Fenoterol
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Clinical Pharmacology
Indications
- asthma attacks or other conditions with reversible airway obstruction, such as chronic obstructive pulmonary disease, obstructive bronchitis, pulmonary emphysema;
- prevention of attacks of bronchial asthma due to physical stress;
- as a bronchodilator before inhalation of other drugs (antibiotics, mucolytic agents, GCS);
- conducting bronchodilation tests in the study of respiratory function.
Composition
Excipients: sodium benzoate - 0.5 mg, disodium edetate dihydrate - 0.554 mg (corresponds to disodium edetate - 0.5 mg), citric acid monohydrate - 1.64 mg (corresponds to anhydrous citric acid - 1.5 mg), water d / and - up to 1 ml.
Fenoterol is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Fenoterol | Nativa | Russia | solution |
Berotec N | Boehringer Ingelheim | Austria | inhalation spray |
Berotec | Boehringer Ingelheim | Austria | solution |
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Dosage and Administration
The drug Fenoterol-native is intended only for inhaled administration.
20 drops = 1 ml.
1 drop = 50 mcg of fenoterol hydrobromide.
Doses should be selected according to the individual needs of the patient; in addition, during treatment the patient must be under the supervision of a physician.
Attacks of bronchial asthma and other conditions accompanied by reversible airway obstruction
Inhalation. 0.5 ml (10 drops = 0.5 mg of fenoterol hydrobromide) is in most cases sufficient for immediate relief of the attack.
If necessary, re-prescription of the drug is injected in 0.5 ml (10 drops = 0.5 mg of fenoterol hydrobromide) up to 4 times / day, but it is possible to reduce the individual dose depending on the effectiveness of the treatment.
In severe cases, if a dose of 1 ml (20 drops) is 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 of up to 2 ml (40 drops) is ineffective, 2 ml (40 drops = 2 mg of fenoterol hydrobromide) are inhaled under the supervision of a doctor.
Prevention of asthma attacks due to physical stress
Inhalation. 0.5 ml (10 drops = 0.5 mg fenoterol hydrobromide) before exercise.
Treatment begins, as a rule, with the lowest recommended dose.
The recommended dose is diluted with 0.9% sodium chloride solution to a final volume of 3-4 ml, sprayed and inhaled until complete consumption of the resulting dilution.
Fenoterol-native should not be diluted with distilled water. The solution is diluted each time before use; the remains of the diluted solution are poured.
Fenoterol-native is recommended to be used with the use of an inhalation device - a nebulizer. In the presence of oxygen breathing apparatus, the solution is best inhaled at a flow rate of 6-8 l / min.
Fenoterol-native can be inhaled simultaneously with cholino-and mucolytic agents. This applies primarily to drugs ipratropium bromide and ambroxol in the form of solutions for inhalation.
Adverse reactions
Frequency determination: very often (> 1/10), often (from 1/100 to 1/10), infrequently (from 1/1000 to 1/100), rarely (from 1/10000 to 1/1000), very rare (<1/10000).
The nervous system: very often - nervousness, anxiety, tremor, headache, dizziness; very rarely - arousal.
Since the cardiovascular system: often - tachycardia, palpitations; very rarely - arrhythmia, increased systolic blood pressure, decreased diastolic blood pressure, myocardial ischemia.
Metabolism and nutrition: often - hypokalemia, hyperglycemia.
On the part of the respiratory system: Infrequently - cough, irritation of the larynx and pharynx; rarely - paradoxical bronchospasm.
On the part of the digestive system: rarely - nausea, vomiting.
On the part of the skin and subcutaneous tissues: infrequently - allergic skin reactions, such as rash, itching, urticaria; rarely - hyperhidrosis.
On the part of the musculoskeletal system: infrequently - muscular weakness, muscle spasm, myalgia.
On the part of the immune system: rarely - hypersensitivity.
Contraindications
- hypersensitivity to fenoterol or any component of the drug;
- hypertrophic obstructive cardiomyopathy;
- tachyarrhythmia;
- age up to 18 years.
With care: hyperthyroidism; hypotension; arterial hypertension; intestinal atony; hypokalemia; diabetes; recent myocardial infarction (within the last 3 months); diseases of the heart and blood vessels, such as chronic heart failure, coronary artery disease, coronary artery disease, heart disease (including aortic stenosis); marked lesions of cerebral and peripheral arteries; pheochromocytoma; glaucoma.
Drug interactions
GCS, anticholinergics, xanthine derivatives (for example, theophylline), cromoglicic acid can enhance the effect of fenoterol.
Beta-adrenergic agents, corticosteroids and diuretics may increase the side effects of fenoterol.
A significant reduction in the bronchodilator action of Fenoterol-Native is possible with simultaneous appointment of beta-blockers.
Beta-agonists should be used with caution in patients receiving MAO inhibitors or tricyclic aptidepressants, since These drugs can enhance the effect of fenoterol.
Inhalation of halogenated hydrocarbon anesthetics (halothane, trichlorethylene, enflurane) can enhance the effect of fenoterol on the cardiovascular system. Halothane contributes to the development of arrhythmia.
The simultaneous appointment of bronchodilators with a similar mechanism of action leads to an additive effect and symptoms of overdose.
Pregnancy and Lactation
There was no negative effect of the drug on the course of pregnancy. However, for pregnant women (especially in the first trimester), the drug is prescribed only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. The possibility of an inhibitory effect of fenoterol on the contractile activity of the uterus should be considered.
Fenoterol passes into breast milk. The safety of the drug during lactation has not been studied. The use of the drug during lactation is possible only in cases where the intended benefit to the mother outweighs the potential risk to the child.
