Atrovent H aerosol 20mcg/dose 10ml 200doses

Atrovent H instruction for use

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Composition

1 inhalation dose contains the active substance: ipratropium bromide monohydrate 0.021 mg (21 μg), which corresponds to ipratropium bromide 0.020 mg (20 μg).
Excipients: ethanol absolute 8.415 mg, purified water 0.281 mg, citric acid 0.002 mg, tetrafluoroethane (HFA134a, propellant) 47.381 mg

Description

A clear, colorless liquid, free from suspended particles, placed under pressure into a solid stainless steel canister, equipped with a metering valve with a plastic core
Pharmacological group: m-holinoblokator
ATX Code: R03BB01

Pharmacological properties

Bronchodilator. It blocks m-holinoretseptory smooth muscle tracheobronchial tree and suppresses reflex bronchoconstriction. Having a structural similarity with the molecule of acetylcholine, it is its competitive antagonist. Anticholinergic drugs prevent an increase in the intracellular concentration of calcium ions, which occurs due to the interaction of acetylcholine with muscarinic receptors located in the smooth muscles of the bronchi.
The release of calcium ions occurs with the help of secondary mediators (mediators), which include ITF (inositol triphosphate) and DAG (diacylglycerol). Effectively prevents the narrowing of the bronchi, resulting from the inhalation of cigarette smoke, cold air, the effects of various bronchospasmic substances, and also eliminates spasm of the bronchi associated with the influence of the vagus nerve. With inhalation, it practically does not have a resorptive effect. Bronchodilation occurring after inhalation of Atrovent H (ipratropium bromide) is mainly a consequence of local and specific effects of Atrovent H on the lungs, rather than the result of its systemic effect.
In controlled 85-90-day studies performed in patients with bronchospasm due to chronic obstructive pulmonary disease, chronic bronchitis and pulmonary emphysema, a significant improvement in lung function was observed for 15 minutes, peaked in 1-2 hours and persisted to 4-6 hours.
In patients with bronchial asthma, a significant improvement in the function of external respiration is noted in 51% of patients.

Pharmacokinetics

The therapeutic effect of Atrovent H is a consequence of its local action in the airways. The development of bronchodilation is not parallel to pharmacokinetic parameters.
After inhalation into the lungs, 10-30% of the administered dose of the drug usually falls (depending on the dosage form and inhalation method). Most of the dose is swallowed and enters the gastrointestinal tract.
Part of the dose of Atrovent H, which enters the lungs, quickly reaches the systemic blood flow (within a few minutes).
The total renal excretion (within 24 hours) of the starting compound is approximately 46% of the intravenously administered dose, less than 1% of the dose administered orally, and approximately 3-13% of the inhalation dose of the drug. Based on these data, it is calculated that the total systemic bioavailability of ipratropium bromide, administered orally and by inhalation, is 2% and 7-28%, respectively.
The kinetic parameters describing the distribution of ipratropium bromide were calculated on the basis of its plasma concentrations after intravenous administration. There is a rapid two-phase decrease in plasma concentration. The apparent volume of distribution during the state of equilibrium concentration (Css) is approximately 176 liters (~ 2.4 l / kg). Atrovent H binds to plasma proteins to a minimum degree (less than 20%). Ipratropium bromide, which is a quaternary amine, does not penetrate the blood-brain barrier. The half-life period during the terminal phase is approximately 1.6 hours.
The total clearance of ipratropium bromide is 2.3 l / min, and the renal clearance is 0.9 l / min. After intravenous administration, approximately 60% of the dose is metabolized by oxidation, mainly in the liver.
The total renal excretion (within 6 days) of an isotope-labeled dose (including the parent compound and all metabolites) was 72.1% after intravenous injection, 9.3% after oral administration, and 3.2% after inhalation. The total isotope-labeled dose, excreted through the intestine, was 6.3% after intravenous injection, 88.5% after oral administration, and 69.4% after inhalation. Thus, the excretion of an isotope-labeled dose after intravenous administration is mainly through the kidneys. The half-life of the starting compound and metabolites is 3.6 hours. The main metabolites that are excreted in the urine bind to muscarinic receptors weakly, and are considered inactive.

Indications

Chronic obstructive pulmonary disease (chronic obstructive bronchitis, emphysema); bronchial asthma (mild and moderate), especially with concomitant diseases of the cardiovascular system.

Contraindications for Atrovent H

Hypersensitivity to atropine and its derivatives; hypersensitivity to ipratropium bromide or to other components of the drug; pregnancy (I trimester).

