Index of drugs

Treatment of acute attacks of dyspnea caused by reversible narrowing of the airways in bronchial asthma, chronic bronchitis and pulmonary emphysema. It is also indicated in long-term symptomatic treatment of bronchial asthma in combination with corticosteroid therapy and in the prevention of exercise-related or allergen-induced asthma.

1 inhalation dose contains 100 μg of Salbutamol in the form of sulphate. The preparation contains anhydrous ethanol.

A selective β-receptor agonist₂- adrenergic in the smooth muscles of the bronchi. It causes short-term (4-6 h), fast occurring (action begins within 5 min) bronchial dilation in the case of reversible obstruction of the airways. After inhalation, about 10-20% of the dose reaches the lower respiratory tract. The remainder of the dose remains in the mouth and throat, from where it is swallowed. Salbutamol, which has reached the airways, is absorbed in the pulmonary parenchyma and enters the circulation, but it is not metabolized in the lungs. Salbutamol binds to plasma proteins at 10%. It is metabolised in the liver and then excreted, mainly in the urine, in unchanged form or in the form of a metabolite - phenolic sulfate. The swallowed portion of the dose is absorbed from the gastrointestinal tract and undergoes first-pass metabolism to phenol sulfate. Most salbutamol is excreted within 72 hours.

Hypersensitivity to the active substance or to any of the excipients. Children under 4 years old. Prevention of abortion for a threatening or premature birth (although salbutamol is administered intravenously and occasionally orally in cases of premature delivery which is not accompanied by complications, inhaled preparations containing salbutamol are not suitable for use in such cases).

Caution should be exercised when using salbutamol in cases of: hyperthyroidism, coronary insufficiency, hypertrophic cardiomyopathy with narrowing of the outflow tract, hypertension, phaeochromocytoma, tachyarrhythmia, diabetes mellitus, use of the following drugs: xanthine derivatives, steroids, diuretics, glycosides digitalis. The patient's response to the preparation should be controlled in a hospital setting by testing lung function tests. Patients who experience deterioration despite having salbutamol therapy or who have previously received doses do not cause symptoms to subside within 3 hours, should consult a physician for additional treatment. Patients who require long-term treatment with salbutamol should be kept under regular control. Bronchodilators should not be used as the sole or primary drug in patients with severe or unstable asthma. The use of maximum recommended doses of inhaled corticosteroids and / or administration of oral corticosteroids should be considered in such patients. Potentially dangerous hypokalemia may be the result of β therapy₂-blowers, administered mainly parenterally or in a nebulized form. Hypokalaemia during an ACUTE, severe asthma attack may be exacerbated by the co-administration of xanthine, steroids, diuretics, digitalis glycosides and hypoxia. Particular attention should be paid to the condition of patients taking these medications; you should monitor the serum potassium in such patients. If paradoxical bronchoconstriction occurs, treatment should be discontinued immediately and alternative therapy instituted. Salbutamol and non-selective blocking drugs for β-adrenergic receptors, eg propranolol should not be used at the same time. Due to the risk of drug effects on the cardiovascular system (including myocardial ischemia), patients with concomitant severe cardiac disease (e.g.coronary heart disease, cardiac arrhythmias or severe heart failure) taking salbutamol should consult a doctor if there is chest pain or other symptoms suggestive of an exacerbation of heart disease. Special attention should be paid to symptoms such as shortness of breath and chest pain which may result from heart or respiratory disorders. The preparation contains anhydrous ethanol (about 11.4% of the total container).

There are no data on the use of salbutamol with carrier gas HFA-134a in pregnant or breast-feeding women. The preparation can be used during pregnancy or breastfeeding only if the expected benefits may outweigh the risk of harmful effects of the drug on the fetus or newborn. High systemic doses at the end of pregnancy may result in suppression of uterine contraction and lead to β-specific₂-mimetic effects on the fetus or infant in the form of tachycardia and hypoglycaemia. Inhalation therapy at the recommended doses should not cause the harmful effects described above at the end of pregnancy.

Common: tension (at the beginning of treatment), tremors, headaches (especially often at the beginning of treatment), dizziness, tachycardia. Uncommon: palpitations (especially at the beginning of treatment). Rare: hypokalaemia (very high doses or in combination therapy with xanthine derivatives, corticosteroids and diuretics), increased serum lactate in rare cases leading to lactic acidosis (after long-term treatment), irritation of the oral mucosa, nausea, vomiting, dryness in the mouth, herpetic stomatitis, muscle cramps, peripheral vasodilatation, irritation of the mucous membrane of the throat. Very rare: hypersensitivity reactions (including angioneurotic edema, urticaria, bronchospasm, hypotension and collapse), insomnia, atrial fibrillation, supraventricular tachycardia and additional cardiac contractions (especially when other β concurrent use are used)₂-mimetic), paradoxical bronchospasm. Not known: myocardial ischemia. After inhalation irritation of the mucous membrane of the mouth and throat may occur. Children: rarely - hyperactivity.

Inhalation.Adults. To alleviate acute asthma attack: 1 dose (100 μg) - minimal starting dose. If necessary, the dose can be increased to 200 μg. 1 dose (100 μg) is given during a single inhalation. In long-term maintenance treatment: 2 doses (2 inhalations) 3 or 4 times a day. In the prevention of exercise-induced asthma attacks or allergens: 2 doses (2 inhalations) 15-20 min before exposure to factors causing bronchospasm. The maximum daily dose is: 200 μg 4 times a day.Children over 4 years old. To alleviate an acute asthma attack or against exposure to an allergen or effort: 1 dose (100 μg). 1 dose (100 μg) is given during a single inhalation. In long-term maintenance treatment: 1 dose (1 inhalation) 3 or 4 times a day. The maximum daily dose is: 200 μg 3 to 4 times a day. In children, the preparation should be used under the supervision of adults. In most patients, the product should be used regularly to achieve optimal treatment results. Because of the possibility of transient hypoxemia, oxygen supplementation should be considered. In all patients, inhalations should not usually be repeated more frequently than every 4 hours. In the immediate administration of salbutamol, 8 inhalations should not be exceeded within 24 hours. The need for frequent adrenal doses or sudden dose increases indicates inadequately controlled or worsening asthma. In long-term treatment, it is recommended to take the medicine temporarily instead of regular use.