

These lifestyle modifications, in conjunction with proper use of your beclomethasone inhaler and other prescribed medications, can significantly improve your asthma control and quality of life.

Remember, asthma management is a collaborative effort between you and your healthcare provider. Regular communication about your symptoms, concerns, and any changes in your condition is crucial for optimal asthma control. With proper use of beclomethasone and a comprehensive management plan, many people with asthma can lead active, symptom-free lives.

Beclomethasone Oral Inhalation: MedlinePlus Drug Information

pronounced as (be kloe meth’ a sone)

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Beclomethasone is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma in adults and children 5 years of age and older. It belongs to a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

Beclomethasone comes as an aerosol to inhale by mouth using an inhaler. It usually is inhaled twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use beclomethasone exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Talk to your doctor about how you should use your other oral and inhaled medications for asthma during your treatment with beclomethasone inhalation. If you were taking an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos), your doctor may want to gradually decrease your steroid dose starting after you begin to use beclomethasone.

Beclomethasone controls symptoms of asthma but does not cure it. Improvement in your asthma may occur as soon as 24 hours after using the medication, but full effects may not be seen for 1 to 4 weeks after using it regularly. Continue to use beclomethasone even if you feel well. Do not stop using beclomethasone without talking to your doctor. Call your doctor if your symptoms or your child’s symptoms do not improve during the first 4 weeks or if they get worse.

Beclomethasone helps to prevent asthma attacks (sudden episodes of shortness of breath, wheezing, and coughing) but will not stop an asthma attack that has already started. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Tell your doctor if your asthma worsens during your treatment.

Do not use your beclomethasone inhaler when you are near a flame or source of heat. The inhaler may explode if it is exposed to very high temperatures.

Each beclomethasone inhaler is designed to provide 50, 100, or 120 inhalations, depending on its size. After the labeled number of inhalations has been used, later inhalations may not contain the correct amount of medication. You should keep track of the number of inhalations you have used. You can divide the number of inhalations in your inhaler by the number of inhalations you use each day to find out how many days your inhaler will last. Throw away the inhaler after you have used the labeled number of inhalations even if it still contains some liquid and continues to release a spray when it is pressed.

Before you use beclomethasone inhaler the first time, read the written instructions that come with the inhaler. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler. Ask your doctor, pharmacist, or respiratory therapist to show you the right way to use the inhaler. Practice using the inhaler in front of him or her, so you are sure you are doing it the right way.

To use the aerosol inhaler, follow these steps:

Keep the inhaler clean and dry with the cover tightly in place at all times. To clean your inhaler, use a clean, dry tissue or cloth. Do not wash or put any part of your inhaler in water.

1. Remove the protective cap.
2. If you are using the inhaler for the first time or if you have not used the inhaler in more than 10 days, prime it by releasing 2 test sprays into the air, away from your face. Be careful not to spray the medication into your eyes or face.
3. Breathe out as completely as possible through your mouth.
4. Hold the inhaler in the upright (mouthpiece up) or horizontal position. Place the mouthpiece between your lips well into your mouth. Tilt your head slightly back. Close your lips tightly around the mouthpiece keeping your tongue below it. Inhale slowly and deeply.
5. Breathe in slowly and deeply through the mouthpiece. At the same time, press down once on the container to spray the medication into your mouth.
6. When you have breathed in fully, remove the inhaler from your mouth and close your mouth.
7. Try to hold your breath for about 5 to 10 seconds, then breathe out gently.
8. If your doctor has told you to take more than 1 puff per treatment, repeat steps 3 through 7.
9. Replace the protective cap on the inhaler.
10. After each treatment, rinse your mouth with water and spit. Do not swallow the water.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before using beclomethasone inhalation,

