The instruction for medical use
the Trade name
the International unlicensed
name Salbutamol Dosage Form Aerosol for inhalations dosed of 100 mkg / a dose, 200 doses
One dose contains
active agent – salbutamol of sulfate of 120.5 mkg (it is equivalent to salbutamol of 100 mkg),
excipients: tetraftoretan, oleic acid, ethanol.
Uniform suspension of white color
Drugs for treatment of obstructive respiratory diseases. A beta 2 — adrenostimulyator selection.
The ATX R03AC02 code
Pharmacokinetics Later properties of inhalation about 10-20% of active agent reaches small bronchial tubes, other quantity settles in upper parts of airways. At intake, including at partial ingestion at inhalation, salbutamol is well absorbed from digestive tract. Presistemny metabolism of salbutamol happens generally in digestive tract by conjugation to ether of inactive sulfate. Because of gradual absorption from bronchial tubes, system levels of salbutamol are low after inhalation of the recommended dose. The maximum concentration in plasma are reached in 2-4 hours. Communication with proteins of plasma – 10%. Gets through a placenta. The system clearance of salbutamol is 30 liters/hour. Salbutamol is removed with urine in not changed look and in the form of a fenolsulfatny metabolite. Elimination half-life makes from 3 to 7 hours. About 72% of a dose are removed with urine a course of 24 hours and consist of 28% of not changed drug and 44% of a metabolite. Salbutamol does not pass through a blood-brain barrier.
Salbutamol is selection agonist β2-адренорецепторов. It stimulates in therapeutic doses β2-адренорецепторы smooth muscles of bronchial tubes, having insignificant impact or without influencing on β1-адренорецепторы at all. Renders bronkhodilatiruyushchy effect, warning or stopping a spasm of bronchial tubes, increases the vital capacity of lungs, reduces resistance in airways. Thus, salbutamol has fast broncholitic effect which lasts for 4-6 hours.
In the recommended therapeutic doses has no negative impact on a cardiovascular system, does not cause increase in arterial blood pressure. To a lesser extent, in comparison with medicines of this group, renders positive hrono- and inotropic action. Causes expansion of coronary arteries.
Has a number of metabolic effects: reduces potassium concentration in plasma, influences a glycogenolysis and discharge of insulin, renders hyper glycemic (especially at patients with bronchial asthma) and the lipolytic effect, increases risk of developing acidosis.
– symptomatic treatment of a bronchospasm, bronchial asthma and/or reversible impassability of airways
– prevention of the bronchospasm caused by physical activity or in situations of inevitable influence of allergen
the Route of administration and doses
Is applied only is inhalation according to the recommendations of the doctor. Salbutamol can be used with a spacer to patients, it is difficult to them to synchronize an aerosol dose with a breath.
Adults (including elderly patients)
apply 100 mkg (1 inhalation) To the termination of a bad attack of a bronchospasm and episodes of intermittent asthma. The dose can be increased to two inhalations if it is necessary.
For prevention of the attack of the bronchospasm caused by physical activity or connected with allergen influence, 1 or 2 inhalations in 10-15 minutes prior to influence of a provocative factor.
The maximum recommended daily dose makes 200 mkg (2 inhalations) 3 or 4 times a day.
Children: the recommended dose for simplification of acute symptoms of asthma, including a bronchospasm, or before influence of allergen or physical activity of 100 mkg (1 inhalation). For prevention of an attack – to 100-200mkg (1-2 inhalations) 4 times a day. If the answer is inadequate, it is possible to use more than one inhalation.
The maximum recommended daily dose makes 100 mkg 4 times a day.
Broncholitic action after each use continues not less than 4 hours, except patients at whom asthma progresses. In case of need increases in a dose or use of system glucocorticosteroids it is necessary to consult with the doctor.
Need of increase in a dose demonstrates progressing of a disease.
Increase in a dose is possible only according to the recommendation of the doctor because of possible development of side effects.
IInstruktsiya on use of an inhaler
Effect of drug can be weakened if an inhaler cold. When cooling a barrel it is recommended to get it from the plastic body and to warm with hands within several minutes. The barrel cannot be sorted, punctured and thrown into fire even if it is empty.
Check of serviceability of an inhaler
it is careful to uncover a mouthpiece, to vigorously stir up an inhaler and to spray two doses of drug in air. If the inhaler was not used within several days, it is good to stir up and spray one dose of drug in air to be convinced of serviceability.
Use of an inhaler
of A. To remove a protective cap from an inhaler mouthpiece. Whether to check a clean and dry mouthpiece.
B. To vigorously stir up an inhaler.
C. To place an inhaler vertically between big and index fingers, having placed a thumb on the basis of, below a mouthpiece.
D. To make a deep exhalation. Then to place a mouthpiece between teeth (without biting it) and to clasp densely with lips.
