FENOTERIX
(Fenoterol)




COMPOSITION

Every dose of drug contains:

Active ingredient: fenoterol hydrobromide 100 mcg.

Excipients: anhydrous citric acid, ethanol, hydrofluoroalkane 134а, purified water.

THERAPEUTIC INDICATIONS

- symptomatic treatment of acute asthma attacks;

- prophylaxis of bronchial asthma attacks;

- symptomatic treatment of bronchial asthma induced by allergic and non-allergic reasons and/or other diseases due to reversible narrowing of the airways, for instance, COPD, complicated or non-complicated by emphysema.

If long-term treatment is needed, concomitant anti-inflammatory therapy should be indicated.

CONTRAINDICATIONS

- hypersensitivity to fenoterol hydrobromide and other ingredients;

- tachyarrhythmia;

- hypertrophic obstructive cardiomyopathy;

- age under 4 years old.

ADVERSE EFFECTS

The following parameters of frequency of adverse reactions are determined in the following way: common (from ≥ 1/100 до to 1/10), uncommon (from ≥ 1/1000 to < 1/100), rarely (from ≥ 1/10000 to < 1/1000), frequency unknown.

Immune system: the frequency is unknown - hypersensitivity reactions (e.g, itching, rash, purpura, thrombocytopenia, swelling of the face).

Metabolism: uncommon - hypokalemia; rarely - hyperkalemia. Hypokalemia can be especially significant in patients with severe asthma who simultaneously receive xanthine derivatives (e.g., theophylline), corticosteroids, and diuretics. In addition, in hypoxia the effect of hypokalemia on cardiac rhythm may be potentiated.

Mental disorders: agitation; unknown frequency - nervousness.
Irritability, hyperactivity, sleep disorders, hallucinations may appear. These reactions were observed mainly in children under the age of 12 years.

Nervous system: часто - tremor, dizziness; unknown frequency - headache.

Cardiovascular system: rarely - arrhythmias, angina pectoris, ventricular arrhythmia; unknown frequency - myocardial ischemia, tachycardia, palpitations, increased systolic blood pressure, decreased diastolic blood pressure.

Respiratory system disorders: common - coughing; uncommon - paradoxical bronchospasm; unknown frequency - throat irritation.
If paradoxical bronchospasm occur, the drug should be withdrawn immediately.

Gastrointestinal disorders: common - nausea; uncommon - vomiting, epigastric burning.

Skin and subcutaneous tissue disorders: common - increased sweating, uncommon - itching; unknown frequency - skin reactions (rash, urticaria).
Musculoskeletal and connective tissue disorders: uncommon - muscle cramps; unknown frequency - muscle spasm, myalgia, muscle weakness, tremor.
Kidney and the urogenital tract disorders: uncommon – urination disturbances.

DOSAGE AND ADMINISTRATION

Unless otherwise indicated, the following dosage regimen for adults and children aged 6 and older is recommended:

For treatment of acute bronchial spasm and sudden episodes of dyspnea, one 100 mcg dose of fenoterol hydrobromide is inhaled (1 inhalation dose).

In most cases, one inhalation dose is enough for fast reversal of symptom. If during 5 minutes there is no relief, one more additional inhalation dose may be administered. If second inhalation dose was not enough for reversal of attack, additional inhalation doses may be required. In these cases it is recommended to consult a doctor immediately. If long-term treatment is needed, the dosage is 1-2 inhaled dose of 100 mcg Fenoterix 3-4 times daily. The time of administration and the dosage of every inhalation should be defined according to the frequency and severity of breathlessness (symptomatically). Concurrent anti-inflammatory maintenance therapy is recommended, especially in bronchial asthma. The interval between inhalations should be not less than 3 hours. Overall daily dose should not exceed 8 inhalations, and maximum single dose should not exceed 4 inhalations as administration of larger doses will not result in additional therapeutic effect but it may increase the risk of serious adverse reactions.

For prophylaxis of asthmatic attacks or before expected contact with allergen, one or two 100 mcg inhalation doses of Fenoterix are indicated, if possible, 10-15 minutes before the contact with allergen.

If not indicated otherwise, the following dosage regimen for children aged 4-6 years:

For treatment of acute bronchial spasm and sudden onset of breathlessness, one 100 mcg inhalation dose of fenoterol hydrobromide (1 inhalation dose)

If long-term treatment is necessary, the dosage is one 100 mcg inhalation dose of Fenoterix 4 times daily. Time of administration and the dose of every inhalation should be determined depending on the frequency and severity of breathlessness (symptomatically).

Concomitant anti-inflammatory maintenance therapy, especially in bronchial asthma, is recommended. The interval between inhalations should be not less than 3 hours. Total daily dose should not exceed 4 inhalations, and maximum single dose should not exceed 2 inhalations, as the administration of higher doses will not result in additional therapeutic effect but may increase the risk pf serious adverse reactions.

For prophylaxis of asthmatic attack or before expected contact with allergen, 1 inhalation dose (100 mcg of fenoterol hydrobromide) is indicated, if possible, 10-15 minutes before the contact with allergen.

For children under 4 years old, this dosage regimen is not indicated.

