Bronchodilator - beta 2-adrenergic agonist

Active ingredient

Release form, composition and packaging

Aerosol for inhalation dosed in the form of a white or almost white suspension.

1 to ensure a yield of 200 doses when using an inhaler, each inhaler contains an amount of suspension equivalent to 240 doses;
2 depending on the equipment used in the production of the drug, up to 10% excess may be included in the production formula active substance;
3 120.5 mcg salbutamol sulfate (micronized, humidified) is equivalent to 100 mcg salbutamol.

Excipients: propellant (1,1,1,2-tetrafluoroethane) - up to 75 mg in 1 dose (up to 18 g in 1 inhaler).

200 doses - aluminum inhalers (1) with a plastic dosing device with a protective cap - cardboard packs with first opening control.

Pharmacological action

Selective agonist of β 2 -adrenergic receptors. IN therapeutic doses acts on β 2 -adrenergic receptors smooth muscle bronchi and has a short-term (4 to 6 hours) bronchodilator effect on β 2 -adrenergic receptors with a rapid onset of action (within 5 minutes) with reversible obstruction respiratory tract.

It has a pronounced bronchodilator effect, preventing or relieving bronchospasm, and reduces resistance in the respiratory tract. Increases vital capacity of the lungs. Increases mucociliary clearance (in chronic bronchitis up to 36%), stimulates mucus secretion, activates the functions of the ciliated epithelium.

At recommended therapeutic doses it does not have any effect negative influence on cardiovascular system, does not cause an increase in blood pressure. To a lesser extent compared to medicines this group has a positive chrono- and inotropic effect. Causes dilation of the coronary arteries.

It has a number of metabolic effects: it reduces potassium concentrations, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, and increases the risk of developing acidosis.

Pharmacokinetics

Suction

After inhalation administration, 10-20% of the dose of salbutamol reaches lower sections respiratory tract. The rest of the dose remains in the inhaler or is deposited in the oropharynx and is then swallowed. The fraction deposited in the respiratory tract is absorbed into lung tissue and blood, but is not metabolized in the lungs.

Distribution

The binding of salbutamol to plasma proteins is 10%.

Metabolism

When it enters the systemic circulation, salbutamol undergoes hepatic metabolism and is excreted primarily by the kidneys unchanged or in the form of phenolic sulfate. The ingested portion of the inhalation dose is absorbed from gastrointestinal tract and undergoes significant first-pass metabolism through the liver to phenolic sulfate. Unchanged salbutamol and the conjugate are excreted primarily by the kidneys.

Removal

Salbutamol administered intravenously has a half-life of 4-6 hours. It is excreted partly by the kidneys and partly as a result of metabolism to inactive 4"-O-sulfate (phenolic sulfate), which is also excreted primarily by the kidneys. Only a small part of the administered dose of salbutamol is excreted through the intestines. Most of the dose of salbutamol administered intravenously, orally or by inhalation, excreted excreted within 72 hours.

Indications

Bronchial asthma:

- relief of symptoms bronchial asthma when they occur;

- prevention of bronchospasm attacks associated with exposure or caused by physical activity;

— use as one of the components in long-term maintenance therapy of bronchial asthma.

Other chronic diseases lungs, accompanied by reversible airway obstruction, including COPD, chronic bronchitis, .

Bronchodilators should not be the only or main component of the treatment of bronchial asthma of unstable or severe course. In the absence of a response to salbutamol in patients with severe disease, it is recommended to treat with GCS in order to achieve and maintain disease control. Failure to respond to salbutamol therapy may indicate the need for urgent consultation doctor or treatment.

Contraindications

- management premature birth;

- threatened abortion;

— increased sensitivity to the components of the drug or any other component included in the drug.

With caution Salbutamol should be used in patients with thyrotoxicosis, tachyarrhythmia, myocarditis, heart defects, aortic stenosis, ischemic heart disease, severe chronic heart failure, pheochromocytoma, decompensated diabetes mellitus, glaucoma.

Dosage

Ventolin is intended only for inhalation administration by inhalation through the mouth.

An increased need for the use of β 2 -adrenergic receptor agonists may be a sign of worsening bronchial asthma. IN similar situation It may be necessary to re-evaluate the patient's treatment regimen with consideration of the advisability of prescribing simultaneous therapy with GCS.

Because overdose may be accompanied by the development adverse reactions, the dose or frequency of use of the drug can be increased only on the recommendation of a doctor.

The duration of action of salbutamol in most patients is from 4 to 6 hours.

In patients who have difficulty synchronizing inspiration with the use of a metering device aerosol inhaler under pressure, a spacer can be used.

In children and infants receiving Ventolin, it is advisable to use a pediatric spacer device with a face mask.

For relief of an attack of bronchospasms adults the recommended dose is 100 or 200 mcg; children- 100 mcg, if necessary, the dose can be increased to 200 mcg. It is not recommended to use the Ventolin inhaler more than 4 times a day. The need for such frequent use of additional doses of Ventolin or a sharp increase in dose indicates a worsening of asthma.

For preventing bronchospasm attacks associated with exposure to an allergen or caused by physical activity, adults- 200 mcg 10-15 minutes before exposure to a provoking factor or load; children- 100 mcg 10-15 minutes before exposure to a provoking factor or load; if necessary, the dose can be increased to 200 mcg.

At long-term maintenance therapy adults- up to 200 mcg 4 times/day; children- up to 200 mcg 4 times/day.

Rules for using the inhaler

Checking the inhaler

Before using the inhaler for the first time or if the inhaler has not been used for a week or longer, you should remove the cap from the mouthpiece by lightly squeezing the cap on the sides, shake the inhaler well and spray two times into the air to ensure that the inhaler is working properly.

Using an inhaler

1. Remove the cap from the mouthpiece by lightly squeezing the sides of the cap.

2. Inspect the mouthpiece inside and out to make sure it is clean.

3. Shake the inhaler well.

4. Hold the inhaler between your index finger and thumb V vertical position upside down, while thumb should be located on the base under the mouthpiece.

