Bromhexine - instructions, indications, composition, method of application. Bromhexine

For pathologies of the respiratory tract, a symptom of which is a cough, doctors often prescribe Bromhexine. Although it is more convenient for children to use such a drug in syrup or in the form of a solution, Bromhexine is also available in tablets. From what age is their use permissible, in what dosage is Bromhexine tablet given to children, and what other medicines can replace it?

Manufacturers and release form

The tablet form of Bromhexine is available:

• Latvian manufacturer Grindeks. Such Bromhexine is intended for children, therefore it is presented with a dosage of 4 mg in one tablet. One pack of this medicine contains 50 tablets.

• Russian manufacturers Dalchimpharm, Biosynthesis, Pharmstandard-leksredstva, Updating, Atoll, Yodillia-pharm, Medisorb, Uralbiopharm. All of these companies produce Bromhexine tablets, each containing 8 mg of the active compound. One pack may contain from 10 to 50 tablets.

• Domestic manufacturer Akrikhin. In the assortment of medicines of such a company there are both tablets with 8 mg of bromhexine and a drug for children (tablets containing 4 mg of the active ingredient). One pack of such Bromhexine can include from 10 to 100 tablets.

• Berlin Chemi company from Germany. This manufacturer offers Bromhexine in the form of yellow-greenish dragees containing 8 mg of the active compound.

Compound

The compound providing the therapeutic effect of Bromhexine tablets is Bromhexine hydrochloride. Additional components of the drug are lactose, starch, wax, sucrose, silicon dioxide and other compounds that should be specified in the annotation to the selected medication.

Operating principle

Bromhexine is classified as a drug with a mucolytic effect, since its main component dilutes mucoprotein and mucopolysaccharide fibers in sputum.

As a result of this action of bromhexine, the viscosity of sputum decreases, and its volume increases. This causes the expectorant effect of the drug, thanks to which the drug helps to get rid of the cough.

Bromhexine also has the ability to improve the formation of surfactant.

Indications

Instructions for use of Bromhexine tablets recommends giving such a medicine for respiratory diseases, if the secret of the patient's bronchi is too viscous and coughs up with great difficulty. The medicine is used for bronchitis, pneumonia, bronchiectasis, asthma, tuberculosis. Bromhexine is also prescribed for cystic fibrosis.

At what age is it allowed to take

Brogmexin tablets intended for children are not recommended for use before 3 years of age.

If it is required to give the drug to a child under 3 years old, the liquid form of Bromhexine (solution / syrup) is used in the treatment, which is allowed for use under the supervision of a pediatrician from birth. Tablets in which the content of the active ingredient is 8 mg are not prescribed to children under 6 years of age.

Contraindications

Tableted Bromhexine should not be used in children with hypersensitivity to any of the components of the drug. Also, such a medicine is contraindicated in ulcerative lesions of the gastrointestinal tract in the acute stage. The appointment of Bromhexine for children with kidney or liver diseases, as well as with bronchial asthma, also requires special care from the pediatrician.

Side effects

The children's body can "respond" to the use of Bromhexine:

• Dyspepsia.
• Vertigo.
• Skin rash.
• Increased activity of liver enzymes.
• Headache.
• Increased perspiration.
• Bronchospasm.

If such symptoms occur during the treatment period, the drug is recommended to be discontinued.

Instructions for use

Bromhexine tablets should be taken three times a day. You can drink the medicine before meals, and after it. The duration of treatment is determined for each child individually, but the deadlines are 4-28 days.

A single dose of the drug depends on the age of the small patient:

• Children 3-5 years old are given 1 children's tablet containing 4 mg of Bromhexine.
• At the age of over 6 years, a single dose of the drug will be either 2 children's tablets or 1 tablet with 8 mg of the active compound.

If necessary, the dosage can be increased by a doctor up to 16 mg per dose.

Instructions for Bromgensin from Berlin-Chemie:

Overdose

If you exceed the dose of Bromhexine, this will lead to nausea and other negative symptoms from the digestive tract. If an overdose is detected within one to two hours after taking an excess of tablets, it is recommended to provoke vomiting, after which give the child plenty of fluids.

Interaction with other drugs

Bromhexine is successfully combined with antibiotics, bronchodilators and many other medicines used in diseases of the respiratory system. It is not only recommended to combine this drug with antitussives, because the suppression of the cough reflex with simultaneous liquefaction of sputum can provoke secretion stagnation and worsening of the patient's condition.

Terms of sale

Storage conditions and shelf life

Keep Bromhexine tablets at home in a dry place where sunlight does not fall. It is important that the tablets cannot be reached by a small child. The storage temperature should not exceed +25 degrees. The expiration date varies from company to company and can range from 2 years or 3 years to 5 years or more.

LP-004535-131117

Trade name of the drug:

Bromhexine

International non-proprietary name:

bromhexine

Dosage form:

tablets for children

Compound:

for 1 tablet:
active substance: bromhexine hydrochloride - 4.00 mg.
Excipients: lactose monohydrate (milk sugar) - 80.23 mg; corn starch - 11.54 mg; povidone K-25 - 3.46 mg; magnesium stearate - 0.77 mg.

Description:

round flat-cylindrical tablets of white or almost white color with a chamfer and a risk mark.

Pharmacotherapeutic group:

mucolytic expectorant.

ATX code:

R05CB02

Pharmacological properties

Pharmacodynamics
Mucolytic (secregolytic) 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.