E. To make a deep breath through a mouth. Continuing to take a deep breath, to press an upper part of an inhaler. pressing of an inhaler has to be at the beginning of a quiet, deep breath.
F. To hold the breath, to take out an inhaler from a mouth and to take away a forefinger from an upper part of an inhaler. To continue to constrain breath as far as it is possible.
H. If it is necessary to continue inhalations, it is necessary to wait about half-minute, holding an inhaler vertically, and then to repeat stages with In on F. After inhalation to put on a dustproof cap a mouthpiece.
Drug is used on doctor’s orders and it is necessary to inform it on any difficulties connected with administration of drug.
By-effects are listed below, proceeding from classification by frequency. Classification of frequency: very often (1/10), it is frequent (1/100, but & lt, 1/10), infrequently (1/1000, but & lt, 1/100), is rare (1/10,000, but & lt, 1/1000) and is very rare (& lt, 1/10000).
– tachycardia, a tremor, a headache, dizziness
– heartbeat, feeling of tension
– nausea, vomiting
– irritation of a mucous membrane of a mouth and throat, change of flavoring feelings
– a muscular spasm
– a hypopotassemia which can be exponentiated by corticosteroids, diuretics and xanthines
– peripheral vasodilation
– muscular spasms
– reactions of hypersensitivity (Quincke’s disease, a small tortoiseshell, a bronchospasm, hypotension and collapse)
– a paradoxical bronchospasm
– disturbance of a warm rhythm, cardiac arrhythmia, including an atrial fibrillation fibrillation of auricles, supraventricular tachycardia and premature ventricular contraction, myocardium ischemia
– drowsiness, fatigue, a stethalgia
As well as in a case with other types of inhalation treatment, can arise a paradoxical bronchospasm with immediate strengthening of goose breathing after drug use. Such state has to be eliminated by means of inhalation bronchodilator of fast action from other pharmacological group. Use of the drug Salbutamol, 100 mkg / a dose has to be immediately stopped, if necessary – alternative treatment is appointed.
– hypersensitivity to any of drug components
– children’s age up to 2 years at use of an inhaler without spacer
Salbutamol are not recommended to be accepted together with other sympathomimetic bronchodilators in the form of inhalations. In case of need uses of adrenergic drugs it is necessary to be careful to avoid disturbance of warm activity.
Salbutamol cannot be accepted together with non-selective beta blockers (including eye dosage forms of beta blockers). Parallel use of cardioselective beta-blockers does not reduce effect of salbutamol. Simultaneous treatment by ksantinovy derivatives, diuretics and glucocorticosteroids can contribute to the development of a serious hypopotassemia. Also together with salbutamol it is impossible to appoint the general anesthetics, tricyclic antidepressants and Maprotilinum, ergotamine and MAO inhibitors. In case of simultaneous use of salbutamol and cardiac glycosides the risk of the arrhythmia caused by a hypopotassemia owing to use of beta-agonists increases.
Patsiyentov it is necessary to warn about need of phase-out of salbutamol at least in 6 hours prior to anesthesia with use of the halogenated anesthetics.
instructions Drug it has to be used through the fixed time intervals according to the recommendations of the doctor. If you passed a dose, it is necessary to use drug immediately as soon as you remembered it, but never accept two doses at once.
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 take a break in several hours (6 h). Reduction of these intervals can take place only in exceptional cases. At use of the dosed aerosol the accurate implementation of the following instructions is necessary: stirring of a barrel with aerosol before each use, accurate synchronization of a breath and intake of drug, the deepest, intensive and rather long breath, breath holding after inhalation on 10 pages. Patients, including children of younger age, it is difficult for them to execute correctly respiratory maneuver, are recommended to use the special adaptation (spacer) increasing respiratory volume and smoothing inaccuracies of an asynchronous breath for drug inhalation.
Treatment of asthma usually has to follow according to the step program at which constant clinical control using tests of function of a respiratory system is necessary.
Bronchodilators should not be the only or main method of treatment of patients with asthma easy persistent, moderate, heavy and unstable. Heavy asthma demands constant medical control as at such patients the risk of heavy asthmatic crisis or even death is high. In such cases the attending physician has to consider the possibility of purpose of the maximum recommended dose or glucocorticoids in the form of inhalation or inside.
Increase in need of use of bronchodilators of short-term action in the form of inhalation for stopping of symptoms, indicates weakening of control of an asthmatic disease. The patient has to be warned that if bronchodilators of short-term action lose the efficiency or more inhalations, than usually are required, he should report about it to the doctor immediately. In such cases it is necessary to overestimate treatment and to consider the possibility of purpose of anti-inflammatory therapy (for example, glucocorticoids in the form of inhalations or a course of glucocorticoids inside).
The sudden and progressing deterioration in an asthmatic disease can threaten the patient’s life, in this case it is necessary to consider the possibility of use of corticosteroids. For patients of risk group it is necessary to exercise day control of the maximum lung volume.
