Ventolinum

General characteristics. Structure:

Aerosol for inhalations dosed in the form of suspension of white or almost white color.

Active ingredient: salbutamol the sulfate micronized 120.5 mkg 28.92 mg
that there correspond to the content of salbutamol ** 100 mkg 240 mg

Excipients: propellant (1,1,1,2-tetraftoretan) in 1 dose - to 75 mg, in 1 inhaler to 18 g.

* for providing an exit of 200 doses at use of an inhaler, each inhaler contains amount of suspension, to equivalent 240 doses.

** depending on the equipment used by production of drug in a production formula it can be included up to 10% of excess of active ingredient.

Pharmacological properties:

The selection agonist β2-адренорецепторов. In therapeutic doses he acts on β2-адренорецепторы smooth muscles of bronchial tubes, exerting insignificant impact or without influencing on β1-адренорецепторы a myocardium at all. Renders the expressed bronkhodilatiruyushchy effect, warning or stopping a bronchospasm, reduces resistance in respiratory tracts. Increases ZhEL. Increases mukotsiliarny clearance (at chronic bronchitis to 36%), stimulates slime secretion, activates functions of a ciliary epithelium.

In the recommended therapeutic doses does not exert negative impact on cardiovascular system, does not cause increase in the ABP. 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 release of insulin, renders hyper glycemic (especially at patients with bronchial asthma) and the lipolytic effect, increases risk of development of acidosis.

After use of inhalation forms 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.

Pharmacokinetics. Absorption and metabolism

After inhalation introduction of 10-20% of a dose of salbutamol reach lower parts of respiratory tracts. Other part of a dose remains in an inhaler or is postponed in a stomatopharynx and then swallowed. The fraction postponed in respiratory tracts is absorbed in pulmonary fabrics and blood, but not metabolized in lungs.

The swallowed part of an inhalation dose is absorbed from a GIT and is exposed to intensive metabolism at "the first passing" through a liver, turning into inactive 4-O-sulfate (phenolic sulfate).

Distribution

Linkng of salbutamol with proteins of plasma makes 10%.

Removal

At in introduction of T1/2 of salbutamol makes 4-6 h. It is removed partially by kidneys in not changed look and partially in in the form of inactive 4-0 sulfates (phenolic sulfate) which is also removed preferential with urine. With a stake only an insignificant part of the entered salbutamol dose is excreted. The most part of the dose of salbutamol entered into an organism in/in in the peroral or inhalation way, is excreted during 72 h.

Indications to use:

Bronchial asthma:

— stopping of attacks of bronchial asthma, including at an exacerbation of bronchial asthma of a heavy current;

— prevention of the attacks of a bronchospasm connected with influence of allergen or caused by an exercise stress;

— use as one of components at a long maintenance therapy of bronchial asthma.

The Chronic Obstructive Pulmonary Disease (COPD) which is followed by reversible obstruction of respiratory tracts, chronic bronchitis.

Route of administration and doses:

The drug Ventolinum is intended only for inhalation introduction. The increased need for use of agonists of beta2-adrenoceptors can be a sign of aggravation of bronchial asthma. In a similar situation revaluation of the scheme of treatment of the patient with consideration of expediency of purpose of simultaneous therapy of GKS can be required.

As the overdose can be followed by development of the undesirable phenomena, the dose or frequency rate of use of drug can be increased only according to the recommendation of the doctor.

Duration of effect of salbutamol at most of patients makes from 4 to 6 h.

At the patients experiencing difficulties in synchronization of a breath using the dosing aerosol inhaler under pressure the spacer can be used.

At the children and babies receiving the drug Ventolinum use of the pediatric speyserny device with a front mask is reasonable.

For stopping of an attack of bronchospasms by the adult the recommended dose makes 100 or 200 mkg; to children - 100 mkg, if necessary the dose can be increased to 200 mkg. Ventolinum is not recommended to apply an inhaler more often the 4th time / Need for frequent use of the maximum doses of the drug Ventolinum or for sudden increase in a dose demonstrates deterioration in a course of asthma.