5. Exhale slowly and deeply, wrap your lips around the mouthpiece without squeezing it with your teeth.

6. By producing as much as possible deep breath through the mouth simultaneously press top part inhaler to release one inhalation dose of salbutamol.

7. Hold your breath for a few seconds, remove the mouthpiece from your mouth, then exhale slowly.

8. To receive the second dose, hold the inhaler in a vertical position, wait about 30 seconds and then repeat steps. 3-7.

9. Close the mouthpiece tightly with the protective cap.

When performing stages 5, 6 and 7, you should not rush. You should begin inhaling as slowly as possible, just before pressing the inhaler valve. It is recommended to practice in front of a mirror the first few times. If a "fog" is visible coming from the top of the inhaler or from the corners of the mouth, then you should start all over again at stage 2.

If the doctor has given other instructions for using the inhaler, the patient must strictly follow them. If the patient has difficulty using the inhaler, he should consult a doctor.

Cleaning the inhaler

The inhaler must be cleaned at least once a week.

1. Remove the metal can from the plastic case and remove the mouthpiece cover.

2. Rinse the plastic case and mouthpiece cover thoroughly under running warm water.

3. Dry the plastic case and mouthpiece cover completely, both outside and inside. Avoid overheating.

4. Place the metal can into the plastic case and put on the mouthpiece cap.

Do not immerse the metal can in water.

Side effects

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥1/10), often (≥1/100 and<1/10), нечасто (≥1/1 000 и <1/100), редко (≥1/10 000 и <1/1 000), очень редко (<1/10 000, включая отдельные случаи). Категории частоты были сформированы на основании клинических исследований препарата и пострегистрационного наблюдения.

From the immune system: very rarely - hypersensitivity reactions, including angioedema, urticaria, bronchospasm, decreased blood pressure and collapse.

Metabolism and nutrition: rarely - hypokalemia. Therapy with beta 2 agonists may lead to clinically significant hypokalemia.

From the nervous system: often - tremor, headache; very rarely - hyperactivity.

From the cardiovascular system: often - tachycardia; infrequently - palpitations; rarely - peripheral vasodilation; very rarely - arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole).

From the respiratory system: very rarely - paradoxical bronchospasm.

From the digestive system: infrequently - irritation of the mucous membrane of the oral cavity and pharynx.

From the musculoskeletal system: infrequently - muscle cramps.

Overdose

Symptoms: signs and symptoms of salbutamol overdose are transient phenomena pharmacologically mediated by stimulation of β-adrenergic receptors, such as decreased blood pressure, tachycardia, muscle tremors, nausea, vomiting. The use of large doses of salbutamol can cause metabolic changes, including hypokalemia, it is necessary to monitor the concentration of potassium in the blood serum .

Treatment: When used in high doses, as well as with overdose of short-acting beta-agonists, the development of lactic acidosis has been observed, therefore, in case of overdose, control over the increase in serum lactate and the possibility of developing metabolic acidosis may be indicated (especially if tachypnea persists or worsens, despite the elimination of other signs bronchospasm such as wheezing).

Drug interactions

Salbutamol is not contraindicated in patients receiving MAO inhibitors.

In patients with thyrotoxicosis, Ventolin enhances the effect of central nervous system stimulants and tachycardia.

And other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmia.

Simultaneous administration with anticholinergic drugs (including inhaled ones) may increase intraocular pressure.

Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.

Special instructions

Bronchodilators should not be the only or main component of the treatment of unstable or severe bronchial asthma.

An increased need for the use of short-acting bronchodilators, in particular β 2 -adrenergic receptor agonists, to relieve the symptoms of bronchial asthma indicates a worsening of the disease. In such cases, the patient's treatment plan should be reconsidered. A sudden and progressive worsening of bronchial asthma can pose a potential threat to the patient's life, therefore, in such situations, the advisability of prescribing or increasing the dose of GCS should be considered. In patients at risk, daily monitoring of peak expiratory flow is recommended.

Therapy with β 2 -adrenergic agonists, especially when administered parenterally or via nebulizer, can lead to hypokalemia.

Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, corticosteroids, diuretics, as well as due to hypoxia. In such situations, it is recommended to monitor the concentration of potassium in the blood serum.

As with other inhalation therapy agents, paradoxical bronchospasm may develop when taking salbutamol with increased wheezing immediately after using the drug. This condition requires immediate treatment using an alternative formulation of salbutamol or another short-acting inhaled bronchodilator. Ventolin should be discontinued immediately, the patient's condition assessed and, if necessary, another fast-acting bronchodilator prescribed to continue treatment.

If there is no effect of using a previously effective dose of inhaled salbutamol for at least 3 hours, the patient should consult a doctor to determine whether any additional measures need to be taken.

Patients should be instructed on the correct use of the Ventolin inhaler.

Impact on the ability to drive vehicles and operate machinery

No data available.

Pregnancy and lactation

Pregnancy

During pregnancy, the drug should be prescribed only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

During post-registration surveillance, rare cases of various malformations in children were identified, including the formation of a cleft palate and malformations of the limbs, while taking salbutamol during pregnancy. In some of these cases, mothers took multiple concomitant medications during pregnancy. Due to the lack of permanent nature of the defects and the background incidence of congenital anomalies of 2 to 3%, a cause-and-effect relationship with the drug has not been established.

Breastfeeding period

Salbutamol is likely to pass into breast milk and is therefore not recommended for use in nursing women unless the expected benefit to the mother outweighs the potential risk to the baby. There is no evidence whether salbutamol present in breast milk is harmful to the newborn.

Fertility

There is no data on the effects of salbutamol on human fertility. In preclinical studies, no undesirable effects on animal fertility were identified.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 30°C; do not freeze, do not expose to direct sunlight. Shelf life – 2 years. Do not use after the expiration date stated on the package.

A rather unpleasant and even dangerous disease is bronchial asthma, which requires the strictest control from the person suffering from it. Asthma is classified as an infectious-allergic disease and is characterized by bronchospasm. Bronchospasm is a sudden contraction of the muscles of the bronchial wall, which is accompanied by a narrowing of the bronchi, which, in turn, leads to a deterioration in ventilation of the lungs. As a result, an attack of suffocation and panic occurs.

