Atrovent N (Aerosol inhalation)
Active material: Ipratropiya bromide
When ATH: R03BB01
CCF: Bronchodilators – m-blocker holinoreceptorov
ICD-10 codes (testimony): J43, J44, J45
When CSF: 12.01.04
Manufacturer: BOEHRINGER Ingelheim International GmbH {Germany}
Pharmaceutical form, composition and packaging
Aerosol for inhalation dose in the form of a transparent, colorless liquid, free from suspended particles.
| 1 dose | |
| ïpratropïya bromide monohydrate | 21 g, |
| that corresponds to ipratropia bromide, anhydrous | 20 g |
Excipients: Ethanol absolute, Purified water, lemon acid, tetrafluoroethane (HFA 134a, propellant).
10 ml (200 doses) – stainless steel cartridges with a metering valve and mouthpiece (1) – packs cardboard.
Pharmacological action
Bronchodilators – m-blocker holinoreceptorov. Does m-cholinergic receptors of bronchial smooth muscle (mainly at the level of large and medium bronchi) and inhibits reflex bronchoconstriction. Having structural similarity with the molecule of acetylcholine, it is a competitive antagonist.
Warns bronchospasm, resulting from the inhalation of cigarette smoke, cold air, the effect of different drugs, and also eliminates bronchospasm, to the effects of the vagus nerve.
When inhalation use almost no resorptive action (for tachycardia must be inhaling about 500 doses, while only 10% reaches the small airways and the alveoli, and the remainder is deposited in the mouth or pharynx and swallowed).
In patients with bronchospasm, associated with COPD (chronic bronchitis and emphysema), drug improves lung function: OFV1 and the mean forced expiratory volume rate25-75% increase by 15% or more after 15 minutes after administration. The maximum effect is achieved after 1-2 h and continuing until the majority of patients 6 hours after administration of Ipratropium bromide.
In 40% patients with asthma showed a significant improvement in external respiration (OFV1 increased 15% and more).
Pharmacokinetics
Absorption
In inhalation introduction to ipratropia bromide is characterized by low absorption by the mucous membrane of the respiratory tract. There is absorbed in the digestive tract.
Distribution and metabolism
Poorly soluble in fats and loosely penetrates through biological membranes.
Metabolised education 8 pharmacologically inactive and active metabolites, having anticholinergic action. Not accumulates.
Deduction
In inhalation introduction ipratropia bromide displayed mainly through the intestines. About 25% the dose imposed output unchanged, the rest of the – as metabolites. Part metabolites also displayed news.
Testimony
- Chronic obstructive pulmonary disease (incl. chronic obstructive bronchitis, emphysema);
- Asthma mild to moderate severity (especially with concomitant diseases of the cardiovascular system).
Dosage regimen
Adults and children over 6 years appoint 2 inhaled dose 4 times / day.
Given the lack of complete information, Atrovent® H in children should be used only on prescription and under the supervision of adults.
The need for increasing doses may indicate a need to review the primary treatment. The total daily dose is not more than 12 inhalations.
For the treatment of exacerbations of chronic obstructive lung disease, you can use Atrovent® solution for inhalation.
Terms of use of the drug
Before using the measured aerosol for the first time, you should double click on the valve prior to the formation of aerosol cloud.
Every time you use a metered aerosol should do the following:
1. Remove the protective cap.
2. Make slow, deep breath.
3. Hold the bottle, embrace the lip tip. The container should be sent upside down.
4. Making the most deep breath, simultaneously, quickly click on the bottom of the container to release 1-th Inhalation dose. For a few seconds, hold your breath, then remove the tip from the mouth and slowly breathe out. Repeat steps for the 2nd dose inhalation.
5. Wear protective cap.
6. If an aerosol can is not used more than 3 days, before applying you must momentarily press the valve until the advent of the aerosol clouds.
The cylinder is designed for 200 inhalations. Then, the cylinder must be replaced. Despite, that the cylinder can be some content, the amount of drug, released during inhalation, decreases.
The container is opaque, Therefore, the amount of the drug in the container can be defined as follows:: removing the protective cap, cylinder is immersed into a container, filled with water. The amount of drug is determined depending on the position of the balloon in water.
