Salbutamol-native - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Bronchodilator. Salbutamol is a stimulant. beta2-adrenergic receptors. Bronchodilating effect is manifested as early as 1-3 minutes after inhalation of the drug and significantly increases by 10 minutes, the maximum of action is reached by 15-20 minutes, the duration of action is 4-5 hours.
In therapeutic doses also has a pronounced stimulating effect on beta2-adrenoreceptors of blood vessels and myometrium. Virtually no effect on beta 1-adrenoreceptors of the heart. Inhibits the release of mast cells from inflammatory mediators and basophils, in particular,anti-IgE-induced release of histamine, leukotrienes and prostaglandin D2, eliminates antigen-dependent suppression of mucociliary transport and the release of neutrophil chemotaxis factor. Suppresses the early and late phase of an allergic reaction. Has a pronounced bronchodilator effect, preventing or reducing spasms of the bronchi, reduces resistance in the airways, increases the vital capacity of the lungs. Positively affects mucociliary clearance, stimulates the secretion of mucus, activates the functions of ciliated epithelium. Prevents the development of an allergen-induced bronchospasm. May cause gingivitis and a decrease in the number of beta-adrenergic receptors, incl. on lymphocytes. Has a number of metabolic effects: reduces the potassium content in the plasma, affects glycogenolysis and insulin secretion, has a hyperglycemic and lipolytic effect, increases the risk of acidosis.
In recommended therapeutic doses does not have a negative effect on the cardiovascular system, does not cause an increase in blood pressure. To a lesser degree, in comparison with the drugs of this group, it has a positive chrono- and inotropic effect. Causes the enlargement of the coronary arteries.It has a tocolytic effect: it lowers the tone and contractile activity of the myometrium.

Pharmacokinetics:When inhaled, 10-20% reaches the small bronchi and gradually absorbed, part of the dose after ingestion is absorbed from the gastrointestinal tract. It is subjected to presystemic metabolism in the liver and intestinal wall. The half-life is about 4 hours. It is excreted in urine and bile, mainly in unchanged form (90%) or in the form of glucuronide.

Indications:Bronchial asthma (for arresting asthma attacks), reversible bronchial obstruction (prevention and treatment), including chronic obstructive pulmonary disease.

Contraindications:Hypersensitivity to the components of the drug, coronary heart disease, severe heart failure, rhythm disturbances (paroxysmal tachycardia, polytopic ventricular extrasystole), myocarditis, heart defects, aortic stenosis, decompensated diabetes mellitus, glaucoma, epipriposition, pyloroduodenal narrowing, kidney and liver disorders with impaired their functions, pregnancy, simultaneous reception of non-selective beta-blockers, children under 18 months of age.

Carefully:Chronic heart failure, arterial hypertension, hyperthyroidism, pheochromocytoma, thyrotoxicosis.

Pregnancy and lactation:Because the salbutamol penetrates into breast milk, its use during the period of breastfeeding is possible only if the expected therapeutic effect for the mother exceeds the potential risk for the child.

Dosing and Administration:The drug "Salbutamol-native" is used by inhalation only with the help of a nebulizer of any design. 1 ml of the drug contains 1 mg of salbutamol hemisuccinate (in terms of salbutamol 0.8 mg / ml). The nebulizer turns the solution into an aerosol for inhalation. When used, the solution should have room temperature (a cold solution can cause a cough effect). Before using the drug, you should carefully read the instructions for using the nebulizer:
1. Prepare the nebulizer for use.
2. Place the drug solution in a nebulizer. Do not mix the solution with other drugs. The solution can be diluted with distilled water or 0.9% sodium chloride.
3. After the end of the inhalation, remove the remaining solution and wash the nebulizer.
When using salbutamol-native solution through a nebulizer, the initial dose of the drug is 2.5 mg for adults and children over 12 years old, but can be increased to 5 mg. Inhalations are carried out every 4-6 hours during the first 24-48 hours of therapy or until the clinical picture stabilizes. Improvement of the condition is observed after inhalation, usually after 10-15 minutes. In severe exacerbation of chronic obstructive pulmonary disease, the frequency of administration of the drug can be significantly increased - it is possible to administer the drug every 30-60 minutes to achieve a clinical effect (in adults up to 40 mg per day).
Use in children from 18 months to 12 years. To relieve an attack of bronchospasm: a single dose of 2 mg for inhalation up to 4 times a day under the supervision of specialists. For prophylaxis 2 mg / day.

