Inspirax, aerosol 20 mcg+50 mcg/dose 200 doses

Combined bronchodilatorial drug. It contains two components with bronchodilator activity: ipratropium bromide – m-cholinoblocker, and fenoterol hydrobromide – beta2-adrenomimetic.

Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties.

Bronchodilation during inhalation administration of ipratropium bromide is mainly due to local rather than systemic anticholinergic action.

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 emphysema.

Pharmacological effect

Combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide – an m-anticholinergic blocker, and fenoterol hydrobromide – a beta2-adrenergic agonist.

Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties.

Bronchodilation with inhaled ipratropium bromide is due primarily to local rather than systemic anticholinergic effects.

Special instructions

The patient should be informed that if shortness of breath (difficulty breathing) suddenly worsens unexpectedly, seek immediate medical attention.

Paradoxical bronchospasm

The drug can cause paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm develops, use of the drug should be stopped 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, one should remember the need to carry out 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-agonists to relieve bronchial obstruction can cause uncontrolled worsening of the disease.

In case of increased bronchial obstruction, increasing the dose of beta2-agonists more than recommended for a long time is not only not justified, but also dangerous. To prevent life-threatening worsening of the disease, consideration should be given to reviewing the patient’s treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids.

Other sympathomimetic bronchodilators should be co-administered with this drug only under medical supervision.

Visual disorders

The drug should be prescribed 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, eye pain) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with β2-adrenergic receptor agonists) entered 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 in front of the eyes in combination with corneal edema and redness of the eyes due to conjunctival vascular injection.

If any combination of these symptoms is observed, the use of eye drops that reduce intraocular pressure and immediate consultation with a specialist is indicated. 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 the mouthpiece. If you do not have a mouthpiece, use a mask that fits tightly to your face. Particular care should be taken to protect the eyes of patients predisposed to the development of glaucoma.

System effects

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

Effect on the cardiovascular system

In post-marketing studies, rare cases of myocardial ischemia have been reported when taking beta-adrenergic agonists.

Patients with underlying serious heart disease (eg, coronary artery disease, arrhythmias, or significant heart failure) receiving the drug should be warned to seek medical attention if heart pain or other symptoms indicating worsening of heart disease occur.

It is necessary to pay attention to symptoms such as shortness of breath and chest pain, because… they can be of both cardiac and pulmonary etiology.

Hypokalemia

Hypokalemia may occur when using β2-adrenergic agonists.
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 drug in the form of an aerosol for inhalation contains a preservative, benzalkonium chloride, and a stabilizer, disodium edetate dihydrate. During inhalation, these components may cause bronchospasm in sensitive patients with airway hyperresponsiveness.

Impact on the ability to drive vehicles and machinery

The effect of the drug on the ability to drive vehicles and use machinery has not been specifically studied.

However, patients should 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 vehicles or using machinery. If patients experience the above unwanted sensations, they should refrain from potentially hazardous activities such as driving or operating machinery.

Active ingredient

Ipratropium bromide, Fenoterol

Composition

Dosed aerosol for inhalation is colorless or light yellow or light brown. or with a brownish-yellowish tint, a transparent solution with the odor of ethanol, under pressure in a monoblock metal cylinder with a metering valve, equipped with an inhaler nozzle with a protective cap; When leaving the container, the drug is sprayed in the form of an aerosol cloud.

ipratropium bromide monohydrate 0.021 mg,
which corresponds to the content of ipratropium bromide 0.02 mg
fenoterol hydrobromide 0.05 mg
Excipients:
ethanol (absolute ethyl alcohol) – 13.313 mg,
purified water – 0.799 mg,
anhydrous citric acid – 0.001 mg,
hydrofluoroalkane (HFA-134a) – 39.07 mg.

Contraindications

Hypertrophic obstructive cardiomyopathy;

tachyarrhythmia;

I and III trimesters of pregnancy;

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

hypersensitivity to fenoterol and other components of the drug;

hypersensitivity to atropine-like drugs.

With caution: 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 the cerebral and peripheral arteries), hyperthyroidism, pheochromocytoma, prostatic hyperplasia, urinary cervical obstruction bladder, cystic fibrosis, second trimester of pregnancy, lactation period, childhood and adolescence from 6 to 18 years (aerosol for inhalation).

Side Effects

The frequency of adverse reactions was determined in accordance with WHO recommendations: very often (>1/10); often (>1/100, 1/1000, 1/10,000, <1/1000); very rare (<1/10,000), including isolated reports; frequency unknown (frequency cannot be calculated from available data).From the immune system: rarely – hypersensitivity reactions, anaphylactic reactions.Metabolism and nutrition: rarely – hypokalemia, metabolic acidosis.Mental disorders: infrequently – nervousness; rarely – anxiety, mental disorders.From the nervous system: infrequently – headache, dizziness, tremor.From 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 before 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 disorders, constipation, diarrhea, swelling of the oral cavity.

Dermatological reactions: rarely – urticaria, skin rash, itching, angioedema, hyperhidrosis.

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

From the urinary system: rarely – urinary retention.

Interaction

The simultaneous use of other beta-agonists, anticholinergic drugs and xanthine derivatives (for example, theophylline) may enhance the bronchodilator effect of the drug.

A significant weakening of the bronchodilator effect of the drug is possible with simultaneous administration of beta-blockers.
Hypokalemia associated with the use of beta-agonists may be exacerbated by the simultaneous use of xanthine derivatives, corticosteroids and diuretics. This fact should be given special attention when treating patients with severe forms of obstructive airway diseases.

Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia may enhance the negative effects of hypokalemia on heart rate. In such cases, it is recommended to monitor serum potassium concentrations.

Beta2-agonists should be prescribed with caution to patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs can enhance the effect of beta-adrenergic drugs.

The use of inhaled halogenated anesthetics, such as halothane, trichlorethylene or enflurane, may increase the cardiovascular effects of beta-adrenergic agents.

Combined use of the drug with cromoglycic acid and/or GCS increases the effectiveness of therapy.

Manufacturer

Binnopharm, Russia