Salamol eco instructions for use, contraindications, side effects, reviews. Salamol eco easy breathing Method of administration and dosage
Bronchodilator - beta 2-adrenergic agonist
Active substance
Release form, composition and packaging
Aerosol for inhalation, dosed, activated by inhalation, in the form of a suspension which, when sprayed onto glass, forms a stain white.
Excipients: hydrofluoroalkane (HFA-134a) - 26.46 mg, ethanol 96% - 3.42 mg.
200 doses - aluminum cylinders (1) - aerosol inhalers activated by inhalation ( Easy breath) (1) - cardboard packs.
pharmachologic effect
Bronchodilator, selective β 2 -adrenergic receptor agonist. In therapeutic doses, the drug acts on β 2 -adrenergic receptors of the smooth muscles of the bronchi, providing a pronounced bronchodilator effect, prevents and relieves bronchospasm, and increases the vital capacity of the lungs. Prevents the release of histamine, a slow-reacting substance from mast cells and neutrophil chemotaxis factors.
Causes a slight positive chrono- and inotropic effect on the myocardium, expands coronary arteries, practically does not reduce blood pressure.
Has a tocolytic effect: reduces tone and contractile activity myometrium. The effect of the drug begins 5 minutes after inhalation administration and continues for 4-6 hours. It has a number of metabolic effects: it reduces the content of potassium ions in, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of developing acidosis.
Pharmacokinetics
Absorption, distribution, metabolism
After inhalation administration, up to 21% of the dose enters the respiratory tract. The rest remains in the device or settles in the oropharynx and is then swallowed.
Part of the dose that enters the respiratory tract is absorbed by lung tissue without being metabolized in the lungs and enters the bloodstream. When it enters the systemic circulation, salbutamol is partially metabolized in the liver and is excreted primarily by the kidneys unchanged or in the form of phenolic sulfate.
Part of the dose received in the gastrointestinal tract is absorbed and undergoes intensive metabolism during the “first pass” through the liver, turning into phenolic sulfate.
The binding of salbutamol to plasma proteins is 10 %. C max in blood plasma - 30 ng/ml. T 1/2 - 3.7-5 hours.
Removal
It is excreted primarily by the kidneys unchanged and in the form of a conjugate. Most of the dose of salbutamol administered IV, orally, or inhaled is eliminated within 72 hours.
Indications
Prevention and relief of bronchospasm:
- for bronchial asthma;
— for chronic obstructive pulmonary disease;
- at chronic bronchitis;
- with emphysema.
Contraindications
— childhood up to 2 years;
- hypersensitivity to the components of the drug.
WITH caution the drug is prescribed for chronic heart failure, hyperthyroidism, arterial hypertension, pheochromocytoma.
Dosage
Adults and children over 12 years old For relief of bronchospasm attacks Salamol Eco Easy Breathing is prescribed at 100-200 mcg (1-2 inhalation doses). For asthma control mild degree gravity- 1-2 doses 1-4 times/day; at medium degree severity of the disease- in the same dose in combination with other anti-asthmatic drugs. For asthma prevention physical effort the drug is used 20-30 minutes before the load, 100-200 mcg (1-2 inhalation doses) per dose.
Children aged 2 to 12 years during development attack bronchial asthma , and also for prevention attacks of bronchial asthma associated with exposure to or caused by physical activity , the recommended dose is 100-200 mcg (1 or 2 inhalations).
The daily dose of Salamol Eco Easy Breathing should not exceed 800 mcg (8 inhalations).
Instructions for using the inhaler
Shake the inhaler several times before use. Then, holding the inhaler vertical position, open the lid. Take a deep breath. Cover the mouthpiece tightly with your lips. Make sure that your hand does not block the ventilation openings on the top of the inhaler and that the inhaler is in an upright position. Take a slow maximum breath through the mouthpiece, hold your breath for 10 seconds or as long as is comfortable. Then you need to remove the inhaler from your mouth and exhale slowly. After use, continue to hold the inhaler in an upright position and close the lid. If you need to do more than one inhalation, close the lid and, after waiting at least one minute, repeat the inhalation process.
Cleaning the inhaler
The top part of the inhaler must be unscrewed and the metal canister removed. Then rinse the lower part of the inhaler in warm water and dry. Then insert the can into place. Close the lid and screw it on top part inhaler to its body. The top of the inhaler is not washed. If the inhaler does not work properly, unscrew the top of the inhaler and manually press on the canister.
Side effects
From the outside nervous system: tremor of the hands (a typical side effect for all beta 2-adrenergic agonists), headache, dizziness, increased excitability, anxiety, sleep disturbance, insomnia. The drug may cause agitation and increased motor activity in children.
