Inspirax solution for inhalation 0.25 mg / ml + 0.5 mg / ml bottle of 20 ml (Ypratropyya bromide, fenoterol)

Pharmacological action

Combined bronchodilator drug. It contains two components with bronchodilator activity: ipratropium bromide - m-anticholinergic, and fenoterol hydrobromide - beta2-adrenergic agonist.

Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatolytic) properties. Bronchodilation with the inhalation of ipratropium bromide is mainly due to local and not systemic anticholinergic action.

ipratropium bromide inhibits the reflexes caused by the vagus nerve, counteracting the effects of acetylcholine - a mediator released from the ends 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, including 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 with the use of phenoterol in high doses. Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions due to the effects 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. In addition, with the use of phenoterol 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 effect of phenoterol, stimulation of 2-adrenoreceptors of the heart, and when used in doses exceeding therapeutic, stimulation of 1-adrenoreceptors. As with other beta-adrenergic drugs, the QTc interval was prolonged when used in high doses.

Tremor is the most common undesirable effect when using -adrenoreceptor agonists. In contrast to the effect on the smooth muscles of the bronchi, tolerance can develop to the systemic influence of ОІ-adrenoreceptor agonists, however, the clinical significance of this manifestation has not been elucidated.

With the combined use of ipratropium bromide and phenoterol, the bronchodilating effect is achieved by exposure to 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 effects is provided for bronchopulmonary diseases accompanied by airway obstruction. The complementary effect is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows you to individually choose an effective dose with almost no side effects.

In patients with bronchospasm associated with COPD (chronic bronchitis and pulmonary emphysema), significant improvement in lung function (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.

Indications

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.

Contraindications

Hypertrophic obstructive cardiomyopathy tachyarrhythmias I and III trimesters of pregnancy children under 6 years of age (aerosol for inhalation), increased sensitivity to phenoterol and other components of the drug, increased sensitivity to atropine-like drugs.

Precautions: angle-closure glaucoma, arterial hypertension, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular diseases (chronic heart failure, IHD, arrhythmia, aortic stenosis, severe cerebral and peripheral arterial lesions), hyperthyroidism pheochromocytoma, prostatic hyperplasia, bladder neck obstruction, cystic fibrosis, II trimester of pregnancy, lactation, childhood and adolescence from 6 to 18 years (aerosol for inhalation).

Directions for use

Dosage and administration should be selected individually. depending on the severity of the attack. Treatment usually begins with the lowest recommended dose and is discontinued after a sufficient decrease in symptoms has been achieved.

Treatment should be carried out under medical supervision (for example, in a hospital). Treatment at home is possible only after consulting a doctor in cases where a fast-acting -Adrenoreceptor agonist in a low dose is not effective enough. The inhalation solution can be recommended for patients in the case when the aerosol for inhalation cannot be used or, if necessary, use in higher doses.

In adults (including the elderly) and adolescents over 12 years of age, with acute attacks of bronchospasm, depending on the severity of the attack, the doses can vary from 1 ml (1 ml = 20 drops) to 2.5 ml (2.5 ml = 50 drops). In especially severe cases, it is possible to use the drug in doses reaching 4 ml (4 ml = 80 drops).

In children aged 6-12 years with acute attacks of bronchial asthma, depending on the severity of the attack, the doses can vary from 0.5 ml (0.5 ml = 10 drops) to 2 ml (2 ml = 40 drops).

In children under 6 years of age (body weight <22 kg) due to the fact that information on the use of the drug in this age group is limited, the use of the following dose is recommended (only under medical supervision): 0.1 ml (2 drops) per kg body weight, but not more than 0.5 ml (10 drops).

Rules for using the drug

Inhalation solution should be used only for inhalation (with a suitable nebulizer) and should not be used orally.

The recommended dose should be diluted with 0.9% sodium chloride solution to a final volume of 3-4 ml, and apply (completely) with a nebulizer.

Inhalation solution should not be diluted with distilled water.

Dilution of the solution should be carried out each time before use. Residues of the diluted solution should be destroyed.

The diluted solution should be used immediately after preparation.

The duration of inhalation can be controlled by the consumption of the diluted solution.