For prevention of attacks of the bronchospasm connected with influence of allergen or caused by an exercise stress, adult-200 mkg in 10-15 min. prior to influence of a provocative factor or loading; to children - 100 mkg in 10-15 min. prior to influence of a provocative factor or loading, if necessary the dose can be raised to 200 mkg.

At a long maintenance therapy the adult - to 200 mkg 4; to children - to 200 mkg 4

Rules of use of an inhaler

Check of an inhaler

Before the first use of an inhaler or if did not use an inhaler week and longer, it is necessary to remove a cap from a mouthpiece, having slightly squeezed a cap from sides, it is good to stir up an inhaler and to make two sprayings in air to be convinced of operability of an inhaler.

Use of an inhaler

1. To remove a cap from a mouthpiece, having slightly squeezed a cap from sides.

2. To examine a mouthpiece from within and outside to be convinced that it is pure.

3. It is good to stir up an inhaler.

4. To keep an inhaler between index and big fingers in vertical position a bottom up, at the same time the thumb has to be located on the basis under a mouthpiece.

5. To make a slow deep exhalation, to clasp a mouthpiece with lips, without squeezing it teeth.

6. Making the deepest breath through a mouth at the same time to press an upper part of an inhaler for release of one inhalation dose of salbutamol.

7. To hold the breath for several seconds, to take out a mouthpiece from a mouth, then to exhale slowly.

8. For receiving the second dose, keeping an inhaler in vertical position, to wait about 30 sec. and then to repeat subitem 3-7.

9. To densely close a mouthpiece a protective cap.

Carrying out stages 5, 6 and 7, it is impossible to hurry. It is necessary to begin a breath as it is possible more slowly, just before pressing the inhaler valve. In the first it is several times recommended to practise in front of the mirror. If the "fog" leaving an upper part of an inhaler or mouth corners is visible, then it is necessary to begin all over again with a stage 2.

If the doctor gave other instructions for use of an inhaler, then the patient has to observe them strictly. If the patient has difficulties with use of an inhaler, then he needs to see a doctor.

Cleaning of an inhaler

The inhaler needs to be cleaned at least 1 time a week.

1. To take a metal barrel from the plastic case and to uncover a mouthpiece.

2. To carefully wash out the plastic case and a cover of a mouthpiece under a stream of warm water.

3. To dry the plastic case and a cover of a mouthpiece completely both outside and inside. Not to allow an overheat.

4. To place a metal barrel in the plastic case and to put on a mouthpiece cover.

Not to immerse a metal barrel in water.

Features of use:

Treatment of bronchial asthma is recommended to be carried out step by step, controlling the clinical response of the patient to treatment and function of lungs,

Bronchodilators should not be the only or main component of therapy of bronchial asthma of an unstable or heavy current.

Increase in need for use of bronchodilators with a short duration of action, in particular agonists of beta2-adrenoceptors, for control of symptoms of bronchial asthma demonstrates deterioration in a course of a disease. In such cases it is necessary to reconsider treatment planning of the patient. The sudden and progressing deterioration in bronchial asthma can pose a potential threat for the patient's life therefore in similar situations it is necessary to consider expediency of appointment or increase in a dose as corticosteroids. At patients of risk group it is recommended to carry out daily monitoring of a peak expiratory rate.

Therapy by agonists of beta2-adrenoceptors, especially at their introduction parenterally or by means of the nebulizer, can lead to a hypopotassemia.

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, corticosteroids, diuretics, and also owing to a hypoxia. In such situations it is recommended to control potassium level in blood serum.

In case of lack of effect of use of earlier effective dose of inhalation salbutamol for, at least, 3 h the patient has to see a doctor regarding need of acceptance of any additional measures.

It is necessary to instruct patients about the correct use of an inhaler Ventolinum.

Influence on ability to driving of motor transport and to control of mechanisms

There are no data.

Side effects:

The undesirable phenomena given below are listed according to defeat of bodies and systems of bodies and occurrence frequency. Frequency of occurrence is defined as follows: very often (> 1/10), it is frequent (> 1/100 and <1/10), infrequently (> 1/1 000 and <1/100), is rare (> 1/10 000 and <1/1 000), is very rare (<1/10 000, including separate cases). Categories of frequency were created on the basis of clinical trials of drug and post-registration observation.

