Active substanceSalbutamolSalbutamol
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  • Dosage form: & nbspaerosol for inhalation dosed
    Composition:

    One inhalation dose contains

    Active substance: Salbutamol sulfate (BP) - 120 μg in terms of salbutamol - 100 μg.

    Excipient: 1,1,1,2-tetrafluoroethane HFA 134 a.

    Description:The contents of the balloon are a white homogeneous suspension.
    Pharmacotherapeutic group: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 beta2-adrenergic receptor agonist. At therapeutic doses it acts on beta2-adrenergic receptors bronchial smooth muscle, exerting a pronounced bronchodilator effect, prevents and relieves bronchoconstriction, increases lung capacity. 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, 10 to 20% 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. When injected into the systemic circulation it may be metabolized in the liver and excreted predominantly in the urine in unchanged form or as phenol 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 in the urine.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 the blood plasma is 30 ng / ml.

    The half-life is 3.7 - 5 hours.

    Indications:Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive bronchitis, emphysema.
    Contraindications:Hypersensitivity to any component of the drug, arrhythmias (paroxysmal tachycardia, polytopic ventricular extrasystoles), myocarditis, valvular heart disease, aortic stenosis, coronary heart disease, hypertension, heart failure, tachyarrhythmia, thyrotoxicosis, pheochromocytoma, decompensated diabetes, glaucoma, epipripadki, pilorodoudenalnoe narrowing, renal or hepatic insufficiency, pregnancy, simultaneous reception of non-selective beta-blockers, children under 2 years old.
    Carefully:Heart failure, hyperthyroidism.
    Pregnancy and lactation:

    Contraindicated during pregnancy.

    In the lactation period is appointed only in those cases,when the expected benefit for the mother exceeds any possible risk to the child.

    Dosing and Administration:

    Adults and children over 12 years of age: 100-200 micrograms of Astalin (1-2 inhalation doses) for arresting attacks of suffocation. To monitor the course of mild asthma - 1-2 dose 1-4 times a day and an average disease severity - at the same dosage in combination with other antiasthmatic agents. 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 old: With the development of asthma attacks, and also to prevent asthma attacks related to exposure to allergen or caused by physical activity, the recommended dose is 100-200 micrograms (1 or 2 inhalation).

    The daily dose of Salbutamol should not exceed 1200 mcg (12 inhalations).

    Side effects:

    Astalin can cause finger tremors, which is a typical side effect of all beta2-adrenergic agonists. 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.

    There may be arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole).

    Overdose:Symptoms: nausea, vomiting, increased excitability, hallucinations, tachycardia, ventricular flutter, widening of peripheral vessels, lowering blood pressure, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremor, 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, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa - severe zhuludochkovyh arrhythmias.

    It is not recommended to simultaneously use Astalin and nonselective beta-adrenoreceptor blockers, such as propranolol.

    Inhibitors of monoamine oxidase and tricyclic antidepressants increase the effect of salbutamol and can lead to a sharp decrease in pressure. Salbutamol enhances the effect of stimulants of the central nervous system, cardiotropic thyroid hormones, increases the likelihood of developing glycosidic intoxication. Reduces the effectiveness of antihypertensive drugs, nitrates.

    Hypokalemia can be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids, 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 Astalin 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.

    The increased need for the use of inhaled beta2-adrenoceptor agonists with 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 inhaled or systemic glucocorticoid steroids should be considered.

    Therapy with beta2-adrenoreceptor agonists can lead to hypokalemia. Particular caution should be exercised in the treatment of severe attacks of bronchial asthma, since in these cases, hypokalemia may be intensified by the simultaneous use of xanthine derivatives,glucocorticosteroids, diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor the potassium level in the blood serum.

    Form release / dosage:Aerosol for inhalation dosed.
    Packaging:

    For 15 grams in an aluminum canister, equipped with a metering valve and a spray nozzle.

    Each cylinder, together with the instruction for use, is placed in a cardboard box.

    Storage conditions:At a temperature not exceeding 30 ° C in a place inaccessible to children. Do not freeze.
    Shelf life:2 years. Do not use after the date shown on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015251 / 04
    Date of registration:13.08.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Cipla Ltd.Cipla Ltd. India
    Manufacturer: & nbsp
    Information update date: & nbsp27.09.2017
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