Атимос
Producer: Chiesi Farmaceutici S.p.A. (Kyezi Pharmatsevtichi S. Square) Italy
Code of automatic telephone exchange: R03AC13
Release form: Liquid dosage forms. An aerosol for inhalations.
General characteristics. Structure:
Active agents: the formoterola fumarates 0,012 mg
Excipients: ethanol, Acidum hydrochloricum, норфлуран (1,1,1,2-tetraftoretan).
Pharmacological properties:
Formoterol is the selection agonist? 2-adrenoretsepter with low relationship to? to 1 adrenoceptors. Has bronchodilatory effect. Activates adenylatecyclase that adenosine monophosphate (tsAMF) which causes activation of a protein kinase leads to increase in quantity cyclic And. The activated protein kinase And inhibits phosphorylation of the key proteins which are responsible for control of a tone of an unstriated muscle. Increase in intracellular concentration of tsAMF also leads to suppression of emission of calcium ions from intracellular stocks. Set of these processes results in broncholitic effect.
Effect of drug comes quickly and the long time remains.
Formoterol effectively prevents the bronchospasm caused by the inhaled allergens, an exercise stress, cold air, a histamine or metasincaline.
Pharmacokinetics. About 90% of drug after inhalation use can be swallowed. It is quickly soaked up from digestive tract. Linkng of a formoterol with proteins of plasma makes 50-65%. The maximum concentration of a formoterol in a blood plasma makes 60% in 15 minutes after use and decreases to 10% in 24 hours after use. Formoterol is exposed to metabolism by direct accession of the rest of glucuronic acid and au demethylation. The elimination half-life makes 4 hours after intravenous administration and 6 hours after intake. Active agent and its metabolites are completely removed from an organism: 36-45% are removed with urine, 50-56% – with a stake within 72 hours after use.
Indications to use:
- Prevention and treatment of a bronchospasm at patients with bronchial asthma;
- Prevention and treatment of the bronchospasm caused by allergens, an exercise stress or cold air.
- Prevention and treatment of bronchial obstruction at patients with the chronic obstructive pulmonary disease (COPD).
Route of administration and doses:
Adults, including elderly patients.
Treatment and prevention:
one or two doses on 12 mkg (12-24 mkg) twice a day.
If it is necessary, one or two additional doses can be entered during the day for relief of symptoms. However if need for acceptance of additional doses becomes more frequent (for example, it is more than two days in a week), it is necessary to see a doctor for treatment review as this situation can mean deterioration in a course of bronchial asthma.
Children at the age of 6 years are also more senior:
one dose on 12 mkg twice a day.
Prevention of the bronchospasm caused by an exercise stress or inevitable contact with the known allergen:
one inhalation on 12 mkg in 15 minutes prior to provocation. Two inhalations on 12 mkg can be required by patients with severe forms of bronchial asthma.
Before the first use (or if the inhaler was not used within three and more days) remove a protective cap from a mouthpiece and make spraying once in air to be convinced that the inhaler works.
Route of administration:
Take an inhaler big and index fingers.
Remove a protective cap from an inhaler mouthpiece.
Take a mouthpiece in a mouth, having densely clasped it with lips and completely exhale through a nose.
Make a long deep breath, having at the same time made pressing a barrel end face an index finger.
After a breath as long as possible hold the breath. For maintenance of purity of a mouthpiece it is recommended to wash out it warm water in process of pollution.
Use of drug for children has to take place under control of adults. It is recommended for prevention of a breath through a nose during inhalation to clamp the child's nostrils.
Features of use:
If systematic treatment is required by inhalation adrenomimetika, patients with bronchial asthma have to receive systematic antiinflammatory treatment. Therefore, if treatment by Atimos is appointed, it is necessary to estimate need of purpose of antiinflammatory therapy.
When patients already take this course of treatment (inhalation or peroral glucocorticosteroids), it needs to be continued without any changes even if improvement of symptoms is observed. Preservation of symptoms of bronchial asthma or need of increase in a dose of Atimos can demonstrate deterioration in a course of bronchial asthma and need of review of treatment.
Associated diseases
If at patients such associated diseases as coronary heart disease, a myocardial infarction, an aggravation of a course of arterial hypertension, disturbance of a cordial rhythm, chronic heart failure, a diabetes mellitus, a prostatauxe, glaucoma are observed, it is necessary to show extra care at the choice of a dose of Atimos.
Owing to hyper glycemic action? 2-adrenomimetik, at patients with a diabetes mellitus it is necessary to control in addition the content of glucose in blood.
