pharmachologic effect
Bronchodilator – selective beta2-adrenergic agonist.
A bronchodilator, in therapeutic doses, has a pronounced stimulating effect on beta2-adrenergic receptors of the bronchi, blood vessels and myometrium. It has virtually no effect on beta1-adrenergic receptors of the heart.
It has a pronounced bronchodilator effect, preventing or stopping bronchospasm, reduces resistance in the respiratory tract, and increases the vital capacity of the lungs. Increases mucociliary clearance (in chronic bronchitis up to 36%), stimulates mucus secretion, activates the functions of the ciliated epithelium. May lead to a decrease in the number of beta-adrenergic receptors. It has a number of metabolic effects: it reduces the concentration of potassium ions in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, and increases the risk of developing acidosis.
In recommended therapeutic doses, it does not have a negative effect on the cardiovascular system and does not cause an increase in blood pressure. To a lesser extent, compared with drugs of this group, it has a positive chrono- and inotropic effect. Causes dilation of the coronary arteries. After using inhalation forms, the action develops quickly, the onset of the effect is after 5 minutes, the maximum is after 30-90 minutes (75% of the maximum effect is achieved within 5 minutes), the duration is 3-6 hours.
Salbutamol-native 1mg/1ml 2.5ml 10 pcs. solution for inhalation
pharmachologic effect
Beta-adrenergic agonist with a predominant effect on β2-adrenergic receptors (localized, in particular, in the bronchi, myometrium, blood vessels). Prevents and relieves bronchospasm; reduces resistance in the respiratory tract, increases the vital capacity of the lungs. Prevents the release of histamine, a slow-reacting substance from mast cells and neutrophil chemotaxis factors. Compared to other drugs in this group, it has a less pronounced positive chrono- and inotropic effect on the myocardium. Causes expansion of the coronary arteries, practically does not reduce blood pressure. It has a tocolytic effect, reducing the tone and contractile activity of the myometrium.
Composition and release form Salbutamol-native 1 mg/1 ml 2.5 ml 10 pcs. solution for inhalation
Solution for inhalation - 1 ml:
- Active ingredients: salbutamol (in the form of sulfate) 1.2 mg, which corresponds to the content of salbutamol 1 mg;
- Excipients: sodium chloride - 9 mg, sulfuric acid solution 0.05M - up to pH 3.0-5.0, water for injection - up to 1 ml.
2.5 ml - ampoules (10) - bags (1) - cardboard packs.
Description of the dosage form
Solution for inhalation in the form of a clear, colorless to slightly brownish or yellowish-brown liquid.
Directions for use and doses
Orally as a bronchodilator for adults and children over 12 years of age - 2-4 mg 3-4 times a day, if necessary, the dose can be increased to 8 mg 4 times a day. Children aged 6-12 years - 2 mg 3-4 times a day; children 2-6 years old - 1-2 mg 3 times a day.
When administered by inhalation, the dose depends on the dosage form used, the frequency of use depends on the indications and the clinical situation.
As a tocolytic agent, it is administered intravenously in a dose of 1-2 mg.
Pharmacodynamics
Bronchodilator. Salbutamol is a beta2-adrenergic receptor stimulant. The bronchodilator effect appears already 1-3 minutes after inhalation of the drug and significantly increases by 10 minutes, the maximum effect is achieved by 15-20 minutes, the duration of action is 4-5 hours.
