Nebula Ventolinum

General characteristics. Structure:

Solution for inhalations in nebula in the form of transparent liquid from colourless till light yellow color.

Active ingredient: salbutamol sulfate of 3 mg, it is equivalent to salbutamol of 2.5 mg

Excipients: sodium chloride, sulphuric acid divorced, the water purified.

Pharmacological properties:

The selection beta2-adrenomimetik. In therapeutic doses works on β2-адренорецепторы smooth muscles of bronchial tubes, exerting insignificant impact on β1-адренорецепторы a myocardium.

Salbutamol inhibits release from mast cells of a histamine, leukotrienes, D2 prostaglandin and other biologically active agents for a long time. Suppresses early and late reactivity of bronchial tubes. Renders the expressed bronkhodilatiruyushchy effect, warning or stopping a spasm of bronchial tubes, reduces resistance in respiratory tracts. Increases the vital capacity of lungs. Increases mukotsiliarny clearance (at chronic bronchitis to 36%), stimulates slime secretion, activates functions of a ciliary epithelium.

Slows down emission of mediators of an inflammation from mast cells and basophiles, in particular the emission of a histamine induced by antibodies to immunoglobulin E eliminates antigenzavisimy suppression of mukotsiliarny transport and allocation of a factor of a chemotaxis of neutrophils. Prevents development of the bronchospasm induced by allergen. Can lead to decrease in number β1-адренорецепторов, including on lymphocytes. 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.

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.

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

After inhalation use system absorption bystry, but low. At intake (including at a partial proglatyvaniye at inhalation) absorption high. From 10% to 20% of a dose comes to lower parts of respiratory tracts. Other part is late in an inhaler or settles in a stomatopharynx and then is swallowed. A part of a dose which remains in respiratory tracts is absorbed by tissues of lungs, without being exposed in them to metabolism, and gets to a blood stream.

Distribution and metabolism

Linkng of salbutamol with proteins of a blood plasma makes 10%.

The swallowed part of the inhalated dose quickly is soaked up from a GIT and is exposed to intensive metabolism at "the first passing" through a liver, turning into phenolic sulfate.

Gets through a placental barrier.

Removal

Not changed drug and conjugate are removed preferential with urine (69-90%). Insignificant quantity (4%) - with bile. The most part of a dose of salbutamol is removed within 72 hours.

Indications to use:

— stopping and prevention of attacks of bronchial asthma (including as a part of complex therapy of the asthmatic status);

— treatment of the bronchial obstruction which is not giving in to traditional broncholitic therapy (including at a chronic obstructive pulmonary disease).

Route of administration and doses:

Apply it is inhalation. The drug Nebula's Ventolinum is not intended for injections.

The drug Nebula's Ventolinum needs to be used under observation of specialists by means of a special inhaler (nebulizer) with a mask, the T-shaped tube or an endotracheal tube. In case of risk of development of a hypoxia owing to hypoventilation, the inhaled air can be enriched with oxygen.

Nebula's Ventolinum is intended for use in not divorced look, however in need of long administration of solution of salbutamol (more than 10 min.) drug can be dissolved sterile 0.9% with chloride sodium solution. The solution which remained unused in the nebulizer camera after inhalation should be poured out.

Since many nebulizers operate only in the presence of a constant flow of air, is not excluded that the sprayed drug will get to the environment. Considering it, Ventolin Nebula it is necessary to apply in well aired rooms; this recommendation especially strictly should be observed in hospitals where several patients can use nebulizers at the same time.

Adults and children are more senior than 1.5 years

Average initial dose of the salbutamol entered it is inhalation by means of the nebulizer, makes 2.5 mg, but it can be increased to 5 mg. Inhalation can repeat 4 times a day. For treatment of heavy obstruction of respiratory tracts adult patients can use drug in higher doses - to 40 mg / - under strict medical control in the conditions of a hospital.

Features of use:

Bronchodilators should not be the only or main component of therapy of bronchial asthma.

Increase in need for use of inhalation agonists β2-адренорецепторов the short duration of action for control of symptoms of bronchial asthma testifies to an exacerbation of a disease. In such cases it is recommended to reconsider treatment planning 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 GKS. At such patients it is recommended to carry out daily control of the maximum expiratory rate.

Use of salbutamol in excessively high doses can lead to development of adverse reactions therefore to resolve an issue of increase in a dose or frequency of use of drug only the doctor has to. The patients applying Ventolin Nebula in house conditions need to be warned that if action of a usual dose becomes less effective or less long, it is impossible to increase independently a dose or frequency of administration of drug, and it is necessary to see a doctor immediately.

