Атровент® N

General characteristics. Structure:

Active ingredient: 0,021 mg (21 mkg) a monohydrate bromide ipratropiya that corresponds to 0,02 mg (20 mkg) an ipratropiya of bromide anhydrous.

Excipients: absolute ethanol, the purified water, citric acid, тетрафторэтан (HFA 134a, propellant).

Bronkhodilatiruyushchy means.

Pharmacological properties:

Pharmacodynamics. Bronkhodilatiruyushchy means. Blocks m-holinoretseptory of smooth muscles of a tracheobronchial tree (preferential at the level of large and average bronchial tubes) and suppresses a reflex bronkhokonstriktion. Having structural similarity to acetylcholine molecule, is his competitive antagonist. Effectively prevents the narrowing of bronchial tubes resulting from inhalation of cigarette smoke, cold air, effect of various bronkhospazmiruyushchy substances and also the spasm of bronchial tubes connected with influence of vagus nerves oppresses. At inhalation use has practically no resorptive effect - development of tachycardia requires inhalation about 500 doses, at the same time only 10% reach small bronchial tubes and alveoluses, and the rest settles in a throat or an oral cavity and is swallowed.

At patients with the bronchospasm connected with chronic obstructive diseases of lungs (chronic bronchitis and emphysema of lungs) improves indicators of function of external respiration: the volume of the forced exhalation for the first second (OFV1) and the maximum sredneekspiratorny flow (% FEF25-75) increases by 15% and more in 15 minutes after administration of drug, the maximum effect is noted in 1-2 hours, and proceeds at most of patients till 6 o'clock.

At patients with bronchial asthma considerable improvement of function of external respiration is noted at 40% of patients (OFV1 increased by 15% and more).

Pharmacokinetics. Absorption - low. It is removed through intestines (25% - in not changed form, other part - metabolites). It is badly dissolved in fats and poorly gets through biological membranes.

In a GIT it is practically not absorbed and removed through intestines. The soaked-up part (small) is metabolized in 8 inactive or poorly active anticholinergic metabolites (it is removed by kidneys). Does not kumulirut.

Indications to use:

Chronic obstructive pulmonary disease (chronic obstructive bronchitis, emphysema of lungs); bronchial asthma (easy and moderately severe), especially with associated diseases of serdechnoksosudisty system.

Route of administration and doses:

The mode of dosing is selected individually. If the doctor it is not appointed differently, for adults and children of school age the following mode of dosing is recommended:
2 inhalation doses (injection) 4 times a day.

The need for increase in a dose can testify to need of review of the main treatment. The general daily dose should not exceed 12 inhalations (injections) a day.

If inhalations are insufficiently effective, or the condition of the patient worsened, it is necessary to see a doctor for change of treatment planning. In case of sudden developing and bystry progressing of a short wind it is necessary to see a doctor immediately.

For treatment of an exacerbation of chronic obstructive diseases of lungs Atrovent solution for inhalations or Atrovent in bottles with a single dose can be used.

Considering lack of the complete information, Atrovent® of N at children should be used only on doctor's orders and under control of adults.

Use of the dosed aerosol. For obtaining the maximum effect it is necessary to use an inhaler correctly. Before use of the dosed aerosol for the first time press the valve before emergence of a cloud of an aerosol twice.

Every time when using of the dosed aerosol it is necessary to follow the following rules:
1. To remove a protective cap.
2. To make a slow full exhalation.
3. Holding a barrel, to clasp with lips a tip. At the same time the arrow and a bottom of an inhaler are turned up.

Fig. 1
 
4. To make the deepest breath and to press at the same time quickly a barrel bottom for release of a dose of an aerosol. For several seconds to hold the breath, then to take out a tip from a mouth and to exhale slowly. To repeat the listed actions for the second inhalation.
5. To put on a protective cap.
6. If the aerosol barrel was not used more than three days, before use it is necessary to press once the valve before emergence of a cloud of an aerosol.

The cylinder is opaque therefore the amount of drug in a cylinder can be defined only in the next way: having removed a protective cap, to ship a cylinder in the capacity filled with water. The amount of drug is defined depending on a cylinder position in water (see fig. 2)

Fig. 2

The cylinder is counted on 200 inhalations. After that the cylinder should be replaced in spite of the fact that in a cylinder there can be a contents quantity as the amount of the medicinal substance which is released at inhalation can be reduced.

