Bromhexine 4 syrup instructions for use. A cough remedy with a mucolytic effect - Bromhexine Berlin Chemie syrup: instructions for use for children of different ages

oral solution

Owner/Registrar

PHARMSTANDART-LEKSREDSTVA JSC

International Classification of Diseases (ICD-10)

Pharmacological group

Mucolytic and expectorant drug

pharmachologic effect

Mucolytic agent with expectorant action. Reduces the viscosity of bronchial secretions by depolarizing the acidic polysaccharides contained in it and stimulating the secretory cells of the bronchial mucosa, which produce a secret containing neutral polysaccharides. It is believed that bromhexine promotes the formation of surfactant.

Pharmacokinetics

Bromhexine is rapidly absorbed from the gastrointestinal tract and is extensively metabolized during the "first pass" through the liver. Bioavailability is about 20%. In healthy patients, Cmax in plasma is determined after 1 hour.

Widely distributed in body tissues. About 85-90% is excreted in the urine mainly in the form of metabolites. The metabolite of bromhexine is ambroxol.

The binding of bromhexine to plasma proteins is high. T 1/2 in the terminal phase is about 12 hours.

Bromhexine crosses the BBB. In small quantities it penetrates the placental barrier.

Only small amounts are excreted in the urine with a T 1/2 of 6.5 hours.

The clearance of bromhexine or its metabolites may be reduced in patients with severely impaired liver and kidney function.

Diseases of the respiratory tract, accompanied by the formation of a difficult-to-separate viscous secret: tracheobronchitis, chronic bronchitis with a broncho-obstructive component, bronchial asthma, cystic fibrosis, chronic pneumonia.

Hypersensitivity to bromhexine.

From the digestive system: dyspeptic phenomena, transient increase in the activity of hepatic transaminases in the blood serum.

From the side of the central nervous system: headache, dizziness.

Dermatological reactions: increased sweating, skin rash.

From the respiratory system: cough, bronchospasm.

special instructions

In case of gastric ulcer, as well as indications of gastric bleeding in history, Bromhexine should be used under medical supervision.

Use with caution in patients suffering from bronchial asthma.

Bromhexine is not used simultaneously with drugs containing codeine, because. this makes it difficult to cough up loose sputum.

It is used as part of combined preparations of plant origin with essential oils (including eucalyptus oil, anise oil, peppermint oil, menthol).

Use during pregnancy and lactation

During pregnancy and lactation, Bromhexine is used in cases where the intended benefit to the mother outweighs the potential risk to the fetus or child.

drug interaction

Bromhexine is incompatible with alkaline solutions.

Inside adults and children over 10 years old - 8 mg 3-4 times / day. Children under the age of 2 years - 2 mg 3 times / day; at the age of 2 to 6 years - 4 mg 3 times / day; at the age of 6 to 10 years - 6-8 mg 3 times / day. If necessary, the dose can be increased for adults up to 16 mg 4 times / day, for children - up to 16 mg 2 times / day.

In the form of inhalations for adults - 8 mg each, children over 10 years old - 4 mg each, at the age of 6-10 years - 2 mg each. At the age of 6 years - used in doses up to 2 mg. Inhalations are carried out 2 times / day.

The therapeutic effect may appear on the 4-6th day of treatment.

Tradename

Bromhexine 4 Berlin-Chemie

International non-proprietary name

Bromhexine

Dosage form

Oral solution 4mg/5ml

Compound

100ml solution contains

active substance - bromhexine hydrochloride 0.080 g

Excipients:

propylene glycol, sorbitol, concentrated apricot flavor, 0.1M hydrochloric acid, purified water.

Description

Clear, colorless, slightly viscous solution with an apricot odor.

Pharmacotherapeutic group

Expectorants. Mucolytics. Bromhexine.

ATX code R05CB02

Pharmacological properties

Pharmacokinetics

After oral administration, Bromhexine is absorbed almost completely; its half-life is approximately 0.4 hours. Tmax when taken orally is 1 hour. The effect of the first passage through the liver is about 80%. Biologically active substances are formed in the process of excretion. Plasma protein binding - 99%.

