Symptomatic treatment of conditions involving reversible airway obstruction, eg asthma or chronic obstructive pulmonary disease with marked reversibility. Prevention of asthma attacks caused by exercise or allergens.
Composition:
1 delivered dose contains 100 μg of Salbutamol, corresponding to 120 μg of Salbutamol sulphate. The drug contains lactose.
Action:
A selective β-receptor agonist2adrenergic. In therapeutic doses, it has selective action on bronchial β receptors2 and low effects on β receptors1 in the heart of. After inhalation, salbutamol exerts a stimulating effect on β receptors2 in the smooth muscle of the bronchi and in this way provides rapid bronchodilation, which reaches a significant degree within a few minutes and lasts for 4-6 h. Salbutamol also causes vasodilation leading to a reflex chronotropic effect and metabolic effects, including hypokalemia. After inhalation, 20-47% of the salbutamol dose passes to further parts of the bronchi (the rest is embedded in the mouth and upper respiratory tract and swallowed) and is absorbed into the lung tissues and circulation, but it is not metabolized in the lung. After getting into the systemic circulation, it becomes available for hepatic metabolism and is excreted primarily in the urine as unchanged drug and as phenolic sulfate. Part of the inhaled dose that is deposited in the mouth or upper respiratory tract is absorbed from the gastrointestinal tract and then excreted in the urine. The majority of the dose is excreted within 72 hours. Salbutamol binds to proteins up to 10%.
Contraindications:
Hypersensitivity to salbutamol or drug auxiliary (lactose).
Precautions:
Bronchodilators should not be the only or primary treatment for patients with chronic asthma. In patients with asthma, the use of the drug should not delay the inclusion and regular use of inhaled corticosteroids. Caution should be used and used only if there are absolute indications in patients with: severe cardiac disorders, and in particular a recent myocardial infarction; coronary disease, hypertrophic cardiomyopathy with narrowing of the outflow tract and tachyarrhythmias; severe and untreated hypertension; aneurysm; hyperthyroidism; diabetes difficult to compensate and pheochromocytoma. Patients with severe heart disease (eg ischemic heart disease, tachyarrhythmias or severe heart failure) who are taking salbutamol for respiratory disease should be advised to seek medical advice in case of chest pain or other symptoms suggestive of an exacerbation of heart disease . In the absence of treatment efficacy (no improvement or worsening of the patient), patients with asthma may need anti-inflammatory therapy, increase the dose of anti-inflammatory drugs or short-term treatment with oral glucocorticosteroids, and patients with chronic obstructive pulmonary disease may require treatment with one or more long-term acting bronchodilators, rehabilitation, use of inhaled corticosteroids or long-term administration of oxygen. Increased consumption of bronchodilators, and in particular short-acting, inhaled β-receptor agonists2-adrenergic to relieve symptoms, indicates a worsening of disease control. Sudden and progressive severity of symptoms may be life-threatening. The patient should be advised that if asthma worsens after the second inhalation or if the patient is unable to use the powder inhaler during an acute asthma attack, seek medical attention immediately. Application of β2- patients, especially parenterally or in the form of nebulisation, may cause potentially severe hypokalaemia - special care should be taken in patients with severe asthma. It is not recommended for children under 6 years of age (insufficient data on safety and efficacy).The amount of lactose contained in the drug usually does not cause problems in people with lactose intolerance.
Pregnancy and lactation:
The safety of the medicine in pregnant women has not been determined. Do not use this medicine during pregnancy unless clearly necessary. Salbutamol is likely to be excreted in milk, but its effects on children are not known, so it should be limited to situations where the expected benefit to the mother may outweigh the potential risk to the child. Inhalation of salbutamol formulations is not appropriate for preterm delivery and should not be used for a threatened miscarriage.
Side effects:
Common: anxiety; slight tremor, dizziness; nausea, taste disorders; sweating; headache, injection site reactions (irritation of the mouth and throat, burning of the tongue). Rare: hypokalemia, hyperglycemia, increased insulin, free fatty acids, glycerol and ketone bodies; excessive activity; tachycardia, arrhythmias (atrial fibrillation, supraventricular tachycardia, additional spasms), palpitations, angina pectoris, effect on blood pressure (depression or elevation); peripheral vasodilation; cough, paradoxical bronchospasm (stop treatment immediately); muscle cramps. Very rare or not known: thrombocytopenia; hypersensitivity reaction; hyperactivity, sleep disorders, hallucinations; myocardial ischemia; collapse; pruritus, rash, erythema, urticaria, angioneurotic edema; nephritis. In addition, allergic reactions may occur.
Dosage:
Inhalation.Adults(including the elderly and adolescents). Alleviation of acute asthma symptoms and alleviation of acute symptoms of chronic obstructive pulmonary disease, including bronchospasm - initial dose of 100 μg (1 dose). Prevention of symptoms of asthma caused by exercise or allergens - 200 μg for 10-15 minutes before exposure. The maximum daily dose on demand should not exceed 800 μg.Children 6-12 years old. Alleviation of acute asthma symptoms, including bronchospasm - initial dose of 100 μg. Prevention of symptoms of asthma caused by exercise or allergens - 100 μg for 10-15 minutes before exposure and another 100 μg if necessary. The maximum daily dose on demand should not exceed 400 μg. In the case of replacement of other inhaler with salbutamol by the drug, dosage adjustment may be necessary. There should be at least one minute break between two inhalations.