Berodual N aeroz d/ingal doser 20mcg+50mcg/dose 200doses 10ml

Aerosol for inhalation dosed Berodual

The drug Berodual® contains two components with bronchodilator activity: ipratropium bromide, an m-anticholinergic blocker, and fenoterol, a β2-adrenergic agonist. Bronchodilation with inhaled ipratropium bromide is due primarily to local rather than systemic anticholinergic effects.

Ipratropium bromide is a quaternary ammonium derivative with anticholinergic (parasympatholytic) properties. The drug inhibits reflexes caused by the vagus nerve, counteracting the effects of acetylcholine, a neurotransmitter released from the endings of the vagus nerve. Anticholinergics prevent the increase in intracellular Ca2+ concentration, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. The release of Ca2+ is mediated by a system of secondary mediators, which include inositol triphosphate (ITP) and diacylglycerol (DAG).

In patients with bronchospasm associated with chronic obstructive pulmonary diseases (chronic bronchitis and emphysema), a significant improvement in lung function (increase in FEV1 and peak expiratory flow by 15% or more) was noted within 15 minutes, the maximum effect was achieved after 1–2 hours and lasted in most patients up to 6 hours after administration.

Ipratropium bromide does not have a negative effect on mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.

Fenoterol selectively stimulates β2-adrenergic receptors at a therapeutic dose. Stimulation of β2-adrenergic receptors activates adenylate cyclase through stimulation of the Gs protein. Stimulation of β1-adrenergic receptors occurs when high doses are used.

Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of mediators of inflammation and bronchial obstruction from mast cells. In addition, when using fenoterol in doses of 0.6 mg, an increase in mucociliary clearance was observed.

The β-adrenergic effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular effect of fenoterol, stimulation of β2-adrenergic receptors of the heart, and when using doses exceeding therapeutic doses, stimulation of β1-adrenergic receptors.

As with the use of other β-adrenergic drugs, prolongation of the QTc interval was observed when using high doses. When fenoterol was used via metered-dose aerosol inhalers (MDIs), the effect was inconsistent and occurred at doses higher than recommended.

However, following administration of fenoterol via nebulizers (inhalation solution in unit dose vials), systemic exposure may be higher than when using the drug via a MDI at recommended doses. The clinical significance of these observations has not been established. The most commonly observed effect of β-adrenergic agonists is tremor. In contrast to the effects on bronchial smooth muscle, tolerance may develop to the systemic effects of β-adrenergic agonists. The clinical significance of this manifestation is unclear. Tremor is the most common adverse effect with β-adrenergic agonists. When these two active substances are used together, the bronchodilator effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the antispasmodic effect on the bronchial muscles is enhanced and a greater breadth of therapeutic action is provided for bronchopulmonary diseases accompanied by constriction of the airways. The complementary effect is such that to achieve the desired effect, a lower dose of the β-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects of the drug Berodual®. In acute bronchoconstriction, the effect of the drug Berodual® develops quickly, which allows its use in acute attacks of bronchospasm.

Berodual, 1 piece, 20 ml, 0.25 mg+0.5 mg/ml, solution for inhalation

Inhalation.

Solution for inhalation.

For adults and children over 12 years of age, to relieve attacks - 20–80 drops (1–4 ml). For long-term therapy - 1-2 ml (20-40 drops) up to 4 times a day. In cases of moderate bronchospasm or the need for auxiliary ventilation - 0.5 ml (10 drops). For children 6-12 years old, to relieve attacks - 0.5-1 ml (10-20 drops) once, for severe attacks - 2-3 ml (40-60 drops), for long-term therapy - 0.5-1 ml ( 10–20 drops) 4 times a day, with moderate bronchospasm - 0.5 ml (10 drops). Children under 6 years of age (body weight less than 22 kg) (only under medical supervision) at the rate of 25 mcg of ipratropium bromide and 50 mcg of fenoterol hydrobromide per 1 kg of body weight, up to 0.5 ml (10 drops) up to 3 times a day.

The recommended dose, immediately before use, is diluted with saline to a volume of 3–4 ml and inhaled through a nebulizer for 6–7 minutes until the solution is completely consumed. Berodual solution for inhalation should not be diluted with distilled water. The solution should be diluted immediately before use; the diluted solution remaining after inhalation should be destroyed.

The dose depends on the inhalation mode and the technical characteristics of the nebulizer. The duration of inhalation can be controlled through the volume of diluted solution.

Berodual solution for inhalation can be used using various commercially available inhalation units. If there is a centralized stationary oxygen supply, the solution is best administered at a rate of 6–8 l/min. If necessary, repeated inhalations are carried out at intervals of at least 4 hours.

Aerosol.

Adults and children over 6 years of age are prescribed 2 inhalation doses. If breathing relief does not occur within 5 minutes, 2 more inhalation doses can be prescribed. If 4 inhalations are ineffective, you should immediately seek medical help.

For long-term and intermittent therapy - 1-2 doses 3 times a day (up to 8 inhalations per day).

To obtain maximum effect, it is necessary to use a dosed aerosol correctly.

Before using the metered-dose aerosol for the first time, shake the can and press the bottom of the can twice.