From the outside of cardio-vascular system: dilatation of peripheral vessels (facial skin hyperemia), slight compensatory increase in heart rate, increase in blood pressure. Arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole) may occur.
Allergic reactions: angioedema, urticaria, erythema, nasal congestion, bronchospasm, arterial hypotension, collapse.
From the outside digestive system: nausea, vomiting, dyspepsia.
Local reactions: irritation of the mucous membrane of the mouth and pharynx (pharyngitis), cough.
From the outside respiratory system : paradoxical bronchospasm.
From the side of metabolism: possible hypokalemia (can pose a serious danger to the patient), reversible hyperglycemia.
Other: muscle cramps.
Overdose
Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, dilatation of peripheral vessels, decreased blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache.
Treatment: discontinuation of the drug, taking cardioselective beta-blockers; If necessary, carry out symptomatic therapy. If overdose is suspected, serum potassium levels should be monitored.
Drug interactions
Theophylline and other xanthines for simultaneous use with salbutamol increase the likelihood of developing tachyarrhythmias; and agents for inhalational anesthesia, levodopa - severe ventricular arrhythmias.
MAO inhibitors and tricyclic antidepressants enhance the effect of salbutamol and can lead to sharp decline HELL.
When used simultaneously, salbutamol enhances the effect medicines with a stimulating effect on the central nervous system, side effect hormones thyroid gland, cardiac glycosides.
When used simultaneously, salbutamol reduces the effectiveness of nitrates.
When used simultaneously with xanthine derivatives, corticosteroids, and diuretics, hypokalemia may increase.
Simultaneous administration with anticholinergic drugs (including inhaled ones) may increase intraocular pressure.
special instructions
In patients with severe or unstable asthma, the use of bronchodilators should not be the main or only method of therapy. The patient must be warned about the need to consult a doctor if the use of the drug Salamol Eco Light Breathing in a standard dose becomes less effective or less durable (the effect of the drug should last at least 3 hours).
Frequent use of salbutamol can lead to increased bronchospasm and various complications (up to sudden fatal outcome), and therefore it is necessary to take breaks of several hours between successive inhalations.
An increased need for the use of inhaled beta 2 -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 reviewed and the issue of prescribing or increasing the dose of inhaled or systemic corticosteroids should be decided.
Therapy with beta 2-agonists may 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 necessary to monitor the level of potassium in the blood serum.
The can of Salamol Eco Easy Breathing should not be pierced, disassembled or thrown into fire, even if it is empty.
Like most other inhalation products in aerosol packages, Salamol Eco Easy Breathing may be less effective if low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes.
Pregnancy and lactation
The drug is contraindicated for use during pregnancy. During lactation ( breastfeeding) are prescribed only in cases where the expected benefit to the mother outweighs any potential risk to the child.
Use in childhood
Contraindication: children under 2 years of age.
For impaired renal function
The drug is contraindicated in renal failure.
For liver dysfunction
The drug is contraindicated in liver failure.
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, protected from direct sun rays place, at a temperature not exceeding 25°C; do not freeze. Shelf life - 3 years.
Beta-adrenergic agonist with a predominant effect on 2-adrenergic receptors.
Drug: SALAMOL ECO
Active substance of the drug:
salbutamol
ATX coding: R03AC02
CFG: Bronchodilator - beta2-adrenergic agonist
Registration number: P No. 013290/01
Registration date: 12/29/06
Owner reg. credential: NORTON WATERFORD (Ireland)
Salamol eco release form, drug packaging and composition.
A dosed aerosol for inhalation, when sprayed onto glass it forms a white spot.
1 dose
salbutamol (as sulfate)
100 mcg
Excipients: ethanol, hydrofluoroalkane (HFA-134a).
200 doses - aluminum cylinders with an inhalation device (1) - plastic cases (1) - cardboard packs.
DESCRIPTION OF THE ACTIVE SUBSTANCE.
All information provided is provided for information only about the drug; you should consult your doctor about the possibility of use.
Pharmacological action Salamol eco
Beta-adrenergic agonist with a predominant effect on 2-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.
Pharmacokinetics of the drug.
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; V small quantities excreted in feces.
Indications for use:
Prevention and relief of bronchospasm in all forms of bronchial asthma. Reversible obstruction respiratory tract for 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 internal pharynx uterus).
Dosage and method of administration of the drug.
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.
Side effects of Salamol eco:
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 as skin rash, urticaria, arterial hypotension, collapse.
Other: tremor of the hands, internal trembling, tension; rarely - paradoxical bronchospasm, muscle cramps.
Contraindications to the drug:
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.
Use 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 salbutamol in early stages pregnancy. Salbutamol is excreted in breast milk, so if it is necessary to use it during lactation, the expected benefits of treatment for the mother and possible risk for a child.