The decrease in plasma concentration is multiphasic. The half-life after which the action stops is about 1 hour. In addition, the terminal half-life is approximately 16 hours. This is due to the redistribution of small amounts of bromhexine in tissues. The volume of distribution is approximately 7 liters per kg of body weight. Bromhexine does not accumulate in the body.

Bromhexine crosses the placental barrier, and also penetrates into the cerebrospinal fluid and breast milk.

Excretion is predominantly through the kidneys, since metabolites are formed in the liver. Due to the high degree of protein binding of bromhexine and its significant volume of distribution, as well as due to its slow redistribution from tissues into the blood, excretion of any significant part of the drug by dialysis or forced diuresis is unlikely.

In severe liver disease, a decrease in the clearance of the parent substance can be expected. In severe renal failure, it is possible to prolong the half-life of bromhexine. Under physiological conditions, nitrosation of bromhexine is possible in the stomach.

Pharmacodynamics

Bromhexine is a synthetic derivative of the plant active ingredient vasicin. It has a secretolytic effect and promotes the evacuation of secretions from the bronchi. Animal experiments have shown that this drug increases the proportion of the serous component in bronchial secretions. This facilitates the transport of sputum by reducing its viscosity and enhancing the work of the ciliary epithelium.

Against the background of the use of bromhexine, there is an increase in the concentration of antibiotics amoxicillin, erythromycin and oxytetracycline in sputum and bronchial secretions. The clinical significance of this effect has not been determined.

Indications for use

As a secretolytic agent in acute and chronic diseases of the bronchi and lungs, accompanied by a violation of the formation and excretion of mucus.

Dosage and administration

Solution for oral administration

Adults and adolescents over 14 years of age - 2-4 scoops of the drug BROMHEXIN 4 BERLIN-CHEMIE three times a day (equivalent to 24-48 mg of bromhexine hydrochloride per day).

Children and adolescents from 6 to 14 years old, as well as patients weighing less than 50 kg - 2 scoops of the drug BROMHEXIN 4 BERLIN-CHEMIE three times a day (equivalent to 24 mg of bromhexine hydrochloride per day).

The use of BROMHEXIN 4 BERLIN-CHEMIE is permitted only in children over 2 years of age and under medical supervision.

Instructions for use in special groups of patients:

The use of the drug BROMHEXINE 4 BERLIN-CHEMIE in case of impaired liver function or in case of serious renal diseases requires special care (Bromhexine should be used at a lower dose or at longer intervals).

The duration of treatment is determined individually in accordance with the indications and the course of the disease. It is allowed to take BROMHEXIN 4 BERLIN-CHEMIE without a doctor's recommendation for no more than 4-5 days.

Side effects

According to the frequency of occurrence, side effects are classified as follows:

Sometimes:

Fever

Hypersensitivity reactions (skin rash, angioedema, difficulty breathing, itching, urticaria)

- nausea, abdominal pain, vomiting, diarrhea

Rarely

- anaphylactic reactions, up to the development of shock

Severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome (see section "Special Instructions").

At the first manifestations of a hypersensitivity reaction, anaphylactic reactions or any unusual changes on the skin and mucous membranes, immediately stop taking BROMHEXIN 4 BERLIN-CHEMIE and consult a doctor.

Reports of possible adverse reactions

Reporting possible side effects after the registration of the medicinal product plays an important role. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals should report any possible adverse reactions.

Contraindications

Hypersensitivity to the active substance or to other excipients

lactation period

Drug Interactions

When using BROMHEXINE 4 BERLIN-CHEMIE in combination with antitussive drugs, a dangerous accumulation of secretion is possible due to the suppression of the cough reflex - therefore, when prescribing this combination of drugs, a particularly thorough examination is necessary.

With the simultaneous use of drugs that cause symptoms of irritation of the gastrointestinal tract, it is possible to increase the irritating effect on the mucous membranes of the gastrointestinal tract.

special instructions

Skin reactions: as a result of the use of bromhexine, in extremely rare cases, severe skin reactions have occurred, for example, Stevens-Johnson syndrome and Lyell's syndrome. If you notice any unusual changes on the skin and mucous membranes, stop taking BROMHEXINE 4 BERLIN-CHEMIE immediately and consult a doctor.