Side effects:A feeling of inner anxiety and a mild tremor in the skeletal muscles, convulsions, a feeling of palpitations, sleep disturbances, paradoxical bronchospasm, coughing, hyperemia of the facial skin, nervous tension, anxiety, headache, dizziness, tachycardia (in pregnancy - at the mother and fetus) dyspepsia, nasal congestion, pharyngitis,retention of urine, sweating, hyperglycemia, increased blood levels of free fatty acids, hypokaemia, angioedema, allergic reactions (urticaria, erythema, edema of the face), lowering blood pressure, arrhythmia, respiratory tract irritation, dryness of the oral and throat mucosa , changes in taste, dermatitis.

Overdose:Symptoms: tachycardia, cardiac rhythm disturbance, peripheral vascular dilatation, lowering of arterial pressure, hypoxemia, hypokalemia, hyperglycemia, muscle tremor, headache, agitation.
Treatment. The withdrawal of the drug and the conduct of symptomatic therapy (the appointment of selective beta-adrenoblockers requires caution in patients with bronchial asthma because of the risk of developing severe bronchospasm).

Interaction:The drug "Salbutamol-native" is well combined with anti-asthmatic drugs of other pharmacological groups (glucocorticosteroids, membrane stabilizers, antihistamines, expectorants, mucolytics, cholinolytics, xanthines).
Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa severe ventricular arrhythmias.
Monoamine oxidase inhibitors and tricyclic antidepressants increase the effect of salbutamol, which can lead to a sharp drop in blood pressure.
It is not recommended simultaneous administration of salbutamol and nonselective beta-blockers (such as propranolol) in patients with bronchial asthma due to the risk of developing severe bronchospasm.
Anticholinergics in the inhalation form, while using at the same time, can cause an increase in intraocular pressure.
Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol. Enhances the effect of stimulants of the central nervous system, a side effect on the heart of the thyroid hormones. The need for nitrates and antihypertensive drugs increases in the case of an increase in heart rate and, as a consequence, blood pressure against the background of treatment with salbutamol. Increases the likelihood of developing extrasystoles against the background of cardiac glycosides.

Special instructions:If the usual dose of the drug becomes less effective, the patient should consult a doctor.
If a paradoxical bronchospasm occurs, it is necessary to immediately stop it with the help of another dosage form of salbutamol or another high-speed inhalation bronchodilator, stop treatment and prescribe therapy with other medications.

Effect on the ability to drive transp. cf. and fur:Data on the negative impact on the ability to drive vehicles and other activities that require special attention and quick reactions are absent. Nevertheless, the question of the possibility of driving a vehicle should be addressed after assessing the individual tolerability of the drug.

Form release / dosage:Solution for inhalation 0.8 mg / ml.

Packaging:2,5; 5; or 10 ml in bottles from drug drotons or bottles of orange glass, corked with rubber stoppers, crimped with aluminum caps. For 10 vials with instructions for use in a pack of cardboard box.

Storage conditions:In a dry, protected from light place, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N000442 / 02

Date of registration:09.06.2009 / 05.02.2016

Expiration Date:Unlimited

The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia

Manufacturer: & nbsp

NATIVA, LLC Russia

Information update date: & nbsp2016-09-15

Illustrated instructions

Instructions

Salbutamol-native (Salbutamol-nativ)