Salbutamol-Teva (Salbutamol-Teva)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSalbutamolSalbutamol
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    • Dosage form: & nbspAerosol for inhalation dosed.
    Composition:1 dose of the drug contains: active substance salbutamol sulfate 124.00 μg (in terms of salbutamol 100.00 μg); Excipients: hydrofluoroalkane (HFA-134a) 26.46 mg, ethanol 3.42 mg.
    Description:Aerosol for inhalation in an aluminum canister under pressure. There must be no external damage, corrosion or leakage. The contents of the canister leave a white spot on the glass when sprayed onto the glass.
    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 stimulator of beta2-adrenergic receptors, which exerts an effect on the smooth muscles of the respiratory tract, causing its relaxation and preventing bronchoconstriction. Reduces resistance in the airways, increases the vital capacity of the lungs. Prevents the release of histamine, leukotrienes, prostaglandin D2 and other biologically active substances from mast cells.The recommended therapeutic doses do not have a negative effect on the cardiovascular system (CCC), does not cause an increase in blood pressure. To a lesser extent compared with the drugs of this group, it has a positive chrono- and inotropic effect. Causes the enlargement of the coronary arteries. It has a number of metabolic effects: it reduces the concentration of potassium ions in the plasma, affects glycogenolysis and insulin secretion, has hyperglycemic (especially in patients with bronchial asthma) and a lipolytic effect, increases the risk of acidosis.
    Pharmacokinetics:During inhalation, 10-20% of the inhaled dose reaches the small bronchi, the rest is deposited in the upper respiratory tract. After inhalation, systemic absorption is fast, but low. The maximum concentration of salbutamol in the blood plasma is observed after 3 hours. The connection with plasma proteins is 10%. It is subjected to presystemic metabolism in the liver and intestinal wall. The half-life period (T1 / 2) is 3-7 hours. It is excreted by the kidneys, mostly unchanged (about 90%) and in the form of an inactive phenol sulfate metabolite (about 60%) for 72 hours and with bile. Salbutamol penetrates the blood-brain barrier, creating concentrations equal to about 5% of the concentration in the blood plasma.
    Indications:Prevention and relief of bronchospasm in bronchial asthma; symptomatic treatment of bronchial obstructive syndrome (including chronic bronchitis and pulmonary emphysema); chronic obstructive pulmonary disease.
    Contraindications:Hypersensitivity to salbutamol and other components of the drug; children under 2 years.
    Carefully:Tachyarrhythmia; cardiac ischemia; myocarditis; heart disease; aortic stenosis; hypertrophic obstructive cardiomyopathy; severe chronic heart failure; arterial hypertension; thyrotoxicosis; pheochromocytoma; simultaneous use with cardiac glycosides; Decompensated diabetes mellitus; pregnancy; the period of breastfeeding.
    Pregnancy and lactation:When using beta-adrenomimetics in early pregnancy at doses recommended for inhalation therapy, no adverse effects on the condition of the mother and fetus were detected.However, when it is necessary to use salbutamol in pregnancy, the expected benefit to the mother and the potential risk to the fetus should be assessed. At present, there is insufficient data on the safety of salbutamol in early pregnancy. Salbutamol excreted in breast milk; therefore, if it is necessary to use during breastfeeding, the expected benefit of treatment for the mother and the possible risk to the child should also be assessed.
    Dosing and Administration:

    The drug Salbutamol-Teva is intended for inhalation with an inhalation device (see "Instructions for the patient on the use of inhalation device ").

    Adults and children over 2 years

    For cupping bronchospasm: on 100 mkg (1 inhalation) 1-4 times a day. If necessary, the dose may be increased to 200 mcg (2 inhalations) 1-4 times a day. For the prevention of bronchospasm: on 100 200 mkg (1-2 inhalations) for 15-30 minutes before physical exertion or possible exposure to an allergen. The maximum daily dose should not exceed 800 mcg (8 inhalations) during the day.

