Salamol-Eko

General characteristics. Structure:

Each dose of drug contains active agent:
Salbutamol of-100 mkg
Excipients: ethanol, гидрофторалкан - 134a
Each inhaler contains 200 doses of drug.

Description: An aerosol for inhalations in an aluminum barrel under pressure. There have to be no external damages, corrosion or leakages. Contents of a barrel leave when spraying on the spot white a cyst flew down

Pharmacological properties:

Pharmacodynamics. Salbutamol is the selection antagonist on β-2-adrenoretseptor. In therapeutic doses he affects β-2-adrenoretseptor of smooth muscles of bronchial tubes, rendering the expressed broncholitic effect, warns and stops a bronchospasm, increases the vital capacity of lungs. Prevents allocation of a histamine, slowly reacting substance from mast cells and factors of a chemotaxis of neutrophils. Causes insignificant positive hrono-and an inotropic effect on a myocardium, expansion of coronary arteries. practically does not reduce arterial pressure. Has tokolitichesky effect: lowers a tone and sokratitelny activity of a myometrium. Effect of drug begins in 5 minutes after inhalation introduction and continues within 4-6 hours. Has a number of metabolic effects: reduces the maintenance of K+ in plasma, influences a glycogenolysis and release of insulin, renders hyper glycemic (especially at patients with bronchial asthma) and the lipolytic effect, increases risk of development of acidosis.

Pharmacokinetics. After inhalation introduction from 10 to 20% of a dose gets into airways. Other part is late in the device or settles in a stomatopharynx and then is swallowed. A part of a dose which remains in respiratory tracts is absorbed by tissues of lungs, without being exposed to metabolism in lungs, and gets to a blood stream. At hit in a system blood stream it can metabolizmrovatsya in a liver and is removed preferential with urine in an invariable look or in the form of phenolic sulfate.
Part of the dose which came to digestive tract is soaked up and exposed to Intensive metabolism during the first passing through a liver, turning into phenolic sulfate. Not changed drug and a conjugate are removed preferential with urine. The most part of the dose of salbutamol entered intravenously, inside or it is inhalation, it is removed within 72 hours. Extent of linkng of salbutamol with proteins of plasma makes 10%. The maximum concentration in a blood plasma - 30 ng/ml. An elimination half-life - 3,7-5 h.

Indications to use:

The prevention and stopping of a bronchospasm at bronchial asthma, the chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema of lungs.

Route of administration and doses:

To adults and children 12 years are more senior: on 100-200 MW Salamol Eko (1-2 inhalation doses) for stopping of attacks of suffocation. For control of the course of asthma of easy severity – on 1-2 doses 1-4 times a day and disease moderate severity - in the same dosage in a combination with other protivoastmatnchesky drugs. For prevention of asthma of physical effort - in 20-30 min. prior to loading 1-2 doses on reception.
To children from 2 to 12 years: at development of an attack of bronchial asthma, and also for prevention of the attacks of bronchial asthma connected with influence of allergen or caused by an exercise stress, the recommended dose makes 100-200 mkg (1 or 2 inhalations).
The daily dose of Salbutamol should not exceed 800 mkg (8 inhalations).

Features of use:

At patients with the heavy or unstable course of bronchial asthma use of bronchodilators should not be the main or only method of therapy.
If action of a usual dose Salamol Eko becomes less effective or less long (effect of drug has to remain not less than 3 hours), the patient should see a doctor.
Frequent use of salbutamol can lead to strengthening of a bronchospasm, sudden death. in this connection between receptions of the next doses of drug it is necessary to do breaks in several hours.
Increase in need for use of inhalation agonists of β-2-adrenoretseptor with a short duration of action for control of symptoms of bronchial asthma testifies to an exacerbation of a disease. In such cases it is necessary to reconsider treatment planning of the patient and to resolve an issue of appointment or increase in a dose of inhalation or system glucocorticosteroids (GKS).
Therapy by agonists of β-2-adrenoretssptor can lead to a hypopotassemia. Extra care is recommended to be shown at treatment of heavy attacks of bronchial asthma as in these cases the hypopotassemia can amplify as a result of simultaneous use of derivatives of xanthine, GKS, diuretics, and also owing to a hypoxia. In such situations it is necessary to control potassium level in blood serum.
The barrel with Salamol Eko cannot be punctured, sorted or thrown into fire even if it is empty. As well as the majority of other means for inhalations in aerosol packages, Salamol Eko can be less effective at low temperatures. When cooling a barrel it is recommended to get it from the plastic case and to warm hands and a current of several minutes.