• tell your doctor and pharmacist if you are allergic to beclomethasone, any other medications, or any of the ingredients in beclomethasone inhalation. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have recently taken. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with beclomethasone inhalation, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• do not use beclomethasone during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Call your doctor if you have an asthma attack that does not stop when using the fast-acting asthma medication, or if you need to use more of the fast-acting medication than usual.
• tell your doctor if you have or have ever had tuberculosis (TB; a serious lung infection), cataracts (clouding of the lens of the eye), glaucoma (an eye disease) or high pressure in the eye. Also tell your doctor if you have any type of untreated infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using beclomethasone, call your doctor.
• if you have any other medical conditions, such as asthma, arthritis, or eczema (a skin disease), they may worsen when your oral steroid dose is decreased. Tell your doctor if this happens or if you experience any of the following symptoms during this time: extreme tiredness, muscle weakness or pain; sudden pain in stomach, lower body, or legs; loss of appetite; weight loss; upset stomach; vomiting; diarrhea; dizziness; fainting; depression; irritability; and darkening of skin. Your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury during this time. Call your doctor right away if you get sick and be sure that all healthcare providers who treat you know that you recently replaced your oral steroid with beclomethasone inhalation. Carry a card or wear a medical identification bracelet to let emergency personnel know that you may need to be treated with steroids in an emergency.
• tell your doctor if you have never had chickenpox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.
• you should know that beclomethasone inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, use your fast-acting (rescue) asthma medication right away and call your doctor. Do not use beclomethasone inhalation again unless your doctor tells you that you should.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Beclomethasone inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• sore throat
• runny or stuffy nose
• back pain
• nausea
• cough
• difficult or painful speech

Some side effects can be serious. If you experience any of the following symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• changes in vision

Beclomethasone inhalation may cause children to grow more slowly. There is not enough information to tell whether using beclomethasone decreases the final height that children will reach when they stop growing. Your child’s doctor will watch your child’s growth carefully while your child is using beclomethasone. Talk to your child’s doctor about the risks of giving this medication to your child.

In rare cases, people who used beclomethasone for a long time developed glaucoma or cataracts. Talk to your doctor about the risks of using beclomethasone and how often you should have your eyes examined during your treatment.

Beclomethasone inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the inhaler upright with the plastic mouthpiece on top at room temperature and away from excess heat and moisture (not in the bathroom). Avoid puncturing the aerosol container, and do not discard it in an incinerator or fire.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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Beclomethasone Dipropionate Inhalation: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor, pharmacist, or respiratory therapist.

Inhale this medication by mouth as directed by your doctor, usually 2 times a day. The dosage is based on your medical condition and response to treatment.

Do not use a spacer device with this medication. You do not need to prime or shake this inhaler before use. If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug (the corticosteroid) last.

To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.

Keep track of the number of inhalations used. Discard the canister after using the labeled number of inhalations on the package, even if it feels as though there is medication left in the canister. Follow the instructions for cleaning the inhaler. Do not wash the inhaler or put any part of it in water.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. This medication works best if used at evenly spaced times. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin using beclomethasone. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.

You may start to feel this medication working within 24 hours, but it may take several weeks or longer to get the full benefit. Tell your doctor if you do not get better or if you get worse.

Active substance BECLOMETASONE (BECLOMETASONUM) | Compendium

Manufacturer:

CAS No: 4419-39-0 C ₂₂ H ₂₉ CIO ₅

MESH: pregna-1,4-diene-3,20-dione, 9-chloro-11,17,21-trihydroxy-16-methyl-, (11 β ,16 β )-.

M _m = 408. 93 Da. log P (octanol-water) = 2.03. Beclomethasone (in the form of dipropionate) is an odorless white or creamy white powder, very slightly soluble in water, well soluble in chloroform, acetone and alcohol.

Presentation: inhalation aerosol, metered dose inhalation aerosol, nasal spray, suspension.

• Pharmacological properties
• Indications BECLOMETASONE
• Application of BECLOMETASONE
• Contraindications
• Side effects
• Special instructions
• Interactions
• Diagnosis
• Recommended alternatives
• Trade names

Medicinal preparations containing the active substance BECLOMETASONE

Beclazon-Eco

inhalation aerosol 100 mcg/dose canister 200 doses with inhalation device, No. 1

Teva Ukraine

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Beclazon-Eco

9 0002 inhalation aerosol 250 mcg/dose can 200 doses with inhalation device, No. 1

Teva Ukraine

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Beclomethasone-Zdorovye

metered nasal spray, suspension 50 mcg/dose vial 180 doses, No. 1

Zdorovye

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Beclofort™ Evohaler™

inhalation aerosol metered dose 250 mcg/dose bottle 200 doses, No. 1

GlaxoSmithKline Export

Pharmacy prices 900 03

Baconase

nasal spray, suspension 50 mcg/dose vial 180 doses, № 1

Glaxo Wellcome

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Local glucocorticosteroids are used as basic therapy for BA, have anti-inflammatory and anti-allergic effects. It 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 action 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 production of lymphokines, macrophage migration is inhibited, the intensity of infiltration and granulation processes decreases, which ultimately improves indicators of the function of external respiration. Increases the number of active β-adrenergic receptors, restores the patient’s response to bronchodilators, and reduces the frequency of their use. Virtually no mineralocorticosteroid activity and resorptive action after inhalation. In therapeutic doses, it has an active local effect without the development of side effects characteristic of systemic corticosteroids. Does not stop bronchospasm, the therapeutic effect develops gradually, usually after 5-7 days of course use of beclomethasone dipropionate.

