Name:
Salbutamol aer. ding.dozirov.100mkgdose in ing.200doz in pack No. 1
Description:
A metal inhaler with a depressed bottom, equipped with a metering valve, containing a suspension of white or almost white color. There should be no damage on the inner surface of the inhaler. The main active ingredient Salbutamol Release form 200 doses in an aluminum inhaler equipped with a plastic dosing device with a protective cap. The assembled inhaler and dosing device, together with instructions for use, are placed in a cardboard box. Dosage 100 mcg / 1 dose 200 doses Special instructions No data available. Pharmacological actionMeans for the treatment of obstructive respiratory diseases. Adrenergic agents for inhalation use. Selective beta-2-adrenergic agonists. ATX code: R03AC02. Pharmacodynamics Salbutamol is a selective beta-2-adrenergic agonist. After inhalation, salbutamol has a stimulating effect on beta-2-adrenergic receptors of bronchial smooth muscles, thus providing rapid bronchodilation, which manifests itself after a few minutes and lasts for 4-6 hours. Pharmacokinetics Salbutamol After inhalation of the drug, its concentration in blood plasma when taking normal doses is negligible (10-50 times less than when taking the drug orally or by injection). There is no relationship between blood levels and efficacy. After pulmonary resorption, the drug is excreted mainly by the kidneys, partly unchanged (less than 2%), partly in the form of inactive metabolites (phenolic sulfates). 1,1,1,2-tetrafluoroethane: a propellant gas After inhalation administration of the drug, the adsorption of 1,1,1,2-tetrafluoroethane is negligible and rapid, the maximum concentration is reached in less than 6 minutes. Animals (mice and rats) showed a slight hepatic metabolism of the drug with the formation of trifluoroacetic acid and trifluoroacetic aldehyde. However, according to the results of kinetic studies conducted among patients taking 1,1,1,2-tetrafluoroethane in the presence of pathologies, cases of the formation of trifluoroacetic acid were not detected. Indications for use Symptomatic treatment of asthma attacks. Symptomatic treatment of exacerbations of bronchial asthma or chronic obstructive bronchitis. Prevention of exercise-induced asthma attacks. Test for the reversibility of bronchial obstruction in the course of functional studies of the respiratory tract. Dosage and administration Dosage Regardless of age: Treatment of attacks and exacerbations of bronchial asthma: when the first symptoms appear, take 1-2 inhalations. Prevention of exercise-induced asthma attacks: 1-2 inhalations 15-30 minutes before the start of physical activity. In general, a dose of 1-2 inhalations is sufficient to treat breathing difficulties. If symptoms persist, the dose can be repeated after a few minutes. The duration of the bronchodilating effect of salbutamol when administered by inhalation is from 4 to 6 hours. In case of recurrence of symptoms, the drug can be repeated. Usually the daily dose of the drug should not exceed 8 inhalations within 24 hours. If this dose is exceeded, the patient should be informed about the need for medical advice in order to review the indications for use (see section “Precautions”). In the case of a severe acute asthma attack or a severe exacerbation of chronic obstructive bronchopneumopathy, the dose of the drug is from 2 to 6 inhalations, which should be repeated every 5-10 minutes until the arrival of emergency medical professionals. In such situations, the use of an inhalation chamber by the patient is recommended, since it helps to accelerate the pulmonary diffusion of salbutamol taken by inhalation. However, repeated depression of the metered dose inhaler and release of doses into the inhalation chamber may reduce the total inhaled dose, and the patient must inhale the drug directly (or, if necessary, after each series of two consecutive depressions) from the inhalation chamber after each depression of the inhaler. In the future, the drug should be repeated in successive cycles. A severe acute attack of bronchial asthma requires hospitalization. In this case, treatment consists of oxygen therapy and systemic corticosteroid therapy. Method of application Inhalation administration using a device in the form of a sealed canister equipped with a mouthpiece. In order to use the device correctly, the physician is advised to ensure that the patient is using the inhaler correctly. If the patient is found to have a lack of synchronization of inhalation and pressing the inhaler, the use of an inhalation chamber is indicated. Also, in such patients, it is possible to use other more adapted types of dosage forms of salbutamol. In children and infants who require treatment with Salbutamol inhalation suspension in the form of an aerosol, it is advisable to use an inhalation chamber equipped with a spacer. The inhaler is not equipped with a dose counter. Use during pregnancy and lactation Pregnancy Salbutamol In clinical practice, there are a sufficient number of documented examples of the use of the drug during pregnancy, which allows us to conclude that salbutamol is safe to use during pregnancy. Therefore, the use of salbutamol during pregnancy by inhalation is acceptable. When taking the drug during pregnancy: There may be a rapid heartbeat in the fetus against the background of tachycardia in the mother. In exceptional cases, there is a persistence of a rapid heartbeat after birth. Similarly, in exceptional cases, there is a postnatal change in the level of glycemia. In the case of taking the drug before childbirth, the peripheral vasodilating effect of beta-2 mimetics should be taken into account. 