Astmasol Neo aerosol 20mkg / dose + 50mkg / dose, 200 dose

Prevention and symptomatic treatment of obstructive airway diseases with reversible airway obstruction, such as bronchial asthma and especially COPD, chronic bronchitis with or without pulmonary emphysema.

Dosed inhalation aerosol

The dose is set individually.

For relief of seizures, adults and children over 6 years of age are prescribed 2 inhalation doses. If relief of breathing does not occur within 5 minutes, 2 more inhalation doses can be prescribed.

The patient should be informed about immediate medical attention if there is no effect after 4 inhalation doses and the need for additional inhalations. Dosed aerosol in children should be used only as directed by a doctor and under the supervision of adults. For long-term and intermittent therapy, 1-2 inhalations are prescribed for 1 reception, up to 8 inhalations / day (on average, 1-2 inhalations 3 times / day). In bronchial asthma, the drug should be used only as needed. Rules for using the drug The patient should be instructed on the correct use of the metered aerosol. Before using the metered aerosol for the first time, double-click on the bottom of the can.

Each time you use a metered-dose aerosol, the following rules must be observed.

1. Remove the protective cap.

2. Take a slow, deep breath.

3. While holding the balloon, grasp the mouthpiece with your lips. The cylinder must be upside down.

4. Making the deepest possible inhalation, simultaneously quickly press the bottom of the balloon until 1 inhalation dose is released. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and exhale slowly. Repeat the steps to obtain the 2nd inhalation dose.

5. Put on the protective cap.

6. If the aerosol can has not been used for more than 3 days, before use, press the bottom of the can once until a cloud of aerosol appears.

The balloon is designed for 200 inhalations. Then the cylinder should be replaced. Although some content may remain in the balloon, the amount of drug released by inhalation is reduced. Since the balloon is opaque, the amount of the drug in the balloon can be determined as follows: after removing the plastic mouthpiece from the balloon, the balloon is immersed in a container filled with water.

The amount of the drug is determined depending on the position of the balloon in the water.

The inhaler should be cleaned at least once a week.

It is important to keep the mouthpiece of the inhaler clean so that the drug particles do not block the release of the aerosol. During cleaning, first remove the protective cap and remove the balloon from the inhaler.

A stream of warm water is passed through the inhaler; make sure to remove the product and / or visible dirt.

After cleaning, shake the inhaler and let it air dry without using heating devices.

Once the mouthpiece is dry, insert the can into the inhaler and put on the protective cap.

The contents of the cylinder are under pressure. The cylinder must not be opened and exposed to heating above 50 ? C.

ipratropium bromide, fenoterol hydrobromide

• Hypertrophic obstructive cardiomyopathy;

• tachyarrhythmia;

• I and III trimesters of pregnancy;

• children under 6 years of age (inhalation aerosol);

• hypersensitivity to fenoterol and other components of the drug;

• hypersensitivity to atropine-like drugs.

• With care: angle-closure glaucoma, arterial hypertension, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular diseases (chronic heart failure, coronary artery disease, arrhythmia, aortic stenosis, severe lesions of cerebral and peripheral arteries), hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, II trimester of pregnancy, lactation, children and adolescents from 6 to 18 years (inhalation aerosol).

pharmachologic effect

Combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic antagonist, and fenoterol hydrobromide - a beta2-adrenergic agonist. Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties. Bronchodilation with inhalation of ipratropium bromide is mainly due to local, rather than systemic, anticholinergic action. Ipratropium bromide inhibits reflexes caused by the vagus nerve, counteracting the effects of acetylcholine, a mediator released from the endings of the vagus nerve. Anticholinergics prevent an increase in the intracellular concentration of calcium ions, which occurs due to the interaction of acetylcholine with muscarinic receptors,located on the smooth muscles of the bronchi. The release of calcium ions is mediated by a system of secondary mediators, which include inositol triphosphate and diacylglycerol. Ipratropium bromide does not adversely affect mucus secretion in the respiratory tract, mucociliary clearance and gas exchange. Fenoterol selectively stimulates ?2-adrenergic receptors at a therapeutic dose. Stimulation of ? 1-adrenergic receptors occurs when high doses of fenoterol are used. Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of inflammatory mediators and bronchial obstruction from mast cells. Besides,when using fenoterol in higher doses, an increase in mucociliary clearance was noted. The effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular action of fenoterol, stimulation of the ?2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic ones, stimulation of the ?1-adrenergic receptors. As with the use of other beta-adrenergic drugs, an increase in the QTc interval has been observed when used in high doses. Tremor is the most frequent undesirable effect when using ?-adrenergic receptor agonists. In contrast to the effect on bronchial smooth muscles, tolerance can develop to the systemic effect of ?-adrenergic receptor agonists, but the clinical significance of this manifestation has not been clarified.With the combined use of ipratropium bromide and fenoterol, the bronchodilatory effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the antispasmodic effect on the muscles of the bronchi is enhanced and a wide range of therapeutic action is provided for bronchopulmonary diseases accompanied by airway obstruction. The complementary action is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects. In patients with bronchospasm associated with COPD (chronic bronchitis and pulmonary emphysema), a significant improvement in lung function (an increase in FEV1 and peak expiratory flow rate by 15% or more) was noted within 15 minutes.the maximum effect was achieved after 1-2 hours and lasted in most patients up to 6 hours after administration.