Each time you use a metered dose aerosol, the following rules must be observed:

1. Remove the protective cap.

2. Take a slow, deep breath.

3. Hold the balloon and wrap your lips around the tip. The cylinder should be pointing upside down.

4. While inhaling as deeply as possible, simultaneously quickly press the bottom of the balloon until one inhalation dose is released. Hold your breath for a few seconds, then remove the tip from your mouth and exhale slowly. Repeat steps to receive the second inhalation dose.

5. Put on the protective cap.

6. If the aerosol can has not been used for more than 3 days, before use, press the bottom of the can once until a cloud of aerosol appears.

The cylinder is designed for 200 inhalations. After this, the cylinder should be replaced. Although some contents may remain in the canister, the amount of drug released during inhalation may be reduced.

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

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

Warning:

The plastic mouth adapter is designed specifically for the Berodual N metered aerosol and serves for precise dosing of the drug. The adapter must not be used with other metered aerosols. You also cannot use metered tetrafluoroethane-containing aerosol Berodual N with any other adapters other than the adapter supplied with the cylinder.

The contents of the cylinder are under pressure. The cylinder must not be opened or exposed to temperatures above 50 °C.

Compound

"Berodual" for inhalation consists of many useful components:

• ipratropium bromide - 0.261 mg (dry residue - 0.25 mg);
• water;
• fenoterol hydrobromide - 0.5 mg;
• disodium salt EDTA (ethylenediaminetetraacetic acid);
• saline solution (sodium chloride);
• benzalkonium chloride;
• monomolar hydrochloric acid (1N).

There is another pharmaceutical form of this medicine, which includes additional components.

Metered aerosol has a slightly different composition:

• ipratropium bromide - 0.021 mg (dry residue - 0.02 mg);
• citric acid (powdered, anhydrous);
• fenoterol hydrobromide – 0.05 mg
• ethanol;
• HFA 134a - 1,1,1,2-tetrafluoroethane;
• water.

The transparent, colorless inhalation solution has no odor. It is filled into an inhaler and inhaled as needed.

Contraindications

It is important to remember about the many diseases for which Berodual is contraindicated:

• intolerance to substances included in the medicine;
• the beginning of pregnancy and the last days before childbirth;
• hypersensitivity to these components;
• tachyarrhythmia;
• obstructive hypertrophic cardiomyopathy.

Fenoterol contained in the solution can affect the heart muscle. Because of this, it contracts more often and with greater force. This can harm the health and well-being of patients suffering from heart disease.

Berodual should be used with great caution for the following ailments:

• heart failure and ischemic heart disease;
• diabetes;
• high blood pressure (hypertension and hypertension;
• glaucoma;
• hyperthyroidism;
• the first three months after myocardial infarction;
• cystic fibrosis;
• vascular pathologies;
• tumors dependent on the activity of hormones (especially pheochromocytoma);
• prostate adenoma;
• pathology of the bladder neck.

The treating doctor will prescribe another analogue drug that is equally effective, but safe for a particular patient.

Overdose symptoms

If a person inhales too much, they may show signs of overdose:

• increased process of bronchial obstruction;
• palpitations, tachycardia;
• decrease or increase in pressure;
• heaviness in the chest, angina pectoris;
• acidosis;
• feeling hot, sweating;
• facial redness;
• increasing the difference between “upper” and “lower” pressure.

The doctor carefully selects the exact dosage. If necessary, the patient may be prescribed tranquilizers.

In what forms is it available?

"Berodual" is produced in three release forms:

1. The solution is a liquid of uniform consistency, colorless, transparent. It is packaged in 2 ml bottles (40 drops). The bottles are packed in a box.
2. Aerosol - packaged in 10 ml containers for 200 injections. Cylinders are stored in packaging.
3. "Berodual N" is available both in the form of an aerosol and in the form of a solution. Has a stronger effect.

Depending on the form of release of Berodual, the instructions for its use may vary.

Indications for use

The instructions for Berodual for inhalation list the main diagnoses for which this drug is prescribed. It is necessary for many diseases and pathological conditions:

• emphysema;
• COPD (chronic obstructive pulmonary disease) with spasms in the bronchi;
• asthma of any origin;
• Chronical bronchitis;
• all respiratory obstructive diseases, in which the airways are partially blocked;
• for preparation before injection of antibiotics, corticosteroids and mucolytics;
• for prevention.

"Berodual" should be used only in accordance with doctor's prescriptions and in recommended doses.

Side effects

The substances contained in Berodual have an extremely active effect on biochemical processes in the body. This often leads to side effects:

• anxiety, nervousness, excitement;
• mydriasis;
• dry mouth;
• corneal edema;
• eye pain, redness, swelling;
• dizziness and headache;
• vomiting and nausea;
• cough;
• trembling of limbs;
• tachycardia;
• increased blood pressure;
• pharyngitis;
• atrial fibrillation;
• throat irritation and swelling;
• violation of visual accommodation;
• spasms in the bronchi and larynx;
• allergy;
• urinary retention;
• hives;
• Quincke's edema;
• skin itching;
• increased sweating;
• stomatitis;
• constipation, impaired intestinal motility, diarrhea.

Patients often feel that they cannot pronounce certain sounds correctly. They can see a slight halo around surrounding objects. Vision becomes blurred.

To reduce side effects, the doctor may prescribe additional medications to the patient.