Ipratropium-nativ, 0.25 mg/ml 20 ml

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

It effectively prevents bronchoconstriction resulting from the action of various bronchospasmic agents, as well as eliminates bronchial spasm associated with the influence of the vagus nerve. When administered inhaled it has practically no resorptive action.

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

Indications

Treatment and prevention of chronic obstructive airways diseases: chronic bronchitis with bronchoobstructive syndrome (with or without emphysema), mild to moderate bronchial asthma, especially with associated cardiovascular disease; bronchospasm in surgical procedures.

The preparation of the respiratory tract before administration in aerosols of antibiotics, mucolytic agents, GCS, sodium cromoglycate.

Active ingredient

Composition

Active ingredient:

0.261 mg ipratropium bromide monohydrate converted to ipratropium bromide 0.25 mg.

Auxiliary substances:

Sodium benzoate,

dinatrium edetate dihydrate (corresponds to dinatrium edetate),

Citric acid monohydrate (corresponds to anhydrous citric acid),

sodium hydroxide to pH 3.4±0.1,

water for injection.

How to take, the dosage

Ipratropium-Nativ is intended to be administered by inhalation by mouth with a nebulizer only. Ipratropium-nativ is not intended for injection or oral administration! The preparation Ipratropium-nativ contains 0.250 mg ipratropium bromide in 20 drops (about 1 ml), respectively 1 drop of the preparation contains 0.0125 mg ipratropium bromide. The dosing regimen is adjusted individually.

Unless otherwise prescribed by the doctor, the following dosing regimen is recommended:

Supportive treatment:Adults (including the elderly): 2.0 ml of ipratropium-nativ (40 drops = 0.5 mg ipratropium bromide) 3 – 4 times daily. Maximum daily dose is 8.0 ml of ipratropium-nativ (2 mg ipratropium bromide).

Acute bronchospasm:Adults (including elderly): 2.0 ml of Ipratropium-nativ (40 drops = 0.5 mg ipratropium bromide); repeated inhalations are possible until the patient’s condition stabilizes; the interval between inhalations is determined by the doctor. Ipratropium-nativ may be used in combination with inhaled β2-adrenomimetics. To ensure correct use, please read these instructions for use carefully. The recommended dose of Ipratropium-nativ immediately before use should be diluted with 0.9% sodium chloride solution until the drug volume reaches 3-4 ml, poured into a nebulizer and inhaled. The remaining solution after inhalation should not be reused, pour it out. The speed and duration of inhalation may depend on the method of inhalation and type of nebulizer. The duration of inhalation should be monitored according to the consumption of the diluted Ipratropium-nativ. When using a centralized oxygen system, the solution is best used at a flow rate of 6 – 8 liters per minute. For inhalations it is recommended to use nebulizers with a mouthpiece (mouthpiece). When using a nebulizer with a mask, an appropriately sized mask should be used. The nebulizer must be kept clean.

Interaction

In concomitant use β2-adrenomimetics and xanthine derivatives potentiate the bronchodilator effect of the drug.

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

In concomitant use with other anticholinergic agents an additive effect is noted.

Patients with closed-angle glaucoma should use Ipratropium-nativ with inhaled β2-adrenomimetics with great caution because the risk of an acute glaucoma attack increases.

Ipratropium-nativ inhalation solution should not be administered simultaneously with inhaled solution of cromoglycic acid, given the possibility of precipitation.

Special Instructions

With caution, use as inhalation in patients with closed-angle glaucoma, urinary tract obstruction due to prostatic hyperplasia.

If emergency relief of an attack of choking is necessary, ipratropium bromide monotherapy is not recommended because its bronchodilator effect develops later than that of beta-adrenomimetics.

The safety and effectiveness of intranasal administration in children younger than 12 years has not been determined.

Influence on driving and operating machinery

In view of the possible effect of ipratropium bromide on visual acuity, caution should be exercised when driving vehicles and other potentially dangerous activities during treatment.

Contraindications

Hypersensitivity to ipratropium bromide.

Predominantly for systemic use: increased intraocular pressure, prostatic hyperplasia, mechanical GI stenosis, tachycardia, megacolon, first trimester of pregnancy.

Side effects

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

The drug ipratropium-nativ, like any inhalation therapy, may 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.

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

Infectious and parasitic diseases: common – flu-like symptoms, upper respiratory tract infections; infrequent – urinary tract infections. Immune system disorders: infrequent hypersensitivity, anaphylactic reactions, angioedema (Quincke’s edema).

Nervous system disorders: often – headache and dizziness.

VIight organ disorders: infrequent – blurred vision, mydriasis, increased intraocular pressure, glaucoma, sharp eye pain, appearance of a halo around objects, conjunctival hyperemia, corneal edema; rarely – accommodation disorders.

Chronic disorders: infrequent – palpitations, supraventricular tachycardia; rare – atrial fibrillation, increased heart rate.

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

Respiratory system, chest and mediastinum disorders: frequently – irritation of the throat, cough, shortness of breath; infrequently – bronchospasm, paradoxical bronchospasm, laryngospasm, swollen throat, dry throat, sinusitis.

Gastrointestinal disorders: frequently – dry mouth, nausea, disorder of gastrointestinal motility; infrequently – diarrhea, constipation, vomiting, dyspepsia, change in taste sensation, stomatitis.

Skin and subcutaneous tissue disorders: infrequent – rash, itching; rarely – urticaria.

Recreational disorders of the kidneys and urinary tract: infrequent – urinary retention. If any of the adverse reactions mentioned in the instructions are aggravated or if you notice any other adverse reactions not specified in the instructions, tell your doctor.

Overdose

Symptoms: no specific symptoms of overdose have been identified. Given the breadth of the therapeutic action and the topical route of administration of Ipratropium-nativ, the occurrence of any serious anticholinergic symptoms is unlikely.

Significant systemic anticholinergic effects are possible, such as dry mouth, accommodation disorders, and increased heart rate.

Treatment: conduct symptomatic therapy.

Similarities