Composition, form of production and packaging
The aerosol for inhalation is dosed, activated by inhalation, in the form of a suspension, which when sprayed onto the glass forms a white spot.
1 dose
salbutamol sulfate 124 mcg,
which corresponds to the content of salbutamol 100 Ојg
[PRING] hydrofluoroalkane (HFA-134a) - 26.46 mg, ethanol 96% - 3.42 mg.
200 doses - aluminum cylinders (1) - aerosol inhalers, activated by inhalation (Light Breathing) (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
A bronchodilator, a selective agonist? 2- adrenoreceptors. In therapeutic doses, the drug acts on? 2- adrenoreceptors of smooth muscles of the bronchi, having a pronounced bronchodilator effect, prevents and stops bronchospasm, increases 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-inotropic effect on the myocardium, dilates coronary arteries, practically does not reduce blood pressure.
Has a tocolytic effect: reduces the tone and contractile activity of the myometrium. The drug starts in 5 minutes after inhalation and lasts for 4-6 hours. It has a number of metabolic effects: reduces the content of potassium ions in the plasma, affects glycogenolysis and insulin release, exerts hyperglycemic (especially in patients with bronchial asthma) and lipolytic effect, increases the risk of acidosis.
PHARMACOKINETICS
Absorption, distribution, metabolism
After inhalation, up to 21% of the dose falls into the respiratory tract. The rest remains in the device or settles in the oropharynx and then is swallowed.
Part of the dose that enters the respiratory tract, is absorbed by the lung tissue, without being metabolized in the lungs, and enters the bloodstream. When it enters the systemic circulation, salbutamol is partially metabolized in the liver and excreted mainly by the kidneys in unchanged form or in the form of phenolic sulfate.
Part of the dose received in the digestive tract is absorbed and subjected to intensive metabolism during the "first passage" through the liver, turning into phenolic sulfate.
The binding of salbutamol with plasma proteins is 10 %. C max in blood plasma - 30 ng / ml . T 1/2 - 3.7-5 h.
Excretion
Displayed mainly kidneys in unchanged form and as a conjugate. Most of the dose of salbutamol administered intravenously, orally or by inhalation, is withdrawn within 72 hours.
INDICATIONS
Prevention and relief of bronchospasm:
- with bronchial asthma;
- with chronic obstructive pulmonary disease;
- with chronic bronchitis;
- with emphysema of the lungs.
DOSING MODE
Adults and children over 12 years of age for relief of attacks of bronchospasm Salamol Eco Light Breathing appoint 100-200 mcg (1-2 inhalation doses). To control the course of asthma of mild severity - 1-2 doses 1-4 times / day; at an average severity of the disease - in the same dose in combination with other anti-asthmatic drugs. For the prevention of asthma physical effort, the drug is used for 20-30 minutes before the load of 100-200 Ојg (1-2 inhalation doses) at the reception.
Children aged 2 to 12 years with the development of an attack of bronchial asthma , as well as to prevent attacks of bronchial asthma associated with exposure to an allergen or caused by physical exertion , the recommended dose is 100-200 Ојg (1 or 2 inhalations).
Daily dose of the drug Salamol Eco Light Breathing should not exceed 800 mcg (8 inhalations).
Instructions for use of the inhaler
Before use, shake the inhaler several times. Then, holding the inhaler in the upright position, open the lid. Make a deep exhalation. Tightly grasp the mouthpiece with your lips. Make sure that the hand does not obstruct the ventilation holes on the top of the inhaler and that the inhaler is in an upright position. Make a slow maximum breath through the mouthpiece, hold your breath for 10 seconds or as long as it is comfortable. Then it is necessary to remove the inhaler from the oral cavity and slowly exhale. After use, while keeping the inhaler in the upright position, close the lid. If more than one inhalation is needed, the lid is closed and, after waiting at least one minute, repeat the inhalation process.
Cleaning the inhaler
The top of the inhaler should be unscrewed and pulled out a metal can. Then rinse the bottom of the inhaler in warm water and dry. Then insert the can into place. Close the cover and screw the upper part of the inhaler to its housing. The upper part of the inhaler is not washed. If the inhaler does not work properly, unscrew its upper part and manually press the can.