Gastric and duodenal ulcer: You should not use BROMHEXINE 4 BERLIN-CHEMIE if you suffer (or have suffered in the past) from a stomach or duodenal ulcer, as Bromhexine may affect the barrier function of the mucous membrane of the gastrointestinal tract.

Lungs and airways: due to the possible accumulation of secretions, caution should be exercised when using BROMHEXINE 4 BERLIN-CHEMIE in patients with impaired bronchial motility and increased secretion of mucus (for example, in such a rare disease as primary ciliary dyskinesia [ciliary dyskinesia]).

Liver and kidney disorders: in case of impaired liver function or serious renal diseases, special care must be taken (use bromhexine at a lower dose or at longer intervals).

In severe renal failure, the accumulation of metabolites of bromhexine, which are formed in the liver, is likely.

Children: The use of BROMHEXINE 4 BERLIN-CHEMIE is permitted only in children from 2 years of age and under medical supervision.

propylene glycol, sorbitol: Due to the propylene glycol contained in the preparation, BROMHEXIN 4 BERLIN-CHEMIE can cause the same symptoms in children as after drinking alcohol.

In this regard, the drug is contraindicated in a rare hereditary disease - congenital fructose intolerance.

Calorie content 2.6 kcal/g sorbitol.

One scoop contains 2 g of sorbitol (a source of 0.5 g of fructose), which is equivalent to approximately 0.17 bread units.

Perhaps a slight laxative effect of the drug due to the sorbitol contained in it.

Pregnancy and lactation

Pregnancy

To date, there is no experience with the use of bromhexine during pregnancy; therefore, the use of BROMHEXINE 4 BERLIN-CHEMIE by pregnant women is allowed only after a thorough assessment of the risks and benefits by a doctor; use in the first trimester of pregnancy is not recommended.

Lactation

Since the active substance is excreted in breast milk, the use of BROMHEXIN 4 BERLIN-CHEMIE during lactation is not allowed.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Unknown

Overdose

Symptoms: cases of overdose in humans, representing a danger, are still unknown.

A study of overdose cases has been published, according to which vomiting was observed in 4 out of 25 cases of overdose with bromhexine, and in three children phenomena such as vomiting were noted, as well as loss and confusion, ataxia, double vision, mild metabolic acidosis and rapid breathing. In children taking up to 40 mg of bromhexine, there were no symptoms even without measures to remove this substance from the body. There are no data on the chronic toxic effect of the drug in humans.

Therapeutic measures: after a significant overdose, circulatory control and, if necessary, symptomatic therapeutic measures are indicated. Due to the low toxicity of bromhexine, more invasive measures to reduce absorption or accelerate elimination are usually not needed. In addition, due to pharmacokinetic features (large volume of distribution, slow redistribution processes and significant protein binding), dialysis and forced diuresis do not significantly affect the excretion of the substance from the body.

Since children over 2 years of age usually have only mild symptoms, even after taking a large dose, there is no need to use antidotes when taking up to 80 mg of bromhexine hydrochloride (i.e. 100 ml of BROMHEXIN 4 BERLIN-CHEMIE) is not needed; for young children, this limit is 60 mg bromhexine hydrochloride (6 mg/kg body weight).

Note: when taking higher doses, the effect of excipients should also be taken into account (see sections "composition" and "Special instructions" - propylene glycol and sorbitol).

Release form and packaging

60 ml in brown glass bottles with a plastic or aluminum screw cap.

1 bottle, together with a measuring spoon and instructions for medical use in the state and Russian languages, is put into a pack of cardboard.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

Not more than 3 months after the first opening of the vial.

Do not use after the expiry date stated on the package.

Terms of dispensing from pharmacies

Over the counter

Manufacturer

Berlin Chemi AG (Menarini Group),

Glieniker Veg 125

12489 Berlin, Germany

Registration certificate holder

Berlin Chemi AG (Menarini Group), Germany

The address of the organization that accepts in the territory of the Republic of Kazakhstan, claims from consumers on the quality of products (goods) and is responsible for post-registration monitoring of the safety of the medicinal product:

Representative office of JSC "Berlin-Chemie AG" in the Republic of Kazakhstan

Tel.: +7 727 2446183, 2446184, 2446185

Fax:+7 727 2446180

E-mail address: [email protected]

Attached files

dragee, oral drops, injection solution, oral solution, syrup, syrup [for children], tablets, tablets [for children]

Pharmachologic effect:

Mucolytic (secretolytic) agent, has an expectorant and weak antitussive effect. Reduces the viscosity of sputum (depolymerizes mucoprotein and mucopolysaccharide fibers, increases the serous component of bronchial secretion); activates ciliated epithelium, increases volume and improves sputum discharge. Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells during respiration. The effect appears after 2-5 days from the start of treatment.

