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    1220
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  • Availability date:
    2020-07-30
  • Dosage form:
    bottle
  • In stock:
    879 Items

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Composition:


active ingredient: ipratropium bromide;


1 ml of the solution contains ipratropium bromide-0.261 MG, which is equivalent to ipratropium bromide anhydrous-0.25 mg;


excipients: benzalkonium chloride, disodium edetate, sodium chloride, 1 g.hydrochloric acid prepared from concentrated hydrochloric acid, purified water.


Dosage form. Solution for inhalation.


Basic physical and chemical properties: transparent colorless liquid.


Pharmacotherapeutic group. Anticholinergic agents. The ATX code is R03BB01.


Pharmacological properties.


Pharmacodynamics.


Freeway® is a medicinal product containing a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. Preclinical studies have shown that ipratropium bromide inhibits vagal reflexes due to its antagonistic interaction with acetylcholine, a mediator that provides vagus nerve impulse transmission. Anticholinergic agents prevent an increase in the intracellular concentration of calcium CA++ions. The effect of acetylcholine on smooth muscle muscarinic receptors is achieved through another mediator system, which consists of inositol triphosphate (ITP) and diacylglycerol (DAG).


Bronchial dilation after inhaled administration of ipratropium bromide is mainly due to local, rather than systemic, effects of the drug.


There are no preclinical or clinical data on the negative effects of ipratropium bromide on airway mucus secretion, mucociliary clearance, or gas exchange.


Clinical trials


In controlled 85-90 – day studies conducted in patients with bronchospasm due to chronic obstructive pulmonary disease (chronic bronchitis and emphysema), a significant improvement in lung function was observed within 15 minutes, and the maximum improvement was observed after 1-2 hours, the effect persisted for 4-6 hours.


Studies conducted in adults and children over 6 years of age have revealed the bronchodilating effect of ipratropium bromide in the treatment of severe asthma-related bronchospasms. In most of these studies, ipratropium bromide was administered in combination with inhaled beta-agonists.


Despite a small amount of data, the therapeutic effect of the drug was revealed in the treatment of bronchospasm caused by infectious inflammation of the bronchioles and bronchopulmonary dysplasia in infants and young children.


Pharmacokinetics.


Absorption.


The therapeutic effect of the drug is manifested by its local effect on the respiratory tract. The duration of the therapeutic effect (bronchodilation) is not related to the pharmacokinetics of the active ingredients of the drug.


After inhalation, approximately 10-30% of the dose of the drug, depending on its composition and inhalation method, mainly settles in the respiratory tract. Most of the dose of the drug is swallowed and passes through the gastrointestinal tract.


Part of the dose that enters the lungs enters the bloodstream very quickly (within a few minutes). Total renal excretion (0-24 hours) of unchanged active substance accounted for 46% of the dose after intravenous administration, less than 1% after oral administration, and approximately 3 to 13% after inhaled administration. Based on these data, the total systemic bioavailability of ipratropium bromide after oral administration and inhalation is 2 %, from 7 to 28%, respectively. Thus, the swallowed part of the dose does not significantly affect the concentration of the active substance in plasma.


Distribution.


Pharmacokinetic parameters that characterize the disposition of ipratropium were calculated based on its concentration in blood plasma after intravenous administration. There is a rapid two-phase decrease in the concentration of the drug in blood plasma. The apparent volume of distribution at equilibrium (Vdss) is approximately 176 L (about 2.4 L/kg). The drug binds to plasma proteins in a small amount (less than 20%). According to preclinical data, quaternary Amine ipratropium does not pass through the placental and blood-brain barrier.


Metabolism.


After intravenous administration, approximately 60% of the dose is metabolized, probably in the liver by oxidation. The detected metabolites formed during hydrolysis, dehydration, or separation of the hydroxymethyl group from Tropic acid show a weak affinity for muscarinic receptors and are considered inactive.


Elimination.


The elimination Half-Life of the final elimination phase is approximately 1.6 hours.


The total clearance of ipratropium is 2.3 L/min, the renal clearance is 0.9 l/min. Approximately 40% of the systemic dose is excreted in the urine, which corresponds to the experimental value of renal clearance – 0.9 l/min.


