Instruction for use: Berodual N

Active substance Ipratropium bromide + Fenoterol

ATX Code R03AL01 Ipratropium bromide + Fenoterol

Pharmacotherapeutic group:

Beta-adrenergic agonist in combination

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

Structure and Composition

A solution for inhalation of 1 ml

ipratropium bromide, 0.261 mg

(Corresponding to 0.25 mg of ipratropium bromide anhydrous)

fenoterol hydrobromide 0.5 mg

in flakonah- 20 ml (1 ml = 20 drops); in box 1 bottle.

Aerosol inhalation dosage 1 dose

ipratropium bromide, 0.021 mg

(Corresponding to 0.02 mg of ipratropium bromide anhydrous)

fenoterol hydrobromide 0.05 mg

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

Excipients: anhydrous citric acid; distilled water; ethanol

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

pharmachologic effect

bronchodilatory.

Flomax contains two components having bronchodilator activity: ipratropium bromide - m-holinoblokator and fenoterol hydrobromide - beta2-agonists. These active ingredients complement each other, resulting in enhanced antispasmodic effect on bronchial muscles.

Bronchodilation when inhaled ipratropium bromide is mainly due to local rather than systemic anticholinergic effects.

In patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema), significant improvement in lung function (increase in forced expiratory volume in 1 second (FEV1) and the average space velocity forced expiratory 15% or more), there is 15 minutes , the maximum effect is achieved after 1-2 hours and lasts for most patients to 6 hours.

Ipratropium bromide does not adversely affect the secretion of mucus in the airways, mucociliary clearance and gas exchange.

Fenoterol hydrobromide selectively stimulating beta2-adrenergic receptors.

Fenoterol relaxes bronchial smooth muscle and blood vessels and prevents the development of bronchospastic reactions, caused by histamine, methacholine, cold air and allergen (immediate hypersensitivity reaction). Fenoterol blocking the release of mediators of inflammation and bronchial obstruction from mast cells, and enhances 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.

When the joint application of the two active substances in the form of metered aerosol achieved bronchodilation effect by acting on different pharmacological targets. The complementary action is such that in order to achieve the desired effect required a lower dose of beta-adrenergic component, which allows individual selection of an effective dose of the substantial absence of side effects.

Indications

Prophylaxis and symptomatic treatment of chronic obstructive respiratory disease with reversible bronchospasm: bronchial asthma, chronic obstructive bronchitis, emphysema complicated or uncomplicated.

Contraindications

Hypersensitivity, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, pregnancy (I term).

Pregnancy and breast-feeding

It contraindicated in I trimester of pregnancy. To use caution during breastfeeding.

It is necessary to consider the possibility of inhibiting H Berodual effect on uterine activity.

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.

There are adverse effects on communication by the eye (see. "Precautions").

Interaction

Beta-adrenergic and anticholinergics, xanthine derivatives (theophylline) may enhance the effect of bronchodilator. Co-administration of other beta-agonists entering the systemic circulation anticholinergics or xanthine derivatives (eg, theophylline) may lead to increased side effects.

Perhaps the significant weakening of bronchodilator action with concomitant administration of beta-blockers.

Concomitant use with MAO inhibitors and tricyclic antidepressants increases the effects Berodual N.

Inhalation of halogenated hydrocarbon anesthetics (halothane, trichlorethylene, enflurane) may increase the effects of Berodual H on the cardiovascular system.

Against the background of Berodual H may develop hypokalemia, which can be enhanced while the appointment of xanthine derivatives, steroids and diuretics. This fact should be given special attention in the treatment of patients with severe obstructive airways disease.

Hypokalemia may increase the risk of arrhythmias in patients receiving digoxin. Additionally, hypoxia may exacerbate the negative effect of hypokalemia on cardiac rhythm. In such cases it is advisable to carry out monitoring of the level of potassium in the blood serum.

Dosing and Administration

Inhalation.

A solution for inhalation. Adults and children over 12 years of cupping - on 20-80 drops (1-4 ml). When long-term therapy - 1-2 ml (20-40 drops) to 4 times per day. In cases of moderate bronchospasm or need auxiliary ventilation - 0.5 ml (10 drops). Children 6-12 years of cupping - 0.5-1 mL (10-20 drops) once, when severe attacks - 2-3 ml (40-60 drops), with long-term treatment - 0.5-1 ml ( 10-20 drops) four times daily, at a moderately expressed bronchospasm - 0.5 ml (10 drops). For children under 6 years of age (body weight less than 22 kg) (only under medical supervision) for 25 mg of ipratropium bromide and fenoterol hydrobromide 50 mg per 1 kg of body weight, and 0.5 ml (10 drops) up to 3 times a day.

The recommended dose is diluted immediately before use with saline to a volume of 4.3 ml nebulized and inhaled for 6-7 minutes until the solution is completely consumed. Flomax solution for inhalation should not be diluted with distilled water. The solution must be diluted before use, remaining after inhalation diluted solution should be discarded.

The dosage depends on the mode and Performance inhalation nebulizer. The duration of inhalation can be controlled by the amount of the diluted solution.

Berodual solution for inhalation may be applied using various commercially available inhalation systems. In the presence of a stationary central oxygen supply, the best solution is administered at a rate of 6-8 l / min. If necessary, repeat the inhalation carried out with an interval of at least 4 hours.

Aerosol. Adults and children over 6 years to designate 2 inhalation doses. After 5 min facilitate respiration does not occur, it is possible to assign another 2 inhalation dose. With the ineffectiveness of 4 inhalations should immediately seek medical help.

During prolonged therapy and intermittent - 3 doses 1-2 times per day (up to 8 inhalations 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 spray 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 H and Flomax is used for accurate dosing of the drug. The adapter should not be used with other dosage aerosols. You can not use aerosol metered tetraftoretanosoderzhaschy Flomax 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 (required regular monitoring of the level of potassium in the blood), prostatic hypertrophy, urinary tract obstruction in patients predisposed to narrow-angle glaucoma.

In the case of sudden appearance and rapid progression of dyspnea (difficulty breathing) should seek medical advice immediately.

Long-term use:

- In patients with bronchial asthma or mild and moderate chronic obstructive pulmonary disease symptomatic treatment may be preferable to regular use;

- In patients with bronchial asthma or steroidzavisimymi forms of chronic obstructive pulmonary disease should be aware of the need for strengthening or anti-inflammatory therapy to control airway inflammation and the disease process.

There have been reports of individual cases of complications in the eye (mydriasis, increased intraocular pressure, angle-closure glaucoma, pain in the eyeball) encountered in Eye spray ipratropium bromide or its combination with beta2-agonists.

Patients should be instructed in detail in the rules regarding the use of metered-dose aerosol inhaler Flomax N.

Pain in the eye, blurred vision, feeling ghosting or color spots before the eyes, combined with redness of the eyes in the form of corneal or conjunctival injection may be signs of an acute attack of angle-closure glaucoma. When you see these symptoms in any combination should begin treatment with eye drops, causing constriction of the pupil and immediately seek specialized medical care.

In patients with a history of cystic fibrosis, possible violations of GI motility.

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. In connection with the depressing effect on the use of generic activities stopped shortly before birth. Avoid contact with eyes.

special instructions

The first application of a new form of metered aerosol Flomax 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.

Storage preparation

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

Keep out of the reach of children.

Shelf-life of Berodual

solution for inhalation 0.25 mg + 0.5 mg / ml 0.25 mg 0.5 + - 5 years.

aerosol for inhalation dose of 20 mg + 0.5 mg / 20 mg dose 0.5 - 3 years.

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