    Between each dose taken must pass at least 4 hours

    Instructions for the patient to use the inhalation device
    Before using the inhalation device for the first time, or if you have not used it for a while, it is necessary to check its health by pressing the valve of the can and releasing the dose of the medicine into the air.
    1. Remove the protective cap from the inhalation device and make sure that the outlet tube of the inhalation device is clean. Keep the inhalation device between the index and thumb in an upright position, with the thumb on the bottom of the inhalation device and the index finger on the dosing valve of the aluminum bottle.
    2. Shake the aluminum canister intensively up and down.
    3. Take a deep breath through your mouth. Clamp the mouth of the inhalation device tightly with your lips.
    4. Take a slow and deep breath. At the moment of inspiration, press the index finger on the balloon metering valve, releasing the dose of Salbutamol-Teva, continue to inhale slowly.
    5. Remove the inhalation device from the mouth and hold your breath for 10 seconds or at a time that will not cause you any discomfort. Slowly exhale.
    6. After inhalation, rinse your mouth with water, trying not to swallow the aerosol that was ingested during the inhalation on the mucous membrane of the mouth.
    7. If more than one dose is required, wait 1 minute and repeat all steps from step 2 to step 6.
    8. Close the inhalation device with a protective cap.
    In steps 3 and 4, do not rush. At the time of release, it is important to inhale as slowly as possible. Before use, practice in front of the mirror. If you notice "steam" coming from the top of the can or from the corners of the mouth, then start again from step 2.

    Cleaning the inhaler
    The inhalation device should be cleaned at least once a week. Remove the aluminum can from the inhalation device. Gently rinse the inhalation device and protective cap with warm water. Do not use hot water! Shake the inhalation device and the protective cap to remove the remaining water and dry them without using heating devices. Do not allow the aluminum container to come into contact with water!