The inhalation drug “Ventolin”, instructions and reviews of which are described below, can alleviate the patient’s condition and also prevent an attack of bronchospasm.

Description of the drug

"Ventolin" is an anti-asthmatic drug used in the treatment and prevention of various diseases of the lungs and bronchi, which lead to spasms of the smooth muscles of the bronchi. "Ventolin" for inhalation is a clear liquid, sometimes light yellow in color.

The active ingredient of the drug is salbutamol, which suppresses bronchial reactivity and helps prevent or eliminate the phenomenon of bronchospasm. The instructions describe the auxiliary components included in the drug “Ventolin” (for inhalation) as substances that facilitate the most convenient administration and uniform distribution of salbutamol in the patient’s body.

Salbutamol, when administered into the respiratory tract, affects the smooth muscles of the bronchi, while ensuring their complete relaxation, reducing airway resistance, and also increasing the volume of inhaled air. In addition, the active ingredient of the drug "Ventolin" stimulates the secretion of the bronchial glands, and also activates the work of the ciliated epithelium of the bronchi, due to which mucus is removed during coughing. In therapeutic doses, salbutamol, the active component of the drug Ventolin (for inhalation), can cause a decrease in blood pressure and an increase in heart rate.

The breakdown products of salbutamol are excreted from the body in urine and partially in feces.

Product release form

The drug is available in the following forms:

• "Ventolin Nebula." For inhalation, a special device is used - a nebulizer. The solution is placed in opaque capsules of 2.5 ml. The cardboard packaging contains 10, 20 and 40 nebulas.

• "Ventolin Evohaler." An aerosol can with a spray mouthpiece that contains 100 mcg/200 doses. The cardboard package contains 1 cylinder.

Indications for use of the drug

As the instructions for the drug “Ventolin” (for inhalation) note, the drug is indicated:

1. For bronchial asthma - to relieve and prevent attacks, treat asthma during exacerbation.
2. For chronic bronchitis.
3. With reversible obstruction.
4. For acute chronic bronchitis.

Contraindications

As for contraindications to the use of the drug "Ventolin" (for inhalation), these include hypersensitivity to one or more components of the drug. Pregnant women who are at risk of premature birth or miscarriage, as well as children under 2 years of age, should not take the medicine.

In addition, you should take the drug with extreme caution:

• with myocarditis;
• with coronary heart disease;
• for heart defects;
• with aortic stenosis;
• with tachyarrhythmia;
• for glaucoma;
• with aortic stenosis;
• with thyrotoxicosis;
• with diabetes mellitus in the stage of decompensation;
• for epilepsy;
• with liver and kidney failure;
• with arterial hypertension;
• during pregnancy and lactation.

The instructions for the drug "Ventolin" (for inhalation) allow in rare cases the use of the drug by pregnant and nursing mothers. In this case, the expected effect on a woman’s health should significantly exceed the risk of developing pathologies in a child or fetus. This warning is due to the fact that in the course of a number of studies, cases of negative effects on the fetus were observed, as a result of which pathologies in the form of a “cleft palate” and congenital deformities of the limbs were identified. Although, on the other hand, a cause-and-effect relationship between taking the medication and fetal pathologies could not be established, since the test mothers also took other medications. There is also no data on the effect of salbutamol, which is the active ingredient of the drug Ventolin for inhalation, on a newborn child. Reviews from doctors therefore exclude the use of the drug by nursing and pregnant women.

Side effects

Side effects from taking Ventolin can be divided into common, infrequent, rare and very rare. Common side effects include headache, dizziness, tachycardia and tremors. Infrequently, palpitations, irritation of the pharynx and oral mucosa occur. In rare cases, hypokalemia and dilation of peripheral blood vessels occur. Very rarely, as reviews from doctors and patients show about the drug “Ventolin” (for inhalation), arrhythmia, hyperactivity, extrasystole, lactic acidosis, superventricular tachycardia, as well as some allergic reactions, such as collapse or decreased blood pressure, urticaria, edema or bronchospasm, may be observed. .

Instructions for use of the drug

1. “Ventolin”: nebulas for inhalation.

The instructions for the drug describe the use of nebulas using a special device - a nebulizer. must be prepared, supplemented with sterile (total volume is 2-2.5 ml). Through a nebulizer, the patient inhales the resulting solution until the aerosol formation completely stops. On average, one inhalation procedure takes about 10 minutes.

Sometimes, in order to speed up the effect, it is allowed to use an undiluted solution of the drug “Ventolin” (for inhalation), the dosage of which is prescribed by the doctor. In this case, the inhalation procedure lasts no more than 5 minutes.

It is very important to carry out the procedure in a well-ventilated area and under the direct supervision of a doctor.

2. Aerosol.

Using an aerosol of the drug “Ventolin” for the first time or if the product has not been used for some time, you should remove the safety cap from the cylinder, while squeezing its edges on the sides. Before use, shake the can well and press the valve to make sure that the aerosol mechanism is working properly.

Having installed the mouthpiece, shake the inhaler again and position the balloon so that its bottom is directed upward, hold the inhaler at the bottom with your index finger, and place your thumb on the base and under the mouthpiece.

Before using the drug directly, the patient should exhale slowly and deeply and clasp the end of the mouthpiece with his lips. Next, you need to press the bottom of the inhaler with your index finger and at the same time inhale deeply through your mouth. After taking one dose of the medicine, you need to hold your breath for a few seconds and then exhale slowly. The next dose of the drug is taken after half a minute. The mouthpiece is then closed with a cap.

When administering the drug "Ventolin" (for inhalation), the patient should under no circumstances rush. Using the aerosol for the first time, you can practice standing in front of a mirror. If traces of escaping aerosol are noticeable in the upper part of the inhaler or in the area of ​​the corners of the mouth during administration, the drug administration procedure should be started over.

The mouthpiece must be cleaned once a week, and:

• before rinsing the mouthpiece with warm running water, you need to remove the bottle from the plastic case and remove the lid;
• Wash the mouthpiece and body under running water without overheating them;
• after all the parts have dried, you should insert the bottle back into the body and close it with the mouthpiece cover;
• The cylinder must not be immersed in water.