Contents of a cylinder are under pressure. The cylinder cannot be opened and subjected to heating above 50 °C.

The tip should be kept clean, in need of it it is possible to wash out in warm water. After use of soap or detergent carefully to wash out a tip clear water.

Attention! The plastic tip is intended only for use with the dosed aerosol of Atrovent® of N and provides the correct drug dosing. The tip should not be used with other dosed aerosols. The dosed aerosol of Atrovent® of N should not be used with any other tips, except the drug delivered by the producer.

Features of use:

It is not recommended for the emergency stopping of an attack of suffocation (the broncholitic effect develops later, than at a beta adrenostimulyatorov).

Patients with a mucoviscidosis have the increased probability of development of delay of motility of digestive tract. Patients have to be able to use correctly Atrovent® of N an aerosol for inhalations dosed.

At the first use of a besfreonovy form of the dosed aerosol of Atrovent® of N patients can note that to taste new drug differs from the former dosage form of drug containing freon a little. Upon transition from one formula of drug to another patients should be warned about possible change of flavoring properties of drug. It is necessary to report that these drugs are interchanged and that flavoring properties have no relation to safety and efficiency of new drug also.

Pregnancy and lactation. Safety of Atroventa® of N during pregnancy at the person is not established. At purpose of drug during the possible or confirmed pregnancy it is necessary to consider a ratio of estimated advantage of purpose of drug and possible risk for a fruit. In preclinical trials embriotoksichesky and teratogenic effect of drug at inhalation and intranasal purpose of the doses considerably exceeding the recommended therapeutic dose for people was not revealed. Data on penetration of Atroventa® of N into breast milk are absent. Though insoluble quarternary cations get into breast milk, it is improbable that Atrovent® of N will have significant effect at inhalation use. However as many drugs are removed with breast milk, it is necessary to appoint with care Atrovent® of N to women in the period of a lactation.

Side effects:

The most frequent undesirable side effects are the headache, nausea, dryness in a mouth, increase in viscosity of a phlegm.

Such undesirable side effects as supraventricular tachycardia, ciliary arrhythmia, heartbeat, accommodation disturbance, disturbance of motility of digestive tract, locks, ischuria, reduction of secretion of sweat glands, dizziness meet seldom and have reversible character. However at patients with obstructive damage of urinary tract the risk of development of an ischuria increases.

There are separate messages on emergence of complications from eyes (such as mydriasis, increase in intraocular pressure, especially for patients with closed-angle glaucoma, eye pain) at hit of drug in eyes.

Eye pain or discomfort, indistinct sight, emergence of an aura and color spots before eyes in combination with a conjunctival and corneal hyperemia can be symptoms of an attack of closed-angle glaucoma. In case of emergence any of these symptoms, it is necessary to appoint the drops causing narrowing of a pupil and to address immediately the ophthalmologist.

As well as at other inhalation therapy, including bronkhodilator, sometimes observe cough, paradoxical bronkhospastichesky reactions are more rare.

There are messages on allergic reactions (an exudative multiformny erythema), including on rash, an itch, a Quincke's disease of language, lips and the person, a small tortoiseshell, a throat spasm, a bronchospasm, and anaphylactic reactions.

Interaction with other medicines:

Beta2-adrenergichesky means and ksantinovy derivatives can strengthen bronkhodilatiruyushchy effect of drug.

The anticholinergic effect amplifies protivoparkinsonichesky means, quinidine, tricyclic antidepressants.

At simultaneous use with other anticholinergics - the additive action.

Contraindications:

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

With care - closed-angle glaucoma, obstruction of urinary tract (a prostate hyperplasia); the lactation period, children's age (up to 6 years).

Overdose:

No specific symptoms of overdose are revealed. Considering the width of therapeutic action and a local route of administration of Atroventa®H, emergence of any serious anticholinergic symptoms is improbable. Insignificant manifestations of systemic anticholinergic action, such as dryness in a mouth, accommodation paresis, increase in heart rate are possible.

Symptomatic treatment.

Storage conditions:

To store at a temperature not above 25 °C, in the place protected from light. To store in the place, unavailable to children. Period of validity of 36 months. Not to use drug after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Aerosol for inhalations dosed 20 mkg / a dose. On 10 ml (200 doses) in a barrel from stainless steel with the dosing valve and a mouthpiece with a protective cover with a logo of the company. A barrel with the application instruction in a cardboard pack.