Ipratropium-nativ, inhalation solution 0.25mg/ml, 20ml 1pc

Composition

Active ingredient:

0.261 mg ipratropium bromide monohydrate in terms of 0.25 mg ipratropium bromide.

Auxiliary substances:

sodium benzoate,

disodium edetate dihydrate (corresponds to disodium edetate),

citric acid monohydrate (corresponds to citric acid anhydrous),

sodium hydroxide up to pH 3.4±0.1,

water for injection.

Pharmacological action

Bronchodilator, blocks m-holinoreceptors of smooth muscles of the tracheobronchial tree (mainly at the level of large and medium bronchi) and suppresses reflex bronchoconstriction. Having a structural similarity to the acetylcholine molecule, it is its competitive antagonist.

Effectively prevents bronchial constriction resulting from the action of various bronchospasm agents, and also eliminates bronchial spasm associated with the influence of the vagus nerve. When inhaled, it has practically no resorptive effect.

The bronchodilating effect develops in 5-15 minutes, reaches a maximum in 1-2 hours and lasts up to 6 hours (sometimes up to 8 hours).

Indications

Treatment and prevention of chronic obstructive airway diseases: chronic bronchitis with bronchial obstructive syndrome (with or without emphysema), mild to moderate bronchial asthma, especially with concomitant diseases of the cardiovascular system; bronchospasm during surgical operations.

Preparation of the respiratory tract before use of antibiotics, mucolytics, corticosteroids, and sodium cromoglycate in aerosols.

Contraindications

Hypersensitivity to ipratropium bromide.

Mainly for systemic use: increased intraocular pressure, prostatic hyperplasia, mechanical gastrointestinal stenosis, tachycardia, megacolon, I trimester of pregnancy.

Side effects

Many of these adverse reactions may be due to the anticholinergic properties of ipratropium bromide.

The drug Ipratropium-native, like any inhalation therapy, can cause local irritation. The most common adverse reactions reported in clinical trials were headache, pharyngeal irritation, cough, dry mouth, gastrointestinal motility disorders (including constipation, diarrhea, and vomiting), nausea, and dizziness.

Adverse reactions are distributed according to the frequency of occurrence. The following criteria were used to estimate the frequency: very common (>1/10); common (from 1/100 to 1/10); infrequent (from 1/1000 to 1/100); rare (from 1/10000 to 1/1000); very rare (>

Infectious and parasitic diseases: often-flu-like symptoms, upper respiratory tract infections; infrequently-urinary tract infections. Immune system disorders: infrequently-hypersensitivity, anaphylactic reactions, angioedema (angioedema).

Nervous system disorders: often-headache, dizziness.

Visual disorders: infrequently-blurred vision, mydriasis, increased intraocular pressure, glaucoma, acute pain in the eyes, the appearance of a halo around objects, conjunctival hyperemia, corneal edema; rarely-accommodation disorders.

Cardiac disorders: infrequently-palpitation sensation, supraventricular (supraventricular) tachycardia; rarely-atrial fibrillation, increased heart rate.

Vascular disorders: frequency unknown-decreased blood pressure (hypotension).

Respiratory, thoracic and mediastinal disorders:  often-pharyngeal irritation, cough, shortness of breath; infrequently – bronchospasm, paradoxical bronchospasm, laryngospasm, pharyngeal edema, dry throat, sinusitis.

Disorders of the gastrointestinal tract: often-dry mouth, nausea, impaired motility of the gastrointestinal tract; infrequently-diarrhea, constipation, vomiting, dyspepsia, changes in taste sensations, stomatitis.

Skin and subcutaneous tissue disorders: infrequently-rash, pruritus; rarely-urticaria.

Renal and urinary tract disorders: infrequently-urinary retention. If any of the side effects listed in the instructions get worse or you notice any other side effects that are not listed in the instructions, tell your doctor.

Interaction

When used simultaneously, beta-2-adrenomimetics and xanthine derivatives potentiate the bronchodilating effect of the drug.

The anticholinergic effect is enhanced by antiparkinsonian drugs, quinidine, tricyclic antidepressants.

When used concomitantly with other anticholinergic agents, an additive effect is noted.

Patients with angle-closure glaucoma should use Ipratropium-native with extreme caution in combination with inhaled beta-2-adrenomimetics, as the risk of developing an acute attack of glaucoma increases.

Ipratropium native, a solution for inhalation, should not be administered simultaneously with an inhaled solution of Cromoglicic acid, given the possibility of precipitation (precipitation).

How to take, course of use and dosage

The drug Ipratropium-native is intended only for inhalation by inhalation through the mouth using a nebulizer. Ipratropium-native is not intended for injection or oral use! 20 drops of Ipratropium native (about 1 ml) contain 0.250 mg of ipratropium bromide, respectively,1 drop of the drug contains 0.0125 mg of ipratropium bromide. The dosage regimen is selected individually.

If the doctor does not prescribe otherwise, the following dosage regimen is recommended:

Supportive treatment: Adults( including the elderly): 2.0 ml of Ipratropium-native (40 drops = 0.5 mg of ipratropium bromide) 3-4 times a day. The maximum daily dose is 8.0 ml of Ipratropium native (2 mg of ipratropium bromide).

Acute bronchospasm: Adults( including the elderly): 2.0 ml of Ipratropium-native (40 drops = 0.5 mg of ipratropium bromide); repeated inhalations are possible until the patient’s condition stabilizes, the interval between inhalations is determined by the doctor. Ipratropium-native can be used together with inhaled beta-2-adrenomimetics. To ensure proper use of the drug, please read these instructions for use carefully. The recommended dose of Ipratropium-native immediately before use should be diluted with 0.9% sodium chloride solution until the volume of the drug reaches 3-4 ml, poured into a nebulizer and inhaled. Do not re-use the remaining solution after inhalation, pour it out. The speed and duration of inhalation may depend on the method of inhalation and the type of nebulizer. The duration of inhalation should be monitored by the amount of diluted Ipratropium native consumed. When using a centralized oxygen system, the solution is best used at a flow rate of 6-8 liters per minute. For inhalation, it is recommended to use nebulizers with a mouthpiece (mouthpiece). When using a nebulizer with a mask, use a mask of the appropriate size. The nebulizer must be kept clean.

Overdose

Symptoms: no specific symptoms of overdose were detected. Given the breadth of the therapeutic effect and the local method of use of Ipratropium native, the appearance of any serious anticholinergic symptoms is unlikely.

Possible minor manifestations of systemic anticholinergic action, such as dry mouth, accommodation disorders, increased heart rate.

Treatment: performing symptomatic therapy.

Special instructions

Use with caution in the form of inhalation in patients with angle-closure glaucoma, urinary tract obstruction due to prostatic hyperplasia.

If you need an emergency relief of a suffocation attack, ipratropium bromide monotherapy is not recommended, since its bronchodilator effect develops later than that of beta-adrenomimetics.

The safety and efficacy of intranasal use in children under 12 years of age has not been determined.

Influence on the ability to drive motor vehicles and manage mechanisms

Given the potential impact of ipratropium bromide on visual acuity, caution should be exercised during treatment when driving vehicles and other potentially dangerous activities.

Form of production

Solution for inhalation

Active ingredient

Ipratropium bromide

Conditions of release from pharmacies

By prescription

Dosage form

solution for inhalation

Purpose

Adults as prescribed by a doctor, Children as prescribed by a doctor

Indications

Pneumonia, Bronchospasm, Bronchial Asthma, Low Learning Rate, Bronchitis