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 pulmonary emphysema.

Active ingredient

Ipratropium bromide, Phenoterol

Composition

Aerosol for inhalation is a colorless or light yellow or light brown or brownish-yellowish transparent solution with an ethanol odor, which is under pressure in a metal monoblock cylinder with a metering valve equipped with an inhaler nozzle with a protective cap; the drug when leaving the cylinder is atomized as an aerosol cloud.

Excipients:

ethanol (absolute ethyl alcohol) – 13.313 mg,

purified water – 0.799 mg,

citric acid anhydrous – 0.001 mg,

hydrofluoroalkane (HFA-134a) – 39.07 mg.

How to take, the dosage

The dose is set individually.

For relieving the attacks in adults and children over 6 years old 2 inhalation doses are prescribed. If breathing relief does not come within 5 minutes, 2 more inhalation doses may be prescribed.
The patient should be informed about immediate medical attention in case of no effect after 4 inhalation doses and the need for additional inhalations.

Dosed aerosol in children should be used only by prescription and under adult supervision.

For prolonged and intermittent therapy, 1-2 inhalations for 1 administration, up to 8 inhalations/day (average, 1-2 inhalations 3 times/day).
In bronchial asthma the drug should be used only as needed.

Rules for use of the drug

The patient should be instructed on the proper use of metered aerosol.

Before using the dispensed aerosol for the first time, you should press the bottom of the can twice.

Each time you use the dispensed aerosol, the following rules must be followed.

1. Remove the protective cap.

2. Make a slow, deep exhalation.

3. Holding the can, wrap your lips around the mouthpiece. The balloon should be pointing upwards.

4. Taking the deepest breath possible, at the same time quickly press the bottom of the balloon until the release of 1 inhalation dose. Hold your breath for a few seconds and then take the mouthpiece out of your mouth and slowly exhale. Repeat for 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 using it you should press once at the bottom of the can until the cloud of aerosol appears.

The can is designed for 200 inhalations. Then the can should be replaced. In spite of the fact that in the cylinder some content may remain, the quantity of the drug released during inhalation decreases.

Because the cylinder is opaque, the amount of drug in the cylinder can be determined as follows: after removing the plastic nozzle from the cylinder, the cylinder is immersed into 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 particles of medication do not block the release of the aerosol.

When cleaning, first remove the protective cap and remove the balloon from the inhaler. A stream of warm water is run through the inhaler to ensure that the product and/or visible debris is removed. After cleaning, the inhaler should be shaken and allowed to air dry without the use of heating devices. Once the mouthpiece is dry, insert the can into the inhaler and put on the protective cap.

The contents of the can is under pressure. The balloon must not be opened and exposed and heated above 50 ° C.

Interaction

Concomitant use of other beta-adrenomimetics, anticholinergic drugs and xanthine derivatives (eg, theophylline) may increase the bronchodilator effect of the drug.

It is possible the significant weakening of bronchodilator action in concurrent administration of beta-adrenoblockers.
Hypokalemia associated with the use of beta-adrenomimetics may be increased by concurrent use of xanthine derivatives, corticosteroids and diuretics. This fact should be paid special attention when treating patients with severe forms of obstructive airways.

Hypokalemia may lead to an increased risk of arrhythmias in patients receiving digoxin. In addition, hypoxia may increase the negative effect of hypokalemia on cardiac rhythm. In such cases, it is recommended to monitor serum potassium concentration.

The beta2-adrenomimetics should be prescribed with caution in patients receiving MAO inhibitors and tricyclic antidepressants, since these drugs can enhance the effect of beta-adrenergic agents.

The use of inhaled halogenated anesthetics, such as halothane, trichloroethylene or enflurane, may increase the effect of beta-adrenergic agents on the cardiovascular system.

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

Special Instructions

The patient should be informed that in case of sudden rapid increase in dyspnea (difficulty in breathing) immediately consult a doctor.

Paradoxical bronchospasm

The drug can cause paradoxical bronchospasm, which may be life-threatening. In case of paradoxical bronchospasm the drug should be immediately discontinued and switch to alternative therapy.

Long-term use

In patients with bronchial asthma the drug should be used only as needed. In patients with a mild form of COPD symptomatic treatment may be preferable to regular use.

In patients with bronchial asthma it should be remembered about the need to conduct or strengthen anti-inflammatory therapy to control the inflammatory process of the airways and the course of the disease.

Regular use of increasing doses of drugs containing beta2-adrenomimetics to relieve bronchial obstruction can cause uncontrolled worsening of the course of the disease.

