The instruction for medical use
A 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 of salbutamol sulfate of 120.5 mkg (it is equivalent to salbutamol of 100 mkg),
excipient – 1,1,1,2-tetraftoretan (HFA-134a propellant), ozone-safe.
Homogeneous suspension of white or almost white color.
Drugs for treatment of obstructive respiratory diseases. Inhalation sympathomimetics. Beta2-adrenostimulyatora selection. Salbutamol.
ATX R03AC02 code
Pharmacokinetics At properties use of aerosol from 10 to 20% of the accepted dose reaches the lower airways where it is adsorbed by pulmonary fabric and gets into vessels of lungs, but is not exposed to metabolism here. The rest remains in the delivery device or settles in a stomatopharynx with further swallowing drug.
The maximum concentration in plasma are reached in 2-4 hours.
Linking with proteins of plasma makes 10%.
At achievement of thresholds the system of circulation, salbutamol is metabolized by means of the hepatic mechanism and emitted mainly with urine in the form of an invariable product and phenol of sulfate.
Salbutamol at the first passing through a liver is metabolized and, in connection with swallowing small amounts in the course of inhalation, in an intestines wall, the main metabolite an inactive sulphatic conjugate which are removed with urine.
Т½, salbutamol at intravenous administration makes 4-6 hours. Salbutamol is quickly removed with urine in the form of an inactive metabolite of 4-O-sulfate and not changed substance, in small amounts is removed with a stake. The most part of the accepted salbutamol is brought out of an organism within 72 hours. Salbutamol does not pass through a blood-brain barrier.
Salbutamol selection agonist 2 of adrenoceptors. Stimulates 2 adrenoceptors of muscles of bronchial tubes in therapeutic doses, rendering broncholitic effect.
Salbutamol has the short duration of action (from 4 to 6 hours) and quick start of action (about 5 minutes from the moment of use).
In the recommended therapeutic doses has no negative impact on a cardiovascular system, does not cause increase in arterial blood pressure.
the Clinical trials conducted at children are younger than 4 years, proved a similar profile of safety in comparison with children of more advanced age, teenagers and adults.
– stopping and prevention of development of a bronchospasm in patients with reversible obstruction of airways (asthma, chronic bronchitis, emphysema)
– for relief of symptoms of an attack of bronchial asthma or their prevention before contact with the known trigger (allergen). Bronchodilators should not be the only or main component of therapy of bronchial asthma. If the patient with asthma does not respond to therapy with salbutamol, it is recommended to apply inhalation GKS to achievement and maintenance of control of symptoms. The insufficient response to therapy by salbutamol can be a signal to urgent medical intervention / therapy.
The route of administration and doses
Salbutamol in the form of aerosol is applied only to inhalations by inhalation of aerosol through a mouth.
Increase in need for intake of 2 agonists can demonstrate deterioration in a course of asthma. In such cases it is recommended to carry out the repeated assessment of the carried-out therapy and to consider the possibility of additional purpose of GKS.
Due to the risk of emergence of side reactions when exceeding the recommended doses, the frequency of reception and the applied doses have to increase only on doctor’s orders.
Duration of effect of the drug Salbutamol at most of patients is 4-6 h.
The persons having difficulties with coordination of a breath and release of medicine from an inhaler can use the drug Salbutamol by means of the device in the form of a spacer.
The need for administration of drug should not exceed 4 times a day (800 mg). Sudden increase in need for drug indicates deterioration in a course of asthma.
To children 4 years are younger use the drug Salbutamol through a spacer.
Stopping of a bad attack of a bronchospasm
Adults: from 100 mkg to 200 mkg of the drug Salbutamol once.
Children: 100 mkg once. In case of need it is possible to increase a dose to 200 mkg.
Prevention of the bronchospasm caused by physical activity or an allergic etiology
Adults: 200 mkg before physical activity or the expected contact with allergen
Children: 100 mkg before physical activity or the expected contact with allergen. In case of need it is possible to increase a dose to 200 mkg.
Long maintenance therapy
by the Adult and to children of 100-200 mkg of drug 4 times a day.
Duration of treatment is determined by the attending physician.
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
Before the first use of an inhaler it is necessary to uncover carefully a mouthpiece, to vigorously stir up an inhaler and to spray two doses of drug in air to be convinced of serviceability of the device. If the inhaler was not used within 5 days and more, it is necessary to stir up and spray it well two doses of drug in air to be convinced of its serviceability.
