Fenoterol-Nativ, for inhalation 1 mg/ml 20 ml 1pc.

Phenoterol-nativ is an effective bronchodilator for prevention and relief of bronchospasm attacks in bronchial asthma and other diseases accompanied by reversible airway obstruction, such as chronic obstructive pulmonary disease, chronic bronchitis, lung emphysema.

Phenoterol is a selective stimulator of β2-adrenoreceptors. When using the drug in higher doses, β1-adrenoreceptors are stimulated (e.g., when prescribed for tocolytic therapy).

The mechanism of action is associated with activation of adenylate cyclase through stimulatory Gs-protein with subsequent increase in formation of cyclic adenosine monophosphate (cAMP) which activates protein kinase A, the latter prevents myosin from binding to actin that prevents contraction of smooth muscles and promotes bronchodilator action and elimination of bronchospasm.

Fenoterol also inhibits the release of inflammatory mediators from mast cells, thus having a protective effect against the effects of bronchoconstrictors such as histamine, methacholine, cold air and allergens. Administration of phenoterol in doses of 0.6 mg increases activity of the bronchial epithelium and accelerates mucociliary transport.

Fenoterol may affect myocardium due to its stimulating effect on β-adrenoreceptors (especially in doses higher than those used for therapy), causing faster and stronger heart beats.

Fenoterol prevents and quickly stops bronchospasm of different genesis. The beginning of action after inhalation is within 5 minutes and maximum period of action is 30-90 minutes; the duration of action is 3-5 hours.

Indications

Active ingredient

Composition

1 ml of inhalation solution contains:

Active substance:

Phenoterol hydrobromide 1.0 mg

Associates:

sodium benzoate 0.5 mg;

dinatrium edetate dihydrate 0.554 mg (corresponding to dinatrium edetate) 0.5 mg;

citric acid monohydrate 1.64 mg (corresponds to anhydrous citric acid) 1.5 mg;

water for injection up to 1.0 ml

How to take, the dosage

The drug “Fenoterol-nativ” is intended for inhalation administration only.
20 drops = 1 ml.
1 drop = 50 mcg of fenoterol hydrobromide.
Doses should be adjusted according to individual patient’s needs. In addition, the patient should be under medical supervision during the treatment.
Bronchial asthma attacks and other conditions accompanied by reversible airway obstruction.
– 0.5 ml (10 drops = 0.5 mg of fenoterol hydrobromide) in most cases is enough to stop an attack immediately;
– If it is necessary to repeat the preparation it is inhaled 0.5 ml (10 drops = 0.5 mg of fenoterol hydrobromide) up to 4 times a day, but it is possible to reduce the individual dose depending on the treatment efficiency;
– in severe cases, if the dose of 1 ml (20 drops) proves ineffective, higher doses from 1 to 1.25 ml (20-25 drops = 1-1.25 mg of fenoterol hydrobromide) may be required;
– in extremely severe cases, if the dose up to 2.0 ml (40 drops) proves ineffective, 2 ml (40 drops = 2 mg of fenoterol hydrobromide) are inhaled under medical supervision.
Prevention of bronchial asthma attacks due to physical exertion:
Inhalation.
– 0.5 ml (10 drops = 0.5 mg of fenoterol hydrobromide) before physical activity.
Treatment is usually started with the lowest recommended dose.
The recommended dose is diluted with 0.9% sodium chloride solution to the final volume of 3-4 ml, sprayed and inhaled until complete consumption of the resulting dilution.
Fenoterol-nativ cannot be diluted with distilled water. The solution is diluted anew each time before use; the remainder of the diluted solution is poured out.
It is recommended to use Fenoterol-nativ with the use of inhalation device – nebulizer. If there is an oxygen-breathing device, the solution is best inhaled at a flow rate of 6-8 l/min.
Fenoterol-nativ can be inhaled simultaneously with choline and mucolytic agents. This applies primarily to preparations ipratropium bromide and ambroxol in the form of inhalation solutions.

Interaction

Glucocorticosteroids, anticholinergic agents, xanthine derivatives (e.g., theophylline), cromoglycic acid may increase the effects of fenoterol.

β-adrenergic agents, glucocorticosteroids and diuretics may increase the side effects of fenoterol.