Pregnancy and the period of breastfeeding

The safety of Atrovent H during pregnancy is not established in humans. When prescribing Atrovent H during a possible or confirmed pregnancy, it is necessary to take into account the ratio of the prospective benefit from the appointment of the drug to the mother and the possible risk to the fetus. Contraindicated use of Atrovent H in the I trimester of pregnancy. Appointment of the drug in the II and III trimesters of pregnancy is possible only if the intended benefit to the mother exceeds the possible risk to the fetus.
In preclinical studies, there was no embryotoxic or teratogenic effects of Atrovent H after its inhalation at doses significantly exceeding the recommended doses in humans.
It is not known whether Ipratropium bromide is excreted in breast milk. However, it is unlikely that ipratropium bromide, especially when it is administered by inhalation, can come with milk in the body of the child in significant quantities. But during the use of the drug Atrovent H breastfeeding mothers should be careful.
There are no clinical data on the effect of ipratropium bromide on fertility. During the application of ipratropium bromide in preclinical studies, no adverse effects on fertility were detected.

Dosing and Administration

Dosing should be carried out individually. During treatment, patients should be under medical supervision. Do not exceed the recommended daily dose during both emergency and maintenance therapy.
If treatment does not lead to significant improvement or the patient's condition worsens, a doctor's consultation is needed to develop a new therapy plan. In case of sudden or rapid increase of dyspnea (difficulty breathing), you should immediately consult a doctor.
The following doses are recommended (unless another dosing regimen is prescribed):

Adults and children over 6 years of age:

2 inhalation doses (injection) 4 times a day. Since the need for increasing doses indicates the possible need for additional methods of treatment, as a rule, over 12 inhalation doses should not be used during the day.
To treat sudden exacerbations of chronic obstructive pulmonary disease, an Atrovent H solution for inhalation may be indicated.
In children, the Atrovent H dosed aerosol should only be used after consultation with a doctor and under the supervision of adults (due to insufficient information).

Use of a dosed aerosol

Proper use is essential for successful therapy.
    Before first use.
Before using the inhaler for the first time, press the bottom of the cylinder 2 times
    Before each use, the following rules must be observed:
1. Remove the protective cap.
2. Take a deep breath out.
3. Hold the inhaler as shown in Fig. 2 and tightly grasp the mouthpiece. Arrow and bottom of the cylinder should be pointed upwards.
4. Take as deep as possible a breath and simultaneously sharply press on the bottom of a cylinder. This will release one inhalation dose. Hold your breath for a few seconds, then take the mouthpiece out of your mouth and exhale. Repeat for the second inhalation dose.
5. After using the inhaler, put on the protective cap.
6. If the metered aerosol inhaler is not used for three days, then before using it, you should press the valve once.
The balloon is not transparent, therefore it is impossible to determine by eye when it becomes empty. The inhaler contains 200 inhalation doses. After using all the doses, it may seem that the bottle still contains a small amount of liquid. However, the inhaler should be replaced in such cases, since it may contain an insufficient amount of Atrovent H.
- Shake the can, it will show if there is any liquid left in it.
- Another way. Remove the plastic mouthpiece from the bottle and place the can in a container of water. The content of the balloon can be estimated depending on its position in the water (Figure 3).
Clean the inhaler at least once a week. It is important to keep the mouthpiece of the inhaler clean in order to prevent the ingestion of a drug that can block the release of the aerosol.
During cleaning, first remove the protective cap and remove the cylinder from the inhaler. Pass a stream of warm water through the inhaler, make sure that the drug is removed and / or visible dirt.
After cleaning, shake the inhaler and allow it to air dry without using heaters. As soon as the mouthpiece dries, insert the balloon into the inhaler and put on the protective cap.

Caveats:

The plastic mouthpiece was developed specifically for the use of Atrovent H metered aerosol, and serves to accurately dispense this drug. This mouthpiece should not be used with other metered aerosols. Do not use the Atrovent H metered aerosol with other mouthpieces.
The aerosol in the cylinder is under pressure.
The container must not be opened or stored at temperatures above 50 ° C