    Side effects:
    The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%,but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rare (including isolated cases) - less than 0.01%; frequency unknown - insufficient data to estimate the frequency of the phenomenon in the population.
    From the cardiovascular system: often - tachycardia; infrequent - a feeling of heartbeat; very rarely - rhythm disturbance (including atrial fibrillation, supraventricular tachycardia and extrasystole); frequency unknown - myocardial ischemia (cause not known).
    Co of the central nervous system (CNS): often - headache, generalized tremor, anxiety; rarely - sleep disorders and hallucinations (especially in children), hyperactivity (in children); very rarely - dizziness, tension.
    From the respiratory system, chest and mediastinum: infrequently-irritation of the mucous membrane of the pharynx; very rarely - a paradoxical bronchospasm.
    From the digestive system: infrequently - irritation of the mucous membrane of the mouth and pharynx, dryness of the mucous membrane of the oral cavity and pharynx; very rarely - nausea, vomiting.
    From the skin: very rarely - itchy skin, dermatitis.
    From the musculoskeletal system: infrequently - myalgia; very rarely - a small tremor (particularly the hands).
    Allergic reactions: very rarely - hypersensitivity reactions (hives, Quincke's edema, arterial hypotension and collapse).
    Other: rarely - hypokalemia, hyperglycemia, lactic acidosis
    Overdose:
    Symptoms: nausea, vomiting, increased excitability, tachycardia, ventricular flutter, lowering of arterial pressure, hypoxemia, lactic acidosis, hypokalemia, hyperglycemia, muscle tremor, headache, hallucinations.
    Treatment: symptomatic; when tachycardia is administered cardioselective beta-blockers. The appointment of selective beta 1-blockers in patients with bronchial asthma requires extreme caution because of the high risk of bronchospasm.
    Interaction:
    Salbutamol is incompatible (pharmacological antagonism) with nonselective beta-blockers, including propranolol, which must also be taken into account when using eye forms of beta-blockers.
    Due to the hypokalemic effect salbutamol enhances the effect of psychostimulating agents on the central nervous system,strengthens cardiotropic action of thyroid hormones, increases the likelihood of developing intoxication with cardiac glycosides.
    Theophylline and other xanthines, when used simultaneously with salbutamol, increase the likelihood of developing tachyarrhythmias; means for inhalation anesthesia, levodopa severe ventricular arrhythmias.
    Possible increase in the number of heartbeats and increased blood pressure when taking salbutamol may necessitate correction of the dose of antihypertensive and antianginal drugs.
    Monoamine oxidase inhibitors, tricyclic antidepressants and cardiac glycosides can enhance the beta-adrenergic effect of salbutamol and lead to a sharp drop in blood pressure.
    With simultaneous use with anticholinergic drugs (including inhalation) may help increase intraocular pressure. Diuretics and glucocorticosteroids (GCS) increase the hypokalemic effect of salbutamol.
    Patients should be instructed to stop taking salbutamol 6 hours before anesthesia with halogen anesthetics.
    Special instructions:
    Before using Salbutamol-Teva it is necessary to make sure that the patient correctly uses the inhalation device to ensure sufficient dosing of the drug.
    Patients using Salbutamol-Teva at home should be warned that if the usual dose becomes less effective or less prolonged, you can not increase the dose or frequency of the drug on your own, but you should immediately consult a doctor.
    A sudden and progressive deterioration in the ability to control the onset of bronchospasm attacks is potentially life-threatening. Consideration should be given to changing the treatment regimen for the patient and / or prescribing additional concomitant therapy.
    Patients who have long-term inhalation of Salbutamol-Teva should visit their doctor regularly.
    Avoidance of aerosol for inhalation in the eyes should be avoided. Care should be taken when treating severe bronchial asthma with high doses of salbutamol. treatment may be accompanied by an increase in the content of lactic acid in the blood serum and, in rare cases, lactic acidosis may develop.
    Patients with concomitant severe cardiovascular diseases, including coronary heart disease, tachyarrhythmias, severe heart failure, hypertrophic obstructive cardiomyopathy, should be warned that with the appearance or increase of symptoms such as pain in the heart, palpitation, an increase in the number of heartbeats, dyspnea, it is necessary to urgently consult a doctor.
    As in the case of other inhalation therapies, there may be cases of paradoxical bronchospasm. In this case, you must immediately stop taking the drug with the appointment of an alternative treatment.
    Salbutamol should be given with caution to patients with thyrotoxicosis. Treatment with beta2-adrenomimetics can lead to severe hypokalemia. Particular caution should be exercised in cases of severe bronchial asthma, since the onset of hypokalemia may be facilitated by concomitant treatment with xanthine derivatives, glucocorticosteroids, diuretics, diuretics, and hypoxia.In such situations it is recommended to monitor the potassium concentration in the serum.
    When used simultaneously with cardiac glycosides, it should be borne in mind that hypokalemia can contribute to the development of intoxication with cardiac glycosides. In patients with diabetes when used beta2-agonists should be considered the possibility of increasing the concentration of glucose in the blood plasma, and, in rare cases, the development of ketoacidosis. The concomitant use of GCS can aggravate this condition. To prevent the decompensation of the course of diabetes, regular monitoring of blood glucose concentration and correction of dosage of hypoglycemic agents should be carried out.
    Aluminum canister with the drug Salbutamol, Teva can not puncture, disassemble or heat up, even if it is empty.
    Effect on the ability to drive transp. cf. and fur:In connection with the possible development of dizziness during treatment with Salbutamol-Teva must be careful when driving and other lesson potentially dangerous activities which require high concentration and psychomotor speed reactions.
    Form release / dosage:
    Aerosol for inhalation dosed with 100 μg / dose.

    Packaging:
    For 200 doses in an aluminum canister with a metering valve, equipped with an inhalation device with a protective cap.
    On 1 cylinder together with the instruction on application place in a cardboard pack.
    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:Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013290 / 01
    Date of registration:30.12.2011
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp18.08.2015
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