Dosage of the drug

The instructions for the drug “Ventolin” (nebulas for inhalation) allow you to take it in diluted or undiluted form. The method of administration and dosage are determined by the attending physician depending on the age and health of the patient.

For children over 12 years of age and adults the drug is prescribed:

• Divorced. Mix 0.5-1.0 ml of Ventolin with saline solution. The total volume should be 2.0-2.5 ml. Next, the resulting solution must be placed in a nebulizer and inhaled until the formation of aerosol stops.
• In its purest form. Place 2.0 ml of the drug in a nebulizer and inhale. On average, the procedure takes no more than 5 minutes.

Children from 2 to 12 years old are prescribed the drug in diluted form. 0.5 ml of the drug “Ventolin” (solution for inhalation) is diluted with physiological solution so that the total volume is 2.0-2.5 ml. The inhalation procedure is carried out using a nebulizer. Sometimes, as prescribed by a doctor, in severe cases the dose of the drug can be increased to 1.0 ml.

The number of procedures is prescribed by the doctor. Repeated inhalation is carried out after 20 minutes, but no more than 4 times a day.

2. Aerosol.

Children over 12 years old and adults:

• 100-200 mcg (1-2 injections) - for acute attacks of bronchospasm.
• 200 mcg (2 injections) - prevention of acute attacks of bronchospasm when exposed to an allergen or physical stress.
• 200 mcg (2 injections) - as maintenance therapy, which is prescribed for a long time.

Children from 2 to 12 years old:

• 100 mcg (1 injection) - for acute attacks of bronchospasm.
• 100 mcg (1 injection) - for the prevention of bronchospasm attacks, 15 minutes before exposure to the provoking factor.
• 100 mcg (1 injection) - as maintenance therapy for a long time. Take no more than 4 times a day.

The drug "Ventolin": inhalation for children

The drug can be prescribed for the prevention and treatment of bronchospasm in children over 2 years of age. In rare cases, the drug is prescribed to children from 18 months. Even less often, the drug is used at an earlier age, since there is no data on the effect of Ventolin on the body of children under 18 months.

As reviews show about the drug “Ventolin” (nebulas for inhalation), it is most often prescribed for a short period of time, taking into account the severity of the disease, the age of the child, concomitant diseases, and the use of other medications.

If it is not possible to use an aerosol or to increase the effectiveness of the drug, the administration of salbutamol may be recommended using a nebulizer. The dosage, nature and frequency of administration of salbutamol are prescribed by the attending physician for each child individually.

Interaction with other drugs

Ventolin and non-selective beta blockers should not be taken at the same time. "Ventolin" can increase tachycardia in thyrotoxicosis. It can also enhance the effects of drugs that stimulate the central nervous system. While taking cardiac glycosides, the drug increases the likelihood of developing arrhythmia. The likelihood of tachyarrhythmias increases when taking Ventolin and Theophylline simultaneously. After taking Ventolin and anticholinergics together, intraocular pressure may increase. During pregnancy, the drug should be used with great caution, as hyperglycemia and tachycardia may occur in the fetus and mother. Taking it can also cause a decrease in blood pressure, and even pulmonary edema.

Analogues of the drug "Ventolin"

Inhalations for children and adults can be carried out with the help of other drugs, the active ingredient of which is also salbutamol. Among the most common analogues are:

• "Salbutamol";
• "Astalin";
• "Salmo";
• "Aloprol";
• "Salbuvent";
• "Salgim";
• "Sterineb Salamol";
• "Salamol";
• "Saltos" and others.

Drug price

The price of the medicine depends on the city and pharmacy where it is purchased. On average, for the drug “Ventolin” (nebulas for inhalation) 2.5 ml/2.5 mg in an amount of 20 pieces you will need to pay from 270 to 300 rubles. For 140-160 rubles. You can purchase Ventolin Evohaler 100 mcg in the form of an aerosol can with a mouthpiece.

Storage conditions

The medicine should be stored in its original packaging at a temperature not exceeding 30 degrees in a place protected from direct sunlight. The product must not be frozen. The shelf life is 2 years. After opening the aluminum foil, nebulas should be stored for no longer than three months. A solution in a nebulizer that has not been completely used cannot be stored.

Instructions for medical use

medicine

Ventolin®

Trade name

Ventolin ®

International nonproprietary name

Salbutamol

Dosage form

Aerosol for inhalation, dosed, 100 mcg/dose, 200 doses

One dose contains

active substance - salbutamol sulfate 120.5 mcg (equivalent to salbutamol 100 mcg),

excipient- 1,1,1,2-tetrafluoroethane (HFA-134a propellant), ozone-safe.

Description

Homogeneous suspension of white or almost white color.

Pharmacotherapeutic group

Drugs for the treatment of obstructive airway diseases. Inhalation sympathomimetics. Beta 2 - selective adrenergic agonists.

ATX code R03AC02

Pharmacological properties

Pharmacokinetics

Absorption

When using an aerosol, 10 to 20% of the dose taken reaches the lower respiratory tract, where it is adsorbed by the lung tissue and penetrates the blood vessels of the lungs, but is not metabolized here. The remaining part remains in the delivery device or settles in the oropharynx with further ingestion of the drug.

Distribution

Plasma protein binding is 10%.

Metabolism

When thresholds are reached by the circulatory system, salbutamol is metabolized through the hepatic mechanism and is excreted primarily in the urine as unchanged product and phenol sulfate.

Salbutamol is metabolized during the first passage through the liver and, due to the ingestion of small quantities during inhalation, in the intestinal wall; the main metabolite is an inactive sulfate conjugate, which is excreted in the urine.

Removal

T ½ of salbutamol when administered intravenously is 4-6 hours. Salbutamol is rapidly excreted in the urine as an inactive metabolite 4'-O-sulfate and unchanged substance; excreted in small quantities in feces. Most of the salbutamol taken is eliminated from the body within 72 hours.