Special instructions for use of Salamol eco.
Use with caution for tachyarrhythmias and other disorders heart rate, 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 only possible in exceptional cases and must be strictly justified.
When using salbutamol there is a risk of developing hypokalemia, therefore during treatment in patients with bronchial asthma severe course The level of potassium in the blood should be monitored. The risk of hypokalemia increases with hypoxia.
Interaction of Salamol eco with other drugs.
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.
Salamol Eco Easy Breathe
Registration number:
P N014097/01-170407Tradename drug: Salamol Eco Easy Breathing.
International nonproprietary name:
Salbutamol.Dosage form:
aerosol for inhalation, dosed, activated by inhalation.Compound:
Each inhaler contains 200 doses of the drug.Active substance
One inhalation dose contains salbutamol sulfate - 124 mcg, equivalent to salbutamol - 100 mcg
Excipients: ethanol, hydrofluoroalkane (HFA-134a).
Description:
Aerosol for inhalation in an aluminum can under pressure, with a release valve and a spray nozzle. There must be no external damage, corrosion or leaks. The contents of the can is a suspension, which, when sprayed onto glass, leaves a white spot. The canister is placed in an inhaler consisting of two parts and a safety cap.
Pharmacotherapeutic group: bronchodilator - selective b-2-adrenergic agonist. ATX code: R03AC02.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Salbutamol is a selective b-2-adrenergic receptor antagonist. In therapeutic doses, it acts on b-2-adrenergic receptors of the smooth muscles of the bronchi, providing a pronounced bronchodilator effect, prevents and relieves bronchospasm, and increases the vital capacity of the lungs. Prevents the release of histamine, a slow-reacting substance from mast cells and neutrophil chemotaxis factors. Causes a slight positive chrono- and inotropic effect on the myocardium, dilation of the coronary arteries, practically does not reduce blood pressure. It has a tocolytic effect: it reduces the tone and contractile activity of the myometrium. The effect of the drug begins 5 minutes after inhalation administration and lasts for 4-6 hours. It has a number of gasbolic effects: it reduces the K+ content in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of developing acidosis.
Pharmacokinetics
After inhalation administration, up to 21% of the dose enters the respiratory tract. The rest is retained in the device or settles in the oropharynx and is then swallowed. Part of the dose that remains in the respiratory tract is absorbed by lung tissue without being metabolized in the lungs and enters the bloodstream. Once in the systemic circulation, it can be metabolized in the liver and excreted primarily by the kidneys unchanged or in the form of phenolic sulfate.
Part of the dose delivered to gastrointestinal tract, is absorbed and undergoes extensive metabolism during the first passage through the liver, turning into phenolic sulfate. The unchanged drug and the conjugate are excreted primarily by the kidneys. Most of a dose of salbutamol administered intravenously, orally, or inhaled is eliminated within 72 hours. The degree of binding of salbutamol to plasma proteins is 10%. The maximum concentration in blood plasma is 30 ng/ml. The half-life is 3.7-5 hours.
INDICATIONS FOR USE
Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, pulmonary emphysema.
CONTRAINDICATIONS
Increased sensitivity to any component of the drug, heart rhythm disturbances ( paroxysmal tachycardia, polytopic ventricular extrasystole), myocarditis, heart defects, aortic stenosis, coronary heart disease, tachyarrhythmia, thyrotoxicosis, decompensated diabetes mellitus, glaucoma, epilepsy, pyloroduodenal narrowing, renal or liver failure, pregnancy, simultaneous administration non-selective beta-blockers, children under 2 years of age.
With caution - chronic heart failure, hyperthyroidism, arterial hypertension, pheochromocytoma.
USE IN PREGNANCY AND LACTATION
Contraindicated during pregnancy. During lactation it is prescribed only in cases where the expected benefit to the mother exceeds any possible risk to the child.
METHOD OF APPLICATION AND DOSES
Adults and children over 12 years old: 100-200 mcg Salamol Eco Easy Breathing (1-2 inhalation doses) to relieve asthma attacks. To control the course of mild asthma - 1-2 doses 1-4 times a day and moderate severity of the disease - in the same dosage in combination with other anti-asthmatic drugs. To prevent asthma from physical exertion - 20-30 minutes before exercise, 1-2 doses per dose.
Children from 2 to 12 years old: in the event of an attack of bronchial asthma, as well as to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical activity, the recommended dose is 100-200 mcg (1 or 2 inhalations).
The daily dose of Salamol Eco Easy Breathing should not exceed 800 mcg (8 inhalations).
