Beriprax^® (Solution) Instructions for Use

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

ATC Code

R03AC04 (Fenoterol)

Active Substance

Fenoterol (Rec.INN registered by WHO)

Dosage Form

Beriprax®

Inhalation solution 1 mg/ml: 20 ml bottle

Dosage Form, Packaging, and Composition

Inhalation solution clear, colorless or with a yellowish tint.

Excipients: benzalkonium chloride – 0.1 mg, disodium edetate dihydrate – 0.5 mg, sodium chloride – 8.6 mg, hydrochloric acid solution 1M – 0.946 mg (to pH 3.2), purified water – up to 1 ml.

20 ml – bottles (1) – carton packs.

Clinical-Pharmacological Group

Bronchodilator drug – beta₂-adrenergic agonist

Pharmacotherapeutic Group

Drugs for the treatment of obstructive airway diseases; adrenergic agents for inhalation administration; selective beta2-adrenergic agonists

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, 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 in the study of external respiratory function.

ICD codes

Dosage Regimen

Administer Beriprax^® inhalation solution via a suitable nebulizer. Individualize the dosage based on the patient’s condition, age, and response.

For acute bronchospasm in adults and adolescents (12 years and older), use 1 mg (1 ml) as a single dose. Repeat if necessary. Do not exceed 4 mg (4 ml) per day.

For chronic maintenance therapy in adults and adolescents, administer 0.5 mg (0.5 ml) up to four times daily. The maximum daily dose is 4 mg (4 ml).

For children aged 6 to 12 years, use 0.5 mg (0.5 ml) for acute relief. The maximum single dose is 0.5 mg, and the maximum daily dose is 2 mg (2 ml).

Use with extreme caution in children under 6 years of age, only under direct medical supervision. Dosage must be determined by a physician.

For prevention of exercise-induced bronchospasm, inhale 0.5 mg (0.5 ml) approximately 15 minutes before physical exertion.

As a bronchodilator prior to inhalation of other drugs (e.g., corticosteroids, mucolytics), administer a single dose of 0.5 mg to 1 mg (0.5-1 ml).

For bronchodilator testing, follow the specific protocol for pulmonary function testing. A typical single dose is 1 mg (1 ml).

Monitor patients for tachycardia or other adverse effects. If a previously effective dose does not provide relief, seek immediate medical advice, as this may indicate worsening asthma.

Do not exceed the recommended dosage. Increased use of beta2-agonists for symptom control indicates deteriorating asthma and requires physician re-evaluation.

Adverse Reactions

Immune system disorders: frequency unknown – hypersensitivity reactions.

Metabolism and nutrition disorders uncommon – hypokalemia, including severe hypokalemia.

Psychiatric disorders: uncommon – agitation; frequency unknown – nervousness.

Nervous system disorders: common – tremor; frequency unknown – headache, dizziness.

Cardiac disorders: uncommon – arrhythmia; frequency unknown – increased systolic blood pressure, decreased diastolic blood pressure, myocardial ischemia, tachycardia, palpitations.

Respiratory, thoracic and mediastinal disorders common – cough; uncommon – paradoxical bronchospasm; frequency unknown – irritation of the larynx and pharynx.

Gastrointestinal disorders uncommon – nausea, vomiting.

Skin and subcutaneous tissue disorders: uncommon – itching; frequency unknown – hyperhidrosis, skin rash, urticaria.

Musculoskeletal and connective tissue disorders 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, inadequately controlled diabetes mellitus, recent myocardial infarction (within the last 3 months), severe organic heart and vascular diseases, such as chronic heart failure, coronary artery disease, coronary artery disease, 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 developing pulmonary edema should be borne in mind.

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.

Influence on the ability to drive vehicles and mechanisms

During the use of fenoterol, patients should be careful 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 in 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 increase in the effect of fenoterol is noted.

Inhalation of halogenated hydrocarbon anesthetics (halothane, trichloroethylene, 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 30°C (86°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.