Pharmacodynamics

Ventolin ® is a selective β 2 -adrenergic receptor agonist. In therapeutic doses, it affects β 2 -adrenergic receptors of the bronchial muscles.

Ventolin ® has a short duration of action (4 to 6 hours) and a rapid onset of action (about 5 minutes from the moment of application).

Children

Clinical studies conducted in children under 4 years of age have demonstrated a similar safety profile compared to older children, adolescents and adults.

Indications for use

As part of complex therapy:

To relieve and prevent the development of bronchospasm in patients with reversible airway obstruction (asthma, chronic bronchitis, emphysema)

To relieve and prevent attacks of bronchial asthma before an expected attack

Bronchodilators should not be the only or main component of asthma therapy. If the patient has asthma

inhaled corticosteroids to achieve and maintain symptom control. Insufficient response to salbutamol therapy may be a signal for urgent medical intervention/therapy.

Directions for use and doses

Ventolin ® in the form of an aerosol is used only for inhalation by inhaling the aerosol through the mouth.

An increased need for β 2 -agonists may indicate a worsening of asthma. In such cases, it is recommended to re-evaluate the therapy and consider the possibility of additional administration of GCS.

Due to the risk of adverse reactions if recommended doses are exceeded, the frequency of administration and doses used should be increased only as directed by a doctor.

The duration of action of Ventolin ® in most patients is 4-6 hours.

Individuals who have difficulty coordinating inhalation and release of medication from an inhaler may use Ventolin ® using a spacer device.

The need to take the drug should not exceed 4 times a day (800 mg). A sudden increase in the need for the drug indicates a worsening of asthma.

For young children, it is better to use Ventolin ® through a spacer.

Relief of an acute attack of bronchospasm

Adults: from 100 mcg to 200 mcg of Ventolin ® once.

Children: 100 mcg once. If necessary, the dose can be increased to 200 mcg.

Warning exercise-induced bronchospasm or allergic etiology

Adults: 200 mcg before physical activity or expected allergen exposure

Children: 100 mcg before physical activity or expected contact with an allergen. If necessary, the dose can be increased to 200 mcg.

Long-term maintenance therapy I

Adults and children 100-200 mcg of the drug 4 times a day.

The duration of treatment is determined by the attending physician.

Instructions for using the inhaler

The effect of the drug may be weakened if the inhaler is cold. When the canister cools, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes. The can cannot be disassembled, pierced or thrown into fire, even if it is empty.

Checking the functionality of the inhaler

Before using the inhaler for the first time, you must carefully remove the cap from the mouthpiece, shake the inhaler vigorously and spray two doses of the drug into the air to ensure that the device is working properly. If the inhaler has not been used for 5 days or more, it should be shaken well and two doses of the drug sprayed into the air to ensure that it is working properly.

Using an inhaler

1. Remove the protective cap from the inhaler mouthpiece. Check the inside and outside of the inhaler, including the mouthpiece, for cleanliness and dryness, and for any loose parts of the device.

2. Shake the inhaler vigorously to evenly mix the contents of the inhaler and to remove any loose parts from the surface of the device.

3. Place the inhaler vertically between the thumb and forefinger, placing the thumb on the base, below the mouthpiece.

4. Exhale deeply (as far as possible). Then place the mouthpiece between your teeth (without biting it) and wrap your lips tightly around it.

5. Take a deep breath through your mouth. While continuing to take a deep breath, press the top of the inhaler.

6. Hold your breath, remove the inhaler from your mouth and remove your index finger from the top of the inhaler. Continue to hold your breath as much as possible.

7. If you need to continue inhalation, you should wait approximately half a minute, holding the inhaler vertically, and then repeat steps 2 to 6.

8. After inhalation, carefully place the dust cap on the mouthpiece.

Attention

Take your time when performing the steps indicated in points 4, 5 and 6. It is important that the inhaler is pressed at the beginning of a calm, deep breath. To be sure that the inhalation is performed correctly, you must first control the method of taking the medicine in front of a mirror. A “haze” appearing from the inhaler, lips or nose during inhalation indicates an incorrect inhalation technique and it is necessary to practice using the inhaler again, starting from point 2.

If your doctor has given you any other recommendations for using the drug, follow your doctor's recommendations. Tell your doctor about any difficulties you have with taking the drug.

Cleaning the inhaler

The inhaler should be cleaned at least once a week.

1. Remove the metal container from the plastic body of the inhaler and remove the mouthpiece cover.

2. Rinse the sprayer with warm running water.

3. Dry the sprayer thoroughly inside and out.

4. Place the container and mouthpiece cover back into place.

DO NOT IMMERSE THE METAL CONTAINER INTO WATER.

Side effects

Very often (>1/10), often (>1/100,<1/10), нечасто (>1/1,000, <1/100), редко (>1/10,000, <1/1,000), очень редко (<1/10,000).

Often

Tremor, headache

Tachycardia

Uncommon

Irritation of the mucous membrane of the mouth and pharynx

Rapid heartbeat

Muscle cramps

Rarely

Hypokalemia (beta 2 agonist therapy may lead to severe hypokalemia)

Peripheral vasodilation

Very rarely

Hypersensitivity reactions including urticaria, angioedema, bronchospasm, hypotension, collapse

Paradoxical bronchospasm

Lactic acidosis (in patients receiving salbutamol by intravenous injection and nebulizer to treat exacerbations of asthma)

Hyperactivity

Arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole

Contraindications

Hypersensitivity to any component included in the composition

drug

Premature birth

Threatened abortion

Forms of release of salbumol not intended for intravenous administration should not be used to terminate premature labor and threatened miscarriage.

Drug interactions

Ventolin ® is not contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs).

Special instructions

Treatment of asthma is usually done in stages, with the patient's response monitored clinically and with pulmonary function tests.

An increased need for β2-agonists may indicate worsening asthma control. In such cases, the patient's treatment plan should be reconsidered.

A sudden and progressive deterioration of bronchial asthma can pose a threat to the patient's life, so in such situations it is necessary to urgently decide on the issue of prescribing or increasing the dose of glucocorticosteroids. In such patients, daily monitoring of peak expiratory flow is recommended.

