Atrovent N aerosol 20mcg/dose 10ml 200doses

Instruction for Atrovent N

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Release form and composition

Dosage form - metered-dose aerosol for inhalation: a clear, colorless liquid that does not contain suspended particles [10 ml (200 doses) in stainless steel cans equipped with a mouthpiece and a metering valve; in a cardboard bundle 1 spray can and instructions for use of Atrovent N].
Composition of 1 inhaled dose of aerosol:
    active substance: ipratropium bromide monohydrate - 21 mcg, which corresponds to 20 mcg ipratropium bromide anhydrous;
    auxiliary components: purified water, citric acid, absolute ethanol, tetrafluoroethane (HFA 134a, propellant).

Pharmacodynamics

The active substance of Atrovent N is ipratropium bromide - a blocker of m-cholinergic receptors, a bronchodilating agent. The substance has the ability to block m-cholinergic receptors of the smooth muscles of the tracheobronchial tree and suppress reflex bronchoconstriction.
Ipratropium bromide is structurally similar to the acetylcholine molecule and is its competitive antagonist. Due to its anticholinergic properties, the drug prevents an increase in the intracellular concentration of calcium ions due to the interaction of acetylcholine with m-cholinergic receptors located in the smooth muscles of the bronchi. The release of calcium ions occurs with the participation of secondary mediators (mediators), including with the help of diacylglycerol (DAG) and inositol triphosphate (ITF).
Atrovent N effectively prevents narrowing of the bronchi under the influence of negative factors, such as inhaling cold air or cigarette smoke, the effect of various bronchoconstrictors. It also eliminates spasm due to the influence of the vagus nerve.
Due to inhalation use, the drug has almost no resorptive effect (the development of tachycardia is possible only after inhalation of approximately 500 doses). Bronchodilation that occurs after inhalation is primarily a consequence of the local and specific effects of ipratropium bromide on the lungs, and not the result of its systemic effect. The drug does not adversely affect gas exchange, mucus secretion in the respiratory tract and mucociliary clearance.
In controlled studies conducted for 85–90 days in patients with bronchospasm due to pulmonary emphysema, chronic bronchitis and chronic obstructive pulmonary disease (COPD), a significant functional improvement in the lungs was observed within 15 minutes after inhalation, reaching a maximum after 1-2 hours , lasted up to 4-6 hours
In bronchial asthma, a significant improvement in the function of external respiration is observed in 51% of patients.

Pharmacokinetics

The therapeutic effect of ipratropium bromide occurs due to its local action in the respiratory tract, so the development of bronchodilation is not parallel to pharmacokinetic parameters.
When Atrovent N is inhaled, only 10-30% of the dose enters the lungs, the rest settles in the mouth or pharynx, is swallowed and enters the gastrointestinal tract. The amount of drug delivered to the lungs reaches the systemic circulation within a few minutes.
The total systemic bioavailability of ipratropium bromide when taken orally and inhaled is 2% and 7–28%, respectively.
No more than 20% binds to plasma proteins.
The kinetic parameters characterizing the distribution of ipratropium bromide were calculated on the basis of its plasma concentrations after intravenous (iv) administration: a rapid two-phase decrease in plasma concentration was noted, the apparent volume of distribution in equilibrium was approximately 2.4 l / kg (average 176 l )
The substance does not cross the placental and blood-brain barriers.
After iv administration, ipratropium bromide of the order of 60% of the dose is metabolized by oxidation (mainly in the liver). By dehydration, hydrolysis, or separation of the hydroxymethyl group from tropic acid, metabolites are formed that have been identified. They are considered inactive, weakly bind to muscarinic receptors, excreted in the urine.
The total clearance of ipratropium bromide is 2.3 ml / min, renal clearance - 0.9 l / min. The elimination half-life (T½) in the terminal phase is approximately 1.6 hours.
The total renal excretion (within 6 days) of a dose labeled with an isotope (ipratropium bromide and all its metabolites) was: with iv administration - 72.1%, with oral administration - 9.3%, with inhalation use - 3, 2%
The total excretion through the intestine of the dose labeled with the isotope was: with iv administration of ipratropium bromide - 6.3%, with oral administration - 88.5%, with inhalation use - 69.4%.
Thus, after iv administration of an isotope-labeled dose, the drug is excreted mainly through the kidneys. T½ of the starting substance and its metabolites is 3.6 hours.

Indications for use

    COPD, including chronic obstructive bronchitis and pulmonary emphysema;
    mild to moderate asthma, especially in patients with concomitant cardiovascular diseases.