Inhalation solution can be used using a variety of commercial nebulizer models. The dose reaching the lungs and the systemic dose depend on the type of nebulizer used and may be higher than the corresponding doses when using a metered-dose aerosol (which depends on the type of inhaler). In cases where there is wall oxygen, the solution is best used at a flow rate of 6-8 l / min.

Follow the instructions for use, maintenance and cleaning of the nebulizer.

Special instructions

The patient should be informed that in case of sudden rapid intensification of shortness of breath (difficulty breathing), consult a doctor immediately.

Paradoxical bronchospasm

The drug can cause paradoxical bronchospasm, which can be life threatening. In the case of the development of paradoxical bronchospasm, the use of the drug should be stopped immediately and switch to alternative therapy.

Long-term use of

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, one should be aware of the need to conduct or strengthen 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 disease. In the case of increased bronchial obstruction, an increase in the dose of beta2-agonists is more than recommended for a long time, not only not justified, 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 prescribed simultaneously with the drug only under medical supervision.

Disorders of the organ of vision

The drug should be prescribed with caution to patients predisposed to the development of angle-closure glaucoma. There are separate reports of complications from the organ of vision (for example, increased intraocular pressure, mydriasis, angle-closure glaucoma, eye pain) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with 2-adrenoreceptor agonists) gets into the eyes. Symptoms of acute angle-closure glaucoma may be pain or discomfort in the eyes, blurred vision, the appearance of a halo in objects and colored spots in front of the eyes in combination with corneal edema and redness of the eyes due to conjunctival injection of blood vessels. 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 proper 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 the mouthpiece. In the absence of a mouthpiece, a mask should be used that fits close to the face. Particular care should be taken to protect the eyes of patients predisposed to the development of glaucoma.

Systemic effects of

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

Effect on the cardiovascular system

Post-marketing studies have reported rare cases of myocardial ischemia when taking -adrenoreceptor agonists. Patients with concomitant serious heart diseases (e.g., coronary heart disease, arrhythmias, or severe heart failure) receiving the drug, should be warned about the need to see a doctor in case of pain in the heart or other symptoms indicating a worsening heart disease. Symptoms such as shortness of breath and chest pain should be noted. they can be both cardiac and pulmonary etiology.

Hypokalemia

Hypokalemia may occur with 2-adrenoreceptor agonists.

In athletes, the use of the drug, due to the presence of phenoterol 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.

Effect 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 must be informed that during treatment with the drug, the development of such undesirable effects as dizziness, tremor, disturbance of accommodation, mydriasis, blurred vision is possible. Therefore, caution should be recommended when driving or using machinery. If patients experience the above unwanted sensations, you should refrain from such potentially dangerous actions as driving vehicles or operating machinery.

Composition

Inhalation solution is clear, colorless or almost colorless, odorless.

1 ml

ipratropium bromide monohydrate 0.261 mg,

corresponding to ipratropium bromide 0.25 mg

phenoterol hydrobromide 0.5 mg

Excipients:

sodium chloride - 8.8 mg,

hydrochloric acid solution 1M - 0.88 mg,

sodium edetate - 0.5 mg,

benzalkonium chloride - 0.1 mg,

purified water - up to 1 ml.

Side effects

The frequency of adverse reactions was determined in accordance with WHO recommendations: very often (> 1/10) often (> 1/100, <1/10) infrequently (> 1/1000, <1/100) rarely (> 1/10 000, <1/1000) is very rare (<1/10 000), including individual messages, the frequency is unknown (the frequency cannot be calculated from the available data).

On the part of 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 sense of anxiety, mental disturbances.

From the nervous system: infrequently - headache, dizziness, tremor.

From the side of the organ of vision: rarely - glaucoma, increased intraocular pressure, disturbances in accommodation, 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 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, dry throat.

From the digestive system: infrequently - vomiting, dry mouth, nausea rarely - stomatitis, glossitis, gastrointestinal motility, constipation, diarrhea, swelling of the oral cavity.

Dermatological reactions: rarely - urticaria, skin rash, itchy skin, angioedema, hyperhidrosis.

From the musculoskeletal system: rarely - muscle weakness, myalgia, muscle spasm.

From the urinary system: rarely - urinary retention.

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Dosage form

solution for inhalation



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