The drug should be used with caution in patients with thyrotoxicosis.

Therapy with b 2 -adrenergic receptor agonists, especially when administered parenterally or via nebulizer, can lead to hypokalemia. Particular caution is recommended when treating severe attacks of bronchial asthma, since in these cases hypokalemia may be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids, and diuretics , and also due to hypoxia. In such situations, it is necessary to monitor the level of potassium in the blood serum. As is the case with the use of other inhaled drugs, the development of paradoxical bronchospasm is possible as a result of the occurrence of a spasm immediately after dosing. If paradoxical bronchospasm occurs, immediate relief is required using an alternative drug or a fast-acting inhaled bronchodilator from a different pharmacological group. Treatment with this form of Ventolin ® should be immediately discontinued and, if necessary, other fast-acting bronchodilators should be prescribed for further use.

If the effect of the usual dose of Ventolin ® becomes less effective or shorter lasting (the effect of the drug should last at least 3 hours), the patient should consult a doctor.

The physician must ensure that the patient is using the inhaler correctly and that there is timing between actuation and inhalation for optimal delivery of the drug to the lungs.

Fertility

There is no data on the effect of the drug on fertility in humans. The drug does not have a negative effect on the fertility of animals.

Pregnancy and lactation

The use of the drug during pregnancy and lactation is justified only if the expected benefit to the mother outweighs the risk to the fetus/infant. Salbutamol is likely excreted in breast milk.

In some studies, polydactyly and cleft palate were identified in children when mothers took drugs during pregnancy, including salbutamol (an unambiguous causal relationship between their occurrence and the use of the drug has not been established), and therefore the risk is estimated at 2-3%. Experimental studies revealed the presence of a teratogenic effect of salbutamol: in mice with subcutaneous administration (doses 11.5-115 times higher than the maximum recommended in humans for inhalation administration), the development of a “cleft palate” was noted; in rabbits when administered orally (doses 2315 times higher than the maximum for inhalation administration) - non-fusion of the skull bones.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

No data available.

Overdose

Symptoms: Most symptoms of salbutamol overdose are transient adverse reactions of beta-agonists.

In case of overdose, hypokalemia may develop, and therefore monitoring of potassium levels in the blood serum is necessary.

When using high therapeutic doses and overdose with short-acting beta-agonists, the development of lactic acidosis was detected.

Treatment: the use of large doses of salbutamol can cause hypokalemia, therefore, if overdose is suspected, serum potassium levels should be monitored. Monitoring of lactate levels and the subsequent development of metabolic acidosis is necessary (especially in the presence or worsening of tachypnea despite the elimination of bronchospasm).

Release form and packaging

Aerosol for inhalation, dosed, 100 mcg/dose, 200 doses.

200 doses are placed in an aluminum container equipped with a dosing valve, a spray nozzle and a protective cap. 1 cylinder, along with instructions for medical use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 30 ºС.

Protect from light and hypothermia.

Keep out of the reach of children!

Shelf life

Do not use after expiration date.

Conditions for dispensing from pharmacies

By prescription

Manufacturer/Packager

Registration Certificate Holder

Glaxo Wellcome Production, France

23, rue Lavoisier, 27091 EVREUX Cedex 9

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

Representative office of GlaxoSmithKline Export Ltd in Kazakhstan

050059, Almaty, Furmanov st., 273

Phone number: +7 701 9908566, +7 727 258 28 92, +7 727 259 09 96

Fax number: + 7 727 258 28 90

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Ventolin helps suppress bronchial reactivity and stimulate the elimination of cough, or prevent bronchospasm. The product also contains additional components that help the main active substance have a more active effect on the body. Ventolin for inhalation increases vital capacity (vital capacity of the lungs), normalizes mucus production, and increases mucociliary clearance.

Salbutamol, which is part of the drug, is a selective Beta-2 adrenergic stimulant.

Ventolin is available in two forms. Forms of release of the drug:

• Ventolin Nebulas - nebulas contain a solution for inhalation with a nebulizer. Nebulas with a volume of 2.5 ml (mg) of 10, 20, 40 pieces.
• Ventolin aerosol is an inhalation aerosol in a spray can. One cylinder contains 200 techniques.

Indications for use

The drug is used to expand the lumen of the airways. This may be necessary for diseases that are accompanied by broncho- or laryngospasm.

The use of Ventolin is indicated for the following diseases:

• bronchial asthma;
• COPD;
• acute bronchitis accompanied by obstruction;
• laryngitis;
• obsessive dry cough;
• inflammation of the paranasal sinuses (sinusitis);
• pneumonia;
• emphysema of pulmonary tissue;
• chronic bronchitis.

Ventolin in nebulas for inhalation is used for bronchial asthma in several cases. The first is to relieve acute attacks of the disease. The second is to prevent deterioration of the condition. This is done before possible contact with allergens and other provoking factors or physical activity. The drug is also used to treat the disease during an exacerbation in combination with other medications. In addition, the instructions for use indicate that the drug is often prescribed by specialists as basic therapy for bronchial asthma.

Directions for use and doses

The correct concentration of the active substance is important to achieve the desired result. It should also be calculated in order to prevent the development of side effects.

The dosage is selected depending on the disease and age (it differs for children and adults) of the patient. The specialist must also take into account the severity of the disease and the severity of clinical manifestations.

When taking the drug in doses that exceed the maximum permissible concentration, overdose symptoms are possible. These include nausea, hypotension, vomiting, and increased heart rate. Hallucinations and convulsions are very rare. To eliminate the manifestations of overdose, cardioselective Beta-blockers are used.

Adults and children over 12 years old

Ventolin can be used either diluted or undiluted. It all depends on the patient’s indications and the severity of the clinical manifestations of the disease. But the decision about the concentration of the drug cannot be made independently. This must be entrusted to an experienced specialist.

Adult patients and children over 12 years of age are most often prescribed to take the drug in its pure, undiluted form. The product in an amount of 2 ml is poured into the nebulizer. The inhalation procedure lasts until an aerosol is formed.