In therapeutic doses, it also has a pronounced stimulating effect on beta2-adrenergic receptors of blood vessels and myometrium. It has virtually no effect on beta1-adrenergic receptors of the heart. Inhibits the release of inflammatory mediators and basophils from mast cells, in particular, anti-IgE-induced release of histamine, leukotrienes and prostaglandin D2, eliminates antigen-dependent suppression of mucociliary transport and the release of neutrophil chemotaxis factor. Suppresses the early and late phases of the allergic reaction. It has a pronounced bronchodilator effect, preventing or stopping bronchospasms, reduces resistance in the respiratory tract, and increases the vital capacity of the lungs. It has a positive effect on mucociliary clearance, stimulates mucus secretion, and activates the functions of the ciliated epithelium. Prevents the development of allergen-induced bronchospasm. May cause desensitization and a decrease in the number of beta-adrenergic receptors, incl. on lymphocytes. It has a number of metabolic effects: it reduces the potassium content in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic and lipolytic effect, and increases the risk of developing acidosis. In recommended therapeutic doses, it does not have a negative effect on the cardiovascular system and does not cause an increase in blood pressure. To a lesser extent, compared with drugs of this group, it has a positive chrono- and inotropic effect. Causes dilation of the coronary arteries. It has a tocolytic effect: it reduces the tone and contractile activity of the myometrium.
Pharmacokinetics
When using an aerosol, rapid absorption of salbutamol into the blood is observed; however, its plasma concentrations when used at recommended doses are very low or do not reach the detection limit.
After oral administration, salbutamol is well absorbed from the gastrointestinal tract. Plasma protein binding is 10%. Metabolized on first pass through the liver and possibly in the intestinal wall; the main metabolite is an inactive sulfate conjugate. Salbutamol is not metabolized in the lungs, so its ultimate metabolism and elimination after inhalation depends on the route of administration, which determines the ratio between inhaled and inadvertently ingested salbutamol.
T1/2 from blood plasma is 2-7 hours. Salbutamol is quickly excreted in the urine in the form of metabolites and unchanged substance; excreted in small quantities in feces.
Indications for use Salbutamol-native 1 mg/1 ml 2.5 ml 10 pcs. solution for inhalation
Prevention and relief of bronchospasm in all forms of bronchial asthma. Reversible airway obstruction in chronic bronchitis and emphysema, broncho-obstructive syndrome in children.
Threatened premature birth with contractile activity of the uterus; childbirth before 37-38 weeks of pregnancy; isthmic-cervical insufficiency, a decrease in fetal heart rate depending on uterine contractions during periods of cervical dilatation and expulsion. For preventive purposes during operations on the pregnant uterus (application of a circular suture in case of insufficiency of the internal os of the uterus).
Contraindications
Threat of miscarriage in the first and second trimesters of pregnancy, premature placental abruption, bleeding or toxicosis in the third trimester of pregnancy; children under 2 years of age; hypersensitivity to salbutamol.
Application Salbutamol-native 1 mg/1 ml 2.5 ml 10 pcs. solution for inhalation during pregnancy and lactation
Salbutamol is contraindicated in cases of threatened miscarriage in the first and second trimesters of pregnancy, premature placental abruption, bleeding or toxicosis in the third trimester of pregnancy.
If it is necessary to use salbutamol during pregnancy, the expected benefits of treatment for the mother should be weighed against the potential risk to the fetus. Currently, there is insufficient data on the safety of the use of salbutamol in early pregnancy. Salbutamol is excreted in breast milk, so if it is necessary to use it during lactation, the expected benefit of treatment for the mother and the possible risk for the child should also be assessed.
Use in children
Contraindicated in children under 2 years of age.
special instructions
Use with caution for tachyarrhythmias and other heart rhythm disorders, arterial hypertension, myocarditis, heart defects, aortic stenosis, diabetes mellitus, thyrotoxicosis, glaucoma, acute heart failure (subject to careful medical supervision).
Increasing the dose or frequency of taking salbutamol should be done under the supervision of a physician. Reducing the interval is possible only in exceptional cases and must be strictly justified.
When using salbutamol, there is a risk of developing hypokalemia, therefore, during treatment in patients with severe bronchial asthma, the level of potassium in the blood should be monitored. The risk of hypokalemia increases with hypoxia.
Overdose
Symptoms: tachycardia, cardiac arrhythmia, peripheral vasodilation, decreased blood pressure, hypoxemia, hypokalemia, hyperglycemia, muscle tremors, headache, agitation.
