Expiration date: 01/2025

The composition and form of issue:

Inhalation solution 1 ml

ipratropia bromide 0, 25 mg

in dropper bottles of 20 ml (1 ml = 20 drops) in a box of 1 bottle.

Aerosol for inhalation dosed 1 dose

ipratropia bromide 0, 021 mg

(which corresponds to 0, 02 mg of ipratropium anhydrous bromide)

propellant: 1, 1, 1, 2-Tetrafluoroethane (HFA 134a)

excipients: citric acid anhydrous distilled water ethanol

in aerosol cans with a mouthpiece of 10 ml (200 doses) in a box of 1 balloon.

Pharmacological action:

Ipratropium bromide is a Quaternary ammonium compound. It has anticholinergic properties. Inhibits vagus nerve reflexes, being a competitive antagonist of the neurotransmitter acetylcholine. It blocks muscarinic receptors in the smooth muscles of the tracheobronchial tree and suppresses reflex bronchoconstriction. The expansion of the bronchi during inhalation is mainly due to local, rather than systemic anticholinergic action of the drug. Effectively prevents narrowing of the bronchi that occurs as a result of inhaling cigarette smoke, cold air, the action of various bronchospasming substances, and also inhibits bronchial spasm associated with the influence of vagus nerves. When inhaled, it practically does not have a resorptive effect — for the development of tachycardia, it is necessary to inhale about 500 doses, while only 10% reaches the small bronchi and alveoli, and the rest settles in the pharynx or oral cavity and is swallowed.

Pharmacokinetics:

With the inhalation route of administration, absorption is extremely low. The concentration of the drug in the blood plasma is at the lower limit of the definition and it is possible to measure it only when using high doses of the active substance. It is excreted mainly through the intestines, about 25% - unchanged, the rest-in the form of metabolites.

Description of pharmacological action:

It has a pronounced broncholytic effect and prevents the development of bronchial spasm. Causes a decrease in the secretion of glands of the bronchial mucosa.

Clinical pharmacology:

In patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema), significant improvements in lung function (increase in forced expiratory volume in 1 s — FEV1 and the average flow speed of the forced exhalation of 25-75% increased by 15% or more) observed after 15 min, the maximum effect is reached after 1-2 hours and lasts in most patients up to 6 h

In patients with bronchospasm associated with bronchial asthma, a significant improvement in lung function (an increase in FEV1 by 15% or more) is observed in 40% of patients.

Indications:

Chronic obstructive pulmonary disease (chronic obstructive bronchitis, emphysema) bronchial asthma (moderate to mild), especially with concomitant diseases of the cardiovascular system.

Contraindications:

Hypersensitivity to atropine and its derivatives, and other components of the drug, pregnancy (I trimester), children under 6 years of age (Atrovent N).

Use during pregnancy and lactation:

Contraindicated in the first trimester of pregnancy, the drug may be prescribed in the second-III trimester of pregnancy and during breastfeeding only if the expected effect of therapy exceeds the potential risk to the fetus or child.

Side effect:

The most common adverse effects are headache, nausea, and dry mouth.

Due to the low systemic absorption of the drug, side effects associated with systemic anticholinergic action, such as tachycardia, palpitations, accommodation disorders, decreased secretion of sweat glands, impaired gastrointestinal motility, urinary retention, are rare and reversible. However, patients with obstructive urinary tract disease have an increased risk of developing urinary retention.

As with other inhalation therapy, including bronchodilators, sometimes there is a cough, less often-paradoxical bronchospasm.

In rare cases, allergic reactions may develop, including urticaria, angioedema, rash, oropharyngeal edema, and anaphylaxis.

There are some reports of eye complications (pupil dilation, increased intraocular pressure, angle-closure glaucoma, eye pain) when ipratropium bromide aerosol or ipratropium bromide aerosol combined with beta2 agonists enters the eyes. Patients must be able to correctly use a metered-dose aerosol.

Drug interaction:

Potentiates the broncholytic effect of beta-adrenomimetics and xanthine derivatives. Increases the cholinolytic effect of other drugs.

Dosage and administration:

Inhalant.

Solution for inhalation: adults and children over 12 years — 0, 5 mg (40 drops) 3-4 times a day through a nebulizer children 6-12 years — 0, 25 mg (20 drops) 3-4 times a day through a nebulizer children under 6 years - 0, 1-0, 25 mg (8-20 drops) 3-4 times a day (under the supervision of a doctor). The recommended dose immediately before use is diluted with saline solution to a volume of 3-4 ml. the Dose depends on the method of inhalation and the quality of spraying. If necessary, repeated inhalations are performed at intervals of at least 2 hours.

Aerosol for inhalation dosed: adults and children older than 6 years — 2 doses of aerosol 4 times a day, if necessary, the dose can be increased to 12 inhalations per day.

Overdose:

No specific symptoms of overdose were detected. There may be minor manifestations of systemic anticholinergic action, such as dry mouth, impaired accommodation, and increased heart rate. Treatment is symptomatic.

Precautionary measures:

0, 025% inhalation solution contains the preservative benzalkonium chloride and the stabilizer ethylenediaminetetraacetic acid. There are reports that these substances, when administered in high doses, can cause bronchospasm in some patients.

It is not recommended to exceed the established daily dose, both for short-term and long-term use of the drug.

Caution should be used in patients with angle-closure glaucoma and urinary disorders due to benign prostatic hyperplasia.

If the drug accidentally enters the eyes of a patient with angle-closure glaucoma, an increase in intraocular pressure may occur.

Pain in the eye or discomfort, blurred vision, the appearance of a halo and colored spots in front of the eyes in combination with conjunctival and corneal hyperemia can be symptoms of an attack of narrow-angle glaucoma. If any of these symptoms appear, you should prescribe drops that cause pupil constriction and immediately contact an ophthalmologist.

If the patient's condition worsens or there is no significant improvement, a doctor's consultation is required to determine a plan for further treatment. In case of sudden and rapid increase in shortness of breath (difficulty breathing), you should immediately consult a doctor.

Children dosed aerosol Atrovent N should be prescribed only after the recommendation of a doctor and under the supervision of adults.

Special instruction:

It is not recommended for emergency relief of an attack of suffocation (the broncholytic effect develops later than in beta-adrenostimulators).

Patients with cystic fibrosis have an increased likelihood of slowing down the gastrointestinal motility.

Patients should be able to correctly use Atrovent N aerosol for inhalation dosed.

The first time you use freon-free form of measured aerosol patients may note that the taste new product differs slightly from the same pharmaceutical form of the drug containing freon. When switching from one form of the drug to another, patients should be warned about possible changes in the taste properties of the drug. It should be reported that these drugs are interchangeable, and that the taste properties are not related to the safety and effectiveness of the new drug.