Salamol Eco Light Breath - instructions for use, dose, side effects, contraindications

Composition:One dose of the drug contains: active substance: salbutamol sulfate 124 mcg (equivalent to salbutamol) 100 mcg; Excipients: hydrofluoroalkane (HFA-134a) 26.46 mg, ethanol 96% 3.42 mg.

Description:Aerosol for inhalation in an aluminum canister under pressure, with an outlet valve and a nebulizer. There must be no external damage, corrosion or leakage. The contents of the can is a suspension, which when sprayed onto the glass leaves a white spot. The balloon is placed in an inhaler consisting of two parts and a safety cover.

Pharmacotherapeutic group:Bronchodilator - beta2-adrenomimetic is selective.

ATX: & nbsp

R.03.A.C Selective beta-2-adrenomimetics

R.03.A.C.02 Salbutamol

Pharmacodynamics:Salbutamol is a selective antagonist of β-2-adrenergic receptors. In therapeutic doses, it acts on β-2-adrenergic receptors of the smooth muscles of the bronchi, exerting a pronounced bronchodilator effect, preventing and arresting bronchospasm, increasing the vital capacity of the lungs.Prevents the release of histamine, a slowly reacting substance from mast cells and neutrophil chemotaxis factors. Causes a slight positive chrono and inotropic effect on the myocardium, the expansion of the coronary arteries, practically does not reduce blood pressure. It has a tocolytic effect: it lowers the tone and contractile activity of the myometrium. The action of the drug begins 5 minutes after inhalation and lasts for 4-6 hours. It has a number of metabolic effects: reduces the content of K + in the plasma affects glycogenolysis and insulin release, has hyperglycemic (especially in asthmatic patients) and a lipolytic effect, increases the risk of acidosis.

Pharmacokinetics:After inhalation, up to 21% of the dose falls into the respiratory tract. The rest is retained in the device or settles in the oropharynx and then swallowed. Part of the dose that remains in the airway is absorbed by the lung tissue, without being metabolized in the lungs, and enters the bloodstream. If it enters the systemic circulation, it can be metabolized in the liver and excreted mainly by the kidneys in an unchanged form or in the form of phenolic sulfate.
Part of the dose received by the gastro-intestinal tract, absorbed and undergoes extensive metabolism during the first pass through the liver, turning in the phenolic sulfate. The unchanged drug and conjugate are excreted mainly by the kidneys. Most of the dose of salbutamol administered intravenously, by mouth or by inhalation, is excreted within 72 hours. The degree of binding of salbutamol with plasma proteins is 10%. The maximum concentration in blood plasma is 30 ng / ml. The half-life is 3.7-5 h.

Indications:Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema.

Contraindications:Hypersensitivity to any component of the product, abnormal heart rhythm (paroxysmal tachycardia, polytopic ventricular extrasystoles), myocarditis, valvular heart disease, aortic stenosis, coronary heart disease, tachyarrhythmia, thyrotoxicosis, decompensated diabetes, glaucoma, epilepsy, pyloroduodenal restriction, renal or hepatic insufficiency , pregnancy, simultaneous reception of non-selective beta-blockers, children under 2 years of age.

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

Pregnancy and lactation:Contraindicated during pregnancy.
During lactation, it is prescribed only in cases where the expected benefit to the mother exceeds any possible risk to the child.

Dosing and Administration:Adults and children over 12 years of age: 100-200 mcg Salamol Eco Light Breathing (1-2 inhalation doses) for relief of asthma attacks. To control the course of asthma of mild severity - 1-2 doses 1-4 times a day and moderate severity of the disease - in the same dosage in combination with other anti-asthmatic drugs. For the prevention of asthma physical effort - for 20-30 minutes before the load 1-2 doses per reception.
Children from 2 to 12 years: with the development of an attack of bronchial asthma, and also to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical exertion, the recommended dose is 100-200 μg (1 or 2 inhalations).
Daily dose of Salamol Eco Light Breathing should not exceed 800 mcg (8 inhalations).
Instructions for use of the inhaler
Shake the inhaler several times.Then, while holding the inhaler in the upright position, open the lid. Take a deep breath out. Tightly grasp the mouthpiece with your lips. Make sure that your hand does not block the ventilation holes on the top of the inhaler and that you keep the inhaler in an upright position. Take a slow maximum breath through the mouthpiece. Hold your breath for 10 seconds or as long as you feel comfortable. Then remove the inhaler from the oral cavity and exhale slowly. After use continue to hold the inhaler in an upright position. Close the cover. If you need to do more than one inhalation, close the lid, wait at least one minute, and then repeat the inhalation process.