Treatment. Discontinuation of the drug and symptomatic therapy (prescribing selective beta-blockers requires caution in patients with bronchial asthma due to the risk of developing severe bronchospasm).
Side effects Salbutamol-native 1 mg/1 ml 2.5 ml 10 pcs. solution for inhalation
From the cardiovascular system: transient dilatation of peripheral vessels, moderate tachycardia.
From the central nervous system: headache, dizziness, nausea, vomiting.
Metabolism: hypokalemia.
Allergic reactions: in isolated cases - angioedema, allergic reactions in the form of skin rash, urticaria, arterial hypotension, collapse.
Other: tremor of the hands, internal trembling, tension; rarely - paradoxical bronchospasm, muscle cramps.
Drug interactions
With simultaneous use of salbutamol with non-cardioselective beta-blockers, mutual suppression of therapeutic effects is possible; with theophylline - the risk of developing tachycardia and arrhythmia, in particular supraventricular extrasystole, increases.
With the simultaneous use of salbutamol and xanthine derivatives, corticosteroids or diuretics, the risk of developing hypokalemia increases.
Directions for use and doses
The drug Salbutamol-SOLOpharm is used by inhalation using inhalers-nebulizers.
Adults, including the elderly, and children over 18 months: the usual single dose is 2.5 mg, when used 3-4 times a day by inhalation through a nebulizer.
If necessary, the dose can be increased to 5 mg 3-4 times a day.
For the treatment of severe airway obstruction in adult patients, higher doses can be used - up to 40 mg / day under strict medical supervision in a hospital setting.
Salbutamol 100 mcg/dose 200 doses 10 ml aerosol doses.
APPROVED by the Order of the Chairman of the Committee for Control of Medical and Pharmaceutical Activities of the Ministry of Health and Social Development of the Republic of Kazakhstan dated "____" ___________20, No. _________ Instructions for the medical use of the drug Salbutamol Trade name Salbutamol International nonproprietary name Salbutamol Dosage form Aerosol for inhalation, dosed, 100 mcg/ dose, 200 doses Composition One dose contains the 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 respiratory diseases. Inhalation sympathomimetics. Beta2-agonists are selective. Salbutamol. ATX code R03AC02 Pharmacological properties Pharmacokinetics 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 pulmonary vessels, but is not metabolized here. The remaining part remains in the delivery device or settles in the oropharynx with further ingestion of the drug. Maximum plasma concentrations are reached after 2-4 hours. Plasma protein binding is 10%. 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. T½ 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. Salbutamol does not cross the blood-brain barrier. Pharmacodynamics Salbutamol is a selective β2-adrenergic receptor agonist. In therapeutic doses, it stimulates β2-adrenergic receptors of the bronchial muscles, providing a bronchodilator effect. Salbutamol has a short duration of action (4 to 6 hours) and a rapid onset of action (about 5 minutes from the moment of application). In recommended therapeutic doses, it does not have a negative effect on the cardiovascular system and does not cause an increase in blood pressure. 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: relief and prevention of the development of bronchospasm in patients with reversible airway obstruction (asthma, chronic bronchitis, emphysema) - to relieve the symptoms of an attack of bronchial asthma or to prevent them before contact with a known trigger (allergen). Bronchodilators should not be the only or main component of asthma therapy. If a patient with asthma does not respond to salbutamol therapy, inhaled corticosteroids are recommended to achieve and maintain symptom control. Insufficient response to salbutamol therapy may be a signal for urgent medical intervention/therapy. Method of administration and dose Salbutamol in the form of an aerosol is used only for inhalation by inhaling the aerosol through the mouth. An increased need for β2-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 the drug Salbutamol in most patients is 4-6 hours. Persons who have difficulty coordinating inhalation and release of the drug from the inhaler can use the drug Salbutamol using a device in the form of a spacer. 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 children under 4 years of age, Salbutamol is administered through a spacer. Relief of an acute attack of bronchospasm Adults: from 100 mcg to 200 mcg of Salbutamol once. Children: 100 mcg once. If necessary, the dose can be increased to 200 mcg. Prevention of exercise-induced bronchospasm or allergic etiology Adults: 200 mcg before exercise or expected allergen exposure Children: 100 mcg before exercise or expected allergen exposure. If necessary, the dose can be increased to 200 mcg. Long-term maintenance therapy 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 serviceability 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 make sure 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 the inhaler 1. Remove the protective cap from the mouthpiece of the inhaler. 