SIDE EFFECT
Salamol Eco Easy Breathing may cause finger tremor, which is a typical side effect of all beta-2 adrenergic agonists. There may be headache, dizziness, increased excitability, anxiety, sleep disturbance, insomnia, dilatation of peripheral blood vessels (facial skin hyperemia), a slight compensatory increase in heart rate, increased blood pressure. Hypersensitivity reactions may develop (including angioedema, urticaria, erythema, nasal congestion, bronchospasm, arterial hypotension and collapse); muscle cramps, nausea, vomiting, dyspepsia.
Inhaled drugs can cause paradoxical bronchospasm. Inhaled drugs can cause irritation of the mucous membrane of the mouth and pharynx (pharyngitis), and cough.
Salbutamol therapy may cause hypokalemia, which may pose a serious risk to the patient, and may also be reversible. metabolic disorders, for example, an increase in blood glucose concentration. The drug may cause agitation and increased motor activity in children.
Arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole) may occur.
OVERDOSE
Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, peripheral vasodilation, decreased blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache.
Treatment: drug withdrawal, cardioselective beta-blockers; symptomatic therapy. If overdose is suspected, serum potassium levels should be monitored.
INTERACTIONS WITH OTHER MEDICINES
Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; agents for inhalation anesthesia, levodopa - severe ventricular arrhythmias.
Monoamine oxidase inhibitors and tricyclic antidepressants enhance the effect of salbutamol and can lead to a sharp decrease in blood pressure.
Salbutamol enhances the effect of stimulants of the central nervous system, the side effects of thyroid hormones, cardiac glycosides. Reduces the effectiveness of antihypertensive drugs and nitrates.
Hypokalemia may increase as a result of the simultaneous use of xanthine derivatives, glucocorticosteroids (GCS), and diuretics.
Simultaneous administration with anticholinergic drugs (including inhaled ones) may increase intraocular pressure.
SPECIAL INSTRUCTIONS
In patients with severe or unstable asthma, the use of bronchodilators should not be the main or only method of therapy. If the action usual dose Salamol Eco Light Breathing becomes less effective or shorter lasting (the effect of the drug should last for at least 3 hours), the patient should consult a doctor.
Frequent use of salbutamol can lead to increased bronchospasm, sudden death, and therefore it is necessary to take breaks of several hours between doses of the drug.
An increased need for the use of inhaled b-2-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 reviewed and the issue of prescribing or increasing the dose of inhaled or systemic corticosteroids should be decided.
Therapy with beta-2 adrenergic receptor agonists 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 necessary to monitor the level of potassium in the blood serum. The can of Salamol Eco Easy Breathing cannot be pierced, disassembled or thrown into fire, even if it is empty. Like most other inhalation products in aerosol packages, Salamol Eco Easy Breathing may be less effective at low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes.
PATIENT INSTRUCTIONS FOR OPERATING THE INHALER
Instructions for using the inhaler
Shake the inhaler several times. Then, holding the inhaler upright, open the cap. Take a deep breath. Cover the mouthpiece tightly with your lips. Make sure your hand is not blocking the vents on the top of the inhaler and that you are holding the inhaler upright. Take a slow, maximum breath through the mouthpiece. Hold your breath for 10 seconds or as long as is comfortable for you. Then remove the inhaler from your mouth and exhale slowly. After use, continue to hold the inhaler upright. Close the lid. If you need to do less than one inhalation, close the lid, wait at least one minute, and then repeat the inhalation process.
Cleaning the inhaler
Unscrew the top of the inhaler. Pull out the metal can. Rinse the bottom of the inhaler in warm water and dry. Insert the can into place. Close the lid and screw the top of the inhaler to its body. Do not wash the top of the inhaler. If the inhaler is not working properly, unscrew the top of the inhaler and press down on the canister by hand.
RELEASE FORM
Aerosol for inhalation dosed, activated by inhalation 100 mcg/dose. 200 doses of the active substance in an aluminum can filled with an aerosol under pressure. The aluminum canister is contained in a breath-activated aerosol inhaler (Light Breathing). Aerosol inhaler with a can is placed in a cardboard box along with instructions for use.
BEST BEFORE DATE
3 years.
Do not use after expiration date.
STORAGE CONDITIONS
At a temperature not exceeding 30 °C, protecting from direct sunlight. Do not freeze. Keep out of the reach of children.
CONDITIONS OF VACATION FROM PHARMACIES
On prescription.
MANUFACTURER
Norton Waterford, Ireland IDA Industrial Park, Cork Road, Waterford, Ireland
Moscow representative office: 107031, Moscow, Dmitrovsky lane, building 9,
Release form
Compound
1 dose of aerosol contains: Active substance: salbutamol sulfate 124 mcg, which corresponds to the content of salbutamol 100 mcg. Excipients: hydrofluoroalkane (HFA-134a) - 26.46 mg, ethanol 96% - 3.42 mg.
