Instruction for use: Berotec N

Active substance: Fenoterol

ATX Code R03AC04 Fenoterol

Pharmacotherapeutic group:

Beta-adrenergic agonist

The nosological classification (ICD-10)

J44 Other chronic obstructive pulmonary disease

Allergic bronchitis, Bronchitis asthma, Asthmatic bronchitis, wheeze bronchitis, Bronchitis is an obstructive, bronchi disease, Shortness of sputum in acute and chronic respiratory diseases, Cough in inflammatory diseases of the lung and bronchus, Reversible airflow obstruction, Reversible obstructive airway disease, Obstructive bronchitis disease, Obstructive lung disease, Obstructive bronchitis, Spastic bronchitis, Chronic lung disease, Chronic nonspecific lung diseases, Chronic obstructive pulmonary disease, Chronic obstructive bronchitis, Chronic obstructive airway disease, Chronic obstructive pulmonary disease, Restrictive lung pathology

J45 Asthma

Asthma physical effort, status asthmaticus, Bronchial asthma, Asthma lung flow, Bronchial asthma with obstruction of sputum discharge, Bronchial asthma heavy currents, Bronchial asthma physical effort, hypersecretory asthma, Hormone-dependent form of bronchial asthma, Relief of asthma attacks in bronchial asthma, Non-allergic asthma, nocturnal asthma, Exacerbation of asthma, Asthma attacks, Endogenous forms of asthma, Night asthma, Cough with bronchial asthma

J46 Status asthmaticus

Asthmatic attack, status asthmaticus, Bronchospasm in bronchial asthma

J98.8.0 * Bronchospasm

Bronchospasm in bronchial asthma, Bronchospasm when exposed to an allergen, bronchospastic reactions, bronchospastic status, bronhospastichesky syndrome, Diseases accompanied by bronchospastic syndrome, reversible bronchospasm, spasmodic cough

Composition

A solution for inhalation of 0.1% 1 ml

1 mg of fenoterol hydrobromide

Excipients: benzalkonium chloride; edetate disodium dihydrate; sodium chloride; 1N. hydrochloric acid; distilled water

in flakonah- dark glass 20 ml (1 ml = 20 drops); In the paper cartons 1 Dropper bottle.

Aerosol inhalation dosage 1 dose

fenoterol hydrobromide 100 g

propellant: 1,1,1,2 - tetrafluoroethane (HFA 134a)

Excipients: citric acid anhydride; distilled water; ethanol

in aerosol cans with a mouthpiece 10 ml (200 doses); in box 1 bottle.

The drug forms

The solution for inhalations: clear, colorless or almost colorless liquid, free from particles. The smell is almost imperceptible.

Pharmacological Properties
Pharmachologic effect

bronchodilatory.

By selectively stimulating beta2-adrenergic receptors. It relaxes the smooth muscles of the bronchi and blood vessels and prevents the development of bronchospastic reactions, caused by histamine, methacholine, cold air and allergen (immediate hypersensitivity reaction). Immediately after the appointment of fenoterol blocking the release of mediators of inflammation and bronchial obstruction from mast cells. Furthermore, when using fenoterol higher doses noted increased mucociliary clearance.

Beta-adrenergic effect of the drug on cardiac activity (increase in power and heart rate) due to the action of vascular fenoterol, stimulation of beta2-adrenergic receptors of the heart, and at doses exceeding therapeutic, - stimulation of beta1-adrenergic receptors. Tremor is the most common adverse effect of using beta-agonists.

The drug reduces contractile activity and tone of the myometrium.

pharmacodynamics

Fenoterol alerts and quickly relieves bronchospasm different genesis. The onset of action after inhalation - 5 min, max - 30-90 minutes duration - 3.6 hours.

Pharmacokinetics

Depending on the method of inhalation and the system used by the inhalation of about 10-30% of active ingredient released from the aerosol preparation after inhalation, reaches the lower respiratory tract, and the remainder is deposited in the upper airways and is swallowed. As a result, a certain amount of inhaled fenoterol gets into the digestive tract. After inhalation of one dose level of absorption is 17% of the administered dose. Suction is biphasic - 30% of fenoterol hydrobromide is rapidly absorbed from the T1 / February 11 min and 70% slowly absorbed from T1 / 2 120 min.

After oral administration absorbed about 60% of fenoterol hydrobromide. Time to Cmax plasma - 2 hours Linking blood plasma -. 40-55%. It is metabolized in the liver. Excreted by the kidneys and the bile as inactive sulfate conjugates.

In parenteral administration, fenoterol hydrobromide respectively output three-phase model with T1 / 2 - 0.42 min, 14.3 min and 3.2 h fenoterol hydrobromide biotransformation occurs only in humans by conjugation with sulphates predominantly in the intestinal wall..

Fenoterol hydrobromide can pass unaltered through the placental barrier and passes into breast milk.

Indications

Prevention and relief of bronchospasm in bronchial asthma, chronic obstructive bronchitis, emphysema. Prevention of asthma of physical effort. Symptomatic treatment of bronchial asthma and chronic obstructive pulmonary disease.

Contraindications

Hypersensitivity, hypertrophic obstructive cardiomyopathy, tachyarrhythmia,

heart disease, aortic stenosis, decompensated diabetes, hyperthyroidism, glaucoma, threatened abortion, pregnancy (I term).

Pregnancy and breast-feeding

It contraindicated in I trimester of pregnancy, use of the drug is possible in II-III trimester of pregnancy and breast-feeding only if the effect of therapy outweighs the potential risk to the fetus or child.

Side effects

CNS: fine tremor, nervousness; rarely - headache, dizziness, disturbance of accommodation; in rare cases - a change of mentality.