Contraindications

Absolute:
    I trimester of pregnancy;
    children under 6 years old;
    increased sensitivity to atropine or its derivatives;
    known hypersensitivity to any component of the aerosol for inhalation Atrovent N.
With extreme caution, only as prescribed by a doctor and under his control, the drug can be used in the following cases:
    cystic fibrosis;
    urinary tract obstruction (for example, with obstruction of the bladder neck or prostatic hyperplasia);
    angle-closure glaucoma;
    II – III trimesters of pregnancy;
    children over 6 years old.

Atrovent N, instructions for use: method and dosage

Atrovent N is used by inhalation.
The doctor selects the optimal dose individually. Unless otherwise specified, adults and children over 6 years of age usually take 2 doses (injection) 4 times a day. In total, it is not recommended to use more than 12 doses during the day, since the need for a larger amount of the drug, as a rule, indicates the need for additional prescription of other methods of treatment.
During the use of the drug, the patient should be under medical supervision. It is forbidden to independently increase the prescribed dose both during maintenance treatment, and during emergency treatment.
If against the background of the use of Atrovent N there is no significant improvement, or the condition worsens, a doctor's consultation is required. Urgently contacting a medical specialist is also necessary in the event of a quick or unexpected increase in shortness of breath (difficulty breathing).
Before the first use of each new inhaler, you should take it upside down, remove the protective cap and double-click on the bottom of the can to make two injections into the air - this is necessary for the correct dosage of the drug. If the inhaler is not used for more than 3 days, one injection into the air is enough.
The process of using an inhaler:
    Remove the protective cap.
    Holding the inhaler upside down (arrow also pointing up), grip the mouthpiece tightly with your lips.
    Take a deep exhale.
    Starting to take a deep breath, press the bottom of the spray can strongly to inhale one dose. Continue to slowly inhale to the maximum, then hold your breath for a few seconds.
    Remove the mouthpiece from the mouth and exhale slowly.
    If it is necessary to administer several doses, repeat steps 2-5.
    Put a protective cap on the inhaler.
The can is opaque, so it is impossible to visually determine the moment when it becomes empty. It contains 200 doses. After using them, it may seem that the bottle still contains some liquid, but it is recommended to replace the bottle with a new one, otherwise there is a risk of not receiving the necessary treatment dose.
You can check the amount of the drug in one of the following ways:
    Shake the balloon - so you can understand whether any liquid remained in it.
    After removing the mouthpiece from the spray can, put it in a container of water. The approximate amount of the drug in the can can be estimated by its position in the water: if the can is drowning, it contains at least ¾ aerosol, if it is immersed in the water upward upright vertically - ½, is immersed in the water upside down and slightly bent to the side - ¼, is immersed into the water upside down and lay on its side - the cylinder is empty.
At least 1 time per week, the inhaler should be cleaned of dust / dirt and aerosol residues - they can interfere with the full release of a new dose.
Rules for cleaning the inhaler:
    Remove the protective cap and remove the cylinder.
    Pass a stream of warm water through the inhaler, make sure that there is no visible dirt and drug residues.
    Shake the inhaler and let it air dry (do not use heaters).
    Insert the cylinder and put on the protective cap.
A plastic mouthpiece is used for accurate dosing of the drug and is intended specifically for use with Atrovent N. aerosol. It is forbidden to use it for dosing other aerosols. Also, you should not use other mouthpieces with Atrovent N.

Side effects

    from the respiratory system: often (from ≥ 1/100 to <1/10) - irritation of the mucous membrane of the pharynx, cough; infrequently (from ≥ 1/1000 to <1/100) - dry pharynx, laryngospasm, swelling of the pharynx, bronchospasm (including paradoxical);
    from the digestive system: often - dry mouth, impaired motility of the gastrointestinal tract, nausea; infrequently - swelling of the oral mucosa, stomatitis, constipation, diarrhea, vomiting;
    from the nervous system: often - headache, dizziness;
    from the immune system: infrequently - hypersensitivity reactions, angioedema, anaphylactic reactions; rarely - urticaria;
    from the urinary system: infrequently - urinary retention;
    from the cardiovascular system: infrequently - a feeling of palpitations, supraventricular tachycardia; rarely - increased heart rate, atrial fibrillation;
    on the part of the organ of vision: infrequently - pain in the eyes, conjunctival hyperemia, mydriasis, blurred vision, corneal edema, the appearance of a halo around objects, an increase in intraocular pressure, glaucoma; rarely - violation of accommodation;
    on the part of the skin and subcutaneous tissues: infrequently - skin rashes, itching.