Indications:

Diseases of the respiratory tract, accompanied by difficulty in the discharge of viscous sputum: tracheobronchitis, bronchitis of various etiologies (including those complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, pneumonia (acute and chronic), cystic fibrosis. Sanitation of the bronchial tree in the preoperative period and during therapeutic and diagnostic intrabronchial manipulations, prevention of accumulation of thick viscous sputum in the bronchi after surgery.

Contraindications:

Hypersensitivity, peptic ulcer of the stomach, pregnancy (I trimester); lactation period; children's age (up to 6 years - for tablet forms). With caution. Renal and / or liver failure; bronchial diseases, accompanied by excessive accumulation of secretion, history of gastric bleeding.

Side effects:

Allergic reactions, nausea, vomiting, dyspepsia, exacerbation of gastric ulcer and duodenal ulcer, dizziness, headache, increased activity of "liver" transaminases (extremely rare). Overdose. Symptoms: nausea, vomiting, diarrhea, dyspeptic disorders. Treatment: artificial vomiting, gastric lavage (in the first 1-2 hours after ingestion).

Dosage and administration:

Bromhexine 4 mg for children is taken orally (syrup, tablets and dragees - for children over 6 years old, drops, oral solution), adults and children over 14 years old - 8-16 mg 3-4 times a day. Children under 2 years old - 2 mg 3 times a day, 2-6 years old - 4 mg 3 times a day, 6-14 years old - 8 mg 3 times a day. If necessary, the dose can be increased by adults up to 16 mg 4 times a day. In the form of inhalations (solution for inhalation) for adults - 8 mg each, children over 10 years old - 4 mg, 2-10 years old - 2 mg. Inhalations are carried out 2 times a day. The solution is diluted with distilled water 1:1 and heated to body temperature to prevent coughing. In case of bronchial obstruction, it is necessary to prescribe a bronchodilator drug before inhalation. Bromhexine 8 drops: inside, adults and adolescents over 14 years old - 23-47 drops 3 times a day; children 6-14 years old and patients weighing less than 50 kg - 23 caps 3 times a day, up to 6 years - 12 caps 3 times a day. The therapeutic effect may appear on the 4-6th day of treatment. Parenterally (in / m, s / c, in / in slowly, for 2-3 minutes) - 2-4 mg 2-3 times a day. The solution for intravenous administration should be diluted with Ringer's solution or sterile water for injection. Patients with renal insufficiency are prescribed smaller doses or increase the interval between injections.

Special instructions:

During treatment, it is necessary to take a sufficient amount of liquid, which increases the expectorant effect of bromhexine. In children, treatment should be combined with postural drainage or chest vibration massage, which facilitates the removal of secretions from the bronchi. It should be borne in mind that ethanol (41% vol.) is part of Bromhexine 8-drops.

Interaction:

Bromhexine 4 mg for children is not prescribed simultaneously with drugs that suppress the cough center (including codeine), as this makes it difficult to discharge thin sputum (accumulation of bronchial secretions in the airways). Incompatible with alkaline solutions. Bromhexine promotes the penetration of antibiotics (amoxicillin, erythromycin, cephalexin, oxytetracycline), sulfanilamide drugs into the bronchial secretion in the first 4-5 days of antimicrobial therapy.

Before using the drug Bromhexine 4 mg for children consult your doctor!

Composition and form of release of the drug

◊ Solution for oral administration transparent, colorless, slightly viscous, with a characteristic apricot odor.

Excipients: propylene glycol - 25 g, sorbitol - 40 g, aromatic concentrate with apricot smell - 0.05 g, hydrochloric acid 0.1M (3.5% solution) - 0.156 g, purified water - 49.062 g.