Absorption is low, with the inhalation route of administration at 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 the first passage through the liver. Communication with blood plasma proteins – 87%. The main part (35-76%) is excreted within 96 hours with feces, mainly in the form of polar metabolites, 10-15% – with urine.

as basic therapy for BA; seasonal and year-round allergic rhinitis, recurrent nasal polyposis, non-infectious inflammatory processes in the nasal cavity.

inhalation use. Adults (including elderly patients) and children over 12 years of age with mild BA (forced expiratory volume (FEV) or peak expiratory flow (PEF) – more than 80%, daily variation in PSV values ​​- less than 20%) – according to 200–600 mcg/day for 2 inhalations; with moderately severe BA (FEV or PSV – 60-80%, daily variation in PSV values ​​- 20-30%) – 600-1000 mcg / day for 2-4 inhalations; Severe BA (FEV or PSV – 60%, daily variation in PSV values ​​- 30%) – 1000-2000 mcg / day for 2-4 inhalations. The maximum daily dose of the drug in adults should not exceed 1 mg, in very severe cases – 1.5-2 mg / day for 3-4 doses. Children aged 6 to 12 years are prescribed at an initial dose of 50-100 mcg 2 times a day. If necessary, the dose can be increased to 400 mcg. The daily dose is divided into 2-4 doses. The maximum daily dose of the drug in children should not exceed 500 mcg. After each inhalation, it is recommended to rinse the mouth with water. Beclomethasone dipropionate containing 250 mcg per dose is not intended for pediatric use.

Intranasal application . The recommended dose for adults and children over the age of 12 is 200 micrograms (2 inhalations, with the first inhalation directed to the upper and the second to the lower part of the nasal passage) 2 times a day in each nasal passage or 100 micrograms in each nasal move 3-4 times a day; the maximum daily dose is 1000 mcg. Children aged 6-12 years – 42-50 mcg in each nasal passage 3-4 times a day. The total daily dose is 252–400 mcg, the maximum is 500 mcg.

hypersensitivity to beclomethasone.

dysphonia, throat irritation, cough, sneezing, paradoxical bronchospasm, eosinophilic pneumonia, allergic reactions, oral and upper respiratory tract candidiasis (with prolonged use and / or when used in high doses). With prolonged use in doses of more than 1.5 mg / day, systemic side effects of corticosteroids, 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), some decrease in the function of the hypothalamic-pituitary-adrenal system is possible, 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.

is used with caution in liver cirrhosis, glaucoma, hypothyroidism, systemic infections, osteoporosis, during pregnancy and lactation.

methandrostenolone, estrogens, β ₂ -adrenergic agonists, theophylline and orally administered corticosteroids increase the effect of beclomethasone.

Beclospir

BEKLOSPIR®

Registration number: LSR-000189/09 dated 16.01.2009

Trade name of the drug: Beclospir®

International nonproprietary name: Beclomethasone

Dosage form: dosed inhalation aerosol

Composition per bottle: 200 doses

Active substance: Beclomethasone dipropionate 0. 012g, 0.024g and 0.060g

Excipients: ethanol (absoluted ethyl alcohol), hydrofluoroalkane (HFA134a) up to 14.02

Description

The contents of the aluminum aerosol can with metering valve is a pressurized suspension that forms a white spot when sprayed onto a glass slide.

ATC code: [R03BA01]

Pharmacotherapeutic group

Glucocorticosteroid for local use.

Pharmacodynamics

Beclomethasone dipropionate is a prodrug and has a weak affinity for glucocorticosteroid (GCS) receptors. Under the action of esterases, it turns into an active metabolite – beclomethasone-17-monopropionate, which has a pronounced local anti-inflammatory effect by reducing the formation of chemotaxis substance (influence on delayed-type allergic reactions). By suppressing the production of arachidonic acid metabolites and reducing the release of inflammatory mediators from mast cells, it inhibits the development of an immediate type of allergic reaction. Improves mucociliary transport, reduces the number of mast cells in the bronchial mucosa, reduces epithelial edema, mucus secretion by bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration processes and granulation. After inhalation, it practically does not have a resorptive effect. Does not stop bronchospasm. The therapeutic effect develops gradually, usually after 5-7 days of course use. By increasing active beta-adrenergic receptors, it restores the patient’s response to bronchodilators, making it possible to reduce the frequency of their use.