If the use of Ventolin is necessary in diluted form, then the required amount of solution components is placed in an inhalation device and inhaled until the end of the formation of aerosol particles. The required ratio of drug and solvent should be calculated by the attending physician, who is familiar with the course of the disease and the patient’s medical history.

Children from 2 to 12 years old

A child under twelve years of age is not allowed to prescribe the medicine in its pure form. In addition, the use of the drug in childhood is permissible for a short time. In this case, it is necessary to take into account the age of the child and the severity of bronchospasm. The risk of developing undesirable consequences and the presence of concomitant ailments are taken into account.

To prevent attacks in children, the drug is administered in the form of an aerosol at a dose of 200 mcg 15 minutes before possible contact with a provoking factor (stress or allergen). As the main therapy for children, which is indicated for a long period of time, the medicine is prescribed in an amount of 100 mcg 4 times a day.

To increase the effectiveness of the procedure, you can use other inhalation devices - spacers. They can be used by patients who have difficulty coordinating movements while using a regular inhaler.

Instructions for use of the solution for inhalation

Inhalations with Ventolin must be used correctly. The success of therapy depends on this. Before use, you should definitely consult a specialist. He will be able to select a dose that will be suitable for the patient. The instructions for using the product in nebulas state that to use the medicine you need a nebulizer with a special mask and an endotracheal tube.

Ventolin in nebulas is available in the form of a solution for inhalation. It is inhaled using a nebulizer until aerosol formation stops. Typically, the duration of a session with a diluted mixture is approximately 10 minutes. If the concentration of the drug has not been changed, then inhalation can last up to 5 minutes.

The room in which the product is inhaled must be well ventilated. The patient must be under the supervision of a doctor during the procedure.

When using the Ventolin Evohale aerosol inhaler, it should be checked for serviceability and shaken before use. Position of the device: the bottom is directed upward, the thumb is placed under the mouthpiece on the base, and the inhaler is held with the index finger.

During inhalation, the patient takes a slow and deep breath while pressing on the bottom, while tightly wrapping his lips around the mouthpiece. Then the breath is held for a couple of seconds.

The next dose of medication, if necessary, can be taken after 30 seconds.

Contraindications

Ventolin, like any other medicine, has a number of conditions in which the use of the drug is limited. Absolute contraindications include intolerance or hypersensitivity to any of the components. In addition, the use of the drug is unacceptable during breastfeeding and during pregnancy there is a risk of premature birth or miscarriage. For the treatment of children under one year of age, the use of Ventolin is contraindicated.

Relative contraindications to the use of an inhaler with medication are the following diseases:

• inflammatory process in the heart muscle (myocarditis);
• glaucoma;
• IHD (coronary heart disease);
• diabetes mellitus, especially in the decompensation phase;
• heart disease;
• epilepsy;
• renal failure;
• arrhythmia type tachycardia;
• aortic stenosis;
• liver failure;
• thyrotoxicosis;
• pheochromocytoma;
• chronic heart failure;
• hypertension.

In these conditions, the use of Ventolin in the form of an inhalation solution is possible. But this must be done carefully and under the constant supervision of a specialist in order to avoid complications or aggravation of the pathological process.

Side effects

The use of the drug sometimes causes a number of undesirable effects. Among them are dysfunctions of the cardiovascular, nervous, respiratory and digestive systems.

The most common disorders that occur are:

• tremor;
• headache;
• increase in heart rate.

Paradoxical bronchospasm develops slightly less frequently. In addition, the following disorders may appear:

• angioedema;
• hives;
• decreased blood pressure (hypotension);
• increased potassium levels;
• bronchial hyperactivity;
• arrhythmia (atrial fibrillation, supraventricular, extrasystole);
• increase in the lumen of peripheral vessels;
• convulsions;
• irritation of the mucous membranes of the mouth and throat.

Rarely does a disorder of the cardiovascular system such as atrial fibrillation develop. Sometimes patients complain of disorders of the oral organs and connective tissue. When Ventolin is used in inhalation using a nebulizer, metabolic disorders may be observed (due to the effect on insulin secretion and glycogenolysis), and it has a lipolytic effect. With prolonged use, keto- and lactic acidosis may occur.

How to dilute Ventolin for inhalation

If long-term use of the drug is necessary, solutions of the drug must be used. To do this, the contents of the Ventolin ampoule are diluted with saline solution. The ratio of the ingredients of the mixture for each patient must be selected individually.

For patients over twelve years of age, the drug is most often diluted in a ratio of 0.5-1 ml per 2 ml of saline. The mixture with Ventolin must be sterile. Up to 12 years of age, dilute 0.5 ml or 2.5 mg of Ventolin in 2.5 ml of solvent.

If the case is severe, then it is permissible for the child to increase the dose to 1 ml and dilute it in 100 mg of saline solution. Inhalation is carried out using a nebulizer at a rate of up to 2 mg/hour.

How to inhale with Ventolin

Before carrying out the procedure, the undiluted mixture or ready-made solution must be heated to a temperature comfortable for inhalation. For patients over twelve years of age, two injections of the mixture are enough to eliminate an attack of suffocation. To prevent worsening of the condition due to possible exposure to a predisposing factor, one inhalation of Ventolin is necessary. This should be done 10-15 minutes before contact with the irritant.

Each inhalation session with Ventalin should be carried out in a ventilated room. The duration of the procedure must be discussed with a specialist. Typically, the duration of inhalation of medication vapor is approximately 10 minutes.

Diseases that are accompanied by broncho-obstructive syndrome cause a lot of discomfort to patients. To avoid unpleasant manifestations of illnesses, it is necessary to take special medications. Ventolin is one of the most effective medications among bronchodilators. Its use after consultation with a doctor significantly improves the patient’s condition.

Price

The price of Ventolin is quite affordable.

Price for Ventolin in Russia - Moscow, St. Petersburg and other cities:

• Ventolin Evohaler, aerosol for inhalation 100 mcg/dose, 200 doses - 120-170 rubles;
• Ventolin Nebula solution for inhalation 2.5 mg/2.5 ml, 20 pcs. — 270-320 rubles.

