Ventolin Nebula - instructions for use, dose, side effects, contraindications

Component	Content (mg / ml)
Active substance:
Salbutamol Sulfate¹	1,2
Excipients:
Sodium chloride	9,0
Sulfuric acid diluted	q.s. to a pH of 3.5-4,5
Purified water	up to 1 ml

Note.

1. 1.2 mg of salbutamol sulfate is equivalent to 1.0 mg of salbutamol.

Description:Transparent liquid from colorless to light yellow color.

Pharmacotherapeutic group:Bronchodilator - beta2-adrenomimetic selective

ATX: & nbsp

R.03.A.C Selective beta-2-adrenomimetics

R.03.A.C.02 Salbutamol

Pharmacodynamics:Mechanism of action

Salbutamol is a selective beta agonist₂adrenoreceptors. In therapeutic doses, it acts on beta₂-adrenoreceptors of smooth muscles of the bronchi and has a short (from 4 to 6 hours) bronchodilator effect on beta₂-adrenoceptors with a rapid onset of action (within 5 minutes) with reversible airway obstruction.

Pharmacokinetics:Suction

After the inhalation, 10-20% of the dose of salbutamol reaches the lower respiratory tract. The rest of the dose remains in the inhaler or is deposited in the oropharynx and then swallowed.The fraction deposited in the respiratory tract is absorbed into the lung tissue and blood, but not metabolized in the lungs.

Distribution

The degree of binding of salbutamol with plasma proteins is 10%.

Metabolism

When entering the systemic circulation salbutamol is subjected to hepatic metabolism and excreted mainly by the kidneys in unchanged form or in the form of phenolic sulfate.

The swallowed portion of the inhalation dose is absorbed from the gastrointestinal tract and subjected to significant metabolism during the "first passage" through the liver, turning into phenolic sulfate. Unchanged salbutamol and conjugate are excreted mainly by the kidneys.

Excretion

Introduced intravenously salbutamol has a half-life of 4-6 hours. It is excreted partially by the kidneys and partly by metabolism to inactive 4'-O-sulfate (phenolic sulfate), which is also excreted mainly by the kidneys. Through the intestine excreted only a small part of the administered dose of salbutamol. Most of the dose of salbutamol administered intravenously, orally or by inhalation, is excreted within 72 hours.

Indications:- Cupping and prevention of asthma attacks, including in the complex therapy of asthmatic status.

- In the complex therapy of other chronic lung diseases accompanied by reversible airway obstruction, including chronic obstructive pulmonary disease (COPD), chronic bronchitis, pulmonary emphysema.

Contraindications:Hypersensitivity to the active substance or any other component included in the preparation.

Children under 18 months of age (there is no evidence of the clinical efficacy of nebulized salbutamol in children under 18 months of age).

Non-injectable dosage forms of salbutamol should not be used for uncomplicated premature birth or for abortion.

Carefully:The drug Ventolin® Nebulas should be used with caution in patients with thyrotoxicosis, tachyarrhythmia, severe chronic heart failure, arterial hypertension, pheochromocytoma, during pregnancy, during breastfeeding, and also to patients who have already taken high doses of other sympathomimetics.

Pregnancy and lactation:Fertility

There is no evidence of the effects of salbutamol on human fertility. In pre-clinical studies, no adverse effects on fertility were detected in animals.

Pregnancy

Pregnant women should be prescribed only if the expected benefit to the mother exceeds the potential risk to the fetus.

In the course of post-registration follow-up, rare cases of various developmental malformations in children, including the formation of "wolf mouth" and developmental limbs, were detected against the background of salbutamol intake by mothers during pregnancy. In some of these cases, mothers took several concomitant medications during pregnancy. Due to the lack of a permanent nature of defects and the background frequency of congenital anomalies, ranging from 2 to 3%, the cause-and-effect relationship with taking the drug has not been established.

Breastfeeding period

Salbutamol probably penetrates into breast milk, and therefore it is not recommended to prescribe it to nursing women, except when the expected benefit for the mother herself exceeds the potential risk to the child.There is no evidence as to whether the person present in breast milk salbutamol harmful effect on the newborn.

Dosing and Administration:The drug Ventolin® Nebulas is intended only for inhalation by inhalation through the mouth.

The drug Ventolin® Nebula is not intended for injection or for oral administration. Increased need for beta agonists₂-adrenoreceptors may be a sign of aggravation of bronchial asthma. In such a situation, a reassessment of the patient's treatment regimen may be required, with consideration of the advisability of concurrent glucocorticosteroid therapy.

Since an overdose may be accompanied by the development of adverse reactions, the dose or multiplicity of the drug may be increased only on the advice of a doctor.

The duration of action of salbutamol in most patients is from 4 to 6 hours.

The drug Ventolin® Nebulas should be used under the supervision of a doctor with the help of a nebulizer. Delivery of the aerosol can be carried out using a face mask, a T-tube or through an endotracheal tube.The lung ventilation mode can be used with intermittent positive pressure, but the need for its use is rare. In case of risk of hypoxia due to hypoventilation, the inhaled air can be enriched with oxygen.