1,1,1,2-tetrafluoroethane: propellant Animal reproduction studies have shown no harmful effects caused by ingestion of 1,1,1,2-tetrafluoroethane contained in this medicinal product. However, the effects of taking 1,1,1,2-tetrafluoroethane in pregnant women have not been established. Lactation Beta-2 mimetics pass into breast milk. The fact of the penetration of the displacing gas and its metabolites into breast milk while taking the drug has not been established. Fertility Information on the effect of salbutamol on fertility in humans is not available. In preclinical studies, an undesirable effect on fertility in animals has not been identified. Precautions Specific instructions Inform the patient about the need to seek immediate medical attention if there is no previously observed relief of the condition in the development of an attack of bronchial asthma. An increased need for the use of bronchodilators, in particular beta-2-agonists, may be a sign of exacerbation of bronchial asthma or obstructive bronchopneumopathy. If the patient’s need for intake of long-acting and short-acting beta-2-mimetic bronchodilators by inhalation increases significantly within a few days, one should be wary (especially if the peak values of the flow meter decrease and / or become irregular) respiratory decompensation, and in asthmatics – the possibility development of status asthmaticus. Therefore, the physician should inform the patient of the need to immediately seek medical attention in such a case without intentionally exceeding the maximum prescribed doses. In such a situation, it is necessary to reconsider the indications for use. A sudden and progressive exacerbation of the course of bronchial asthma can be life-threatening. In such a situation, corticosteroid therapy or an increase in the dosage of existing corticosteroid therapy should be considered. In addition, in adult patients with asthma, inhaled corticosteroid therapy should be considered when the use of beta-2 mimetic agonists is needed more than once a week. In this case, it is necessary to inform the patient that the improvement in his clinical condition should not be the result of changes in therapy, in particular, discontinuation of inhaled corticosteroids without medical advice. As with the use of other drugs for inhalation therapy, immediately after the use of the drug, paradoxical bronchospasm may develop, which manifests itself in a more pronounced difficulty in breathing and increased wheezing. Bronchospasm requires treatment with an alternative formulation of the drug or another bronchodilator for inhalation therapy (if available). The use of the drug Salbutamol inhalation should be immediately discontinued and, if necessary, another fast-acting bronchodilator should be prescribed to continue treatment. Drugs with a sympathomimetic effect, which include salbutamol, can cause disturbances in the activity of the cardiovascular system. According to the data obtained during the post-registration period of the drug, as well as in the literature, there have been cases of myocardial ischemia associated with the use of salbutamol. Patients with severe underlying cardiopathy (eg, coronary artery disease, arrhythmias, or severe heart failure) should be advised to contact their physician if chest pain or other symptoms suggestive of an exacerbation of heart disease occur. Attention should be paid to the assessment of symptoms such as shortness of breath and chest pain, which can be due to both heart disease and diseases of the respiratory system. Precautions for use In case of bronchial infection or severe bronchorrhea, appropriate treatment should be considered to promote optimal diffusion of the drug in the respiratory tract. Salbutamol should be used with caution in patients taking significant doses of other sympathomimetic drugs. Administration of salbutamol at normal doses by inhalation via a sealed balloon device does not usually cause adverse reactions in patients suffering from hyperthyroidism, coronary circulation disorders, obstructive cardiomyopathy, ventricular arrhythmia, arterial hypertension, diabetes mellitus, in contrast to salbutamol, which is taken using a nebulizer orally or by injection, which should be used with caution in such patients. Therapy with beta-2 mimetics at high doses (especially when administered parenterally or by nebulizer) can lead to potentially severe hypokalemia, which can cause cardiac arrhythmias. In such cases, it is recommended to control the level of potassium in the blood serum, in particular, with the simultaneous use of xanthine derivatives, corticosteroids, diuretics, due to hypoxia, as well as in patients with a high risk of developing torsades de pointes arrhythmias (long QT interval or therapy that can prolong the interval QT). Like other beta-2-adrenergic agonists, salbutamol can cause an increase in blood glucose levels. Cases of ketoacidosis have been reported in diabetic patients. Concomitant use of corticosteroids may enhance this effect. Extremely rare cases of lactic acidosis associated with the use of high doses of short-acting beta-2-agonists, administered intravenously or by inhalation using a nebulizer, were noted mainly in patients undergoing therapy for the relief of exacerbation of bronchial asthma (see section “Side effects “). An increase in lactic acid levels can cause difficulty breathing or compensatory hyperventilation, which can be misinterpreted as a sign of failed asthma treatment due to inappropriate increase in the dosage of short-acting beta-agonists. Therefore, the risk of developing lactic acidosis should be closely monitored, especially in severe cases. Athletes: Athletes should be aware that this medicinal product contains an active substance that may show positive results in anti-doping control tests. Interactions with other drugs Not recommended combinations + Non-selective beta-blockers It is not recommended to prescribe salbutamol in combination with non-selective beta-blockers, such as