Fenotair^® (Aerosol) Instructions for Use

Marketing Authorization Holder

Binnopharm JSC (Russia)

ATC Code

R03AC04 (Fenoterol)

Active Substance

Fenoterol (Rec.INN WHO registered)

Dosage Form

Fenotair®

Metered-dose inhalation aerosol 100 mcg/1 dose: canisters 200 doses

Dosage Form, Packaging, and Composition

Metered-dose inhalation aerosol in the form of a transparent, colorless or light yellow, or light brown, or with a brownish-yellowish tint solution with the smell of ethanol, under pressure in a monoblock metal canister with a metering valve, equipped with an inhalation nozzle with a protective cap; the drug, when exiting the canister, is sprayed in the form of an aerosol cloud.

Excipients: ethanol – 15.597 mg, purified water – 1.04 mg, anhydrous citric acid – 0.001 mg, norflurane – 35.252 mg.

200 doses – canisters with a metering valve, with an inhalation nozzle (1) – cardboard packs.

Clinical-Pharmacological Group

Bronchodilator drug

Pharmacotherapeutic Group

Bronchodilator agent – selective beta2-adrenomimetic

Pharmacological Action

Beta-adrenomimetic. It acts primarily on β₂-adrenergic receptors. The mechanism of action is associated with the activation of adenylate cyclase coupled to the receptor, which leads to an increase in the formation of cAMP, which stimulates the work of the calcium pump, as a result of which the concentration of calcium in myofibrils decreases.

When used as a bronchodilator, it dilates the bronchi, increases the frequency and volume of breathing, and improves the function of the bronchial ciliated epithelium. It has a vasodilating effect, reduces the contractile activity and tone of the myometrium.

As a tocolytic agent, it is used orally and intravenously. Along with lowering the tone and contractile activity of the myometrium, it improves uteroplacental blood flow, which leads to an increase in the concentration of oxygen in the fetal blood.

Pharmacokinetics

After inhalation, 10-30% of fenoterol reaches the lower respiratory tract. The remainder is deposited in the upper respiratory tract and in the mouth and is then swallowed. The absolute bioavailability of fenoterol after inhalation is 18.7%. After oral administration, approximately 60% of the fenoterol dose is absorbed. Plasma protein binding is from 40 to 55%. Fenoterol undergoes intensive metabolism in the liver by conjugation to glucuronides and sulfates. The swallowed portion of the fenoterol dose is metabolized primarily by sulfation. This metabolic inactivation of the parent substance begins already in the intestinal wall. Fenoterol is excreted by the kidneys and with bile in the form of inactive sulfate conjugates. After inhalation, 2% of the dose is excreted through the kidneys unchanged within 24 hours. Fenoterol can cross the placental barrier and enter breast milk.

Indications

Attacks of bronchial asthma or other conditions with reversible airway obstruction, chronic bronchitis, COPD; prevention of bronchial asthma attacks due to physical exertion. As a bronchodilator before inhalation of other drugs (antibiotics, mucolytic agents, glucocorticosteroids). Conducting bronchodilator tests when examining the function of external respiration.

ICD codes

Dosage Regimen

Administer via oral inhalation only. Individualize the dosage based on the patient’s condition and response.

For relief of an acute asthma attack, use one inhalation (100 mcg). If adequate relief is not achieved within 5 minutes, a second inhalation may be taken. Do not exceed a total of two inhalations for an acute episode.

For prevention of exercise-induced bronchospasm, use one to two inhalations (100-200 mcg) approximately 15 minutes before physical exertion.

For ongoing management of bronchospasm in chronic obstructive pulmonary disease (COPD) or asthma, the usual dose is one inhalation (100 mcg) up to three to four times daily. Do not exceed a total daily dose of eight inhalations (800 mcg).

As a bronchodilator prior to administering other inhaled medications (e.g., corticosteroids, mucolytics), use one inhalation (100 mcg) several minutes beforehand.