The bronchodilator effect of Fenoterol-nativ may be significantly reduced when β-adrenoblockers are prescribed at the same time.

Patients receiving monoamine oxidase inhibitors or tricyclic antidepressants should be cautioned when prescribing β-agonists because these drugs can potentiate the effects of fenoterol.

Inhalation of halogenated hydrocarbon anesthetics (halothane, trichloroethylene, enflurane) may increase the cardiovascular effects of fenoterol. Halothane promotes arrhythmia.

The simultaneous administration of bronchodilators with a similar mechanism of action leads to additive effects and overdose phenomena.

Special Instructions

Other sympathomimetic bronchodilators may be used concomitantly with Fenoterol-nativ only under medical supervision.

In case of acute, rapidly increasing dyspnea (difficulty in breathing), consult a physician immediately.

In long-term use of the drug:

– the relief of bronchial asthma attacks may be preferable to regular use of the drug (symptomatic treatment);

– patients should be evaluated regularly to determine if additional or more intense anti-inflammatory treatment (e.g., glucocorticosteroid inhalation) is needed to control airway inflammation and prevent long-term exacerbations of bronchial asthma.

If bronchial obstruction worsens, it is considered unacceptable and may even be risky to increase the frequency of administration of β2-agonists contained in drugs such as Fenoterol-Nativ beyond the recommended doses. In such a situation, the treatment plan and especially the adequacy of anti-inflammatory therapy should be reconsidered.

The treatment with β2-agonists may result in marked hypokalemia. Particular caution should be exercised in severe bronchial asthma, as this effect may be enhanced by concomitant use of xanthine derivatives, glucocorticosteroids and diuretics. In hypoxia, the effect of hypokalemia on se

Myocardial ischemia associated with β2-agonists has been observed in rare cases.

Phenoterol use in patients with hypokalemia who receive cardiac glycosides may cause arrhythmias.
In diabetic patients, regular monitoring of plasma glucose should be performed during treatment.
The drug contains the stabilizer disodium edetate, which in some patients may cause bronchospasm.
The use of fenoterol may lead to positive results of tests for abuse of psychoactive drugs for non-medical reasons, as well as for doping in athletes.

Influence on the ability to drive vehicles and other vehicles, to operate moving mechanisms

There have been no studies to study the effect of the drug on the ability to drive vehicles and operate mechanisms. In case of side effects when using the drug, one should refrain from driving vehicles and operating machinery.

Contraindications

With caution: Hyperthyroidism, arterial hypotension, arterial hypertension, intestinal atony, hypokalemia, diabetes mellitus, recent myocardial infarction (within the last 3 months), heart disease, vascular disease such as chronic heart failure, coronary heart disease, coronary artery disease, heart defects (including aortic stenosis), pronounced lesions of cerebral and peripheral arteries, pheochromocytoma, glaucoma.

Side effects

Cardiovascular system disorders: often – tachycardia, palpitations; very rarely – arrhythmia, increased systolic blood pressure, decreased diastolic blood pressure, myocardial ischemia.

Metabolism and nutrition disorders: often – hypokalemia, hyperglycemia.

Nervous system disorders: very often – nervousness, anxiety, tremor, headache, dizziness; very rarely – agitation.

Digestive system disorders: infrequent – nausea, vomiting.

The skin and subcutaneous tissue: infrequent allergic skin reactions such as rash, itching, urticaria; rarely – hyperhidrosis.

Muscular system and related tissue disorders: infrequent – muscle weakness, muscle spasm, myalgia.

Respiratory system: infrequent – cough, irritation of the larynx and pharynx, rarely – paradoxical bronchospasm.

Immune system disorders: rarely – hypersensitivity.

Overdose

Symptoms: tachycardia, palpitations, decreased or increased blood pressure, increased pulse pressure, pain behind the chest, arrhythmias, feeling of blood rush to the face, tremor, metabolic acidosis, headache, dizziness, anxiety, agitation, hypokalemia.

Treatment: sedatives, tranquilizers, in severe cases intensive symptomatic therapy. β-adrenoblockers (preferably selective β1-adrenoblockers) may be prescribed as specific antidotes; the possibility of increasing bronchial obstruction should be taken into account and the doses of these drugs in patients with bronchial asthma should be chosen with caution.

Similarities