Overdose

There are no specific symptoms of an overdose of ipratropium bromide. Perhaps the development of signs of systemic anticholinergic effects, such as dry mouth, an increase in heart rate, and visual impairment. Given the local method of application and the spectrum of therapeutic effect of Atrovent N, the occurrence of any serious anticholinergic manifestations is unlikely.
Overdose treatment is symptomatic.

special instructions

In rare cases, after inhalation, immediate-type hypersensitivity reactions occur, their signs may be a rash, urticaria, oropharyngeal edema, angioedema, bronchospasm, anaphylaxis.
Like any inhalation agent, Atrovent N can cause a potentially life-threatening paradoxical bronchospasm. In this case, the drug is immediately canceled and alternative therapy is prescribed.
Special care should be taken when inhaling the drug to prevent it from getting into the eyes. The aerosol is released only with a strong pressure on the balloon and enters the oral cavity from the mouthpiece, so the likelihood of contact with the eyes is low.
If inhaled ipratropium bromide gets into the eyes, complications from the organ of vision, such as mydriasis, eye pain, increased intraocular pressure, and development of angle-closure glaucoma, may occur.
With caution, Atrovent N should be used in patients with a predisposition to angle-closure glaucoma.
Acute angle-closure glaucoma can manifest itself with the following symptoms: discomfort or pain in the eyes, the appearance of colored spots in front of the eyes or a halo in objects, blurred vision in combination with corneal edema and redness of the eyes due to conjunctival vascular injection. If any combination of the described phenomena occurs, you need to apply eye drops that reduce intraocular pressure, and immediately consult a doctor.
It is necessary to take into account a small amount of ethanol in the composition of Atrovent N: in 1 dose - 8.415 mg.
If the effect of therapy is not sufficiently pronounced or the condition worsens, a doctor’s consultation is required, which will adjust the treatment regimen. Immediate medical attention is also needed in case of sudden onset and rapid progression of shortness of breath.

Influence on the ability to drive vehicles and complex mechanisms

Special studies on the effect of ipratropium bromide on the patient's cognitive and psychomotor functions have not been conducted. Considering the likelihood of tremor, dizziness and mydriasis, visual impairment and eye accommodation, caution should be exercised during drug treatment. In the case of the development of these phenomena, it is recommended to refrain from performing potentially hazardous activities, including driving a car and working with complex mechanisms.

Pregnancy and lactation

In the course of preclinical studies, neither the embryotoxic nor teratogenic effects of the drug were revealed during its inhalation use in doses significantly exceeding those recommended for humans. However, the safety of ipratropium bromide during pregnancy in humans has not been established. In this regard, Atrovent N is contraindicated in the I trimester, in the II – III trimesters it can be used only in cases where the benefit for a woman is definitely higher than the potential risks to the fetus.
Whether ipratropium bromide is excreted in breast milk is not known. However, given the inhalation method of its use, the receipt of significant quantities of the drug is unlikely. Nevertheless, the use of Atrovent N during lactation should be carried out with caution.
Clinical studies on the effect of ipratropium bromide on fertility have not been conducted. According to preclinical data, there is no negative effect on reproductive function.

Use in childhood

Atrovent N Inhalation Aerosol is contraindicated in children under 6 years of age, at an older age it should be used only as directed by a doctor, and also under close supervision of adults to avoid taking an excessive dose or improper use of the inhaler.

With impaired renal function

Atrovent N should be used with caution in patients with urinary tract obstruction.

Drug interaction

The simultaneous prolonged use of other anticholinergics is not recommended, since the possible effects of such combinations have not been studied.
The bronchodilator effect of Atrovent N can be enhanced by xanthine derivatives and beta-adrenergic agents.
The anticholinergic effect of the drug is enhanced by tricyclic antidepressants, quinidine and antiparkinsonian drugs.

Terms and conditions of storage

Keep out of reach of children in compliance with a temperature regime not exceeding 25 ° C. Do not open the cylinder or expose it to heat above 50 ° C (aerosol is under pressure).
Shelf life is 3 years.

Reviews for Atrovent N

Patients leave positive reviews about Atrovent N, noting its high bronchodilating efficacy, relatively low cost, as well as a convenient inhaler.

Terms of sell

You don't need a prescription to buy Atrovent N.