Salbutamol

Package leaflet (information for patients)

Tradename
Salbutamol

Dosage form
Tablets 2 mg.

Description
Round, flat, beveled to the edge white tablets with an imprint in the form of the brand name "V" on one side.

Structure
Active ingredient: Salbutamol 2 mg.
Excipients: microcrystalline cellulose 102, calcium stearate, aerosil ® 200 (hydrophilic pyrogenic silicon dioxide).

Pharmacotherapeutic group
Means for the treatment of obstructive airway diseases, Beta2-selective adrenomimetic

Pharmacological properties
Beta- adrenergic agonist with a predominant effect on β2-adrenergic receptors. In therapeutic doses, salbutamol acts on β2-adrenergic receptors of the smooth muscles of the bronchi and has a short-term (4 to 6 hours) bronchodilatory effect on β2-adrenergic receptors with a rapid onset of action in case of reversible airway obstruction.
Prevents and relieves bronchospasm ; reduces resistance in the airways, increases lung capacity. Prevents the release of histamine, a slow-reacting substance from mast cells and neutrophil chemotaxis factors. Increases mucociliary clearance (in chronic bronchitis up to 36%), stimulates mucus secretion, activates the functions of the ciliated epithelium.
In recommended therapeutic doses, it does not adversely affect the cardiovascular system, does not cause an increase in blood pressure. To a lesser extent, in comparison with drugs of this group, it has a positive chrono - and inotropic effect on the myocardium. Causes expansion of the coronary arteries.
It has a number of metabolic effects: it reduces the concentration of potassium in the blood plasma, affects glycogenolysis and insulin secretion, has hyperglycemic (especially in patients with bronchial asthma) and lipolytic effects, and increases the risk of acidosis.
Pharmacokinetics
After oral administration, salbutamol is well absorbed from the gastrointestinal tract.
Plasma protein binding is 10%.
Metabolized during the "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 final metabolism and excretion after inhalation depends on the route of administration, which determines the ratio between inhaled and unintentionally swallowed salbutamol.
T1 / 2 from blood plasma is 3-7 hours. It is excreted by the kidneys, mainly unchanged (about 90%) and in the form of an inactive phenolsulfate metabolite (about 60%) within 72 hours, and with bile.
Salbutamol penetrates the BBB, creating concentrations equal to approximately 5% of the concentration in blood plasma.

Indications for use
Symptomatic treatment of bronchial asthma attacks.
Symptomatic treatment of exacerbations of bronchial asthma or chronic obstructive bronchitis.
Preventing exercise-induced asthma attacks.
Test for reversibility of bronchial obstruction during functional airway studies.

Method of administration and dosage
You should always take Salbutamol exactly as prescribed by your healthcare professional. If in doubt, please consult your healthcare professional or pharmacist.
Swallow the tablets with water.
If you notice that the tablets are not working properly, seek the advice of your doctor.
Adults:
The usual dose is 4 mg 3 or 4 times a day. Your doctor may gradually increase your dose to the maximum daily dose of 8 mg 3 or 4 times a day. In some patients, the therapeutic dose is 2 mg 3 or 4 times a day.
Elderly age or patients with sensitivity to this drug or other similar drugs:
The starting dose is 2 mg 3 or 4 times a day.
Children aged 2-6:
1-2 mg 3 or 4 times a day.
Children aged 6-12:
2 mg 3 or 4 times a day.
Children over 12 years old:
2-4 mg 3 or 4 times daily.
Children under 2 years old:
Not recommended.

Side effects
Stop using Salbutamol and contact your doctor right away if you experience:
Allergic reactions such as swelling of the face, lips, throat or tongue, white or red, swollen, itchy skin rashes (urticaria), difficulty breathing, hypotension, collapse.
Pain in the chest, jaw, or shoulder (which may be accompanied by shortness of breath, nausea, or vomiting).
Talk to your doctor if you have any of the following side effects or if you notice other side effects not listed in this leaflet:
Increased levels of lactic acid in the body: heart palpitations, nausea, abdominal pain.
Low blood potassium: muscle twitching or weakness, irregular heartbeat.
Others: headache, high blood sugar, mild tremors (usually in the hands), tension, dilation of blood vessels, which can cause myocardial hyperfunction and increased heart rate, irregular heartbeat, muscle spasm, fluid accumulation in the lungs. Diabetics may experience an increase in the number of ketone bodies in the body ( ketoacidosis ).

Contraindication
Allergic reaction to one of the components of the preparation.
Intolerance to this drug (sudden onset of 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.