When studying the excretion balance for 6 days using a radioactively labeled drug, it was 72.1%, 9.3% and 3.2% of the dose of the labeled product (both unchanged and in the form of metabolites) in the urine after intravenous, oral and inhaled administration, respectively. The proportion of fecal excretion after intravenous administration was 6.3 %, after oral administration - 88.5 %, after inhalation – 69.4 %. Elimination of the drug after intravenous administration, determined by the use of a radioactively labeled product, occurs mainly through the kidneys. The elimination half-life measured with an isotope-labeled preparation (measurement for the initial compound and metabolites) is 3.6 hours.


Clinical characteristics.


Indications.


Freeway® inhalation solution is intended for use as a bronchodilator in the maintenance therapy of bronchospasm, chronic obstructive pulmonary diseases (COPD), including chronic bronchitis and emphysema of the lungs, as well as in bronchial asthma.


Contraindications.


Hypersensitivity to atropine and its derivatives (such as ipratropium bromide), or to any excipient.


Interactions with other drugs and other types of interactions.


Long-term use of freeway® with other anticholinergic agents has not been studied. Therefore, long-term use of freeway® with these drugs is not recommended.


Drugs that affect beta-adrenergic receptors and xanthine derivatives may enhance the bronchodilator effect.


Concomitant use of ipratropium bromide and beta-mimetics during inhalation may increase the risk of acute glaucoma in patients with a history of angle-closure glaucoma.

Application features.


Hypersensitivity


After administration of the drug, immediate hypersensitivity reactions may occur, which is confirmed by rare cases of rashes, urticaria, angioedema, edema of the oral and throat mucosa, bronchospasm and anaphylaxis.


Paradoxical bronchospasm


Like other inhaled medications, Freeway® can cause paradoxical bronchospasm, which can be life-threatening. In case of paradoxical bronchospasm, immediately stop using the drug and use another treatment.


Complications from the visual organs


It is recommended to use the drug with caution in patients with a tendency to develop angle-closure glaucoma.


There are few reports of visual complications (such as mydriasis, increased intraocular pressure, angle-closure glaucoma, eye pain) resulting from exposure to an aerosol containing only ipratropium bromide or its combination with beta2 agonists.


Eye pain or discomfort, blurred vision, the appearance of a halo around a light source or colored spots in front of the eyes against the background of redness of the eyes caused by conjunctival hyperemia and corneal edema may be symptoms of acute angle-closure glaucoma. If the above symptoms occur in any combination, you should start treatment with myotic medications and immediately consult a doctor.


Patients should be instructed on the correct use of freeway®.


Do not allow the solution or the drug sprayed during inhalation to get into the eyes. It is recommended to inhale the drug sprayed with a nebulizer through the mouthpiece. In the absence of a mouthpiece, the drug can be inhaled through an inhalation mask, but it should fit snugly to the face. Patients with a tendency to develop glaucoma should take special care to protect their eyes.


Effects on the kidneys and urinary system.


Caution is recommended when using the drug in patients with urinary tract obstruction (for example, prostatic hyperplasia or bladder neck stenosis).


Disorders of gastrointestinal motility


Patients with cystic fibrosis may be more susceptible to gastrointestinal motility disorders.


Local action


The preparation contains a preservative – benzalkonium chloride and a stabilizer – disodium edetate. In patients with airway hypersensitivity, these components may cause bronchospasm during inhalation.


Use during pregnancy or lactation.


Pregnancy


The safety of using ipratropium bromide during pregnancy has not been established. The drug can only be used during a confirmed or suspected pregnancy if the expected benefit to the mother exceeds the potential risk to the fetus. Preclinical studies have not revealed embryotoxic or teratogenic effects of ipratropium bromide when used by oral or intranasal inhalation at doses significantly higher than recommended for human use.


Breast-feeding


It is not known whether the drug passes into breast milk. It is unlikely that the drug, which is administered by inhalation, can enter the child's body in significant quantities. Freeway® should be used with caution in women who are breast-feeding.


Fertility


There are no clinical data on the effect of ipratropium bromide on fertility. Preclinical studies conducted with ipratropium bromide did not reveal any negative effects on fertility.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


Studies to determine the effect of the drug on the ability to drive a car and other mechanical means have not been conducted. However, patients should be warned that side effects such as dizziness, accommodation disorders, mydriasis and blurred vision may occur during therapy with Freeway®. Care should be taken when driving vehicles or operating mechanisms. In case of any of the adverse reactions, the patient should avoid performing potentially dangerous actions, such as driving vehicles or operating mechanisms.