Cleaning the inhaler
Unscrew the top of the inhaler. Remove the metal can. Rinse the bottom of the inhaler in warm water and dry. Insert the can into place. Close the lid and screw the upper part of the inhaler to its housing. Do not wash the top of the inhaler. If the inhaler does not work properly, unscrew the upper part of the inhaler and manually press the can.

Side effects:Salamol Eco Light Breathing can cause finger tremors, which is a typical side effect for all agonists (β-2-adrenergic receptors.There may be headache, dizziness, irritability, anxiety, sleep disturbance, insomnia, increased peripheral vascular (redness of skin), small compensatory increase in heart rate, increased blood pressure. Hypersensitivity reactions may occur (including angioedema, hives, erythema, nasal congestion, bronchospasm, arterial hypotension and collapse); muscle cramps, nausea, vomiting, indigestion.
Inhalation drugs can cause a paradoxical bronchospasm.
Inhalation preparations can cause irritation of the mucous membrane of the mouth and pharynx (pharyngitis), cough.
Salbutamol therapy can cause hypokalemia, which can be a serious danger to the patient, as well as reversible metabolic disorders, for example, an increase in the concentration of glucose in the blood.
The drug can cause excitation and increased motor activity in children. May cause arrhythmias (including atrial fibrillation, supraventricular tachycardia and arrhythmia).

Overdose:Symptoms include nausea, vomiting, anxiety, hallucinations, tachycardia, ventricular flutter, expansion of peripheral blood vessels, lowering blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache.
Treatment: withdrawal of the drug, cardioselective beta-blockers; symptomatic therapy. If you suspect an overdose, you should monitor the potassium level in the blood serum.

Interaction:Theophylline and other xanthines with simultaneous application with salbutamol increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa severe ventricular arrhythmias.
It is not recommended at the same time to use Salamol Eco Light Breath and non-selective beta-blockers, such as propranolol.
Monoamine oxidase inhibitors and tricyclic antidepressants increase the effect of salbutamol and can lead to a dramatic decrease in pressure.
Salbutamol enhances the effect of stimulants of the central nervous system, the side effect of thyroid hormones, cardiac glycosides. Reduces the effectiveness of antihypertensive drugs, nitrates.
Hypokalemia can be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids (GCS), diuretics.
Simultaneous administration with anticholinergics (including inhalation) may help increase intraocular pressure.

Special instructions:In patients with a severe or unstable course of bronchial asthma, the use of bronchodilators should not be the primary or only method of therapy.
If the effect of the usual dose of Salamol Eco Light Breathing becomes less effective or less prolonged (the drug should last at least 3 hours), the patient should consult a doctor.
Frequent use of salbutamol can lead to increased bronchospasm, sudden death, and therefore between the doses of regular doses of the drug should take breaks in a few hours.
Increasing the need for inhaled agonists (β-2-adrenoceptors with a short duration of action to control the symptoms of bronchial asthma indicates an exacerbation of the disease. In such cases, the treatment plan of the patient should be reviewed and the question of prescribing or increasing the dose of inhalation or systemicGCS.
Therapy with beta-2-adrenergic agonists can lead to hypokalemia. It is recommended to exercise extreme caution in the treatment of severe attacks of bronchial asthma, because in these cases, hypokalemia may increase as a result of simultaneous use of xanthine derivatives, GCS, diuretics, and also due to hypoxia. In such situations, it is necessary to monitor the potassium level in the blood serum.
Balloon with Salamol Eco Light Breathing can not be pierced, disassembled or thrown into the fire, even if it is empty. Like most other inhalation agents in aerosol packages, Salamol Eco Light Breathing can be less effective at low temperatures. When cooling the can, it is recommended to remove it from the plastic case and warm it with your hands for several minutes.

Form release / dosage:Aerosol for inhalation dosage activated by inhalation 100 μg / dose.

Packaging:200 doses of the active substance in an aluminum canister filled with aerosol under pressure. The aluminum cylinder is in an aerosol inhaler, activated by inhalation (Light Breath). The aerosol inhaler with a balloon is placed in a cardboard box together with instructions for use.

Storage conditions:At a temperature of no higher than 25 ° C, protecting from direct sunlight. Do not freeze.
Keep out of the reach of children.

Shelf life:3 years.
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014097 / 01

Date of registration:17.04.2007

Expiration Date:Unlimited

The owner of the registration certificate:Norton Waterford, acting under the trade name Ivex Pharmaceuticals IrelandNorton Waterford, acting under the trade name Ivex Pharmaceuticals Ireland Ireland

Manufacturer: & nbsp

Norton Waterford Trading as IVAX Pharmaceuticals Ireland Ireland

Information update date: & nbsp2016-09-15

Illustrated instructions

Instructions

Salamol Eco Light Breath (Salamol Eco Easi Breath)