If earlier used effective dose of salbutamol in the form of inhalation is not able to stop symptoms, at least for 3 hours, the patient is recommended to see a doctor for making decision on use of additional measures.
For increase in efficiency of therapy of the patient it is necessary to train in the correct use of an inhaler and in an initiation of treatment to apply an inhaler under observation of medical personnel.
With care appoint salbutamol to patients with a thyrotoxicosis, heart failure, hypertensia, aneurysm, disturbance of tolerance to glucose, diabetes, a pheochromocytoma, myocardium ischemia, tachycardia and a hypertrophic subaortic stenosis and when sharing with cardiac glycosides,
the Patients having cardiovascular diseases including in the anamnesis, for example, coronary heart disease, arrhythmia or heavy heart failure, when prescribing of salbutamol it have to be warned rather obligatory address to the doctor in case of developing of a stethalgia or other symptoms of exacerbation of a cardiovascular disease. It is necessary to estimate attentively emergence of such symptoms as short wind and a stethalgia as they can be a consequence of both cardiovascular, and bronchopulmonary functional disturbances.
Use of agonists beta 2 – adrenoceptors can cause potentially dangerous hypopotassemia. The extra care should be observed at heavy attacks of asthma as this effect can be enhanced by combined use of derivatives of xanthine, steroids, diuretics and a hypoxia. In such situations it is regularly recommended to control potassium concentration levels in serum.
Salbutamol and non-selective beta blockers should not be applied together (pharmacological antagonism).
Salbutamol contains a component which can yield positive take at doping control.
Use by elderly patients
of Correction of a dose is not required.
Children: use of drug has to take place under observation of the adult.
Pregnancy and the period of a lactation
In separate researches is revealed a polydactylia at children against the background of reception by mothers during salbutamol pregnancy (the unambiguous causal relationship of its emergence is not established with administration of drug). In pilot studies the presence of teratogenic effect at salbutamol is revealed: at mice at p / to introduction (the doses by 11.5-115 times exceeding maximum recommended at the person for inhalation introduction) development of a wolf mouth, at rabbits was noted at oral appointment (the doses by 2315 times exceeding maximum for inhalation introduction) – not fusion of bones of a skull. Adrenergic bronchodilators can be applied at pregnancy as the potential risk of a placentary anoxemia for a fruit against the background of uncontrollable bronchial asthma considerably exceeds the risk connected with their use. However at their use during pregnancy it is necessary to be careful as adrenergic bronchodilators can cause tachycardia and a hyperglycemia in mother (especially in the presence of diabetes) and a fruit and also to cause a retarde birth, decrease in the ABP, a fluid lungs in mother. It is recommended to apply salbutamol at pregnancy only in urgent cases and when the expected advantage exceeds potential risk for a fruit.
In case of need uses of drug during feeding the breast recommends to refuse breastfeeding.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Should refrain from driving and work with mechanisms to those patients at whom, especially at high doses, specific side reactions, especially in an initiation of treatment are observed or at combined use with alcohol. At control of motor transport and work with mechanisms it is necessary to be careful because of a possibility of side reactions on salbutamol, such as muscular spasms and tremor
Symptoms: more frequent – a hypopotassemia, a lowering of arterial pressure, excitement, tachycardia, a muscular tremor, nausea, vomiting, less frequent – a hyperglycemia, a respiratory alkalosis, an anoxemia, a headache, rare – hallucinations, spasms, a tachyarrhythmia, trembling of ventricles, expansion of peripheral vessels.
Treatment: at salbutamol overdose the best antidotes are cardioselective beta blockers. However blockers of β-adrenoceptors need to be applied with care because of danger of emergence of a bronchospasm. Use of high doses of salbutamol can cause a hypopotassemia therefore at suspicion on overdose it is necessary to control potassium level in blood serum and to fill shortage oral drugs of potassium, except for patients with a heavy hypopotassemia, in this case intravenous administration of drugs of potassium can be required.
The form of release and packing
the Aerosol for inhalations dosed of 100 mkg / a dose, place 200 doses in the aluminum cylinder supplied with the dosing valve, a raspylitelny nozzle and a protective cap.
On 1 cylinder together with the instruction for medical use in the state and Russian languages place in a pack from cardboard
to Store at a temperature not over 30 ºС.
To store out of children’s reach!
To protect from influence of direct sunshine, not to store near heat sources.
Not to freeze.
not to apply a period of storage upon termination of an expiration date.
According to the prescription
the Producer Laboratorio Aldo Union S.A., to / Baronessa de Malda, 73 08950 Esplugues de Liobregat, Barcelona, Spain
the Name and the country of the owner of the registration certificate
of CJSC Inteli Generix Nord,
Sheyminishkyu 3 St., 09312 Vilnius, Republic of Lithuania
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of the Laboratorio organization packer Aldo Union S.A., Spain
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