Dosage and administration.


Doses


The dose should be selected individually for each patient. During treatment, patients should be under the supervision of a doctor. Do not exceed the recommended daily dose.


The patient should be informed that if there is no therapeutic effect from the use of the drug or if the condition worsens, he should consult a doctor who will prescribe a new treatment regimen. Urgent consultation with a doctor is necessary in case of sudden occurrence or growth of suffocation (dyspnoea).


Unless otherwise prescribed by the doctor, it is recommended to use the drug in the following doses (20 drops = approximately 1 ml; 1 drop = 0.0125 ipratropium bromide anhydrous).


Maintenance therapy:


Adults (including the elderly) and children over 14 years of age:


2.0 ml (40 drops = 0.5 mg) 3 - 4 times a day


Children aged 6-14 years:


Given the lack of sufficient information on the use of the drug in this age group, inhalation at the dose indicated below should be carried out under the supervision of a doctor:


1.0 ML (20 drops = 0.25 mg) 3 - 4 times a day


Children under 6 years of age:


Given the lack of sufficient information on the use of the drug in this age group, inhalation at the dose indicated below should be carried out under the supervision of a doctor:


0.4 - 1.0 ML (8-20 drops = 0.1 - 0.25 mg) 3 - 4 times a day.


Administration of the drug in a daily dose exceeding 2 mg for adults and children over 14 years of age, as well as 1 mg for children under 14 years of age, should be carried out under the supervision of a doctor.


Method of application


The recommended dose of the drug should be diluted with 0.9% sodium chloride solution until a volume of 3 - 4 ml is obtained, poured into a nebulizer and inhaled until the solution runs out. The solution should be prepared immediately before each use; unused diluted solution should be discarded.


The dosage regimen may depend on the method of inhalation and the characteristics of the nebulizer. the duration of inhalation can be controlled by the volume of dilution of the solution.


Inhalations using Freeway® solution can be carried out using various models of nebulizers available on the market. When using a centralized oxygen device, it is better to inhale at a solution flow rate of 6 – 8 liters per minute.


The drug can be used together with drugs that dilute sputum and facilitate its elimination.


Do not use Freeway® and disodium cromoglycate simultaneously in the same neibulaser, as this may lead to precipitation.


Children.


The drug is used in pediatric practice. Children under 6 years of age should be used under medical supervision.


Overdose.


No overdose-specific symptoms were found. Given the wide therapeutic range and local administration of the drug, the occurrence of serious anticholinergic symptoms is unlikely. As with other anticholinergic agents, the expected symptoms of overdose are: dryness of the oral mucosa, impaired accommodation and tachycardia.


Adverse reactions.


Many of the following side effects can be attributed to the anticholinergic properties of ipratropium bromide. Like all inhaled medications, Freeway® may cause local irritation. Data on side effects were obtained in clinical trials and post-marketing surveillance.


The most common side effects reported during clinical trials were: headache, throat irritation, cough, dry oral mucosa, pharyngitis, impaired gastrointestinal motility ( including constipation, diarrhea, and vomiting), nausea, and dizziness.


The frequency of adverse reactions is indicated according to the MedDRA classification: very often (> 1/10); often (> 1/100 to 1/1000 to 1/10 000 to


From the cardiovascular system


Infrequently: increased heart rate, supraventricular tachycardia.


Rare: atrial fibrillation, increased heart rate.


From the nervous system


Often headache, dizziness.


From the side of the visual organs


Infrequently: blurred vision, mydriasis, increased intraocular pressure, glaucoma, eye pain, halo around the light source, conjunctival hyperemia, corneal edema.


Rare: accommodation disorders.


From the respiratory system, chest and mediastinum


Common: throat irritation, cough.


Infrequently: bronchospasm, paradoxical bronchospasm, laryngeal spasm, swelling of the throat mucosa, dry throat.


From the gastrointestinal tract


Often: dry mouth, nausea, impaired gastrointestinal motility.


Infrequently: diarrhea, constipation, vomiting, inflammation of the oral mucosa, swelling of the oral cavity.


From the urinary system


Infrequently: urinary retention.


From the skin and subcutaneous tissue


Infrequent: skin rash, pruritus, angioedema.


Rare: urticaria.


From the immune system


Infrequently hypersensitivity, anaphylactic reactions.

Tags: Ipratropium Bromide