The instruction for medical use
of SALBUTAMOL medicine
the Trade name
the International unlicensed
name Salbutamol Dosage Form Aerosol for inhalations dosed, 100 mkg / a dose
1 cylinder contains
active agent: salbutamol of sulfate of 0.029 g (in a look recalculation for 100% substance, is equivalent to salbutamol) 0.024 g
excipients: oleyl alcohol of 0.015 g, ethanol (the alcohol rectified) of 0.485 g, R 134a propellant (1,1,1,2-tetraftoretan, HFA 134a) 13.659 g (up to 12.00 ml).
Drug represents the white or almost white suspension which is sprayed at an exit from a cylinder in the form of an aerosol stream.
Drugs for treatment of obstructive respiratory diseases. Inhalation sympathomimetics. Beta2adrenostimulyatory selection.
The ATX R03AC02 code
Pharmacokinetics Later properties of inhalation introduction of 10-20% of a dose of salbutamol reach the lower airways. The rest of a dose remains in an inhaler or settles on a mucous membrane of a stomatopharynx and then is swallowed. The fraction which settled on a mucous membrane of airways is absorbed in pulmonary fabrics and blood, but not metabolized in lungs.
Extent of linking of salbutamol with proteins of plasma makes about 10%.
Salbutamol is metabolized in a liver and excreted mainly with urine in not changed look and in the form of phenolic sulfate. The swallowed part of an inhalation dose is absorbed from digestive tract and is exposed to active metabolism at the first passing through a liver, turning into phenolic sulfate. Not changed salbutamol and a conjugate are excreted mainly with urine.
Elimination half-life of salbutamol of 4-6 h. It is removed by kidneys partially in not changed look and partially in the form of an inactive metabolite 4′ – About-sulfate (phenolic sulfate). An insignificant part is removed with bile (4%), with
a stake. The most part of a dose of salbutamol is excreted during 72 h.
Salbutamol is selection agonist of b2-adrenoceptors. In therapeutic doses it affects b2-adrenoceptors of smooth muscles of bronchial tubes, having insignificant impact on myocardium b1-receptors. Renders the significant bronkhodilatiruyushchy effect, warning or stopping a spasm of bronchial tubes, reduces resistance in airways. Increases the vital capacity of lungs.
After use of inhalation forms the action develops quickly, the beginning of effect – in 5 min., at most – in 30-90 min. (75% of the maximum effect are reached within 5 min.), duration – 4-6 h.
as a part of complex therapy:
– for stopping and prevention of development of a bronchospasm in patients with reversible obstruction of airways (asthma, chronic bronchitis, emphysema)
– for stopping and prevention of attacks of bronchial asthma before an expected attack
of Bronkhodilyatatora 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 aerosol for inhalations dosed 100 mkg / a dose is intended only for inhalation introduction.
To resolve an issue of increase in a dose or frequency of use of drug
only the doctor can.
It is not recommended to use drug more often than 4 times a day. The need for frequent use of the maximum doses of drug or for sudden increase in a dose demonstrates deterioration in a course of the disease.
Adults (including patients of advanced age). Long maintenance therapy in bronchial asthma as a part of complex therapy: the recommended dose makes to 200 mkg (2 inhalations) 4 times a day.
Stopping of an attack of a bronchospasm: the recommended dose makes 100-200 mkg (1-2 inhalations).
Prevention of the attacks of a bronchospasm connected with influence of allergen or caused by physical activity: the recommended dose makes 200 mkg (2 inhalations) in 10-15 min. prior to influence of a provocative factor.
Children since 2 years. 100 mkg once. In case of need it is possible to increase a dose to 200 mkg.
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.
Rules of use of drug:
Preparation for the first use:
Before the first use of drug it is necessary to remove a protective cap from a nozzle inhaler. Then vigorously to stir up a cylinder vertical movements, to turn a cylinder a nozzle inhaler down and to make two squirts in air to be convinced of adequate operation of the valve. At a break in use of drug for several days it is necessary to make one dispersion in air after careful stirring of a cylinder.
1. To remove a protective cap from a nozzle inhaler. To be convinced of purity of internal and external surfaces of a nozzle inhaler.