In the case of increased bronchial obstruction, increasing the dose of beta2-agonists beyond the recommended dose for a long time is not only unwarranted, but also dangerous. To prevent a life-threatening worsening of the course of the disease, a review of the patient’s treatment plan and adequate anti-inflammatory therapy with inhaled corticosteroids should be considered.

Other sympathomimetic bronchodilators should be administered simultaneously with the drug only under medical supervision.

Visual disorders

The drug should be prescribed with caution in patients predisposed to the development of closed-angle glaucoma.

There have been isolated reports of ocular complications (e.g., increased intraocular pressure, mydriasis, closed-angle glaucoma, eye pain) that developed when inhaled ipratropium bromide (or ipratropium bromide in combination with β2-adrenoreceptor agonists) was in the eye.

Symptoms of acute closed angle glaucoma may include pain or discomfort in the eyes, blurred vision, haloing of objects and colored spots in front of the eyes combined with corneal edema and red eyes, due to conjunctival vascular injection.

If any combination of these symptoms is noted, the use of eye drops that reduce intraocular pressure and immediate consultation with a specialist is indicated. Patients should be instructed on the proper use of the inhalation solution.

To prevent eye contact with the solution, it is recommended that the solution used with the nebulizer be inhaled through a mouthpiece. If a mouthpiece is not available, a mask that fits snugly over the face should be used. Particular care should be taken to protect the eyes of patients predisposed to the development of glaucoma.

Systemic 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, in prostatic hyperplasia or bladder neck obstruction), the drug should be prescribed only after careful risk/benefit assessment, 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 β-adrenoreceptor agonists.

Patients with concomitant serious heart disease (e.g., CHD, arrhythmias or severe heart failure) receiving the drug should be warned about the need to seek medical attention in case of heart pain or other symptoms indicating worsening heart disease.

It is necessary to pay attention to such symptoms as shortness of breath and chest pain because they may be of cardiac or pulmonary etiology.

Hypokalemia

Hypokalemia may occur when using β2-adrenoreceptor agonists.
In athletes due to fenoterol may lead to positive results in doping tests.

Excipients

The drug in aerosol form for inhalation contains a preservative, benzalkonium chloride and stabilizer – diacetate dihydrate. During inhalation these components may 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 should be informed that during the drug treatment such adverse events as dizziness, tremor, accommodation disorders, mydriasis, blurred vision may occur.

Therefore, caution should be recommended when driving motor transport or using machinery. If patients experience the above undesirable sensations, they should refrain from potentially dangerous activities such as driving vehicles or operating machinery.

Contraindications

Hypertrophic obstructive cardiomyopathy;

tachyarrhythmia;

I and III trimesters of pregnancy;

children under 6 years (aerosol for inhalation);

hypersensitivity to fenoterol and other components of the drug;

hypersensitivity to atropine-like preparations.

With caution: Closed-angle glaucoma, arterial hypertension, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart and vascular disease (chronic heart failure, CHD, arrhythmia, aortic stenosis, pronounced lesions of cerebral and peripheral arteries), hyperthyroidism, pheochromocytoma, prostatic hyperplasia, bladder cervical obstruction, cystic fibrosis, II trimester pregnancy, lactation, childhood and adolescence from 6 to 18 years (aerosol for inhalation).

Side effects

The frequency of adverse reactions was determined according to WHO recommendations: Very common (>1/10); common (>1/100, <1/10); infrequent (>1/1000, <1/100); rare (>1/10 000, <1/1000); very rare (<1/10 000), including individual reports; frequency unknown (frequency cannot be calculated from available data).

Immune system: rare – hypersensitivity reactions, anaphylactic reactions.

Metabolism and nutrition: rare – hypokalemia, metabolic acidosis.

Mental disorders: infrequent – nervousness, rarely – anxiety, mental disorders.

Nervous system: infrequent – headache, dizziness, tremor.

Visually: rarely – glaucoma, increased intraocular pressure, accommodation disorders, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, appearance of a halo around objects and color spots before eyes.

Cardio-vascular system: infrequent – tachycardia, palpitations, increased systolic blood pressure, rare – arrhythmia,
atrial fibrillation, supraventricular tachycardia, myocardial ischemia, increased diastolic BP.

Respiratory system: frequently – cough, infrequently – pharyngitis, dysphonia, rarely – bronchospasm, pharyngeal irritation, pharyngeal edema, laryngospasm, paradoxical bronchospasm, dry throat.

The digestive system: infrequent – vomiting, dry mouth, nausea, rarely – stomatitis, glossitis, GI motility disorders, constipation, diarrhea, edema of the mouth.

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

Musculoskeletal system: rare – muscle weakness, myalgia, muscle spasm.

Urinary system: rare – urinary retention.

Similarities

Berodual, Berodual N, Astmasol