Nebula's Ventolinum should be applied with care at patients who already accepted high doses of other sympathomimetics.

Salbutamol needs to be applied with care at patients with a thyrotoxicosis.

Isolated cases of development of acute closed-angle glaucoma in the patients receiving a combination of salbutamol and a bromide ipratropiya 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 it is necessary to teach to use correctly the nebulizer and to warn about inadmissibility of hit in eyes of solution or an aerosol.

Therapy by agonists β2-адренорецепторов, 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, GKS and diuretics, and also owing to a hypoxia. In such situations it is necessary to control potassium concentration in blood serum.

As well as other agonists of β-adrenoceptors, salbutamol can cause reversible metabolic changes, for example increase in concentration of glucose in blood. At patients with a diabetes mellitus development of a decompensation and in some cases - ketoacidosis is possible. Simultaneous use of GKS can strengthen this effect.

The nebulizer does not demand synchronization of a breath of the patient with inhalation that allows to use widely it at children of early age and elderly, it is difficult for them to execute respiratory maneuver.

Use in pediatrics

Data on clinical performance of salbutamol in nebula at children are younger than 1.5 years are absent.

Side effects:

Allergic reactions: seldom - a Quincke's disease, a small tortoiseshell, a hypopotassemia.

From TsNS: often - a tremor, a headache; seldom - a hyperactivity.

From cardiovascular system: often - tachycardia; seldom - arrhythmia, supraventricular tachycardia, premature ventricular contraction, a ciliary arrhythmia, expansion of peripheral vessels.

From respiratory system: seldom - a paradoxical bronchospasm.

From the alimentary system: seldom - irritation of a mucous membrane of an oral cavity and throat.

From a musculoskeletal system: seldom - 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 strengthens action of stimulators of TsNS, tachycardia. Strengthens probability of development of premature ventricular contraction against the background of reception of cardiac glycosides.

Theophylline and other xanthines at simultaneous use increase probability of development of tachyarrhythmias; means for inhalation anesthesia, a levodopa - heavy ventricular arrhythmias. Simultaneous use with anticholinergics (including inhalation) can promote increase in intraocular pressure. Diuretics and GKS strengthen a hypopotassemia which salbutamol can cause.

Contraindications:

— children's age up to 1.5 years;

— hypersensitivity to any component of drug.

With care use drug in the presence in the anamnesis of a tachyarrhythmia, heavy chronic heart failure, arterial hypertension, thyrotoxicosis, a pheochromocytoma, and also at pregnancy and in the period of a lactation.

 

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

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

Strictly controlled clinical trials on studying of teratogenecity of salbutamol were not conducted. In separate researches the polydactylia at children whose mothers during pregnancy accepted salbutamol is revealed (the unambiguous causal relationship of developing of this pathology is not established with administration of drug).

Adrenergic bronchodilators can be applied at pregnancy as the potential risk of a placental anoxemia for a fruit against the background of uncontrollable bronchial asthma considerably exceeds the risk connected with their use. However at use it is necessary to be careful as drug can cause tachycardia and a hyperglycemia in mother (especially in the presence of a diabetes mellitus) and a fruit, and also to cause a retarde birth, decrease in the ABP and a fluid lungs in mother.

Salbutamol probably gets into breast milk therefore the feeding women are not recommended to use drug, except for cases when the expected advantage of therapy for mother exceeds any potential risk for the child. It is unknown whether the salbutamol which is present at breast milk exerts any negative impact on the newborn child.

 

Use for children

Data on clinical performance of salbutamol in nebula at children are younger than 1.5 years are absent.

Overdose:

Symptoms: are observed more often - a hypopotassemia, decrease in the ABP, lactoacidosis, tachycardia, a muscular tremor, vomiting; are observed less often - excitement, a hypophosphatemia, a leukocytosis, a respiratory alkalosis; seldom - hallucinations, paranoia, spasms, a tachyarrhythmia.

Treatment: symptomatic, at a tachyarrhythmia enter cardioselective β-adrenoblockers..........

Storage conditions:

List B. Drug should be stored in not opened package at a temperature below 30 °C. A period of validity - 3 years.

After opening of a package drug should be stored at a temperature below 30 °C in the place protected from light. A period of validity - 3 months.

Drug should be stored in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

2.5 ml - ampoules polyethylene, soldered among themselves in the form of a strip (10) - packages from aluminum foil laminated (2) - packs cardboard.