For bronchodilator testing in pulmonary function diagnostics, follow the specific protocol prescribed by the physician.

If the therapeutic effect becomes less effective or lasts for a shorter duration, or if the inhaler use increases significantly, seek immediate medical advice. This may indicate a worsening of the underlying condition requiring reassessment of therapy.

Prime the inhaler before first use and if it has not been used for more than three days. To prime, release two test sprays into the air away from the face.

Clean the inhaler actuator regularly, at least once per week, to prevent medication buildup and blockage.

Adverse Reactions

From the immune system: frequency unknown – hypersensitivity reactions.

From metabolism infrequently – hypokalemia, including severe hypokalemia.

From the psyche: infrequently – agitation; frequency unknown – nervousness.

From the nervous system: often – tremor; frequency unknown – headache, dizziness.

From the cardiovascular system: infrequently – arrhythmia; frequency unknown – increased systolic blood pressure, decreased diastolic blood pressure, myocardial ischemia, tachycardia, palpitations.

From the respiratory system often – cough; infrequently – paradoxical bronchospasm; frequency unknown – irritation of the larynx and pharynx.

From the digestive system infrequently – nausea, vomiting.

From the skin and subcutaneous tissues: infrequently – itching; frequency unknown – hyperhidrosis, skin rash, urticaria.

From the musculoskeletal system frequency unknown – muscle weakness, muscle spasm, myalgia.

Contraindications

Hypersensitivity to fenoterol; hypertrophic obstructive cardiomyopathy; tachyarrhythmia; children’s age – depending on the dosage form.

With caution

Arterial hypotension, arterial hypertension, hyperthyroidism, hypokalemia, insufficiently controlled diabetes mellitus, recent myocardial infarction (within the last 3 months), severe organic diseases of the heart and blood vessels, such as chronic heart failure, coronary artery disease, coronary artery diseases, heart defects (including aortic stenosis), severe lesions of cerebral and peripheral arteries, pheochromocytoma.

Use in Pregnancy and Lactation

During pregnancy, especially in the first trimester, and during breastfeeding, it should be used with caution, only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

It is possible to use in children according to indications, in doses and dosage forms recommended for the corresponding age. It is necessary to strictly follow the instructions in the instructions for fenoterol preparations regarding contraindications for the use of specific dosage forms of fenoterol in children of different ages.

In children under 6 years of age, it should be used with caution, only under medical supervision.

Geriatric Use

It should be prescribed with caution to elderly patients to avoid worsening of concomitant diseases.

Special Precautions

When used in obstetrics in patients with water metabolism disorders, disorders of the cardiovascular and respiratory systems, the possibility of pulmonary edema should be taken into account.

During the use of fenoterol, it is recommended to monitor the level of potassium in the blood; with oral or intravenous administration, control of blood pressure, heart rate of the patient and fetal heart rate is necessary.

When using fenoterol in pregnant women, the inhibitory effect of fenoterol on the contractile activity of the uterus should be taken into account.

Fenoterol should be used with caution simultaneously with corticosteroids.

It is not recommended to use Fenoterol simultaneously with calcium preparations, vitamin D preparations, mineralocorticoids.

Effect on the ability to drive vehicles and mechanisms

During the use of fenoterol, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Beta-adrenergic, anticholinergic agents, xanthine derivatives, corticosteroids and diuretics may enhance the action and side effects of fenoterol (especially with hypokalemia).

A significant decrease in the effectiveness of fenoterol is possible with the simultaneous use of beta-blockers.

With simultaneous use with MAO inhibitors and tricyclic antidepressants, an enhancement of the effect of fenoterol is noted.

Inhalation of halogenated hydrocarbon anesthetics (halothane, trichlorethylene, enflurane) may enhance the effect of fenoterol on the cardiovascular system.

Simultaneous administration of bronchodilators with a similar mechanism of action leads to an additive effect and overdose phenomena.

Fluorothane sensitizes the myocardium to the action of fenoterol, contributing to the development of arrhythmia.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.