Pharmacological effect
Bronchodilator, selective β2-adrenergic receptor agonist. in therapeutic doses, the drug acts on β2-adrenergic receptors of the smooth muscles of the bronchi, providing a pronounced bronchodilator effect, prevents and relieves bronchospasm, and increases the vital capacity of the lungs. prevents the release of histamine, a slowly reacting substance from mast cells and neutrophil chemotaxis factors. Causes a slight positive chrono- and inotropic effect on the myocardium, dilates the coronary arteries, practically does not reduce blood pressure. Has a tocolytic effect: reduces the tone and contractile activity of the myometrium. the effect of the drug begins 5 minutes after inhalation administration and continues for 4-6 hours. It has a number of metabolic effects: it reduces the content of potassium ions in plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect , increases the risk of developing acidosis.
Pharmacokinetics
Absorption, distribution, metabolism After inhalation, up to 21% of the dose enters the respiratory tract. The rest remains in the device or settles in the oropharynx and is then swallowed. The portion of the dose that enters the respiratory tract is absorbed by lung tissue without being metabolized in the lungs and enters the bloodstream. When it enters the systemic circulation, salbutamol is partially metabolized in the liver and is excreted primarily by the kidneys unchanged or in the form of phenolic sulfate. Part of the dose entering the gastrointestinal tract is absorbed and undergoes intensive metabolism during the first passage through the liver, turning into phenolic sulfate. Binding of salbutamol to proteins plasma is 10%. Cmax in blood plasma - 30 ng/ml. T1/2 - 3.7-5 hours. Excretion: Excreted mainly by the kidneys unchanged and in the form of a conjugate. Most of the dose of salbutamol administered IV, orally, or inhaled is eliminated within 72 hours.
Indications
Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, pulmonary emphysema.
Contraindications
Hypersensitivity to any component of the drug, cardiac arrhythmias (paroxysmal tachycardia, polytopic ventricular extrasystole), myocarditis, heart defects, aortic stenosis, coronary heart disease, tachyarrhythmia, thyrotoxicosis, decompensated diabetes mellitus, glaucoma, epilepsy, pyloroduodenal narrowing, renal or hepatic failure , pregnancy, simultaneous use of non-selective beta-blockers, children under 2 years of age.
Precautionary measures
The drug should be stored out of the reach of children, protected from direct sunlight, at a temperature not exceeding 25°C; do not freeze.
Use during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy. During lactation (breastfeeding) it is prescribed only in cases where the expected benefit to the mother outweighs any potential risk to the child.
Directions for use and doses
Adults and children over 12 years of age: 100-200 mcg of Salamol Eco Easy Breathing (1-2 inhalation doses) to relieve asthma attacks. To control the course of mild asthma - 1-2 doses 1-4 times a day and moderate severity of the disease - in the same dosage in combination with other anti-asthmatic drugs. For the prevention of physical exertion asthma - 20-30 minutes before exercise, 1-2 doses per dose. Children from 2 to 12 years old: with the development of an attack of bronchial asthma, as well as to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical activity, The recommended dose is 100-200 mcg (1 or 2 inhalations). The daily dose of Salamol Eco Easy Breathing should not exceed 800 mcg (8 inhalations).
Side effects
Salamol Eco Easy Breathing may cause finger tremor, which is a typical side effect of all beta-2 adrenergic agonists. Headache, dizziness, increased excitability, anxiety, sleep disturbance, insomnia, dilation of peripheral blood vessels (facial skin flushing), a slight compensatory increase in heart rate, and increased blood pressure may occur. Hypersensitivity reactions may develop (including angioedema, urticaria, erythema, nasal congestion, bronchospasm, hypotension and collapse); muscle cramps, nausea, vomiting, dyspepsia. Inhaled drugs can cause paradoxical bronchospasm. Inhaled drugs can cause irritation of the mucous membrane of the mouth and pharynx (pharyngitis), cough. Therapy with salbutamol can cause hypokalemia, which can pose a serious danger to the patient, as well as reversible metabolic disorders, for example, an increase in blood glucose concentrations. The drug may cause agitation and increased motor activity in children. Arrhythmias may occur (including atrial fibrillation, supraventricular tachycardia and extrasystole).
Overdose
Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, peripheral vasodilation, decreased blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache. Treatment: drug withdrawal, taking cardioselective beta-blockers; If necessary, carry out symptomatic therapy. If overdose is suspected, serum potassium levels should be monitored.