Pharmacokinetics

More than 25% of the inhaled dose is deposited in the respiratory tract, the remaining amount is in the mouth, pharynx and is swallowed. In the lungs, before absorption of beclomethasone, dipropionate is extensively metabolized to the active metabolite beclomethasone-17-monopropionate. Its systemic absorption occurs in the lungs (36% lung fraction), in the gastrointestinal tract (26% of the swallowed dose). The absolute bioavailability of unchanged beclomethasone dipropionate and beclomethasone-17-monopropionate is, respectively, about 2 and 62% of the inhaled dose. Beclomethasone dipropionate is absorbed rapidly (Tmax – 0. 3 h), beclomethasone-17-monopropionate is absorbed more slowly (Tmax – 1 h). Distribution in tissues for beclomethasone dipropionate is 20 liters and for beclomethasone-17-monopropionate – 424 liters. 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). T1 / 2 is 0.5 and 2.7 hours, respectively.

Indications for use

Bronchial asthma of various forms in adults and children over 4 years of age (basic therapy).

Contraindications

Hypersensitivity to any component of the preparation.

Use with caution in glaucoma, systemic infections (bacterial, including pulmonary tuberculosis, viral, fungal, parasitic), osteoporosis, liver cirrhosis, hypothyroidism. Pregnancy and lactation

With extreme caution only if the potential benefit to the mother outweighs the possible risk to the fetus and child.

Dosage and administration

Inhalation.

The dose is selected individually (it can be increased until a clinical effect appears or reduced to the minimum effective dose). The initial dose is determined by the severity of bronchial asthma. The daily dose is divided into several doses.

Adults and children aged 12 and over.

Recommended initial doses of the drug: – mild bronchial asthma (forced expiratory volume (FEV) or peak expiratory flow rate (PSV) – more than 80%, daily variation in PSV values ​​- less than 20%) – 200-600 mcg / day;

– moderate bronchial asthma (FEV or PSV – 60-80%, daily variation in PSV – 20-30%) – 600-1000 mcg / day;

– severe bronchial asthma (FEV or PSV – 60%, daily variation of indicators – more than 30%) – 1000-1200 mcg / day.

The treatment of bronchial asthma is based on a stepwise approach – therapy is started according to the step corresponding to the severity of the disease. GCS inhalation is prescribed at the second stage of therapy.

Stage 2. Basic therapy: beclomethasone dipropionate – 100–400 mcg 2 times a day. Stage 3. Basic therapy: inhaled corticosteroids in a high or standard dose, but in combination with inhaled administration of long-acting beta2-adrenergic agonists. Beclomethasone dipropionate – in a high dose (800-1600, in some cases up to 2000 mcg / day).

Stage 4 (severe asthma). Beclomethasone dipropionate – 800–1600 mcg / day, in some cases – megadoses up to 2000 mcg / day.

Stage 5 (severe asthma). Beclomethasone dipropionate – in a high dose (see step 3.4).

Children 4 to 12 years of age: up to 400 micrograms daily in divided doses.

Special groups of patients: there is no need to adjust the dose in the elderly, in patients with renal and hepatic insufficiency. Skipping a single dose of the drug: in case of accidental skipping of inhalation, the next dose must be taken at the scheduled time in accordance with the treatment regimen.

Side effects

From the respiratory system: upper respiratory tract candidiasis (the likelihood of development increases at doses of more than 400 mcg / day), dysphonia (hoarseness), irritation of the pharyngeal mucosa (the use of a spacer reduces the likelihood of their development), paradoxical bronchospasm (immediately stop with a short-acting inhaled beta2-adrenergic agonist).

From the digestive tract: oral candidiasis (the likelihood of development increases with doses of more than 400 mcg / day), nausea, unpleasant taste sensations.

Allergic reactions: hypersensitivity reactions including rash, urticaria, itching, redness and swelling of the eyes, face, lips and mucous membranes of the mouth and throat.

Other: possible systemic effects, incl. headache, bruising or thinning of the skin, decreased function of the adrenal cortex, osteoporosis, growth retardation in children and adolescents, cataracts, glaucoma.

Interaction with other drugs

There are no confirmed data on the interaction of beclomethasone dipropionate with other drugs.