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 your thumb and forefinger, placing your 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 actions indicated in paragraphs 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), infrequently (>1/1,000, <1/100), rarely (>1/10,000, <1/1,000), very rare (<1/10,000). Often - tremor, headache - tachycardia Uncommon - irritation of the mucous membrane of the mouth and pharynx - palpitations - muscle cramps Rarely - hypokalemia (therapy with β2-agonists can lead to severe hypokalemia) - dilation of peripheral vessels Very rarely - hypersensitivity reactions, including urticaria, angioedema, bronchospasm, hypotension, collapse - paradoxical bronchospasm - lactic acidosis (in patients receiving salbutamol by intravenous injection and nebulizer for the treatment of exacerbations of bronchial asthma) - hyperactivity - arrhythmia, including atrial fibrillation, supraventricular tachycardia and extrasystole Providing data on suspected side effects reactions of the drug is a very important point, allowing for continuous monitoring of the risk/benefit ratio of the drug. Health care professionals should provide information about any suspected adverse reactions to the contacts listed at the end of the prescribing information and through the national reporting system. Contraindications - hypersensitivity to any component of the drug - premature labor - threatened abortion Forms of salbutamol not intended for intravenous administration should not be used to terminate premature labor and threatened miscarriage. Drug interactions It is not recommended to simultaneously use the drug Salbutamol and non-selective beta-adrenergic receptor blockers, such as propranolol. Salbutamol is not contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs). Special instructions For children under 4 years of age, Salbutamol is administered through a spacer. 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, heart failure, myocardial ischemia, tachyarrhythmia, hypertrophic cardiomyopathy. Patients with cardiovascular diseases, including a history of, for example, coronary heart disease, arrhythmia or severe heart failure, when prescribed salbutamol, should be warned that they must consult a doctor in the event of chest pain or other symptoms of exacerbation of cardiovascular disease. vascular disease. Symptoms such as shortness of breath and chest pain should be carefully assessed as they may be due to both cardiovascular and bronchopulmonary dysfunction. Therapy with β2-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, glucocorticosteroids, diuretics, as well as 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. You should immediately stop treatment with this form of Salbutamol, and, if necessary, prescribe other fast-acting bronchodilators for further use. If the effect of the usual dose of Salbutamol 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. Salbutamol should be used with caution in patients who have already taken high doses of other sympathomimetics. Like other beta-adrenergic agonists, salbutamol can cause reversible metabolic changes, such as an increase in blood glucose concentrations. Patients with diabetes may develop decompensation, and in some cases, the development of ketoacidosis. Concomitant use of glucocorticosteroids may enhance this effect. When used intravenously, as well as when using a nebulizer solution of short-acting beta-agonists, very rare cases of lactic acidosis associated with high therapeutic doses in patients with exacerbation of bronchial asthma have been described. Increased lactate levels lead to shortness of breath and compensatory hyperventilation, which can be misinterpreted as symptoms of improperly treated asthma. This may lead to erroneous increases in doses of short-acting beta-agonists, so monitoring for increased serum lactate and therefore metabolic acidosis is recommended. 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 (a clear causal relationship between their occurrence and drug use 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 Considering the possible side effects, care must be taken when driving a vehicle and potentially dangerous mechanisms. 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: 2 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer Glaxo Wellcome Production, France Zone Idustrelle n`2, 23 rue Lavoisier, 27000 EVREUX Packer Glaxo Wellcome Production, France Zone Idustrelle n`2, 23 rue Lavoisier, 27000 EVREUX Registration certificate holder Laboratories GlaxoSmithKline, France 100 , rout de Versailles 78163 MARLY-LE-ROI Cedex Address of the organization that accepts claims from consumers on the quality of products (products) in the territory of the Republic of Kazakhstan Representative office of GlaxoSmithKline Export Ltd. in Kazakhstan 050059, Almaty, Furmanov St., 273 Telephone number, Number Fax: + Email address
special instructions
Bronchodilators should not be the only or main component of the treatment of unstable or severe bronchial asthma.