Interaction with other drugs
Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; and agents for inhalation anesthesia, levodopa - severe ventricular arrhythmias. It is not recommended to simultaneously use the drug Salamol Eco Easy Breathing and non-selective beta-blockers (such as propranolol). MAO inhibitors and tricyclic antidepressants enhance the effect of salbutamol and can lead to a sharp decrease in blood pressure. With simultaneous the use of salbutamol enhances the effect of drugs with a stimulating effect on the central nervous system, side effects of thyroid hormones, cardiac glycosides. When used simultaneously, salbutamol reduces the effectiveness of antihypertensive drugs and nitrates. When used simultaneously with xanthine derivatives, corticosteroids, diuretics, hypokalemia may increase. Simultaneous administration with anticholinergics means (including inhalation) may increase intraocular pressure.
special instructions
In patients with severe or unstable asthma, the use of bronchodilators should not be the main or only method of therapy. The patient must be warned about the need to consult a doctor if the use of the drug Salamol Eco Light Breathing in a standard dose becomes less effective or shorter lasting (the effect of the drug should last at least 3 hours). Frequent use of salbutamol can lead to increased bronchospasm and various complications (up to sudden death), therefore it is necessary to take breaks of several hours between successive inhalations. An increased need for the use of inhaled beta2-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 and the issue of prescribing or increasing the dose of inhaled or systemic corticosteroids should be decided. Therapy with beta2-adrenergic agonists 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 necessary to monitor the level of potassium in the blood serum. The can of Salamol Eco Easy Breathing should not be pierced, disassembled or thrown into a fire, even if it is empty. Like most other inhalation products in aerosol packages, Salamol Eco Easy Breathing may less effective at low temperatures. When the canister cools down, it is recommended to remove it from the plastic case and warm it with your hands for a few minutes.
Name: Salamol-Eco
Salamol-Eco
pharmachologic effect
Salamol-Eco is a bronchodilator drug that affects beta2-adrenergic receptors. Salamol-Eco contains salbutamol, a selective beta2-adrenergic receptor agonist. When using the drug, stimulation of beta2-adrenergic receptors of the smooth muscle layer of the bronchi, its relaxation and an increase in the lumen of the bronchi are noted. Salbutamol for inhalation use have a quick and short-term bronchodilator effect.
Salbutamol is useful for relieving acute attacks of bronchospasm and as a maintenance therapy for chronic diseases respiratory tract with symptoms of obstruction.
Pharmacokinetics
The therapeutic result and bioavailability of salbutamol during inhalation use of Salamol-Eco aerosol and aerosols with freon are identical. Salbutamol when inhaled reaches lower sections lungs, and also enters the gastrointestinal tract. After systemic absorption, salbutamol is metabolized in the liver. After entering the gastrointestinal tract active substance undergoes first-pass metabolism.
Salbutamol is excreted mainly by the kidneys.
Salbutamol is not metabolized in lung tissue, the severity of the therapeutic effect does not depend on serum levels.
The average half-life of salbutamol is 2–7 hours; when used by inhalation, the half-life increases.
Indications for use
Salamol-Eco is used in the treatment of patients with reversible obstructive respiratory diseases, including emphysema and bronchial asthma, as well as obstructive bronchitis. Salamol-Eco can be used both to relieve bronchospasm attacks and to prevent the development of attacks.
Salamol-Eco can be used as prophylactic in patients with obstructive diseases, in particular bronchial asthma, to prevent bronchospasm associated with physical activity or contact with an allergen.
Salamol-Eco in complex treatment can be used for long-term maintenance treatment of patients with bronchial asthma of varying severity.
Mode of application
Salamol-Eco is used by inhalation. To relieve acute attacks and maintenance therapy (prevent the development of bronchospasm), salbutamol is recommended to be used only when necessary. Permanent use salbutamol may lead to the development of tolerance and a decrease in bronchodilator effect.
The duration of use and dosage of Salamol-Eco aerosol is prescribed by a specialist.
Adult patients are often recommended to use a minimum single dosage of 100 mcg of salbutamol. If necessary, the amount can be increased to 200 mcg of salbutamol per 1 inhalation. At acute attack the aerosol should be used immediately after the onset of symptoms of bronchospasm.
To prevent the development of bronchospasm, adults are advised to use 100 mcg of salbutamol 10–15 minutes before exercise or contact with an allergen. Do not use more than 8 inhalations in 24 hours.
If the patient notices an increase in the need for inhalation drugs, including an increase in the frequency of use of the Salamol-Eco aerosol or the need to increase the dosage, you should consult a specialist, since similar situation indicates a worsening of asthma or decreased sensitivity to salbutamol (which requires a revision of the treatment regimen and the prescription of alternative drugs).
For children to relieve bronchospasm, as well as to prevent the development of an asthma attack, 100 mcg of salbutamol is prescribed (at the first sign of bronchospasm or 10–15 minutes before exercise or contact with an allergen). If necessary, a specialist may recommend increasing the single dosage to 200 mcg of salbutamol. Children should not use more than 4 inhalations in 24 hours. The need to increase the frequency of use of Salamol-Eco aerosol or the dosage of salbutamol indicates a worsening of asthma and requires immediate consultation with a specialist.