Side effect

The frequency of adverse reactions was determined in accordance with the WHO recommendations: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); very rare (<1/10 000), including isolated reports; the frequency is unknown (the frequency cannot be estimated from the available data). From the immune system: rarely - hypersensitivity reactions, anaphylactic reactions. From the side of metabolism and nutrition: rarely - hypokalemia, metabolic acidosis. Mental disorders: infrequently - nervousness; rarely - a feeling of anxiety, mental disturbances. From the nervous system: infrequently - headache, dizziness, tremors. From the side of the organ of vision: rarely - glaucoma, increased intraocular pressure, accommodation disturbances, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia,the appearance of a halo around objects and colored spots in front of the eyes. From the side of the cardiovascular system: infrequently - tachycardia, palpitations, increased systolic blood pressure; rarely - arrhythmia, atrial fibrillation, supraventricular tachycardia, myocardial ischemia, increased diastolic blood pressure. From the respiratory system: often - cough; infrequently - pharyngitis, dysphonia; rarely - bronchospasm, pharyngeal irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dryness of the pharynx. From the digestive system: infrequently - vomiting, dry mouth, nausea; rarely - stomatitis, glossitis, gastrointestinal motility disorders, constipation, diarrhea, oral edema. Dermatological reactions: rarely - urticaria, skin rash, pruritus, angioedema, hyperhidrosis. From the musculoskeletal system: rarely - muscle weakness, myalgia, muscle spasm.From the urinary system: rarely - urinary retention.

Application during pregnancy and lactation

Data from preclinical studies and experience with the combination of ipratropium bromide and fenoterol show that the components of the drug do not have a negative effect during pregnancy. Consideration should be given to the possibility of an inhibitory effect of fenoterol on the contractile activity of the uterus. The drug is contraindicated in the first and third trimesters of pregnancy (the possibility of weakening labor with fenoterol). The drug should be used with caution in the II trimester of pregnancy. Fenoterol is excreted in breast milk. There is no evidence that ipratropium bromide passes into breast milk. The use of the drug during breastfeeding is possible only if the potential benefit to the mother outweighs the potential risk to the child.

Application in children

Inhalation aerosol is contraindicated for use in children under 6 years of age. Care should be taken to prescribe the drug in the form of an aerosol for inhalation to patients aged 6 to 18 years. Use in elderly patients

The drug is approved for use in elderly patients

special instructions

The patient should be informed that in the event of an unexpected rapid increase in shortness of breath (difficulty breathing), you should immediately consult a doctor.

Paradoxical bronchospasm

The drug can cause paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm develops, the drug should be discontinued immediately and switched to alternative therapy.

Long-term use

In patients with bronchial asthma, the drug should be used only as needed. In patients with mild COPD, symptomatic treatment may be preferable to regular use. In patients with bronchial asthma, it should be remembered that it is necessary to conduct or intensify anti-inflammatory therapy to control the inflammatory process of the respiratory tract and the course of the disease. Regular use of increasing doses of drugs containing beta2-adrenergic agonists to relieve bronchial obstruction can cause an uncontrolled worsening of the course of the disease. In the case of increased bronchial obstruction, increasing the dose of beta2-agonists more than the recommended dose for a long time is not only unjustified, but also dangerous.To prevent a life-threatening worsening of the course of the disease, consideration should be given to revising the patient's treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids. Other sympathomimetic bronchodilators should be administered concurrently with the drug only under medical supervision.

