Expiration date: 03/2025

The composition and form of issue:

Solution for inhalation. 1 ml contains:

ipratropium bromide 0.25 mg

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

excipients: citric acid anhydrous distilled water ethanol 

in aerosol containers with a mouthpiece at the 10 ml (200 doses), in box 1 cylinder.

Pharmacological action:

Ipratropium bromide is a Quaternary ammonium compound. It has anticholinergic properties. Inhibits reflexes vagus nerve, being a competitive antagonist of neurotransmitter acetylcholine. Blocks muscarinic receptors of smooth muscles of the tracheobronchial tree and inhibits reflex bronchoconstriction. Bronchodilation during inhalation introduction is due mainly to local rather than systemic anticholinergic drug. It effectively prevents the narrowing of the bronchi, resulting from the inhalation of cigarette smoke, cold air, activity of different bronchospasmolytic substances and also inhibits the spasm of bronchi associated with influence of the vagus nerve. Inhalation use almost no resorptive action provides for the development of tachycardia it is necessary inhaling about 500 doses, with only 10% reaches the small bronchi and alveoli, and the rest settles in the throat or mouth and swallowed.

Pharmacokinetics:

Inhalation routes of administration absorption is extremely low. The concentration of the drug in the blood plasma is at the lower boundary define and measure it is possible only at application of high doses of active substance. Excreted mainly through the intestines, around 25% unchanged, the remainder as metabolites.

Description pharmacological action:

Has a marked bronchodilator effect and prevents the development of bronchospasm. Causes a decrease in the secretion 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 1 — 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 asthma, significant improvements in lung function (increase in FEV1 by 15% or more) is noted in 40% of patients.

Indications:

Chronic obstructive pulmonary disease (chronic obstructive bronchitis, emphysema) bronchial asthma (mild and medium severity), 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 up to age 6 years (Atrovent H).

Application of pregnancy and breast-feeding:

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

Side effects:

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

Due to the low systemic absorption of the drug, the side effects associated with systemic anticholinergic effects such as tachycardia, palpitations, accommodation disturbances, reduced secretion of sweat glands, impaired motility of the gastrointestinal tract, urinary retention are rare and reversible. However, patients with obstructive lesions of the urinary tract increases the risk of urinary retention.

As with other inhaled therapy including bronchodilators, sometimes there is cough, rarely — paradoxical bronchospasm.

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

There were sporadic reports on the occurrence of complications in the eyes (mydriasis, increased intraocular pressure, angle-closure glaucoma, eye pain) when injected aerosol ipratropium bromide or combined with beta2-agonists ipratropium bromide aerosol in the eyes. Patients must be able to correctly use a metered-dose aerosol.

Drug interactions:

Bronholiticeski potentiates the effect of beta-agonists and xanthine derivatives. Intensifies anticholinergic effects of other drugs.

Method of application and dose:

Inhalation.

Mortar for inhalations: adults and children over 12 years — 0.5 mg (40 drops) 3-4 times daily via nebulizer to children 6-12 years of age: 0.25 mg (20 drops) 3-4 times daily via nebulizer for children up to 6 years — 0.1–0.25 mg (8 to 20 drops) 3-4 times daily (under medical supervision). Recommended dose immediately before use diluted with physiological saline to a volume of 3-4 ml. Dose depends on the method of inhalation and the quality of spraying. In case you need to re-inhalation is carried out with an interval of not less than 2 hours.

An aerosol for inhalations dosed: adults and children over 6 years — 2 dose aerosol 4 times daily, if necessary, the dose may be increased to 12 inhalations a day.

Overdose:

No specific overdose symptoms have not been identified. Possible minor manifestations of the systemic anticholinergic actions such as dry mouth, disturbance of accommodation, increased heart rate. Treatment is symptomatic.

Precautions:

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

It is not recommended to exceed the daily dose as in the short-term and long-term use of the drug.

With caution the drug should be used in patients with angle-closure glaucoma and urinary disorders due to benign prostatic hyperplasia.

In case of accidental ingestion drug in the eye of the patient with closed angle glaucoma may increase intraocular pressure.

Eye pain or discomfort, blurred vision, appearance of bloom, and color spots before eyes combined with conjunctival and corneal congestion may be symptoms of an attack of narrow-angle glaucoma. In case you see any of these symptoms, you should assign drops, causing constriction of the pupil, and immediately contact an ophthalmologist.

In the case of deterioration of the patient or of the lack of significant improvement is necessary to consult a doctor to determine the treatment plan. In the event of a sudden and rapid amplification of dyspnea (difficulty breathing), you should immediately consult a doctor.

Children metered-dose aerosol Atrovent N should be used only after doctor's recommendation and under the supervision of adults.

Special instructions:

Not recommended for the emergency relief of choking (bronholiticeski effect develops later than that beta-agonists).

Patients with cystic fibrosis have an increased chance of development slow the motility of the gastrointestinal tract.

Patients must be able to correctly use Atrovent N aerosol for inhalations 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 you switch from one drug to another, patients should be warned about the possible change in the taste properties of the drug. Should be reported that these drugs interchangeably, and that the taste properties are not relevant to the safety and efficacy of a new drug.