Instructions for the patient on operation of an inhaler
Instructions for use of an inhaler
Check work of an inhaler before its first use and also if you did not use it any time.
1. Remove a cap from an inhaler. Make sure that in an output tube there is no dust and dirt.
2. You keep a barrel in vertical position, having put a thumb on a bottom, and an index finger - on a barrel top.
Intensively stir up a barrel up-down.
3. Make deeper exhalation (without tension). Densely clamp lips an output tube of a barrel.
4. Take a slow deep breath. At the time of a breath press an index finger the barrel valve, released a medicine dose. Continue to inhale slowly.
5. Take out a tube of an inhaler from a mouth and hold the breath for 10 seconds or on so many on how many you will be able without tension. Slowly exhale.
6. If more than one dose of medicine are required, wait about a minute and then repeat actions, since a step 2. Put on back a cap an inhaler.
When performing steps 3 and 4 you do not hurry. At the time of release of a dose of medicine it is important to take a breath as it is possible more slowly. In the beginning be trained about a mirror. If you notice "steam" which is coming out a top of a barrel or mouth corners, then start over again from a step 2.
Cleaning of an inhaler
The inhaler should be cleaned, at least, weekly. Take out a metal barrel from a plastic case and rinse a case and a cap warm water. Do not use hot water. Carefully dry up, but do not use for this purpose heating devices. Place a barrel back in a case and put on a cap. Do not dip a metal barrel into water.

Side effects:

Salamol Eko can cause a tremor of fingers which is typical side effect for all agonists of β-2-adrenoretseptor. The headache, dizziness, hypererethism, uneasiness, a sleep disorder, sleeplessness, expansion of peripheral vessels (a dermahemia of the person), insignificant compensatory increase in heart rate, increase in arterial pressure, emergence of pains in a thorax, an arfalgiya can be noted. The hypersensitivity reactions (including a Quincke's disease, a small tortoiseshell, an erythema, a nose congestion, a bronchospasm, an arterial giiotenziya and a collapse) can develop; muscular spasm, nausea, vomiting, dyspepsia.
Inhalation drugs can cause a paradoxical bronchospasm.
Inhalation drugs can cause irritation of a mucous membrane of an oral cavity and throat (pharyngitis), cough.
Therapy by salbutamol can cause a hypopotassemia which can constitute serious danger to the patient, and also reversible metabolic disturbances, for example, increase in concentration of glucose in blood.
Drug can cause excitement and increase in a physical activity in children.
Emergence of arrhythmias is possible (including fibrillation of auricles, subventricular tachycardia and premature ventricular contraction).

Interaction with other medicines:

Theophylline and other xanthines at simultaneous use with salbutamol increase probability of development of tachyarrhythmias; means for inhalation anesthesia, a levodopa – heavy ventricular arrhythmias.
Salamol Eko and non-selective blockers of beta adrenoceptors, such as propranolol is not recommended to apply at the same time.
Monoamine oxidase inhibitors and tricyclic antidepressants strengthen effect of salbutamol and can lead to sharp pressure decrease.
Salbutamol strengthens action of stimulators of the central nervous system, side effect of hormones of a thyroid gland, cardiac glycosides. Reduces efficiency of hypotensive drugs, nitrates.
Gipokaliyemnya can amplify as a result of simultaneous use of derivatives of xanthine, glucocorticosteroids, diuretics.
Co-administration with anticholinergics (including inhalation) can promote increase in intraocular pressure.

Contraindications:

Hypersensitivity to any component of drug, disturbance of a rhythm (a Bouveret's disease, polygon ventricular premature ventricular contraction), myocarditis, heart diseases, an aortal stenosis, coronary heart disease, a tachyarrhythmia, a thyrotoxicosis, a dekompensirovanny diabetes mellitus, glaucoma, epipripadka, piloroduodenalny narrowing, a renal or liver failure, pregnancy, a concomitant use of non-selective beta adrenoblockers, children's age to the 2nd is put.
With care - chronic heart failure, a hyperthyroidism, arterial hypertension, a pheochromocytoma.

Use at pregnancy and a lactation
It is contraindicated during pregnancy.
In the period of a lactation it is appointed only when the expected advantage for mother exceeds any possible risk for the child

Overdose:

Symptoms: nausea, vomiting, hyperexcitability, hallucinations, tachycardia, trembling of ventricles, expansion of peripheral vessels, lowering of arterial pressure, anoxemia, acidosis, hypopotassemia, hyperglycemia, muscular tremor, headache.
Treatment: drug withdrawal, cardioselective beta adrenoblockers; symptomatic therapy. At suspicion on overdose it is necessary to control potassium level in blood serum.

Storage conditions:

Period of validity 3 years. Not to use after expiry date. At a temperature not above 30 °C. protecting from direct sunshine. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Aerosol for inhalations dosed 100 mkg / a dose.
On 200 doses in the aluminum barrel with the inhalation device placed in a plastic case. The barrel is placed in a cardboard pack with the application instruction.