From immune system: very seldom - hypersensitivity reactions, including a Quincke's disease, a small tortoiseshell, a bronchospasm, hypotension and a collapse.

From a metabolism and food: seldom - a hypopotassemia. Therapy by beta2-agonists can lead to clinically significant hypopotassemia.

From a nervous system: often - a tremor, a headache; very seldom - a hyperactivity.

From heart: often - tachycardia; infrequently - palpitation; very seldom - arrhythmias (including a ciliary arrhythmia, supraventricular tachycardia and premature ventricular contraction).

From vessels: seldom - peripheral vasodilation.

From respiratory system, bodies of a thorax and a mediastinum: very seldom - a paradoxical bronchospasm. As well as when using other means for inhalation therapy, the paradoxical bronchospasm with strengthening of rattles at once after drug use can develop. This state demands immediate treatment with use of an alternative form of release or other high-speed inhalation bronchodilator. The drug Ventolinum it is necessary to cancel, estimate immediately the patient's condition, and, if necessary, to appoint alternative therapy.

From a GIT: infrequently - irritation of a mucous membrane of an oral cavity and throat.

From skeletal and muscular and connecting fabric: infrequently - muscular spasms.

Interaction with other medicines:

It is not recommended to apply at the same time salbutamol and non-selective blockers of β-adrenoceptors, such as propranolol.

Salbutamol is not contraindicated to patients who receive MAO inhibitors.

At patients with a thyrotoxicosis Ventolinum strengthens action of stimulators of TsNS, tachycardia.

Theophylline and other xanthines at simultaneous use with salbutamol increase probability of development of a tachyarrhythmia.

Co-administration with anticholinergics (including inhalation) can promote increase in intraocular pressure.

Diuretics and GKS strengthen gipokaliyemichesky effect of salbutamol.

Contraindications:

— conducting premature birth;

— the menacing abortion;

— hypersensitivity to drug components.

With care it is necessary to apply salbutamol at patients with a thyrotoxicosis, a tachyarrhythmia, myocarditis, heart diseases, an aortal stenosis, coronary heart disease, heavy chronic heart failure, arterial hypertension, a pheochromocytoma, a dekompensirovanny diabetes mellitus, glaucoma.

Use of the drug VENTOLINUM at pregnancy and feeding by a breast

At pregnancy drug is appointed only when the expected advantage of therapy for mother exceeds potential risk for a fruit.

During post-registration observation exceptional cases of various malformations at children, including formation of "a wolf mouth" and malformations of extremities, against the background of reception of salbutamol at pregnancy were revealed. In some of these cases of mother accepted several accompanying medicines during pregnancy. In view of lack of constant nature of defects and the background frequency of developing of congenital anomalies making from 2 to 3%, relationship of cause and effect is not established with administration of drug.

Salbutamol probably gets into breast milk and therefore are not recommended to appoint it the feeding women unless the expected advantage for the patient outweighs potential risk for the child. There are no data on whether harmful action renders the salbutamol which is present at breast milk on the newborn.

Use at abnormal liver functions
With care it is necessary to use drug if at patients in the anamnesis the liver failure is noted.

Use at renal failures

With care it is necessary to use drug if at patients in the anamnesis the renal failure is noted.

Use for children

Potivopokazaniye: children's age up to 2 years.

Overdose:

Symptoms: signs and symptoms of overdose of salbutamol are the passing phenomena pharmacological mediated by stimulation of beta and adrenergic receptors such as decrease in the ABP, tachycardia, muscular tremor, nausea, vomiting. Use of high doses of salbutamol can cause a hypopotassemia, it is necessary to control potassium level in blood serum.

Treatment: it is necessary to cancel drug and to appoint the corresponding symptomatic therapy, such as use of cardioselective blockers of beta adrenoceptors for patients with existence of cardial symptomatology (for example, tachycardia, a heart consciousness). Blockers of beta adrenoceptors should be used with care at patients with a bronchospasm in the anamnesis.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 30 °C; not to freeze, not to subject to influence of direct sunshine. A period of validity – 2 years.

Issue conditions:

According to the recipe

Packaging:

200 doses - inhalers aluminum (1) with the plastic portioning device with a protective cap - packs cardboard.