Side effects of Atrovent H

Many of these undesirable effects may be a consequence of the anticholinergic properties of Atrovent H. Atrovent H, like any inhalation therapy, can cause local irritation. Adverse reactions of the drug were determined on the basis of data obtained in clinical studies and during pharmacological supervision of the use of the drug after its registration.
The most common side effects reported in clinical trials were headache, pharyngeal irritation, coughing, dry mouth, gastrointestinal motility disorders (including constipation, diarrhea and vomiting), nausea and dizziness
Immune system disorders
hypersensitivity
anaphylactic reaction
Disturbances from the nervous system
- headache
- dizziness
Disturbances on the part of the organ of sight
- blurred vision
- mydriasis
- increased intraocular pressure
- glaucoma
- Pain in the eyes
- the appearance of a halo around objects
congestion hyperemia
- corneal edema
- disruption of accommodation
Heart Disease
- palpitations
- supraventricular tachycardia
- atrial fibrillation
- increased heart rate
Disturbances from the respiratory, thoracic and mediastinal organs
- pharyngeal irritation
- cough
- bronchospasm
- paradoxical bronchospasm
- laryngospasm
- swelling of the pharynx
- Dryness of pharynx
Disorders from the gastrointestinal tract
- dry mouth
- nausea
- disorders of motility of the gastrointestinal tract
- diarrhea
- constipation
- vomiting
- stomatitis
- edema of the oral cavity
Changes in the skin and subcutaneous tissues
- a rash
- itching
- angioedema
- urticaria
Disorders from the kidneys and urinary tract
- retention of urine

Overdose

Symptoms of a specific overdose have not been revealed. Given the breadth of the therapeutic effect and the local use of Atrovent H, the appearance of any major anticholinergic symptoms is unlikely. There may be minor manifestations of systemic anticholinergic action, such as dry mouth, visual impairment, increased heart rate. Treatment is symptomatic.

Interactions with other drugs

Long-term combined use of Atrovent H inhalations with other anticholinergic drugs has not been studied. Therefore, long-term joint use of Atrovent H with other anticholinergic drugs is not recommended.
Beta-adrenergic agents and xanthine derivatives can enhance the bronchodilator effect of Atrovent H.
The anticholinergic effect is enhanced by antiparkinsonian agents, quinidine, tricyclic antidepressants.

special instructions for Atrovent H

Hypersensitivity

After applying Atrovent H, immediate hypersensitivity reactions may occur, as indicated by rare cases of rash, hives, angioedema, edema of the oropharynx, bronchospasm and anaphylaxis.

Paradoxical bronchospasm

Atrovent H, like other inhaled medications, can cause paradoxical bronchospasm, which can endanger life. In the case of paradoxical bronchospasm, the use of Atrovent H should be stopped immediately and an alternative therapy should be prescribed.

Complications from the eyes

The drug Atrovent H in patients who are predisposed to the development of acute angular glaucoma should be used with caution.
There are some reports of complications from the eyes (including the development of mydriasis, increased intraocular pressure, the development of acute angular glaucoma, pain in the eyes) in those cases when inhaled ipratropium bromide (used alone or in combination with a beta2-adrenoreceptor agonist) in the eyes. Symptoms of acute acute angular glaucoma may be pain or discomfort in the eyes, blurred vision, the appearance of a halo in objects and color spots in front of the eyes in combination with red eyes due to injection of conjunctival vessels and edema of the cornea. If any combination of these symptoms develops, the use of eye drops, reducing intraocular pressure, and immediate consultation of a specialist is indicated.
Patients should be instructed about the correct use of Atrovent H.
Care should be taken to prevent the aerosol from entering the eyes. Since the aerosol is released from the can only when the patient presses it and comes from the mouthpiece into the mouth, the risk of getting it into the eyes is small.

Effects on kidney function and urination

The drug Atrovent H should be used with caution in patients with existing obstruction of the urinary tract (eg, with prostatic hyperplasia or bladder neck obstruction).

Disturbances of motility of the gastrointestinal tract

Patients with cystic fibrosis may be predisposed to violations of the motility of the gastrointestinal tract.
Patients should be able to correctly use Atrovent H aerosol for inhalation dosed. The patient should be informed that if inhalations are not effective or if the condition worsens, you should consult a doctor to change the treatment plan. In case of sudden onset and rapid progression of dyspnea, the patient should also immediately consult a doctor.

Effects on the ability to drive and use machinery

The effects of the drug on the ability to drive vehicles and the use of mechanisms have not been specifically studied. However, patients need to be informed that during the treatment with Atrovent H they may experience such undesirable sensations as dizziness, accommodation disorders, mydriasis and blurred vision. Therefore, care should be taken when driving vehicles or using mechanisms.

Form of issue

Aerosol for inhalation dosed with 20 μg / dose.
For 10 ml (200 doses) in a stainless steel can with a metering valve and a mouthpiece with a protective cap with the company logo. Balloon with instructions for use in a cardboard box.

Storage conditions

Store at a temperature of no higher than 25 ° C, in a place protected from light.
Keep out of the reach of children.
Shelf life - 36 months.
Do not use the product after the expiry date printed on the package.

Conditions of leave from pharmacies

To buy Atrovent H you don't need a prescription.