Hypopotassemia
Potentially treatment? 2-adrenomimetikam can cause a hypopotassemia. This action can be strengthened by a hypoxia and the accompanying treatment therefore extra care needs to be shown concerning the patients having bronchial asthma.
In these conditions it is recommended to control potassium level in a blood plasma.
Paradoxical bronchospasm
Development of a paradoxical bronchospasm is possible. In this case it is necessary to stop immediately use of drug and to appoint alternative treatment.
It is recommended to follow strictly the dosage recommended in the instruction to avoid serious side effects, first of all from cardiovascular system.
This medical supply contains ethanol.
For athletes: drug use not in the medical purposes is regarded as dope: it causes doping effect and gives positive reaction at a doping test.
Undesirable effects, in case of their manifestation, can affect ability of driving or work with mechanisms.
The barrel is under pressure: not to subject to influence of high temperature, not to pierce, not to throw into fire, even empty. To store and use at the room temperature no more than 3 months since the beginning of use.
Side effects:
From skeletal and muscular system:
sometimes (1/1000 – 1/100): tremor;
seldom (1/10000 – 1/1000): muscle pain, myotonia.
From cardiovascular system:
sometimes: strong heartbeat;
seldom: tachycardia, lowering of arterial pressure.
From the central and peripheral nervous system:
sometimes: headache;
seldom: excitement, dizziness, concern, nervousness, sleeplessness.
From a respiratory organs:
sometimes: cough;
seldom: paradoxical bronchospasm.
Local reactions:
seldom: irritation of a stomatopharynx.
Others:
sometimes: weakness, allergic reactions (itch, urticaria, Quincke's disease, rash), flavoring changes, nausea, dryness in a mouth, hypopotassemia.
Interaction with other medicines:
Antiarrhytmic means of Ia of a class (quinidine, Disopyramidum, новокаинамид) and the III class (солатол, амидарон), fenotiazina, antihistaminic drugs, inhibitors of a monoaminooxidase (MAO), tricyclic antidepressants, erythromycin for intravenous administration, pentamidine, сультоприд, винкомицин, галофантрин, bepridit can extend a QT interval and increase risk of ventricular arrhythmia (risk of development of arrhythmia like "pirouette") (also see. "Contraindications").
Simultaneous use of other adrenergic drugs can lead to aggravation of side effects of Atimos.
Simultaneous treatment by derivatives of xanthines, glucocorticosteroids or diuretics can strengthen potential gipokaliyemichesky action beta 2 - адреномиметиков. The hypopotassemia can increase risk of emergence of cases of cardiac arrhythmias at the patients receiving naperstnyanka drugs.
beta adrenoblockers can reduce Atimos's action. Thus, drug should not be used at the same time with beta adrenoblockers (including eye drops), except for cases when use is dictated by need.
Because of the maintenance of a small amount of ethanol manifestation of interaction at the patients with hypersensitivity accepting Disulfiramum or metronidazole is possible.
Contraindications:
- hypersensitivity to a formoterol or other component of drug;
- tachyarrhythmia;
- atrioventricular block of the III degree;
- idiopathic subaortal stenosis;
- hypertrophic subaortic stenosis;
- thyrotoxicosis;
- lengthening of an interval of QT (QTc> 0.44 sec.);
- children up to 6 years;
- feeding by a breast.
With care
Coronary heart disease, myocardial infarction, aggravation of a course of arterial hypertension, disturbance of a cordial rhythm, chronic heart failure in decompensation stages, a diabetes mellitus, a prostatauxe, glaucoma, pregnancy.
Pregnancy and lactation
Safety of use of Atimos during pregnancy and a lactation is not established. Use of drug during pregnancy is possible only if the expected advantage exceeds possible risk.
The person has no data on penetration of a formoterol into breast milk. It is necessary to stop breastfeeding at Atimos's use.
Overdose:
At overdose there are symptoms, typical for beta-adrenergic agonists, such as nausea, vomiting, headache, tremor, drowsiness, strong heartbeat, tachycardia, ventricular arrhythmia, the lowered/increased arterial pressure, a metabolic acidosis, a hypopotassemia, a hyperglycemia.
At emergence of symptoms of overdose the symptomatic treatment is shown. In hard cases hospitalization. Use of cardioselective beta adrenoblockers at respect for extreme care as use of these means can cause a bronchospasm can be considered.
Storage conditions:
At a temperature + 2-8 °C, in the place protected from the sun, far from heating devices. Not to freeze.
To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
Aerosol for inhalations dosed 12 mkg / a dose.
The aluminum barrel with the dosing valve containing 100 or 120 doses of drug. On 1 barrel with an inhaler and the instruction place in a cardboard pack.