propranolol, as concomitant therapy. + Halogen anesthesia drugs (halothane) During obstetric surgery, there is an increase in uterine inertia with the risk of bleeding; in addition, there is a risk of developing a serious ventricular arrhythmia with an increase in cardiac reactivity. Combinations requiring precautions for use + Antidiabetic medicinal products Taking beta-2 mimetics is associated with an increase in glycemia, which can be interpreted as a decrease in the effect of antidiabetic therapy, therefore, it may be necessary to change antidiabetic therapy (see section “Precautions”) . Increased monitoring of blood and urine is recommended. Contraindications Allergic reaction to one of the components of the drug. Intolerance to this drug (unexpected cough or development of bronchospasm immediately after taking the drug). In this case, you should stop treatment and prescribe a different therapy or other methods of application. Composition Active substance: salbutamol sulfate 120.5 mcg per dose (equivalent to 100 mcg of salbutamol). Excipients: propellant GR106642X (1,1,1,2-tetrafluoroethane, also known as HFA 134a or norflurane). Does not contain freon chlorofluorocarbons. Overdose Signs and symptoms of overdose of salbutamol are transient phenomena, expressed in an increase in the pharmacodynamic action of beta-2-agonists (see sections “Precautions” and “Side effects”). An overdose of salbutamol may result in hypokalemia. Therefore, in case of an overdose, it is necessary to control the concentration of potassium in the blood serum. Cases of nausea, vomiting and hyperglycemia have been noted mainly in children and in cases where overdose was the result of oral administration of salbutamol. Cases of lactic acidosis have been reported with high doses of rapid-acting beta-2-agonists. Therefore, in case of overdose, it is necessary to control the concentration of lactate in the blood serum, as well as the risk of developing lactic acidosis, in particular, in the case of persistence or worsening of tachypnea, despite the disappearance of such symptoms of bronchospasm as wheezing, which may be associated with the development of metabolic acidosis. Necessary actions: observation and symptomatic treatment. Side effectsUndesirable reactions are listed depending on the anatomical and physiological classification and frequency of occurrence, which is defined as follows: very often (? 1/10), often (? 1/100 and < 1/10), sometimes (? 1/1000 and < 1/100), rarely (? 1/10,000 and < 1/1000) and very rarely (< 1/10,000), including isolated cases. Very common and frequent adverse reactions have mainly been identified in clinical studies. Rare and very rare adverse reactions, as well as reactions with an unknown frequency, have been reported in spontaneous reports. Organ class Adverse effects Frequency Immune system reactions Hypersensitivity reactions, including: angioedema, urticaria, severe itching, bronchospasm, hypotension, collapse. Very rarely From the side of metabolism Hypokalemia. * Very rarely From the side of the nervous system Headache, tremor. Often Psychiatric disorders Behavioral disorders: irritability, agitation. Very rarely From the side of the heart Tachycardia Often Palpitations Infrequently Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole). Very rare Myocardial ischemia (see Precautions section). Frequency unknown ** Vascular Peripheral vasodilation. Very rarely From the side of the respiratory system, organs of the chest and mediastinum Paradoxical bronchospasm *** Very rarely From the side of the gastrointestinal tract Irritation of the mucous membrane of the oral cavity and pharynx. Uncommon Musculoskeletal disorders Muscle cramps Uncommon * High doses of beta-2 mimetics may cause reversible hyperglycemia and hypokalemia upon discontinuation of treatment. ** The incidence of myocardial ischemia cannot be established, as it was reported in spontaneous reports obtained during post-marketing surveillance. *** As with other drugs for inhalation therapy, there is a possibility of coughing and, in rare cases, paradoxical bronchospasm immediately after inhalation. It is recommended that you stop taking this drug and use another equivalent rapid-acting bronchodilator to relieve bronchospasm. In the future, it is recommended to review the treatment in order to prescribe alternative therapy, if necessary. Extremely rare cases of lactic acidosis have been noted in patients taking salbutamol intravenously or by inhalation with a nebulizer in the treatment of severe exacerbations of bronchial asthma. Digestive disorders (nausea, vomiting) may also occur. Informing about possible side effects Providing information about suspected adverse reactions identified after registration is of great importance, as it allows for continuous monitoring of the balance of benefits and risks of the medicinal product. Healthcare professionals can report any suspected adverse reactions through the national reporting system. Storage conditions At a temperature not exceeding 30 ° C, do not freeze, do not allow exposure to sunlight. Keep out of the reach of children. Like most other aerosol inhalers, Salbutamol may be less effective at low temperatures. When cooling the cartridge, it is recommended to remove it from the plastic case and warm it with your hands for several minutes. The can must not be disassembled, punctured or thrown into the fire, even if it is empty. 100mcg/dose 200 doses #1
Salbutamol aerosol for inhalation dosed 100mcg/dose 200 doses №1
$20.00
SKU: 333
Category: Asthma treatment
INN | Salbutamol |
---|---|
The code | 333 |
Barcode | 5 900 008 026 727 |
Dosage | 100mcg/d 200dose |
Active substance | Salbutamol |
Manufacturer | Glaxo Wellcome Production, France |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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