2. To vigorously stir up a cylinder vertical movements.
3. To turn a cylinder a nozzle inhaler down, to hold a cylinder vertically between a thumb both average and index fingers so that the thumb was under a nozzle inhaler.
4. To make the deepest exhalation, then to place a nozzle inhaler in a mouth between teeth and to capture it lips, without biting at the same time.
5. Beginning a breath through a mouth, to press an upper part of a cylinder to make delivery of a dose of drug, at the same time to continue to inhale slowly and deeply.
6. To hold the breath, to take out a nozzle inhaler from a mouth and to remove a finger from an upper part of a cylinder. To continue to hold the breath as far as it is possible.
7. If it is necessary, to execute the following inhalation. For this purpose it is necessary to wait about 30 seconds, holding a cylinder vertically. After that to execute inhalation according to the iinstruktion stated in Paragraphs 2-6.
To close a nozzle inhaler a protective cap.
To perform operations according to Paragraphs 4, 5 and 6, slowly. Important, just before delivery of a dose to begin to inhale as it is possible more slowly. The first several times it is necessary to use drug after the training in front of the mirror. If on each side a mouth there is cloudlet, then it is necessary to begin with Paragraph 2 again.
The nozzle inhaler should be cleaned at least once a week.
1. To remove a protective cap from a nozzle inhaler, and to remove a nozzle inhaler from a cylinder.
2. To carefully wash out a nozzle inhaler and a protective cap under warm flowing water.
3. To carefully dry up a nozzle inhaler and a protective cap inside and outside.
4. To put on a nozzle inhaler a cylinder and a rod of the valve, to close a free opening of a nozzle inhaler a protective cap.
Not to place a cylinder in water!
On frequency side effects can be divided into the following categories: very frequent (≥ 1/10), frequent (≥ 1/100 and & lt, 1/10), infrequent (≥ 1/1000 and & lt, 1/100), rare (≥ 1/10,000 and & lt, 1/1000), very rare (& lt, 1/10,000).
From the immune system: seldom – dermatitis, it is very rare – reactions of hypersensitivity, including a Quincke’s disease, rash.
From exchange processes: seldom – a hypopotassemia.
From nervous system: often – a tremor, a headache, uneasiness, it is rare – dizziness, drowsiness, fatigue, is very rare – hyperactivity.
From a cardiovascular system: often – tachycardia, heart consciousness, it is rare – expansion of peripheral vessels with a dermahemia, discomfort or pain of a breast, is very rare – arrhythmia, including fibrillation of auricles, supraventricular tachycardia, premature ventricular contraction, a lowering of arterial pressure and collapse.
From a respiratory system: seldom – cough, irritation of airways, it is very rare – a bronchospasm (paradoxical or caused by hypersensitivity to drug).
From digestive tract: seldom – dryness or irritation of a mucous membrane of a mouth and throat, change of flavoring feelings, nausea, vomiting.
From a musculoskeletal system: seldom – myotonia.
– hypersensitivity to any component of drug
– children’s age up to 2 years
– conducting premature births
– the menacing abortion
is not recommended to use at the same time the drug Salbutamol and non-selective blockers of β-adrenonoretseptor, such as propranolol.
The drug Salbutamol is not contraindicated to patients who receive monoamine oxidase inhibitors (IMAO).
Strengthens action of stimulators of the central nervous system.
Theophylline and other xanthines at simultaneous use raise
a likelihood of development of tachyarrhythmias.
Simultaneous use with m-holinoblokatorami (including inhalation) can promote increase in intraocular pressure.
Diuretics and glucocorticosteroids strengthen gipokaliyemichesky effect of salbutamol.
With care to apply at a tachyarrhythmia, myocarditis, heart diseases, an aortal stenosis, coronary heart disease, heavy chronic heart failure, arterial hypertension, a thyrotoxicosis, a pheochromocytoma, dekompensirovanny diabetes, glaucoma, epileptic seizures, a renal or liver failure, a concomitant use of non-selective b-adrenoblockers.
It is necessary to instruct patients about the correct use of the drug Salbutamol. The correct use of drug and accurate implementation of the instruction is necessary to provide hit of salbutamol in bronchial tubes. In an initiation of treatment it is necessary to use drug under observation of medical personnel and after the training in front of the mirror.
