The instruction for medical use
of Ventolin® medicine respiratory раствор®
the Trade name
of Ventolin® respiratory раствор®
the International unlicensed
name Salbutamol Dosage Form Solution for the nebulizer, 5 mg/ml
of 1 ml of solution contains
active agent – salbutamol of 5 mg (it is equivalent salbutamol to sulfate),
excipients: solution the chloride benzalkoniya, sulphuric acid diluted, the water purified.
Transparent liquid from colourless till light yellow color.
Drugs for treatment of obstructive respiratory diseases. Inhalation sympathomimetics. Beta2-adrenostimulyatora selection. Salbutamol
ATX R03AC02 Code
Pharmacokinetics Absorption At properties inhalation use of drug 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.
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 allocated 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 is removed with urine.
Т½ of salbutamol at intravenous administration makes 4-6 hours. Salbutamol is quickly removed with urine in the form of an inactive metabolite 4 ‘-O-sulfates 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.
of Ventolin® respiratory раствор® – selection agonist β2-адренорецепторов. In therapeutic doses influences on β2-адренорецепторы muscles of bronchial tubes.
Вентолин® respiratory раствор® has the short duration of action (from 4 to 6 hours) and quick start of action (about 5 minutes from the moment of use).
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)
– 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
of Ventolin® respiratory раствор® is applied only is inhalation by inhalation of drug through a mouth.
Increase in need for reception β2-агонистов 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 Ventolin® respiratory раствор® at most of patients is 4-6 h.
Ventolin® solution respiratory раствор® is not intended for intravenous administration or for intake.
Aerosol can be inhaled through a front mask, a respiratory tube (T – configurations) or an endotracheal tube. In certain cases it is necessary to create positive pressure at ventilation. When there is a risk of a hypoxia, it is necessary to add oxygen to respiratory mix.
As many nebulizers operate only in the presence of constant air flow, the medicine it is possible that sprayed will get to the environment therefore Ventolin® respiratory раствор® should be applied in well aired rooms. This recommendation especially strictly should be observed in hospitals where in one room several patients can use nebulizers at the same time.
Вентолин® respiratory раствор® apply through a respirator or the nebulizer only under careful control of the doctor.
Introduction it is possible to carry out 4 times a day.
Adults and children are more senior than 12 years
Ventolin® respiratory раствор® in number of 0.5-1.0 ml (there correspond 2.5-5.0 mg of salbutamol) dilute with sterile normal saline solution for injections before obtaining the total amount of 2.0-2.5 ml. The received solution is inhaled by means of the nebulizer until formation of aerosol ends. When using of correctly adjusted nebulizer duration of the procedure is about 10 minutes.
For periodic introduction it is also possible to use not divorced Ventolin® respiratory раствор®. For this purpose 2.0 ml of the drug Ventolin® respiratory раствор® (there correspond 10.0 mg of salbutamol) place in the nebulizer, and the patient inhales the sprayed solution before a bronkhodilatation. Usually on it from 3 to 5 minutes are required.
Higher dose of salbutamol, up to 10 mg can be required by some adult patients for what not divorced drug is inhaled via the nebulizer, formation of aerosol will not end yet.
Children from 18 months to 12 years
the Usual dose makes 0.5 ml (corresponds to 2.5 mg of salbutamol) diluted in 2.0-2.5 ml of sterile normal saline solution for injections. However, increase in a dose up to 5.0 mg of salbutamol can be required by some children.
In need of continuous introduction of Ventolin® respiratory раствор® dilute before obtaining concentration 50-100 mg of salbutamol in 1 ml. For this purpose 1-2 ml of drug dilute with sterile normal saline solution before obtaining the final volume of 100 ml which is entered in a look by aerosols via the nebulizer. Usual rate of administering – 1-2 mg an hour.
Children are younger than 18 months
Efficiency of introduction of Ventolina® respiratory раствора® by means of the nebulizer at children 18 months are younger it is not established. Due to a possibility of development of a passing anoxemia, it is necessary to provide a possibility of performing oxygenotherapy.
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
– a cardiopalmus
– a hypopotassemia (therapy β2-агонистами can lead to a significant 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 a bad attack of bronchial asthma)
– arrhythmia, including an atrial fibrillation, supraventricular tachycardia and premature ventricular contraction
of the Contraindication
– hypersensitivity to any component which is a part of drug
– premature births
– the menacing abortion
of the Form of release of a salbumamol, 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 Ventolin® and non-selective blockers of β-adrenonoretseptor, such as propranolol.
The drug Ventolin® respiratory раствор® is not contraindicated to patients who receive monoamine oxidase inhibitors (IMAO).
instructions Treatment of Asthma it 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 reception β2-агонистов 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 a course of 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.
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 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 the Ventolin® drug treatment respiratory раствор®, and if necessary to appoint other high-speed bronchodilator for further treatment.
Вентолин® respiratory раствор® it is applied only to inhalation use by inhalation of drug through a mouth. Drug should not be used in or in the form of injections.
The patients receiving the Ventolin® drug treatment respiratory раствор® at home have to be warned that if usual simplification became weaker or duration of effect of the medicine became less, they should not raise independently a dose or frequency of administration of drug at all, without having consulted to the treating doctor.
Вентолин® respiratory раствор® it is necessary to apply with care at patients who already accepted high doses of other sympathomimetics.
Isolated cases of development of acute closed-angle glaucoma in the patients receiving a drug Ventolin® combination respiratory раствор® and a bromide ipatropiya by means of the nebulizer were celebrated. Considering this fact, it is necessary to be careful at simultaneous use of salbutamol and anticholinergics by means of the nebulizer. Patients have to study the corresponding instruction for the correct use and not allow hit of solution in eyes.
As well as other agonists of beta adrenoceptors, Ventolin® respiratory раствор® 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.
It was very seldom reported about developing of the milk acidosis connected with use of Ventolina® respiratory раствора® at patients with exacerbation of bronchial asthma. 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 inappropriate strengthening of treatment by high-speed beta agonists 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 observe care 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, lactic acidosis is possible.
Treatment: control of level of potassium in serum of blood, level of a lactate and the subsequent development of a metabolic acidosis (especially at presence or at deterioration in a tachypnea despite elimination of a bronchospasm).
During continuous introduction of Ventolina® respiratory раствора® any signs of overdose usually are eliminated at the termination of administration of drug, if necessary symptomatic therapy is carried out.
The form of release and packing
On 20 ml of solution place in the glass opaque bottle closed by a plastic cap.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from light at
a temperature not over 25 ºС.
To store out of children’s reach!
Contents of a bottle to use a period of storage within 28 days after opening.
Not to take the drug after an expiration date.
According to the prescription
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