Description
Release form
Dosage inhalation aerosol.
Packaging
Bottle 120 doses.
Pharmacological action
Pharmaceutical group: bronchodilating agent – selective beta2-adrenergic agonist.
Pharmaceutical action: Atimos is a bronchodilating drug, a selective agonist of 2-adrenergic receptors with low affinity for 1-adrenergic receptors. The mechanism of action is associated with the activation of adenylate cyclase, which leads to an increase in the amount of cyclic AMP (cAMP), which causes the activation of protein kinase A.
Activated protein kinase A inhibits the phosphorylation of key proteins, responsible for controlling smooth muscle tone. An increase in the intracellular concentration of cAMP also suppresses the release of calcium ions from the depot. The combination of these processes leads to a bronchodilator effect.
The action of the drug is fast and lasts a long time. Formoterol effectively prevents bronchospasm caused by inhaled allergens, exercise, cold air, histamine, or methacholine.
Pharmacokinetics:
Absorption and distribution of
About 90% of the drug after inhalation can be swallowed. After oral administration, it is rapidly absorbed from the digestive tract. Cmax of formoterol in blood plasma is 60% 15 minutes after application and decreases to 10% 24 hours after application.
Distribution of
The binding of formoterol to plasma proteins is 50-65%.
Metabolism and excretion
Formoterol is metabolized by direct addition of the glucuronic acid residue and o-demethylation.
The active substance and its metabolites are completely excreted: 36-45% is excreted in the urine, 50-56% with feces within 72 hours after application.
T1 / 2 is 4 hours after iv administration and 6 hours after oral administration.
Indications
a and treatment of bronchospasm in patients with asthma
Prevention and treatment of bronchospasm induced by allergens, exercise and cold air.
Prevention and treatment of bronchial obstruction in patients with chronic obstructive pulmonary disease (COPD).
Contraindications
Hypersensitivity to formoterol or another component of the drug
tachyarrhythmia
atrioventricular block III grade
idiopathic subaortic stenosis
With caution
Coronary heart disease, myocardial infarction, exacerbation of hypertension, heart rhythm disturbance, chronic heart failure in the decompensation stage, diabetes mellitus, prostate hypertrophy, glaucoma, pregnancy.
Pregnancy and lactation
Safety of Atimos during pregnancy and lactation has not been established. The use of the drug during pregnancy is possible only if the expected benefit exceeds the possible risk.
There is no data on the penetration of formoterol into human milk. It is necessary to stop breastfeeding with Atimos.
Special instructions
If systematic treatment with inhaled adrenergic agonists is required, patients with bronchial asthma should receive systematic anti-inflammatory treatment. Therefore, if treatment with Atimos is prescribed, the need for anti-inflammatory therapy should be assessed.
Composition of
1 dose of the preparation contains: Active ingredients:
formoterol fumarate 0.012 mg
Excipients:
Ethanol,
hydrochloric acid,
norflurane (1,1,1,2-tetrafluoroethane).
Dosage and administration of
Adults, including elderly patients, are prescribed 12-24 mcg (1-2 doses) 2 times a day for the treatment and prevention of Atimos.
Children 6 years of age and older are prescribed 12 mcg (1 dose) 2 times a day.
Side effects of
From the musculoskeletal system:
sometimes (1/1000 – 1/100): rarely
tremor (1/10000 – 1/1000): muscle pain, muscle cramps. From the cardiovascular system: sometimes: strong heartbeat
rare: tachycardia, lowering blood pressure. From the central and peripheral nervous system: sometimes:
headache rarely: agitation, dizziness, anxiety, nervousness, insomnia. On the part of the respiratory system: sometimes: cough
rarely: paradoxical bronchospasm. Local reactions: rare: oropharyngeal irritation.
Others: sometimes: weakness, allergic reactions (itching, urticaria, angioedema, rash), taste changes, nausea, dry mouth, hypokalemia.
Drug interactions
Antiarrhythmic drugs of class Ia (quinidine, disopyramide, novokainamide) and class III (solatol, amidarone), phenothiazines, antihistamines, monoamine oxidase inhibitors (MAOs), tricyclic antidepressants, vinidin, erythromide halofantrine, bepridil can extend the QT interval and increase the risk of ventricular arrhythmias (risk of developing pirouette type arrhythmias).
The concomitant use of other adrenergic drugs can aggravate the side effects of Atimos.
Concomitant treatment with xanthine derivatives, glucocorticosteroids or diuretics may enhance the potential hypokalemic effect of 2-adrenergic agonists. Hypokalemia may increase the risk of cardiac arrhythmias in patients receiving digitalis preparations.
-adrenergic blockers can reduce the effect of Atimos. Thus, the drug should not be used simultaneously with -Adrenergic blockers (including eye drops), unless the application is dictated by necessity.
Due to its low ethanol content, interactions may occur in hypersensitive patients taking disulfiram or metronidazole.
Storage Conditions
At a temperature of + 2-8 ° C, away from heating appliances, in a place protected from the sun. Do not freeze.
Keep out of the reach and sight of children.
The Expiration of
is 18 months. Do not use after the date stated on the package.
active substance
Formoterol
Terms of leave from pharmacies
by the recipe of
lekarstvennaja form
aerosols for ynhalyatsyy
For prescription
For children prescribed by doctor, Children over 12 years old, For adults as prescribed by the doctor
Chiesi Pharmaceuticals S.P.A., Italy