As well as at use of other inhalation drugs, the therapeutic effect can decrease when cooling a cylinder. Therefore before
use the cylinder with drug has to be heated-up to room
temperature (to warm a cylinder with hands for several minutes, it is impossible to apply other ways!).
Contents of cylinders are under pressure therefore cylinders cannot be heated, broken, pierced or burned, even when they will be empty.
In case of unpleasant feelings in a mouth and irritations in a throat after inhalation of companies it is necessary to rinse water.
Bronchodilators should not be the only or main component of therapy of bronchial asthma of an unstable or heavy course.
If action of a usual dose of drug becomes less effective or less long (effect of drug has to remain not less than 3 hours), the patient should see a doctor. Increase in a dose or frequency of intake of salbutamol should be carried out only under control of the doctor.
Reduction of an interval between reception of the following doses is possible only in exceptional cases and has to be strictly proved. Increase
in need for use of inhalation agonists of b2-adrenoceptors with a short duration of action for treatment of bronchial asthma demonstrates exacerbation of a disease. In such cases it is necessary to revise the treatment plan of the patient. Reception of high doses of salbutamol at exacerbation of asthma can cause a syndrome of ricochet (each following attack becomes more intensively). At a heavy attack of suffocation the break between inhalations has to be not less than 20 minutes. The risk of complications increases both with the considerable duration of treatment, and at sharp drug withdrawal. Prolonged use of salbutamol has to be followed by use of anti-inflammatory drugs for basic therapy.
The sudden and progressing deterioration in bronchial asthma can pose a threat for the patient’s life therefore in similar cases 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.
Therapy by agonists of b2-adrenoceptors, especially at their parenteral administration or at use 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 cases it is necessary to control potassium level in
The forms of production of salbutamol which are not intended for intravenous administration should not be applied to the termination of premature births and the menacing abortion.
At the patients experiencing difficulties in synchronization of a breath using the dosing aerosol inhaler under pressure
the spacer can be used.
At children 4 years receiving drug are younger, use of the pediatric speyserny device with a front mask is reasonable.
Use during pregnancy and 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 (the doses by 11.5-115 times exceeding most recommended at the person for inhalation introduction) the 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 drug on ability to run motor transport and potentially dangerous mechanisms
As Salbutamol can cause such side effects as spasms and dizziness, it is recommended to show the increased care at the first receptions or to refuse control of vehicles and occupations other potentially dangerous types of activity.
Symptoms: more frequent – a hypopotassemia, a lowering of arterial pressure, tachycardia, a muscular tremor, nausea, vomiting, less frequent – excitement, a hyperglycemia, a respiratory alkalosis, an anoxemia, a headache, rare – hallucinations, spasms, a tachyarrhythmia, trembling of ventricles, expansion of peripheral vessels.
Treatment: the best antidotes are cardioselective b-adrenoblockers. However blockers of b-adrenoceptors need to be applied with care (risk of development 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.
The form of release and packing
On 200 doses (on 12 ml) drug place in cylinders aluminum monoblock with internal protection, pressurized by the dosing valve and supplied with a nozzle inhaler with a protective cap.
Apply with method of a stencil or dry offset printing the text on a cylinder or paste the self-adhesive label.
Each cylinder together with a nozzle inhaler and a protective cap and also the instruction for medical use in the state and Russian languages is placed in a cardboard pack.
To Store storage conditions at a temperature not above 25 °C. Not to freeze.
To store far from a heating system and direct sunshine.
To protect from falling, blows.
To store out of children’s reach!
not to use a period of storage until expiry date.
According to the prescription
Russia CJSC Binnofarm Producer,
124460, Moscow, Zelenograd, Designer Guskov St., 3, building 1.
The owner of the registration certificate
of CJSC Binnofarm, Russia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Forpost-Investitsii i razvitiye LLP, Republic of Kazakhstan, 010000, Astana, Region of Esil, Orynbor St., 8, entrance No. 3, 6 floor, office of VP 11/1. Ph. +7 (7172) 727-818, fax: +7 (7172) 727-819, e-mail address:
To Develop B.Tukenova@forpost.kz