Special instructions
Other sympathomimetic bronchodilators can be used simultaneously with Fenoterol-native only under medical supervision.
In acute, rapidly aggravated dyspnea, the patient should immediately consult a doctor.
With prolonged use of the drug:
- relief of asthma attacks may be preferable to regular use of the drug (symptomatic treatment);
- it is necessary to conduct regular examination of patients in order to identify the need for additional or more intensive anti-inflammatory treatment (for example, inhaled GCS) in order to control airway inflammation and prevent long-term exacerbations of asthma.
In case of increased bronchial obstruction, it is considered unacceptable and it may even be risky to increase the frequency of beta intake.2agonists contained in drugs such as Fenoterol Native, in excess of the recommended doses. In such a situation, the treatment plan and, especially, the adequacy of anti-inflammatory therapy should be reviewed.
When treating beta2agonists may develop severe hypokalemia. Particular caution should be exercised in severe bronchial asthma, since This effect can be enhanced by the concomitant use of xanthine derivatives, GCS and diuretics. During hypoxia, the effect of hypokalemia on the heart rhythm may be enhanced. In such situations, it is recommended to regularly monitor the concentration of potassium in the serum.
In rare cases, myocardial ischemia has been observed, associated with beta2agonists.
The use of fenoterol in patients with hypokalemia who receive cardiac glycosides can cause arrhythmia.
In patients with diabetes mellitus during treatment, it is necessary to regularly monitor plasma glucose.
The drug contains a stabilizer of disodium edetate, which in some patients may cause bronchospasm.
The use of fenoterol can lead to positive results of tests for the abuse of psychoactive drugs for non-medical indications, as well as for doping in athletes.
Influence on ability to drive motor transport and control mechanisms
Studies on the effect of the drug on the ability to drive vehicles and control mechanisms have not been conducted. In the case of side effects when using the drug should refrain from driving vehicles and driving mechanisms.
Overdosage
Symptoms: tachycardia, increased heartbeat, decrease or increase in blood pressure, increased pulse pressure, chest pain, arrhythmias, feeling of hot flushes to the face, tremor, metabolic acidosis, headache, dizziness, anxiety, agitation, hypokalemia.
Treatment: sedatives, tranquilizers, in severe cases, conduct intensive symptomatic therapy. Beta-blockers may be prescribed as specific antidotes (preferably selective beta1-blockers); It is necessary to take into account the possibility of increasing bronchial obstruction and carefully select the doses of these drugs in patients suffering from bronchial asthma.
- Brand name: Fenoterol
- Active ingredient: Fenoterol
- Dosage form: Solution for inhalation clear, colorless or with a faint yellowish tinge.
- Manufacturer: Native
- Country of Origin: Russia
Studies and clinical trials of Fenoterol (Click to expand)
- Chiral separation of the β2-sympathomimetic fenoterol by HPLC and capillary zone electrophoresis for pharmacokinetic studies
- Effect of fenoterol stereochemistry on the β2 adrenergic receptor system: Ligand-directed chiral recognition
- Comparison of isotachophoresis, capillary zone electrophoresis and high-performance liquid chromatography for the determination of salbutamol, terbutaline sulphate and fenoterol hydrobromide in pharmaceutical dosage forms
- Fenoterol effects on the in vitro immune response
- Application of a Nafion-modified carbon paste electrode for the adsorptive stripping voltammetric determination of fenoterol in pharmaceutical preparations and biological fluids
- High-performance liquid chromatographic assay for the simultaneous determination of ipratropium bromide, fenoterol, salbutamol and terbutaline in nebulizer solution
- Oxitropium bromide: An acute dose response study of a new anticholinergic drug in combination with fenoterol in asthma and chronic bronchitis
- Determination of fenoterol hydrobromide by sequential injection analysis with spectrophotometric detection
- Quantitative determination of fenoterol and fenoterol derivatives in rat plasma using on-line immunoextraction and liquid chromatography/mass spectrometry
- HPLC–electrospray mass spectrometric assay for the determination of (R,R)-fenoterol in rat plasma
- Fenoterol but not dobutamine increases erythropoietin production in humans
- Comparison of bronchodilator effectiveness of fenoterol and isoetharine: Bynum L, Gross G, Loudermilk J Ann Allergy 50:252–255 Apr 1983
- Screening of β-2 agonists and confirmation of fenoterol, orciprenaline, reproterol and terbutaline with gas chromatography–mass spectrometry as tetrahydroisoquinoline derivatives
- High-performance liquid chromatographic determination of the β2-selective adrenergic agonist fenoterol in human plasma after fluorescence derivatization
- A time-saving method for the determination of the β2 sympathomimetics terbutaline, salbutamol and fenoterol. Preliminary results
- Voltammetric determination of isoxsuprine and fenoterol in dosage forms and biological fluids through nitrosation
- Determination of fenoterol in human plasma by HPLC with fluorescence detection after derivatization
- Fenoterol increases erythropoietin concentrations during tocolysis
- Fenoterol stimulates human erythropoietin production via activation of the renin angiotensin system
- Inhibition by fenoterol of human eosinophil functions including β2-adrenoceptor-independent actions
- Efficacy and safety of ipratropium bromide plus fenoterol inhaled via Respimat® Soft Mist™ Inhaler vs. a conventional metered dose inhaler plus spacer in children with asthma
- The bronchodilator effect of a fixed-combination metered aerosol (fenoterol and ipratropium bromide)
- Effects of nebulized fenoterol, associated with ipratropium or steroids, on the heart rate of infants under one year of age with acute wheezing
- Bronchodilator effect of fenoterol and ipratropium bromide in infants with acute wheezing: Use of MDI with a spacer device