Overdose
Signs and symptoms of salbutamol overdose are transient phenomena, expressed in increased pharmacodynamic action of beta-2-agonists (see the sections "Precautions " and "Side effects").
An overdose of salbutamol may result in hypokalemia. Therefore, in the event of an overdose, it is necessary to control the serum potassium concentration.
Cases of nausea, vomiting and hyperglycemia were observed mainly in children and in cases where the overdose was the result of oral ingestion of salbu tamol.
Cases of lactic acidosis have been reported with higher doses of rapid-acting beta-2 agonists. Therefore, in case of an 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 bronchospasm symptoms as wheezing, which may be associated with the development of metabolic acidosis.
Action required: Follow-up and symptomatic treatment.

Precautions
In the case of bronchial infection or profuse bronchorrhea, appropriate treatment should be provided 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.
Taking salbutamol in usual doses by inhalation using a device in the form of a sealed balloon usually does not 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 with an oral nebulizer or injection, which should be administered with caution in these patients.
Higher doses of beta-2 mimetics (especially when given parenterally or with a nebulizer ) can lead to potentially severe hypokalemia, which can cause cardiac arrhythmias. In such cases it is recommended to control the potassium level in blood serum, in particular, while the use of derivatives of xanthine, corticosteroids, diuretics, due to hypoxia, and in patients with a high risk of arrhythmias such as "pirouette" (elongated interval QT or therapy with The ability to lengthen QT interval).
Like other beta-2- adrenergic receptor agonists, salbutamol can cause an increase in blood glucose levels. Cases of ketoacidosis have been reported in diabetic patients. Concomitant use of corticosteroids may increase 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 with a nebulizer, were observed mainly in patients undergoing therapy to relieve exacerbation of bronchial asthma (see the section "Side effects "). An increase in lactic acid may cause breathing difficulties or compensatory hyperventilation, which can be misinterpreted as a sign of asthma failure due to inappropriate increases in the dosage of short-acting beta-agonists. Therefore, the risk of developing lactic acidosis should be closely monitored, especially in severe cases.

Interaction with other medicinal products
Please tell your doctor or pharmacist if you are taking or have recently taken any other drugs, including over-the-counter drugs. In particular:
diuretics, guanethidine, reserpine, or methyldopa (to treat high blood pressure)
monoamine oxidase (MAO) inhibitors, such as tranylcypromine (used to treat depression)
tricyclic antidepressants, such as amitriptyline (for depression)
beta blockers such as propranolol,
corticosteroids,
theophylline (for the treatment of respiratory pathologies),
inhalation anesthetics (consult your doctor or dentist if you are going to undergo dental or surgical procedures),
digoxin, to treat heart problems,
xanthines such as theophylline, aminophylline (for asthma), drugs for diabetes.

Special instructions
Inform the patient about the need for immediate medical attention if the previously observed relief of the condition does not occur with 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 an exacerbation of bronchial asthma or obstructive bronchopneumopathy. If within a few days the patient's need for the consumption of long-acting and short-acting beta-2-mimetic bronchodilators by inhalation has increased significantly, one should be afraid (especially if the peak values of the flow meter decrease and / or become irregular) of respiratory decompensation, and in asthmatics - the possibility development of status asthmaticus. Consequently, the doctor must 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, it is necessary to provide for corticosteroid therapy or an increase in the dosage of existing corticosteroid therapy. In addition, in adult patients with asthma, inhaled corticosteroid therapy should be carried out when the use of mimetic beta-2-agonists is necessary more often 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, the termination of inhaled corticosteroid intake without a medical opinion.
As with the use of other drugs for inhalation therapy, immediately after using the drug, paradoxical bronchospasm may develop, which manifests itself in more pronounced difficulty in breathing and increased wheezing. Bronchospasm requires treatment with an alternative form of drug release or another bronchodilator for inhalation therapy (if available). The use of the drug Salbutamol by inhalation should be stopped immediately and, if necessary, another fast-acting bronchodilator should be prescribed to continue treatment.
Medicines with sympathomimetic action, 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 use, as well as in the literature, cases of the development of myocardial ischemia associated with the use of salbutamol were noted. Patients with severe underlying cardiopathy (eg, coronary artery disease, arrhythmia, or severe heart failure) should be advised to consult a physician if chest pain occurs or other symptoms suggest an exacerbation of heart disease. Attention should be paid to the assessment of symptoms such as shortness of breath and chest pain, which can be a consequence of both heart disease and respiratory diseases.

Pregnancy and elbowing
If you are pregnant, plan to become pregnant, or are breastfeeding, talk with your doctor or pharmacist before taking this drug.
If you have a severe form of bronchial asthma, your doctor can monitor your condition by taking certain tests more thoroughly.

Influence on the ability to drive vehicles and work with mechanisms
Does not affect

Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life
3 years. Do not use after the expiration date printed on the package.

Vacation conditions
On prescription.

Packaging
Salbutamol 2 mg Tablets. There are 10 tablets in a blister. 3 blisters are packed in a cardboard box together with an enclosed leaflet.