Use of an inhaler
1. To remove a protective cap from an inhaler mouthpiece. To check internal and external parts of an inhaler, including a mouthpiece, regarding purity and dryness and also regarding existence of loose parts of the device.
2. To vigorously stir up an inhaler for uniform hashing of contents of an inhaler and also for removal of all loose parts from the surface of the device.
3. To place an inhaler vertically between big and index fingers, having placed a thumb on the basis of, below a mouthpiece.
4. To make an exhalation deep (as far as possible). Then to place a mouthpiece between teeth (without biting it) and to clasp densely with lips.
5. To make a deep breath through a mouth. Continuing to take a deep breath, to press an upper part of an inhaler.
6. 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.
7. If it is necessary to continue inhalations, it is necessary to wait about half-minute, holding an inhaler vertically, and then to repeat stages from the 2nd for the 6th.
8. After inhalation it is careful to put on a dustproof cap a mouthpiece.
you do not hurry when performing the actions specified in Paragraph 4, 5 and 6. It is important that pressing of an inhaler came at the beginning of a quiet, deep breath. To be sure that inhalation is executed correctly, it is necessary to control for a start a way of drug intake in front of the mirror. Appearing during inhalation from an inhaler, lips or a nose of a smoke points to the wrong technology of inhalation and it is necessary again, to practice starting with Paragraph 2 in use of an inhaler.
If your doctor made to you any other recommendations about drug use, follow the recommendations of your doctor. Inform the doctor on any difficulties connected with administration of drug.
Cleaning of an inhaler
it is necessary to clean the Inhaler not less once a week.
1. To take a metal container from the plastic body of an inhaler and to uncover a mouthpiece.
2. To wash the spray with warm flowing water.
3. To carefully dry the spray from within and outside.
4. To place back into place a container and a cover of a mouthpiece.
DO NOT LOWER the METAL CONTAINER IN WATER.
Very often (& gt, 1/10), it is frequent (& gt, 1/100, & lt, 1/10), infrequently (& gt, 1/1.000, & lt, 1/100), is rare (& gt, 1/10.000, & lt, 1/1.000), is very rare (& lt, 1/10.000).
– a tremor, a headache
– irritation of a mucous membrane of a mouth and throat
– heart consciousness
– a hypopotassemia (therapy by 2 agonists can lead to the expressed hypopotassemia)
– expansion of peripheral vessels
is Very rare
– reactions of hypersensitivity, including urticaria, a Quincke’s disease, a bronchospasm, hypotonia, collapse
– a paradoxical bronchospasm
– lactoacidosis (at the patients receiving salbutamol in the form of intravenous injections and by means of the nebulizer for treatment of exacerbations of bronchial asthma)
– arrhythmia, including an atrial fibrillation, supraventricular tachycardia and premature ventricular contraction
the Providing data on expected side reactions of drug is very important point allowing to carry out continuous monitoring of a ratio risk/advantage of medicine. Health workers should provide information on any expected adverse reactions on the contacts specified at the end of the instruction for medical use and also through the national system of collection of information.
– hypersensitivity to any component which is a part of drug
– premature births
– the menacing abortion
of the Form of production of salbutamol, not intended for intravenous administration, should not be applied to the termination of premature births and the menacing abortion.
it is not recommended to use at the same time the drug Salbutamol and non-selective blockers – adrenoceptors, such as propranolol.
The drug Salbutamol is not contraindicated to patients who receive monoamine oxidase inhibitors (IMAO).
to Children are younger than 4 years use the drug Salbutamol through a spacer.
Treatment of asthma is usually carried out step by step, at the same time reaction of the patient should be controlled clinically and according to functional pulmonary tests.
Increase in need for intake of 2 agonists can demonstrate deterioration in control of asthma. In such cases it is necessary to revise the treatment plan of the patient.
The sudden and progressing deterioration in bronchial asthma can pose a threat for the patient’s life therefore in similar situations it is necessary to resolve urgently an issue of appointment or increase in a dose of glucocorticosteroids. At such patients it is recommended to carry out daily monitoring of peak expiratory rate.