Price for Ventolin in Ukraine:

• Ventolin Evohaler, aerosol for inhalation 100 mcg/dose, 200 doses - 75-85 hryvnia;
• Ventolin Nebula solution for inhalation 2.5 mg/2.5 ml, 20 pcs. — 170-180 hryvnia.

Analogs

Ventolin for inhalation has a fairly low price, but if for some reason you need to find analogues, then drugs containing the same active ingredient are:

• Salbutamol;
• Volmax;
• Sterineb Salamol;
• Nebutamol;
• Saltos;
• Astalin;
• Salben;
• Salamol;
• Aloprol and others.

You can find Ventolin in pharmacies aerosol (Ventolin inhaler). In addition, Ventolin in nebulas is sold in the form solution for inhalation . The medicine can also be found in tablets and in the form syrup .

Pharmacological action

Bronchodilator means.

Pharmacodynamics and pharmacokinetics

The drug is used to prevent bronchospasms . This bronchodilator , or rather - selective beta-2 adrenergic agonist . It increases lung capacity and mucociliary clearance , activates the work ciliated epithelium , improves mucus secretion, expands coronary arteries , reduces potassium content, acts as hyperglycemic And lipolytic agent , influences glycogenolysis and the release of insulin, increases the risk of appearance.

The medicine acts quite quickly, almost 5 minutes after application (maximum - after 30-90 minutes). The duration of the effect is about 5 hours.

10-20% of salbutamol after use ends up in the lower respiratory tract. They are absorbed into the lung tissue and blood, but are not broken down. The remaining amount of the active substance is retained in the inhaler or in the oropharynx, after which it is swallowed and actively broken down as it passes through the liver and is converted into phenolic sulfate .

The degree of binding to plasma proteins is approximately 10%.

Salbutamol entering the blood is broken down within 72 hours in the liver and is excreted mainly in the urine in the form phenolic sulfate or in an unchanged state. A small part is excreted in the feces.

Indications for use

The inhaler and its solution with Ventolin are used for chronic forms, and COPD with reversible airway obstruction.

Contraindications

The medicine cannot be used for chronic heart failure , hypersensitivity to components, children under 18 months, .

Side effects

As a rule, side effects include fingers and anxiety. In addition, the following undesirable reactions are possible:

• hypersensitivity in the form, hypotension , bronchospasm , collapse ;
• hyperactivity;
• paradoxical bronchospasm ;
• muscle cramps;
• hypokalemia ;
• lactic acidosis ;
• strong heartbeat;
• dilatation of peripheral vessels;
• extrasystole ;
• supraventricular ;
• irritation of the mucous membrane of the mouth and pharynx.

Instructions for use of Ventolin (Method and dosage)

The instructions for use of Ventolin warn that the medicine must be used correctly, regardless of the form of release, otherwise the treatment process may go wrong.

In addition, the drug must be taken only after consultation with a doctor.

The instructions for Ventolin for inhalation in the form of an aerosol indicate that to use the drug it is necessary to use nebulizer with a mask and endotracheal tube .

Ventolin Nebula, which is sold in the form of an inhaler solution, is used without dilution. The duration of inhalation is about 10 minutes. The medicine can be diluted with a sterile sodium chloride solution (0.9%). It must be used in well-ventilated rooms, as some of the drug enters the environment.

The instructions for Ventolin Nebula for inhalation recommend a dose of 2.5 mg. If necessary, it can be increased to a maximum of 5 mg. Frequency of use – 3-4 times a day. For adult patients, if necessary, in a hospital setting, the dosage is increased to 40 mg per day.

The inhalation aerosol is designed for approximately 200 uses. It can be used by adult patients and children over 2 years of age after being prescribed by a specialist. For long-term maintenance therapy, adults are usually prescribed 200 mcg up to 4 times a day. To prevent bronchospasms in childhood, 100-200 mcg (1-2 inhalations) is used.

The syrup is prescribed to adult patients, 2 ml 3-4 times a day. If necessary, the dosage can be increased to 4 ml.

Overdose

When using the drug in excess doses, it is possible hypokalemia , tachycardia , nausea, decreased blood pressure, muscle tremors , vomiting, agitation, respiratory alkalosis , headache , hyperglycemia , hypoxemia . In rare cases they appear, tachyarrhythmia , peripheral vasodilation, convulsions, ventricular flutter .

Used for treatment cardioselective beta blockers , but with caution if medical history have seizures bronchospasm .

Interaction

Ventolin for inhalation is not recommended for use in combination with non-selective beta-adrenergic blockers . In patients with this drug also increases the effect of nervous system stimulants and tachycardia .

If you combine an aerosol and an inhalation solution with xanthines , the probability of occurrence increases tachyarrhythmias . WITH Levodopa and inhalation agents increases the risk of developing severe ventricular arrhythmia . Together with anticholinergic medications may increase intraocular pressure. When prescribed with diuretics And GKS rises hypokalemic effect .

Terms of sale

The drug is sold by prescription only.

Storage conditions

The medicine should be kept out of the reach of children and well protected from light. It cannot be frozen or heated; the optimal temperature is no higher than 30 °C.

Best before date

The drug should be stored for no longer than 2 years.

Analogs

Level 4 ATX code matches:

Analogs of Ventolin, as well as Ventolin Nebula and Ventolin Easy Breathing in pharmacies can usually be obtained as follows:

• Ventilor ;
• Nebutamol ;
• Salamol Steri-Neb ;
• Salamol-Eco ;
• Salamol-Eco Easy Breathing ;
• Salbutamol-Inteli ;
• Salbutamol-Neo .

They all have different prices. In many cases, analogues cost less than Ventolin itself.

For children

Inhalations for children can be used for cupping seizures bronchospasm at a dosage of 100-200 mcg (1-2 inhalations). Maintenance therapy with Ventolin – up to 200 mcg 4 times a day (2 inhalations). For prevention, 100-200 mcg is used 10-50 minutes before the provoking factor (1-2 inhalations).

For children, Babyhaler or Volumatic spacers are used.

Clinical effectiveness of this product in children under 18 months when used nebulizer has not been studied.