Patients taking Salbutamol-SOLOpharm at home should be warned that if the effect of the usual dose becomes less effective or shorter lasting, they should not independently increase the dose or frequency of use of the drug, but should immediately consult a doctor.
When using the drug, avoid contact of the solution with the eyes.
As with other inhalation therapies, cases of paradoxical bronchospasm may occur. In this case, you must immediately stop taking the drug and prescribe an alternative treatment. Solutions that do not correspond to a neutral pH level may cause paradoxical bronchospasm in some patients.
Salbutamol may cause reversible metabolic changes, such as an increase in blood glucose concentrations. In patients with diabetes mellitus, decompensation may develop; in some cases, the development of ketoacidosis has been reported. Concomitant use of glucocorticosteroids may enhance this effect.
Rare cases of lactic acidosis have been reported associated with the use of high doses of short-acting beta2-agonists via nebulizer, mainly in patients with exacerbation of bronchial asthma. An increase in lactate concentration can lead to shortness of breath and compensatory hyperventilation, which may be misinterpreted as signs of unsuccessful treatment of bronchial asthma and lead to an unjustified increase in the use of short-acting beta2-agonists. Therefore, it is recommended to monitor the concentration of lactate in the blood serum, as well as monitor the possible subsequent development of metabolic acidosis.
Salbutamol should be prescribed with caution to patients with thyrotoxicosis.
Treatment with beta2-agonists can lead to significant hypokalemia. Particular caution should be exercised in cases of severe bronchial asthma, since the occurrence of hypokalemia can be promoted by concomitant treatment with xanthine derivatives, glucocorticosteroids, diuretics, as well as hypoxia. In such situations, it is recommended to monitor serum potassium levels. The drug Salbutamol-SOLOpharm should not be used to prevent premature birth or if there is a threat of miscarriage.
Ventolin nebula 1 mg/ml n20 solution for inhalation
Latin name
Ventolin
Release form
Solution for inhalation.
Package
Ampoules 20 doses.
pharmachologic effect
Salbutamol is a selective b2-adrenergic receptor agonist. In therapeutic doses, it acts on b2-adrenergic receptors of bronchial smooth muscle, having little or no effect on b1-adrenergic receptors of the myocardium.
Indications
Bronchial asthma
— relief of attacks of bronchial asthma, including exacerbation of severe bronchial asthma;
- prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical activity;
— use as one of the components in long-term maintenance therapy of bronchial asthma.
Chronic obstructive pulmonary disease (COPD), accompanied by reversible airway obstruction, including chronic bronchitis and emphysema.
Contraindications
— Hypersensitivity to any component of the drug.
— Management of premature birth.
- Threatened abortion.
— Children up to 2 years old.
Use during pregnancy and breastfeeding
During pregnancy and lactation, the drug is prescribed only in cases where the expected benefit to the mother exceeds any possible risk to the fetus.
Salbutamol is likely to pass into breast milk, so it is not recommended for nursing women to take it unless the expected benefit to the mother outweighs any potential risk to the baby. It is not known whether salbutamol present in breast milk has any negative effects on a newborn baby.
special instructions
Patients should be instructed on the correct use of the Ventolin inhaler.