The drug Ventolin® Nebulus is intended for use in undiluted form, however, if it is necessary to prolong administration (more than 10 minutes), the drug can be diluted with a sterile 0.9% solution of sodium chloride.

Since many nebulizers operate only in the presence of a constant flow of air, it is possible that the sprayed product will enter the environment. With this in mind, Ventolin® Nebula should be used in well-ventilated areas, especially in hospitals, where several patients can simultaneously use nebulizers in the same room.

Treatment of chronic bronchospasm, resistant to traditional therapy and treatment of acute severe bronchial asthma (asthmatic status)

Adults and children over 18 months of age

The average initial dose of salbutamol administered by inhalation with a nebulizer is 2.5 mg, but can be increased to 5 mg.Inhalation can be repeated 4 times a day. To treat severe airway obstruction in adult patients, higher doses may be administered - up to 40 mg / day under strict medical control in a hospital setting.

The clinical efficacy of the drug Ventolin® Nebulas in children under the age of 18 months is not established. In view of the possibility of developing transient hypoxemia, consideration should be given to the possibility of additional oxygen therapy.

INSTRUCTION FOR THE USE OF NEBUL

The drug Ventolin® Nebula can be diluted with a sterile 0.9% solution of sodium chloride. The solution left unused in the nebulizer chamber should be poured.

Step-by-step instruction

I. Use of nebulas.

II. Breeding nebula.

III. After using nebulas.

I. Use of nebulas

1. A strip made up of nebules is in a bag of laminated aluminum foil. Do not open the package before using nebula.

2. To open the package, cut the edge of the bag with the scissors along the indicated dotted line.

3. Hold a strip consisting of nebula, in one hand, with the second hand grasp the last nebula in the row.

4. Turn the nebula down and away from yourself.

5.Put the remaining nebulas back into the bag and place the bag back in the cardboard box.

6. While holding the separated nebula by the top, turn the body of the nebula to open it.

7. Place the open end of the nebula in the nebulizer chamber and slowly squeeze the nebula. Make sure that the contents of the nebula are completely poured into the nebulizer chamber.

8. Collect the nebulizer and use it according to the instructions for its use.

Make sure that the "fog" formed during inhalation does not get in your eyes!

II. Nebuling

1. Do not dilute the contents of nebulas without specifying a doctor.

2. If the doctor recommended diluting the solution, pour the contents of the nebulus into the nebulizer chamber.

3. Add the amount of sterile 0.9% sodium chloride solution recommended by the doctor. To dilute the liquid from the nebulus, use only a sterile 0.9% solution of sodium chloride.

4. Close the nebulizer camera cover and shake gently to mix the contents.

III. After using nebulas

1. For each procedure, use a new nebula. The nebula should only be opened before use. If there is some liquid left in the nebula, it should not be used for subsequent inhalations.

2. Pour the solution left in the nebulizer chamber after inhalation.

3.Clean the nebulizer, as recommended in the instructions for its use.

Side effects:The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.

Frequency of occurrence of undesirable reactions

Immune system disorders

Very rarely: hypersensitivity reactions, including angioedema, hives, bronchospasm, arterial hypotension and collapse.

Disorders from the metabolism and nutrition

Rarely: hypokalemia. Therapy with beta drugs₂agonists can lead to clinically significant hypokalemia. Very rarely: lactic acidosis. Very rare cases of lactic acidosis have been reported in patients who received salbutamol intravenously and in the form of nebula for the treatment of exacerbations of bronchial asthma.

Disturbances from the nervous system

Often: tremor, headache. Very rarely: hyperactivity.

Heart Disease

Often: tachycardia. Infrequent: a feeling of palpitations. Very rarely: arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole.

Vascular disorders

Rarely: peripheral vasodilation.

Disturbances from the respiratory system, chest and mediastinal organs

Very rarely: paradoxical bronchospasm.

Disorders from the gastrointestinal tract

Infrequent: irritation of the mucous membrane of the oral cavity and pharynx.

Disturbances from musculoskeletal and connective tissue

Infrequently: muscle cramps.

Overdose:Symptoms

The most common signs and symptoms of overdose of salbutamol are transient phenomena pharmacologically caused by stimulation of beta-adrenergic receptors (see sections "Special instructions" and "Side effect"). The use of large doses of salbutamol can cause hypokalemia, it is necessary to monitor the potassium concentration in the blood serum.

It was reported about the development of lactic acidosis with the use of high doses,as well as with short-acting beta-agonists overdose, therefore, in case of overdose it is recommended to monitor the increase in lactate concentration in the blood serum and the associated development of metabolic acidosis (especially if tachypnea persists or worsens, despite the elimination of other signs of bronchospasm such as wheezing).

Treatment

Treatment should be symptomatic.

Interaction:It is not recommended to apply simultaneously salbutamol and nonselective beta-adrenergic receptor blockers, such as propranolol.