The interval between inhalations of Salamol-Eco should be at least 4 hours.
Patients with impaired renal and hepatobiliary system functions do not require dosage adjustment.
Inhalation technique Salamol-Eco
When performing inhalation, the patient should be in a sitting or standing position, keeping his back straight. The inhaler should be held vertically, with the applicator down, during the entire time of use (the inhalation device only works in a vertical position).
When using a new medicine for the first time, and also if there has been a break of more than 5 days in using the inhaler, 2 test sprays should be carried out in the air to obtain the correct dosage.
Before using the inhaler, make sure that the plastic part of the inhaler is clean (if necessary, clean the applicator according to the instructions).
During use, it is suggested to hold the inhaler with your thumb and index finger from the bottom and top of the cylinder, respectively. Having placed the inhaler vertically between the thumb and forefinger, shake the canister thoroughly (up and down movements) and proceed to inhalation:
If it is necessary to use two doses, repeat the procedure after 1 minute.
Immediately after use, the oral applicator must be closed with a protective cap.
To prevent contamination of the oral applicator, it is recommended to clean it once a week or more often (as necessary).
Patients who have not previously used inhaled bronchodilators should be instructed by the attending physician, who should also check the technique of using the inhaler. If the technique for using the drug Salamol-Eco is violated, its effectiveness may decrease.
If necessary (in particular for children or debilitated patients), the inhaler can be held with both hands (for easier release of the salbutamol dosage), in which case both index fingers are placed on the top of the inhaler, and both large ones are placed on the bottom.
Caring for the Salamol-Eco inhaler
Side effects
During treatment with the Salamol-Eco inhaler, the following adverse events were recorded in patients:
- Metabolism: hypokalemia, lactic acidosis.
- Central nervous system: sleep disorders, hyperactivity in children, hallucinations, tremor, headache.
- CVS: tachycardia, palpitations. In most cases, tachycardia is not accompanied by peripheral vasodilation, but in some cases dilatation of peripheral vessels was noted against the background of tachycardia. In isolated cases, when using salbutamol, the development of arrhythmia was observed, including extrasystole, supraventricular tachycardia and atrial fibrillation, as well as coronary disease hearts of unknown etiology.
- Respiratory system: irritation of the pharyngeal mucosa, paradoxical bronchospasm.
- Gastrointestinal tract: nausea, irritation of the oral mucosa.
Patients are also likely to experience allergic reactions, including hypotension, urticaria, Quincke's edema and collapse.
In some cases, when using Salamol-Eco aerosol, patients experienced muscle pain.
When using the drug Salamol-Eco, patients are likely to experience paradoxical bronchospasm immediately after inhalation. In such cases, it is necessary to stop using the Salamol-Eco aerosol, re-diagnosis and prescribe alternative treatment.
Contraindications
Salamol-Eco is not used in the treatment of patients with intolerance to salbutamol or the auxiliary components of the drug.
Salamol-Eco should not be used if there is a threat of spontaneous abortion or premature birth.
It is necessary to use the drug Salamol-Eco with caution in the treatment of patients with coronary insufficiency, thyrotoxicosis, arterial hypertension, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, as well as while taking cardiac glycosides for the treatment of cardiovascular diseases.
Salamol-Eco is used with caution in diabetes mellitus (changes in plasma glucose levels are likely).
In pediatrics, Salamol-Eco is used only in patients over 4 years of age.
Pregnancy
Salamol-Eco has not been studied in women during pregnancy. No safety data inhalation drugs, containing the same substance as Salamol-Eco, in pregnant women. No evidence was found in animal studies negative influence spray substance, which is part of the drug Salamol-Eco, on the course of pregnancy and fetal development.
Studies of inhaled forms of salbutamol in pregnant women (in the early stages) indicate the absence of a negative effect of therapeutic doses on the course of pregnancy and fetal development.
Systemic use of salbutamol in the last months of pregnancy can lead to depression labor activity, as well as changes in the activity of beta2-adrenergic receptors in newborns, which can manifest as hypoglycemia and tachycardia in infants whose mothers received salbutamol. Such effects are theoretically not expected with inhaled therapeutic doses of salbutamol.
The active component Salamol-Eco penetrates into breast milk. Salamol-Eco should not be used in nursing women without consulting a specialist and assessing the risks for the newborn.
Drug interactions
Propranolol and other substances from the group of beta-blockers, when used in combination, significantly reduce the effect of salbutamol (up to the complete disappearance of the effect of the drug Salamol-Eco).