60 ml - dark glass bottles (1) complete with a measuring spoon - packs of cardboard.
100 ml - dark glass bottles (1) complete with a measuring spoon - packs of cardboard.

pharmachologic effect

Mucolytic agent with expectorant action. Reduces the viscosity of bronchial secretions by depolarizing the acidic polysaccharides contained in it and stimulating the secretory cells of the bronchial mucosa, which produce a secret containing neutral polysaccharides. It is believed that bromhexine promotes the formation of surfactant.

Pharmacokinetics

Bromhexine is rapidly absorbed from the gastrointestinal tract and is extensively metabolized during the "first pass" through the liver. Bioavailability is about 20%. In healthy patients, Cmax is determined after 1 hour.

Widely distributed in body tissues. About 85-90% is excreted in the urine mainly in the form of metabolites. Bromhexine is a metabolite.

The binding of bromhexine to plasma proteins is high. T 1/2 in the terminal phase is about 12 hours.

Bromhexine crosses the BBB. In small quantities it penetrates the placental barrier.

Only small amounts are excreted in the urine with a T 1/2 of 6.5 hours.

The clearance of bromhexine or its metabolites may be reduced in patients with severely impaired liver and kidney function.

Indications

Diseases of the respiratory tract, accompanied by the formation of a difficult-to-separate viscous secret: tracheobronchitis, chronic bronchitis with a broncho-obstructive component, cystic fibrosis, chronic pneumonia.

Contraindications

Hypersensitivity to bromhexine.

Dosage

Inside adults and children over 10 years old - 8 mg 3-4 times / day. Children under the age of 2 years - 2 mg 3 times / day; at the age of 2 to 6 years - 4 mg 3 times / day; at the age of 6 to 10 years - 6-8 mg 3 times / day. If necessary, the dose can be increased for adults up to 16 mg 4 times / day, for children - up to 16 mg 2 times / day.

In the form of inhalations for adults - 8 mg each, children over 10 years old - 4 mg each, at the age of 6-10 years - 2 mg each. At the age of 6 years - used in doses up to 2 mg. Inhalations are carried out 2 times / day.

The therapeutic effect may appear on the 4-6th day of treatment.

Side effects

From the digestive system: dyspeptic phenomena, transient increase in the activity of hepatic transaminases in the blood serum.

From the side of the central nervous system:, dizziness.

Dermatological reactions: increased sweating, skin rash.

From the respiratory system: cough, bronchospasm.

drug interaction

Bromhexine is incompatible with alkaline solutions.

special instructions

In case of gastric ulcer, as well as indications of a history of gastric ulcer, Bromhexine should be used under the supervision of a physician.

mucolytic agents.

Compound

The active substance is Bromhexine.

Manufacturers

Berlin-Chemie AG (Germany), Berlin-Chemie AG/Menarini Group (Germany)

pharmachologic effect

Mucolytic, expectorant, antitussive.

Causes depolarization of mucoprotein and mucopolysaccharide polymer molecules (mucolytic effect).

Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells during respiration, their protection from adverse factors, the improvement of the rheological properties of bronchopulmonary secretion, its sliding along the epithelium and sputum secretion from the respiratory tract.

When taken orally within 30 minutes, it is almost completely absorbed.

In plasma, it binds to proteins.

Penetrates through the BBB and placental barriers.

In the liver, it undergoes demethylation and oxidation.

Excreted by the kidneys.

With repeated use, it can accumulate.

Side effect

Gastrointestinal disorders (nausea, vomiting, dyspepsia, exacerbation of peptic ulcer), increased activity of aminotransferases, allergic skin reactions, angioedema.

Indications for use

Acute and chronic diseases of the bronchi and lungs with impaired sputum discharge.

Contraindications

Hypersensitivity, pregnancy (especially in the first trimester), breastfeeding (it is necessary to stop for the period of treatment).

Method of application and dosage

Inside, with liquid.

Adults and adolescents over 14 years old - 23-47 drops 3 times a day; children from 6 to 14 years old and patients whose body weight is below 50 kg - 23 drops 3 times a day, up to 6 years old - 12 drops 3 times a day.

Patients with severe renal insufficiency should reduce the single dose or increase the interval between doses.

Overdose

No data.

Interaction

Promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline) into the lung tissue.

special instructions

Be wary appoint with peptic ulcer of the stomach and duodenum.