Salamol-Eko Easy Breath

General characteristics. Structure:

Active agent
One inhalation dose contains salbutamol sulfate - 124 mkg are equivalent to salbutamol - 100 mkg
Excipients: ethanol, гидрофторалкан (HFA-134a).

Description:
Aerosol for inhalations in an aluminum barrel under pressure, with the final valve and the sprayer. There have to be no external damages, corrosion or leakages. Contents of a barrel represent suspension which when spraying on glass leaves a spot of white color. The barrel is placed in an inhaler, two-piece and a safety cover.

Pharmacological properties:

Pharmacodynamics. Salbutamol is the selection antagonist of b-2-adrenoceptors. In therapeutic doses he affects b-2-adrenoceptors 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 the inotropic effect on a myocardium, expansion of coronary arteries, practically does not reduce arterial pressure. Has токолитическос 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. Possesses a number of m of gabolichesky 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 to 21% 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 be metabolized in a liver and is removed preferential by kidneys 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 by kidneys. 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 mkg Salamol Eko Easy Breath (1-2 inhalation doses) for stopping of attacks of suffocation. For control of the course of asthma of easy severity - on 1-2 doses of 1 - 4 time a day and disease moderate severity - in the same dosage in a combination with other antiasthmatic 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 Salamol Eko Easy Breath 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 Easy Breath 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 b-2-adrenoceptors 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 GKS.

Therapy by agonists of b-2-adrenoceptors 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 Easy Breath 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 Easy Breath 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 within several minutes.

THE INSTRUCTION FOR THE PATIENT ON OPERATION OF THE INHALER

Instruction for use of an inhaler
Stir up an inhaler several times. Then, keeping an inhaler in vertical position, open a cover. Make a deep exhalation. Densely capture a mouthpiece lips. Make sure that your hand does not block air vents on an upper part of an inhaler and that you keep an inhaler in vertical position. Make a slow maximum breath through a mouthpiece. Hold the breath for 10 seconds or so as far as to you it is convenient. Then remove an inhaler from an oral cavity and slowly exhale. After use continue to keep an inhaler in vertical position. Close a cover. If you need to make less than one inhalation, close a cover, wait, at least, one minute, and then repeat inhalation process.

Cleaning of an inhaler
Turn off an upper part of an inhaler. Pull out a metal barrel. Propoloskayte also dry up the lower part of an inhaler in warm water. Insert a barrel into place. Close a cover and fasten an upper part of an inhaler to its case. Do not wash an upper part of an inhaler. If the inhaler works incorrectly, turn off its upper part and manually press a barrel.

Side effects:

Salamol Eko Easy Breath can cause a tremor of fingers which is typical side effect for all agonists of b-2-adrenoceptors. 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 can be noted. The hypersensitivity reactions (including a Quincke's disease, a small tortoiseshell, an erythema, a nose congestion, a bronchospasm, arterial hypotension and a collapse) can develop; muscular spasms, 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, supraventricular 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 is not recommended to apply at the same time Easy Breath and neselektivpy beta adrenoblockers, such as propranolol.

Inhibitors of a monoaminooxidase 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.

The hypopotassemia can amplify as a result of simultaneous use of derivatives of xanthine, glucocorticosteroids (GKS), diuretics.

Co-administration with anticholinergics (including inhalation) can promote increase in intraocular pressure.

Contraindications:

Hypersensitivity to any component of drug, disturbance of a cordial rhythm (a Bouveret's disease, polytopic ventricular premature ventricular contraction), myocarditis, heart diseases, an aortal stenosis, coronary heart disease, a tachyarrhythmia, a thyrotoxicosis, a dekompensirovanny diabetes mellitus, glaucoma, epilepsy, piloroduodenalny narrowing, a renal or liver failure, pregnancy, a concomitant use not of the selection beta adrenoblockers, children's age up to 2 years.

With care - chronic heart failure, a hyperthyroidism, arterial hypertension, a pheochromocytoma.

USE AT PREGNANCY AND THE 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:

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. A period of storage - 3 years.

Issue conditions:

According to the recipe

Packaging:

Aerosol for inhalations dosed activated by a breath of 100 mkg / a dose. On 200 doses of active agent in an aluminum barrel, the aerosol filled under pressure. The aluminum barrel is in the aerosol inhaler activated by a breath (Easy Breath). The aerosol inhaler with a barrel is placed in a cardboard pack together with the application instruction.