With simultaneous use of salbutamol with digoxin, tricyclic antidepressants and monoamine oxidase inhibitors, there is an increased likelihood of adverse reactions from the SSS.
The development of undesirable effects is likely with the combined use of salbutamol and halogenated hydrocarbons for anesthesia. Patients should stop using Salamol-Eco aerosol no later than 6 hours before the start of anesthesia using halogenated hydrocarbons.
Overdose
In case of an overdose of the drug Salamol-Eco, tremor, headache, tachycardia and peripheral vasodilation were recorded in patients. In some cases, hypokalemia, agitation and hyperglycemia were observed in the setting of an overdose of salbutamol.
Cardioselective beta-adrenergic receptor blockers are used as an antidote for salbutamol intoxication. It should be taken into account that in patients with a personal history of bronchospasm, the use of beta blockers may be life-threatening (such drugs should be used with caution and with constant monitoring of respiratory function).
In case of an overdose of the drug Salamol-Eco, the level of potassium (taking into account the risk of hypokalemia) and glucose in the blood serum should be monitored.
Release form
Inhalation dosed aerosol Salamol-Eco, 200 doses in cylinders, 1 cylinder with a spray device in a cardboard box.
Storage conditions
Salamol-Eco should be kept out of the reach of children. No specific temperature conditions are required.
Shelf life – 3 years.
You cannot freeze the drug Salamol-Eco, or heat, pierce or disassemble the cylinder (including after the drug in the cylinder has run out).
Synonyms
Salbutamol, Ventolin.
See also the list of analogues of the drug Salamol-Eco.
Compound
1 dose of Salamol-Eco contains:
Salbutamol – 100 mcg;
Other components: norflurane, anhydrous ethanol.
The aerosol does not contain freons.
Pharmacological group
Medicines used to treat bronchi and lungs Anti-asthmatic medicines Beta-adrenergic receptor stimulants
Nosological classification (ICD-10)
Chronic bronchitis, unspecified (J42) Emphysema (J43) Chronic obstructive pulmonary disease, unspecified (J44.9) Asthma (J45) Status asthmaticus (J46) Bronchospasm (J98.8.0*) Premature labor (O60)
Active substance
salbutamol
ATX
Manufacturer
Teva, Norton Waterford
Additional information about the manufacturer
Country of origin: Ireland, Czech Republic.
Additionally
The contents of the container are under pressure; when the container cools, the therapeutic effect of the drug Salamol-Eco decreases.
The specialist must explain to the patient correct technique using Salamol-Eco aerosol. You also need to make sure that the patient uses the drug correctly and that salbutamol reaches the target areas of the respiratory tract.
Treatment of patients with bronchial asthma should be carried out in stages with mandatory monitoring of the dynamics of the patient's condition and performing pulmonary function tests.
The patient should be notified that if the need for the drug Salamol-Eco increases (the need to increase the dose or frequency of use of the aerosol to achieve the desired effect), consultation with a specialist and correction of the treatment regimen are required. A change in the need for salbutamol may indicate negative dynamics throughout bronchial asthma and potential danger for the patient's life.
Patients with persistent asthma should receive basic therapy corticosteroids.
Sudden and progressive negative dynamics of asthma require an increase in salbutamol dosage and/or prescription oral corticosteroids(any changes to the treatment regimen can only be carried out by the treating specialist).
Patients at high risk of deterioration should have their maximum expiratory flow checked daily.
If it is necessary to use the Salamol-Eco aerosol for a long time, regular consultations with a specialist are necessary.
High dosages of salbutamol, including those used for relief acute conditions and in the treatment of patients with severe asthma, can lead to the development of lactic acidosis (this condition occurs independently after discontinuation of salbutamol).
The use of sympathomimetics can lead to the development of undesirable effects from the cardiovascular system, for example, during post-marketing studies, data were obtained on the occurrence of myocardial ischemia with regular use of salbutamol. Patients with cardiovascular disease (including arrhythmia, myocardial ischemia and severe heart failure) should use salbutamol with caution and seek immediate medical attention. medical care when there is chest pain and other signs of exacerbation of heart disease. It should be taken into account that chest pain and shortness of breath can be caused by both diseases of the respiratory system and diseases of the cardiovascular system.
The likelihood of hypokalemia during therapy with salbutamol increases with combined therapy with diuretics, steroids and xanthine derivatives, as well as with hypoxia.
Salbutamol can lead to hyperglycemia, which may require dosage adjustment of hypoglycemic drugs in patients with diabetes mellitus. In some patients with diabetes mellitus, when using an aerosol form of salbutamol, hyperglycemia was recorded, which could not be corrected, as well as ketoacidosis. The effect of salbutamol on glucose levels is enhanced by the combined use of glucocorticosteroids.