Overdose

Acute overdose may lead to a temporary decrease in the function of the adrenal cortex, which does not require emergency treatment, because. it recovers 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. In this case, it is necessary to monitor the reserve function of the adrenal cortex. Treatment with the drug can be continued in doses sufficient to maintain the therapeutic effect.

Precautions

If the drug is prescribed against the background of oral corticosteroids, the dose of the latter remains the same. In this case, the patient must be in a relatively stable condition. After about 1-2 weeks, the daily dose of oral corticosteroids begins to be gradually reduced according to the scheme, depending on the duration of the previous therapy and on the initial dose of corticosteroids. 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), while in the first months after the transition, the patient’s condition should be carefully monitored until his pituitary-adrenal the system will not recover sufficiently to provide an adequate response to stressful situations (for example: trauma, surgery or infection). When transferring patients from systemic corticosteroids to inhaled, allergic reactions are possible (for example: allergic rhinitis, eczema), which were previously suppressed by systemic drugs. Patients with reduced function of the adrenal cortex, transferred to inhalation therapy, should have a supply of corticosteroids and always carry a warning card with them indicating that in stressful situations they need additional systemic administration of corticosteroids (after eliminating the stressful situation, the dose of corticosteroids can again be reduced). 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 corticosteroids. An indirect indicator of therapy failure is the more frequent use of short-acting beta2-agonists than before. With the development of paradoxical bronchospasm, it is necessary to immediately stop using the drug, assess the patient’s condition, conduct an examination and prescribe therapy with other drugs. With prolonged use of any inhaled corticosteroids, especially at high doses, systemic effects may occur (see “Side Effects”), but the likelihood of their development is much lower than with the appointment of corticosteroids inside. Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids should be reduced to the minimum effective dose that controls the course of the disease. The drug at a dose of 1500 mcg / day does not cause significant suppression of adrenal function in most patients. In connection with the possible adrenal insufficiency, when transferring a patient taking GCS orally to inhalation therapy, special care must be taken and the indicators of the function of the adrenal cortex should be regularly monitored. Special care should be taken when treating patients with tuberculosis, both active and inactive, with inhaled corticosteroids. There are no data on the effect of the drug on the ability to drive a car / mechanisms.

Special instructions

Before prescribing inhalation drugs, it is necessary to instruct the patient about the rules for their use, ensuring the most complete entry of drugs into the lungs. The development of oral candidiasis is most likely in patients with a high level of precipitating anti-candidiasis antibodies (indicative of previous candidiasis). After inhalation, the mouth and throat should be rinsed with water. For the treatment of candidiasis while continuing therapy with the drug, topical antifungal agents can be used. The drug is not intended for stopping seizures, but for regular daily use. Short-acting beta2-adrenergic agonists (for example, salbutamol) are used to stop seizures. 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, systemic corticosteroids and / or an antibiotic should be prescribed if an infection develops. It is recommended to regularly monitor the growth dynamics of children receiving inhaled corticosteroids for a long time. Abrupt discontinuation of the drug is not recommended. It is necessary to protect the eyes from getting the drug; for the prevention of damage to the skin of the eyelids, nose, washing after inhalation is recommended. The medicine can must not be pierced, disassembled or thrown into fire, even if it is empty. When cooling the can, it is recommended to remove it from the plastic case and warm it with your hands for several minutes (at low temperatures, the drug may be ineffective).

Instructions for the patient to use the inhaler

Check the operation of the inhaler before using it for the first time, and also if you have not used it for some time.

1. Remove the cap from the inhaler. Make sure the outlet tube is free of dust and dirt.

2. Hold the can upright with your thumb on the bottom and your index finger on the top of the can. Shake the can vigorously up and down.

3. Inhale as deeply as possible (without exertion). Close the outlet tube of the can tightly with your lips.

4. Inhaling slowly and deeply, press the valve of the can with your index finger to release the dose of medicine. Continue to inhale slowly.

5. Remove the inhaler tube from your mouth and hold your breath for 10 seconds or as long as you can without exertion. Exhale slowly.

6. If more than one dose is needed, wait about a minute and then repeat from step 2. Put the cap back on the inhaler.

Take your time when performing steps 3 and 4. At the time of release of the dose of the drug, it is important to inhale as slowly as possible. Practice in front of a mirror first. If you notice “steam” coming out of the top of the can or the corners of your mouth, start again from step 2.

Cleaning the inhaler

Clean the inhaler at least once a week. Remove the metal can from the plastic case and rinse the case and cap with warm water. Do not use hot water. Dry thoroughly without using heating devices. Place the can back into the case and put on the cap.