SIDE EFFECT
From the nervous system: tremor of the hands (a typical side effect for all beta 2 -adrenomimetics), headache, dizziness, increased excitability, anxiety, sleep disturbance, insomnia. The drug can cause excitation and increased motor activity in children.
From the cardiovascular system: the widening of the peripheral vessels (hyperemia of the facial skin), a slight compensatory increase in heart rate, an increase in blood pressure. There may be arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole).
Allergic reactions: angioedema, urticaria, erythema, nasal congestion, bronchospasm, arterial hypotension, collapse.
On the part of the digestive system: nausea, vomiting, indigestion.
Local reactions : irritation of the mucous membrane of the mouth and pharynx (pharyngitis), cough.
On the part of the respiratory system : a paradoxical bronchospasm.
From the side of metabolism: hypokalemia is possible (may pose a serious danger to the patient), reversible hyperglycemia.
Other: muscle cramps.
CONTRAINDICATIONS
- violations of the heart rhythm (paroxysmal tachycardia, polytopic ventricular extrasystole, tachyarrhythmia);
- myocarditis;
- heart defects, aortic stenosis;
- IHD;
- thyrotoxicosis;
Decompensated diabetes mellitus;
- glaucoma;
- epilepsy;
- pyloroduodenal constriction;
- liver failure;
- kidney failure;
- Pregnancy;
- simultaneous reception of non-selective beta-blockers;
- Children under 2 years;
- Hypersensitivity to the components of the drug.
With caution appoint a drug for chronic heart failure, hyperthyroidism, arterial hypertension, pheochromocytoma.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy. During lactation (breast-feeding) is prescribed only in those cases, when the expected benefit for the mother exceeds any potential risk to the child.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in case of liver failure.
APPLICATION FOR CHILDREN
Contraindication: children under 2 years.
SPECIAL INSTRUCTIONS
In patients with severe or asthmatic bronchial asthma, the use of bronchodilators should not be the primary or only method of therapy. The patient should be warned about the need to consult a doctor if the use of the drug Salamol Eco Light Breathing in a standard dose becomes less effective or less prolonged (the drug should last at least 3 hours).
Frequent use of salbutamol can lead to increased bronchospasm and various complications (up to a sudden lethal outcome), and therefore between the next inhalation you need to take breaks in a few hours.
Increased demand for inhaled beta 2 -adrenomimetics with short duration of action to control 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 inhaled or systemic SCS should be decided.
Therapy with beta 2 -adrenomimetics can lead to hypokalemia . Particular caution should be exercised in the treatment of severe seizures of the bronchial asthma, because in these cases hypokalemia can be enhanced by the 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.
A balloon with a preparation of 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 packs, the preparation 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.
OVERDOSE
Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, peripheral vasodilation, decreased blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremor, headache.
Treatment: withdrawal of the drug, the use of cardioselective beta-blockers; if necessary, conduct symptomatic therapy. If you suspect an overdose, you should monitor the potassium level in the blood serum.
DRUG INTERACTION
Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; and means for inhalation anesthesia, levodopa - severe ventricular arrhythmias.
It is not recommended at the same time to use the drug Salamol Eco Light Breath and nonselective beta-blockers (such as propranolol).
MAO inhibitors and tricyclic antidepressants increase the effect of salbutamol and can lead to a sharp decrease in blood pressure.
With the simultaneous use of salbutamol enhances the effect of drugs with a stimulating effect on the central nervous system, the side effect of thyroid hormones, cardiac glycosides.
With the simultaneous use of salbutamol reduces the effectiveness of antihypertensive drugs, nitrates.
When used simultaneously with xanthine derivatives, GCS, diuretics, hypokalemia may be increased.
Simultaneous administration with anticholinergic agents (including inhalation) may help increase intraocular pressure.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from direct sunlight, at a temperature of no higher than 25 В° C; Do not freeze. Shelf life - 3 years.