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The tip must be kept clean, If necessary, it can be washed in warm water. After using SOAP or detergent tip should be thoroughly rinsed with water.
Plastic tip is only intended for use with metered aerosol Atrovent® N and serves for precise dosing of the drug. Tip do not use with other measured aerosols. Also, you cannot use metered aerosol Atrovent® N with other tips.
Side effect
The most frequent adverse events: headache, nausea, dry mouth, increase viscosity rate.
Effects, associated with anticholinergic drug: supraventricular tachycardia, heartbeat, ccomodation, reduced secretion of the sweat glands, violation of GASTROINTESTINAL motility, urinary retention (due to the low systemic absorption of the drug are rare, and are reversible). In patients with obstructive lesions of the urinary tract increases the risk of urinary retention.
The respiratory system: possible cough; rarely – paradoxical bronchospasm.
On the part of the organ of vision: in some cases, eye contact aerosol observed pupil increase, increased intraocular pressure (especially in patients with narrow-angle glaucoma), zakrыtougolynaya glaucoma, eye pain. Eye pain or discomfort, blurred vision, ghosting and color spots before the eyes, combined with conjunctival and corneal hyperemia may be symptoms of an attack of angle-closure glaucoma.
Allergic reactions: possible skin rash, itch, angioedema language, lips and face, hives, laringospazm, bronchospasm, mnogoformnaya Erythema ekssoudatus, anaphylactic reactions.
Contraindications
- I trimester of pregnancy;
- Hypersensitivity to atropine and its derivatives;
- Hypersensitivity to ipratropium bromide and other ingredients.
FROM caution should be prescribed the drug for angle-closure glaucoma, urinary tract obstruction (incl. prostatic hyperplasia), lactation (breast-feeding), as well as children under the age of 6 years.
Pregnancy and lactation
Safety of Atrovent® N during pregnancy in humans is not installed.
Do not use this Atrovent® In the first trimester of pregnancy.
The appointment of the drug in the II and III trimester of pregnancy is possible only in case, if the expected benefit of therapy to the mother outweighs the potential risk to the fetus.
IN experimental studies There were no embryotoxic and teratogenic action of the drug in inhalation and intra appointment at doses, significantly in excess of the recommended therapeutic dose for humans.
The data on the allocation of ipratropium bromide in breast milk are absent. Although lipid-insoluble quaternary cations penetrate into breast milk, unlikely, that Atrovent® N will provide a meaningful action in inhalation use. It should be used with caution during lactation (breast-feeding).
Cautions
Not recommended to prescribe the drug for emergency relief of asthma attacks (tk. bronchodilator effect develops later, than that of beta-agonists).
Cystic Fibrosis in patients with increased risk of violations of the GASTROINTESTINAL motility.
The patient should be taught the proper use of Atrovent® N spray for inhalations dosed.
The patient should be informed, if inhaled insufficiently effective or deteriorated condition, It is necessary to consult a physician to change the treatment plan. In case of a sudden occurrence and rapid progression of the shortness of the patient also should immediately consult your doctor.
In case of any symptom attack zakratougolna glaucoma (eye pain, discomfort, blurred vision, the appearance of halos and color spots before eyes combined with kon″ûnktival′noj and corneal hyperemia) should appoint drops, causing constriction of the pupil, and immediately contact an ophthalmologist.
Overdose
Symptoms: specific symptoms of overdose have been identified. Given the breadth of therapeutic action, and how to use local Atrovent® N, the emergence of any serious anticholinergic symptoms are unlikely. Slight manifestations of systemic anticholinergic action (incl. dry mouth, accommodation disturbances, increase in heart rate).
Treatment: symptomatic therapy.
Drug Interactions
With simultaneous use of beta2-adrenomimetiki and Xanthine derivatives potenziruut bronhodilatirtee action Atroventa® N.
With simultaneous use of Atrovent® N with protivoparkinsoničeskimi means, xinidinom, tricyclic antidepressants amplified antiholinergicescoe effect of the drug.
With simultaneous use of Atrovent® N with other anticholinergic drugs noted additivoe effect.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children, dark place at a temperature no higher than 25 ° C. Shelf life – 3 year.
The cylinder is under pressure. The container can not be opened and exposed to heat above 50 ° C.