Salbutamol is not contraindicated in patients receiving monoamine oxidase (MAO) inhibitors.

In patients with thyrotoxicosis salbutamol enhances the effect of stimulants of the central nervous system and tachycardia. Salbutamol increases the likelihood of developing extrasystole against the background of cardiac glycosides.

Theophylline and other xanthines, when used simultaneously, increase the likelihood of developing tachyarrhythmias. Simultaneous use with agents for inhalation anesthesia and levodopa increases the likelihood of developing severe ventricular arrhythmias.Simultaneous administration with anticholinergics (including inhalation) may help increase intraocular pressure. Diuretics and glucocorticosteroids increase the hypokalemic effect of salbutamol.

Special instructions:Treatment of bronchial asthma is recommended to be carried out step by step, controlling the lung function and the patient's clinical response to treatment.

Bronchodilators should not be the only or main component of asthma therapy for unstable or severe flow.

Increased demand for short-acting bronchodilators, in particular beta-agonists₂-adrenoreceptors, to relieve the symptoms of bronchial asthma indicates a worsening of the course of the disease. In such cases, the patient's treatment plan should be reviewed.

A sudden and progressive deterioration in the control of bronchial asthma can pose a potential threat to the life of the patient, so in such situations, the expediency of prescribing or increasing the dose of glucocorticosteroids should be considered. In patients at risk, daily monitoring of peak expiratory flow is recommended.

Therapy with beta agonists₂-adrenoceptors, especially when administered parenterally or with a nebulizer, can lead to hypokalemia.

Particular caution should be exercised in the treatment of severe attacks of bronchial asthma, because in these cases, hypokalemia can be exacerbated by the simultaneous use of xanthine derivatives, glucocorticosteroids, diuretics, and also due to hypoxia. In such situations, it is recommended to monitor the potassium concentration in the blood serum.

As with other agents for inhalation therapy, when taking salbutamol, paradoxical bronchospasm may develop with increased wheezing immediately after application of the drug. This condition requires immediate treatment using an alternative form of salbutamol release or another short-acting inhaled bronchodilator. The preparation of Ventolin® Nebulas should be immediately withdrawn, the patient's condition assessed, and, if necessary, another high-speed bronchodilator should be prescribed to continue treatment. The drug Ventolin® Nebulas should only be used by inhalation by inhalation through the mouth.The drug is not intended for injection or for oral administration.

Patients who use Ventolin® Nebula at home should be warned that if the effect of the usual dose becomes less effective or less prolonged, you can not increase the dose or frequency of the drug yourself, and you should immediately consult a doctor.

A small number of cases of development of acute angle-closure glaucoma in patients receiving a combination of salbutamol and ipratropium bromide with a nebulizer was reported. Given this fact, caution should be exercised when using salbutamol and anticholinergics simultaneously with a nebulizer. Patients should receive appropriate instructions for the proper use of the drug Ventolin® Nebulas, and should be warned against the ingress of a solution or "mist" into the eyes.

Like other beta-adrenergic agonists, salbutamol can cause reversible metabolic changes, such as an increase in the concentration of glucose in the blood. Patients with diabetes mellitus may develop decompensation, in some cases, reported the development of ketoacidosis.Simultaneous use of glucocorticosteroids can enhance this effect.

It was reported that very rare cases of lactic acidosis associated with the use of high doses of beta agonists₂-adrenoceptor short-acting intravenously or with the help of a nebulizer, mainly in patients with exacerbation of bronchial asthma (see section "Side effect"). An increase in lactate concentration may lead to dyspnea and compensatory hyperventilation of the lungs, which may be misinterpreted as signs of unsuccessful asthma treatment and lead to an unreasonable increase in the appointment of beta agonists₂adrenoreceptors of short action. Therefore, it is recommended to monitor the concentration of lactate in the blood serum, and also to monitor the possible subsequent development of metabolic acidosis.

Effect on the ability to drive transp. cf. and fur:Data on the effect of the drug Ventolin® Nebulas on the ability to drive vehicles, mechanisms are absent.

Form release / dosage:Solution for inhalation, 1 mg / ml.

Packaging:By 2.5 ml of the drug in the nebula, which is an ampoule of low-density polyethylene. On 10 nebula are welded to each other in the form of a strip.Each strip is hermetically sealed in a bag of laminated aluminum foil. For 2 bags together with instructions for use are placed in a cardboard box.

Storage conditions:Store the unopened bag at a temperature below 30 ° C.

Store the opened package at a temperature below 30 ° C in the dark place. Keep out of the reach of children.

Shelf life:Unopened package: 3 years.

Opened package: 3 months.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N011022

Date of registration:04.05.2010

Expiration Date:Unlimited

The owner of the registration certificate:Aspen Pharma Petit Co., Ltd.Aspen Pharma Petit Co., Ltd. Russia

Manufacturer: & nbsp

ASPEN BAD OLDESLOE, GmbH Germany