With care use drug at patients with a thyrotoxicosis, heart failure, myocardium ischemia, a tachyarrhythmia, a hypertrophic cardiomyopathy.
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.
Therapy by agonists of b2-adrenoceptors, especially at their introduction parenterally or by means of the nebulizer, can lead to a hypopotassemia. The extra care is recommended to be shown at treatment of heavy attacks of bronchial asthma as in these cases the hypopotassemia can amplify as a result of simultaneous use of derivatives of xanthine, glucocorticosteroids, diuretics and also owing to a hypoxia. In such situations it is necessary to control potassium level in blood serum.
As well as in a case using other inhalation drugs, development of a paradoxical bronchospasm as a result of emergence of a spasm right after introduction of a dose is possible. At emergence of a paradoxical bronchospasm its immediate stopping by means of alternative drug or high-speed inhalation bronchodilator from other pharmacological group is required. It is necessary to stop immediately treatment by this form of Salbutamol, and if necessary to appoint other high-speed bronchodilators for further use.
If action of a usual dose of the drug Salbutamol becomes less effective or less long (effect of drug has to remain not less than 3 hours), the patient should see a doctor.
The doctor has to be convinced of correctness of use of an inhaler by the patient and synchronization between reduction of the device in action and a breath for optimum delivery of drug to lungs.
Salbutamol should be applied with care at patients who already accepted high doses of other sympathomimetics.
As well as other agonists of beta adrenoceptors, salbutamol increase in concentration of glucose in blood can cause reversible metabolic changes, for example. At patients with diabetes the development of a decompensation, and in some cases development of ketoacidosis is possible. Simultaneous use of glucocorticosteroids can enhance this effect.
At intravenous use and also when using solution for the nebulizer of beta-agonists of short action, very exceptional cases developing of milk acidosis connected with high therapeutic doses at patients with exacerbation of bronchial asthma are described. Increase in level of a lactate leads to short wind and a compensatory hyperventilation which can be mistakenly interpreted as symptoms of the wrong treatment of asthma. It can lead to wrong increase in doses of beta-agonists of short action therefore it is recommended to carry out monitoring of increase in level of a lactate in serum and, therefore, a metabolic acidosis.
the person has no data on influence of drug on fertility. Drug has no negative impact on fertility of animals.
Pregnancy and the period of a lactation
Use of drug during pregnancy and a lactation is justified only when the expected advantage for mother exceeds risk for the fruit/baby. Salbutamol is probably emitted with breast milk.
In separate researches the polydactylia and splitting of the sky at children against the background of reception by mothers is revealed during pregnancy of drugs among which there was a salbutamol (the unambiguous causal relationship of their emergence is not established with administration of drug) in this connection degree of risk is estimated as 2-3%. In pilot studies the presence of teratogenic effect of salbutamol is revealed: at mice at p / to introduction (doses, at 11.5-115 time exceeding most 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.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering possible side effects, it is necessary to be careful when driving and potentially dangerous mechanisms.
Symptoms: the majority of symptoms of overdose by salbutamol are passing side reactions of beta-agonists.
At overdose the development of a hypopotassemia in this connection monitoring of level of potassium in blood serum is necessary is possible.
At use of high therapeutic doses and overdose by beta-agonists of short action the development of lactic acidosis was revealed.
Treatment: 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. Control of level of a lactate and the subsequent development of a metabolic acidosis (especially at presence is necessary or at deterioration in a tachypnea despite elimination of a bronchospasm).
A form of release and packing
the Aerosol for inhalations dosed 100 mkg / a dose, 200 doses.
On 200 doses place 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 storage conditions at
a temperature not higher than 30 S. Zashchishchat from light and overcooling.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
According to the prescription
Glakso Vellk Production, France
Zone Idustrelle n ‘2, 23 rue Lavoisier, 27000 EVREUX
Glakso Vellk Production, France
Zone Idustrelle n’ 2, 23 rue Lavoisier, 27000 EVREUX
Owner of the registration certificate
Laboratori GlaksoSmitKlyayn, France
100, rout de Versailles 78163 MARLY-LE-ROI Cedex
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Predstavitelstvo kompanii GlaksoSmitKlyayn Export Ltd in
Kazakhstan 050059, Almaty, Furmanov St., 273
Phone number: +7 727 258 28 92, +7 727 259 09 96
Fax number: + 7 727 258 28 90
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