Bronchodilators should not be the only or main component of the treatment of unstable or severe bronchial asthma.
If the effect of the usual dose of Ventolin becomes less effective or less durable (the effect of the drug should last at least 3 hours), the patient should consult a doctor.
An increased need for the use of inhaled β2-adrenergic agonists with a short duration of action to control the symptoms of bronchial asthma indicates an exacerbation of the disease. 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.
Very high doses of salbutamol can lead to the development of adverse reactions, so only a doctor can decide on increasing the dose or frequency of use of the drug. Patients using Ventolin Nebula at home should be warned that if the effect of the usual dose becomes less effective or less durable, they should not independently increase the dose or frequency of administration of the drug, but should immediately consult a doctor.
Ventolin Nebula should be used with caution in patients who have already taken high doses of other sympathomimetics.
Salbutamol should be used with caution in patients with thyrotoxicosis.
Therapy with β2-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, glucocorticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor the level of potassium in the blood serum.
Compound
1 dose contains 100 mcg of salbutamol (in the form of salbutamol sulfate).
Directions for use and doses
Ventolin dosed aerosol is intended for inhalation administration only.
Only a doctor can decide whether to increase the dose or frequency of use of the drug.
It is not recommended to use the Ventolin inhaler more than 4 times a day. The need for frequent use of maximum doses of Ventolin or a sudden increase in dose indicates a worsening of the disease.
Adults (including elderly patients)
Relieving an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).
Prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical activity: the recommended dose is 200 mcg (2 inhalations) 10-15 minutes before exposure to the provoking factor.
Long-term maintenance therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day.
Ventolin can be administered through the Volumatic spacer.
Children
Relieving an attack of bronchospasm: the recommended dose is 100-200 mcg (1-2 inhalations).
Prevention of bronchospasm attacks associated with exposure to an allergen or caused by physical activity: the recommended dose is 100-200 mcg (1-2 inhalations) 10-15 minutes before exposure to the provoking factor.
Long-term maintenance therapy: the recommended dose is up to 200 mcg (2 inhalations) 4 times a day.
Ventolin can be administered through the Babyhaler or Volumatic spacer.
Side effects
Salbutamol may cause mild tremor of skeletal muscles, which is usually most pronounced in the arms and is a characteristic side effect of all β2-adrenergic agonists. Occasionally, patients experience headache, peripheral vasodilatation, and a slight compensatory increase in heart rate. Very rarely, hypersensitivity reactions develop (including angioedema, urticaria, bronchospasm, hypotension and collapse), muscle cramps, and tachycardia.
Inhaled drugs can cause paradoxical bronchospasm. Paradoxical bronchospasm must be immediately relieved with another dosage form of salbutamol or another fast-acting inhaled bronchodilator. You should immediately stop using the Ventolin inhaler, assess the patient's condition, conduct the necessary examination and prescribe appropriate therapy.
Inhaled medications may cause irritation to the mucous membranes of the mouth and throat.
Therapy with beta2-adrenergic agonists sometimes causes hypokalemia, which can pose a serious danger to the patient.
Like other beta2-adrenergic agonists, salbutamol may occasionally cause mental agitation and increased motor activity in children.
In patients with a predisposition to the development of arrhythmias, salbutamol can cause cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole.
Drug interactions
It is not recommended to use salbutamol and non-selective beta-adrenergic receptor blockers simultaneously, such as propranolol.
Salbutamol is not contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs).
Overdose
In case of overdose of salbutamol, the best antidotes are cardioselective b-blockers. However, beta-adrenergic blockers should be used with caution in patients with a history of bronchospasm attacks. The use of large doses of salbutamol can cause hypokalemia, therefore, if overdose is suspected, serum potassium levels should be monitored.
Storage conditions
Store at temperatures below 30°C.
Best before date
2 years.