Cardio-vascular system: tachycardia, palpitations (especially in patients with aggravating factors); rarely (if used in high doses) - DBP reduction, increase Sad arrhythmia.

From the respiratory system: rarely - cough, local irritation; very rarely - paradoxical bronchospasm.

From the digestive tract: nausea, vomiting.

Allergic reactions: seldom - rash, angioedema swelling of the tongue, lips and face, urticaria.

Other: hypokalemia, increased sweating, fatigue, myalgia, cramps, urinary retention.

Dosing and Administration

Inhalation.

A solution for inhalation. Adults and children over 12 years, for the relief of asthma attacks - 0.5 mL (0.5 mg - 10 drops), in severe cases - 1-1.25 ml (1-1.25 mg - 20-25 drops) in extremely severe cases (under medical supervision) - 2 ml (2 mg - 40 drops).

Prevention of asthma and exercise-symptomatic treatment of asthma and chronic obstructive pulmonary disease - 0.5 ml (0.5 mg - 10 drops) to 4 times per day.

Children 6-12 years old (weight 22-36 kg) for the relief of an attack of bronchial asthma - 0.25-0.5 ml (0.25-0.5 mg - 5-10 drops), in severe cases - 1 ml ( 1 mg - 20 drops) in extremely severe cases (under medical supervision) - 1.5 ml (1.5 mg - 30 drops).

Prevention of asthma and exercise-symptomatic treatment of asthma and other conditions with reversible airway narrowing - 0.5 ml (0.5 mg - 10 drops) to 4 times per day. For children under 6 years of age (body weight less than 22 kg) (only under medical supervision) - about 50 mg / kg on reception (0.25-1 mg - 5-20 drops) up to 3 times a day.

The recommended dose is diluted immediately before use with saline to a volume of 3.4 ml. The dosage depends on the method and quality inhalation spray. If necessary, repeat the inhalation carried out with an interval of at least 4 hours.

Aerosol. An acute attack of asthma - one dose, optionally after 5 min inhalation can be repeated. The following use of the drug may not be earlier than 3 hours. If there is no effect, and require additional inhalation should immediately seek medical help to a nearby hospital.

Prevention of asthma and exercise-symptomatic treatment of asthma and other conditions involving reversible airway narrowing - 1-2 1 dose per intake, but not more than 8 doses per day.

For maximum effect, you must use the correct metered aerosol.

Before using the metered aerosol for the first time shake the bottle, and double-click the bottom of the container.

Every time you use a metered aerosol is necessary to observe the following rules:

1. Remove the protective cap.

2. Make a slow, deep breath.

3. Hold the bottle, grasp the tip of the lips. The container should be sent upside down.

4. Making the most deep breath at the same time quickly press the bottom of the bottle to release one inhalation dose. For a few seconds, hold your breath, then take a tip from the mouth and breathe out slowly. Repeat the steps for the second inhalation dose.

5. Place the protective cap.

6. If the aerosol can is not used for more than 3 days prior to use should be pressed once to the bottom of the container before the aerosol cloud.

The container is designed for 200 inhalations. Thereafter, the cylinder must be replaced. Despite the fact that the cylinder can be some amount of content, the amount of drug released during inhalation can be reduced.

The cylinder is opaque, so the amount of drug in the container can be determined only by the following method: removing the cap, the cylinder is immersed into a container filled with water. The amount of drug is determined depending on the position of the cylinder in water.

The tip should be kept clean, if necessary, it can be washed in warm water. After using the soap or detergent, rinse thoroughly with clean water tip.

Warning: The plastic adapter is specifically designed for oral metered aerosol Berotek H and serves for exact dosing of the drug. The adapter should not be used with other dosage aerosols. You can not use aerosol metered tetraftoretanosoderzhaschy Berotek H with any other adapters except for the adapter supplied with the balloon.

The cylinder is under pressure. The cylinder must not be opened and exposed to heat above 50 ° C.

Overdose

Symptoms: tachycardia, palpitation, arterial hyper- or hypotension, increased pulse pressure, anginal pain, arrhythmias, flushing, tremor.

Treatment: the appointment of sedatives, tranquilizers, in severe cases - intensive therapy. As antidotes are recommended cardioselective beta-blockers. However, keep in mind the possible strengthening of bronchial obstruction under the influence of beta-blockers and carefully select a dose for patients with asthma or chronic obstructive pulmonary disease.

Precautionary measures

Be wary appoint diabetes, recent myocardial infarction, severe diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma.

When using beta2-agonists may develop severe hypokalemia.

In acute, rapidly evolving dyspnoea (difficulty breathing) should consult a doctor immediately.

It should be borne in mind that the use of cupping large doses for a long time may cause uncontrolled deterioration of the course of the disease and determine the need for correction of the basic anti-inflammatory therapy with inhaled corticosteroids.

Particular caution should be exercised in severe asthma, as This effect can be enhanced by concomitant use of xanthine derivatives, glucocorticoids, and diuretics. Additionally, hypoxia may increase the effects of hypokalemia on cardiac rhythm. In such situations, we recommend regular monitoring of potassium serum levels.

special instructions

The first application of a new form of metered aerosol Berotek H patients may note that a new drug to taste a little different from the previous dosage form containing freon. In the transition from one form to another, patients should be warned about a possible change in taste sensation. It is also reported that these drugs interchangeably, and that taste properties are not related to the safety and efficacy of a new drug.

Other sympathomimetic bronchodilators should be administered simultaneously with berotek H only under medical supervision.

Storage

The temperature is not above 30 ° C (do not freeze).

Keep out of the reach of children.

Shelf-life

solution for inhalation of 1 mg / ml - 5 years.

aerosol for inhalation dose of 100 mcg / dose - 3 years.

Do not use beyond the expiration date printed on the package.