Violations of the organ of vision

The drug should be administered with caution to patients predisposed to the development of angle-closure glaucoma. There are isolated reports of complications from the organ of vision (for example, increased intraocular pressure, mydriasis, angle-closure glaucoma, pain in the eyes) that develop when inhaled ipratropium bromide (or ipratropium bromide in combination with agonists of ?2-adrenergic receptors) gets into the eyes. Symptoms of acute angle-closure glaucoma may include pain or discomfort in the eyes, blurred vision, the appearance of a halo on objects and colored spots before the eyes, combined with corneal edema and redness of the eyes due to conjunctival vascular injection. If any combination of these symptoms is noted, the use of eye drops that reduce intraocular pressure is indicated, and immediate consultation with a specialist.Patients should be instructed on the correct use of the inhalation solution. To prevent the solution from getting into the eyes, it is recommended that the solution used with a nebulizer be inhaled through a mouthpiece. In the absence of a mouthpiece, a mask that fits snugly to the face should be used. Particular care should be taken to protect the eyes of patients prone to developing glaucoma.

Systemic Effects

For diseases such as recent myocardial infarction, diabetes mellitus with inadequate glycemic control, severe organic diseases of the heart and blood vessels, hyperthyroidism, pheochromocytoma, or obstruction of the urinary tract (for example, with prostatic hyperplasia or obstruction of the bladder neck), the drug should be prescribed only after a careful assessment of the risk / benefit ratio, especially when used in doses higher than recommended.

Effects on the cardiovascular system

In post-marketing studies, there have been rare cases of myocardial ischemia when taking ?-adrenergic receptor agonists. Patients with concomitant serious heart disease (for example, coronary artery disease, arrhythmias, or severe heart failure) receiving the drug should be warned about the need to consult a doctor in case of pain in the heart or other symptoms indicating worsening heart disease. Symptoms such as shortness of breath and chest pain should be monitored. they can be of both cardiac and pulmonary etiology.

Hypokalemia

When using agonists? 2-adrenergic receptors, hypokalemia may occur. In athletes, the use of the drug, due to the presence of fenoterol in its composition, can lead to positive results of doping tests.

Excipients

The preparation in the form of an aerosol for inhalation contains a preservative, benzalkonium chloride, and a stabilizer, disodium edetate dihydrate. During inhalation, these components can cause bronchospasm in sensitive patients with airway hyperresponsiveness.

Influence on the ability to drive vehicles and mechanisms

The effect of the drug on the ability to drive vehicles and use mechanisms has not been specifically studied. However, patients should be advised that during treatment with the drug, the development of such undesirable phenomena as dizziness, tremor, disturbance of accommodation, mydriasis, blurred vision is possible. Therefore, caution should be advised when driving or using machinery. If patients experience the above undesirable sensations, one should refrain from such potentially dangerous actions as driving vehicles or operating machinery.

Drug interactions

The simultaneous use of other beta-adrenergic agonists, anticholinergic drugs and xanthine derivatives (for example, theophylline) can enhance the bronchodilatory effect of the drug. A significant weakening of the bronchodilating effect of the drug is possible with the simultaneous administration of beta-blockers. Hypokalemia associated with the use of beta-adrenergic agonists can be exacerbated by the simultaneous use of xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention in the treatment of patients with severe obstructive airways disease. Hypokalemia may increase the risk of arrhythmias in patients receiving digoxin. In addition, hypoxia can exacerbate the negative effects of hypokalemia on heart rate.In such cases, it is recommended to monitor the concentration of potassium in the blood serum. Beta2-adrenomimetics should be used with caution in patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs are able to enhance the action of beta-adrenergic drugs. The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, can increase the effects of beta-adrenergic drugs on the cardiovascular system. The combined use of the drug with cromoglycic acid and / or corticosteroids increases the effectiveness of therapy.The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene, or enflurane, can increase the effects of beta-adrenergic drugs on the cardiovascular system. The combined use of the drug with cromoglycic acid and / or corticosteroids increases the effectiveness of therapy.The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, can increase the effects of beta-adrenergic drugs on the cardiovascular system. The combined use of the drug with cromoglycic acid and / or corticosteroids increases the effectiveness of therapy.