Instruction for use of the drug:

For maximum efficacy the metered dose aerosol should be properly used. The inhalation should be made in sitting or standing position. Before using the metered dose aerosol for the first time, press the tube bottom twice. The following rules should be followed every time during the use of the metered dose aerosol:

  1. Pull off the protective cap.
  2. Take a deep and full breath.
  3. Holding the tube, firmly take the mouthpiece with your lips, and in this case the pointer and the bottom of the tube should be directed upwards.
  4. Both take maximum deep breath and quickly press the bottom of the tube until one inhalation dose is released. Hold your breath for several seconds, then take the mouthpiece out of mouth and exhale slowly. If repeated inhalation is needed, the same actions may be repeated (steps 2-4).
  5. Out the mouthpiece on.
  6. If aerosol tube was not used for more than 3 days, then before the administration it is recommended to press the bottom of the tube several times.

The tube is not transparent, that is why it is impossible to see when it becomes empty. The tube is designed for 200 inhalations, after that it should be replaced. Regardless of some amounts of the drug may stay in the tube, the quantity of drug substance released during inhalation, may be decreased.

The quantity of the drug substance may be determined by extracting the tube from plastic part of the inhaler and dip it into container filled with water.

The quantity of drug substance is estimated according to the position of tube in water (picture 1).

It is required to wash the inhaler not less frequently than once per week. It is important to keep the mouthpiece clean to prevent the accumulation drug substance and blockage of the aerosol stream.

For cleaning it is recommended to remove the protective cap and pull the tube out of the plastic part of the inhaler, which should then be washed with warm water until traces of the drug substance and / or dirt disappear.

After cleaning, it is required to shake the plastic part of the inhaler, and to dry it in air, without using any heater. After drying, the plastic part is inserted into the tube, and protective cap is set.

Caution: plastic mouthpiece is designed especially for Fenoterix and is suitable for precise dosing. The mouthpiece should not be used with other metered dose aerosols. Also it is impossible to use Fenoterix with any other mouthpiece, except supplied with the drug. The content of the tube is under pressure. Do not open and expose to heating over 50°С.

SPECIAL INDICATIONS

Fenoterix should be administered only after careful estimation of risk/benefit profile in the following diseases: severe cardiovascular diseases, recent myocardial infarction, ichaemic heat disease, administration of cardiac glycosides,uncontrolled arterial hypertension, aneurysm, hyperthyroid, decompensated diabetes mellitus, phaeochromocytoma.

Other sympathomimetic bronchodilators may be concomitantly administered with Fenoterix only under medical supervision. Concomitant administration of fenoterol and anticholinergic bronchodilator is possible. In case of unexpected development and fast progressing of dyspnea it is advised to apply to a doctor.

Long-term administration of the drug:

- rapid relief of symptoms of bronchial asthma may be more preferable than regular administration of drug (symptomatic treatment);

- it is required to have regular examination of patients in order to determine if additional or more intensive anti-inflammatory treatment (for example, corticosteroid inhalations) is necessary.

Regular administration of rising doses of the drugs containing β2 adrenoceptor agonist, like Fenoterix, for relief of bronchial obstruction, may result in uncontrolled aggravation. In case of aggravation of bronchial obstruction, simple long-term dose increase of β2 adrenoceptor agonists, including Fenoterix, exceeding the recommended one, is unjustified and even dangerous.

For prevention of life-threatening aggravation, the treatment plan and anti-inflammatory therapy with inhalation corticosteroids should be reconsidered. Serious hypokalemia may develop in case of β2-adrenoceptor agonist’s administration. Therefore, special caution should be exercised in case of severe asthma, as concomitant administration of β2-adrenoceptor agonists and xanthine derivatives, glucocorticoids and diuretics may result in hypokalemia. Moreover, effect of hypokalemia on heart rate may potentiate in hypoxia. Hypokalemia may cause increased predisposition to arrhythmia in patients on therapy with digoxin. Potassium plasma levels should be monitored.

Administration of sympathomimetic drugs, including Fenoterix, may affect cardiovascular system. Due to the administration of beta-adrenergic agonists, there is a small probability of myocardial ischemia.

Patients with severe cardiac diseases (for example, ischemic heart disease, arrhythmia or acute heart failure), who administer Fenoterix, should be informed that in case of chest pain or other symptoms of cardiac aggravation, they should consult a doctor. Special attention should be paid to the symptoms like chest pain and dyspnea, as they may be resulted from respiratory or cardiac disturbances.

If high doses are administered to patients with diabetes mellitus, blood sugar levels may increase, therefore blood sugar levels should be monitored in such patients.

PREGNANCY AND LACTATION

The results of pre-clinical trials and available data on experience of clinical use of the drug have not determined any negative effect on pregnancy. But the drug should be administered with caution in pregnancy (especially in the first trimester) and only in case if expected benefit for mother overweighs the possible risk for fetus.

The possibility of inhibiting effect of fenoterol on uterus contractive activity should be taken into consideration.

Pre-clinical data have shown that fenoterol is excreted in breast milk. The safety of the drug administration in lactation has not been determined. During lactation the administration of the drug is possible only when expected benefit for mother overweighs the potential risk for infant.

MANUFACTURED FORM AND PACKAGE

Metered-dose aerosol for 200 doses in a metal tube with a metering valve and mouth-piece with a protective cap. Metal tube with a leaflet in a carton box.

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