Pharmacokinetics
When administered orally, Bromhexine is almost completely (99%) absorbed into the gastrointestinal tract within 30 minutes. Bioavailability - low (the effect of the primary "passage" through the liver). Bromhexine in plasma binds to proteins, penetrates the blood-brain and placental barriers, as well as into breast milk. In the liver, bromhexine undergoes demethylation and oxidation, and is metabolized to the pharmacologically active ambroxol. Half-life (T½) -15 hours (due to slow reverse diffusion from tissues). Excreted by the kidneys. In chronic renal failure, the excretion of bromhexine metabolites is impaired. With repeated use, Bromhexine can accumulate.

Indications for use

Acute and chronic bronchopulmonary diseases, accompanied by difficulty in expectorating viscous sputum: tracheobronchitis, bronchitis of various etiologies (including those complicated by bronchiectasis), bronchial asthma, pulmonary tuberculosis, pulmonary emphysema, pneumonia (acute and chronic), pneumoconiosis, 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 to the components of the drug, gastric ulcer and duodenal ulcer, pregnancy, breastfeeding, children under 3 years of age, hereditary lactose intolerance, glucose-galactose malabsorption, lactase deficiency.
Carefully
Use in patients with a history of gastric bleeding, with bronchial diseases accompanied by excessive accumulation of secretions, with a history of episodes of hemoptysis, renal and / or liver failure.

Use during pregnancy and during breastfeeding

Bromhexine crosses the placental barrier and also into breast milk. The drug is contraindicated for use during pregnancy and during breastfeeding.
If necessary, the use of the drug during lactation for the duration of treatment should stop breastfeeding.

Dosage and administration

Inside, regardless of the meal.
Children over 10 years: 24-48 mg (6-12 tablets) divided into 3 doses per day (daily dose - 24-48 mg of bromhexine).
Children from 6 to 10 years old, as well as patients weighing less than 50 kg - 12-24 mg (3-6 tab.) divided into 3 doses per day (daily dose - 12-24 mg of bromhexine).
Children from 3 to 6 years old - 6-12 mg (11/2 -3 tab.) divided into 3 doses per day (daily dose - 6-12 mg of bromhexine).
The therapeutic effect may appear on the 4-6th day of treatment.
The course of treatment is from 4 to 28 days.
Patients with renal insufficiency are prescribed smaller doses or increase the interval between doses.

Side effect

From the gastrointestinal tract: abdominal pain, dyspepsia, incl. nausea, vomiting, exacerbation of peptic ulcer of the stomach and duodenum.
allergic reactions: hypersensitivity reactions (skin rash, itching, angioedema, rhinitis), urticaria, fever, anaphylactic reactions, including anaphylactic shock.
From the skin and subcutaneous tissues: Stevens-Johnson syndrome, Lyell's syndrome, acute generalized exangematous pustulosis.
Other: dizziness, headache, increased activity of "liver" transaminases in the blood serum.

Overdose

The following symptoms are possible: nausea, vomiting, diarrhea and other gastrointestinal disorders.
Treatment: There is no specific antidote. In case of overdose, it is necessary to induce vomiting, and then give the patient liquid (milk or water). Gastric lavage is recommended within 1-2 hours after taking the drug.

Interaction with other drugs

Bromhexine is not prescribed simultaneously with drugs that suppress the cough center (including those containing codeine), as this makes it difficult for thin sputum to pass (accumulation of bronchial secretions in the airways).
Bromhexine promotes the penetration of antibiotics (amoxicillin, ampicillin, erythromycin, cephalexin, oxytetracycline), sulfanilamide drugs into the bronchial secretion in the first 4-5 days of antimicrobial therapy. The combined use of bromhexine with some non-steroidal anti-inflammatory drugs (salicylates, phenylbutazone or butadione) can cause irritation of the gastric mucosa.

special instructions

Very rarely, the occurrence of Stevens-Johnson and Lyell syndromes, which are temporally associated with taking the drug Bromhexine, has been reported. If changes occur on the skin or mucous membranes, stop taking the drug and consult a doctor.
During treatment, it is recommended to consume a sufficient amount of fluid, which supports the secretolytic effect of bromhexine.
In children, treatment should be combined with postural drainage or chest vibration massage, which facilitates the evacuation of secretions from the bronchi.

Influence on the ability to drive vehicles and work with mechanisms

Taking the recommended therapeutic doses (16 mg 3 times a day) does not affect the speed of the patient's psychomotor reactions. In the event of the development of side effects when using the drug, care should be taken when driving vehicles and mechanisms.

Release form

Tablets for children 4 mg.
10, 20, 25, 30, 40 or 50 tablets in a blister pack made of PVC film and printed lacquered aluminum foil.
10, 20, 30, 40, 50 or 100 tablets in polyethylene terephthalate or polypropylene drug jars, sealed with high pressure polyethylene lids with first opening control or with a "push-turn" system or low pressure polyethylene lids with first opening control autopsy.
One jar or 1, 2, 3, 4, 5 or 10 blister packs together with instructions for use are placed in a carton (pack).

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C.
Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date.

Holiday conditions

Released without a prescription.

Manufacturer

OOO "Ozon"

Legal address:
445351, Russia, Samara region, Zhigulevsk, st. Pesochnaya, 11.

Address of production, including for correspondence and receipt of claims:
445351, Russia,
Samara region, Zhigulevsk, st. Gidrostroiteley, d. 6.

Name: Bromhexine

Name: Bromhexine (Bromhexin)

Indications for use:
Acute and chronic inflammatory diseases of the trachea, bronchi, lungs; bronchiectasis (lung disease with the formation of cavities in the lung tissue filled with sputum), pneumoconiosis (the common name for an occupational respiratory disease); in the pre- and postoperative period, the product is used in bronchography.

Pharmachologic effect:
Increases the secretion of bronchial glands and reduces the viscosity of sputum, which gives a pronounced expectorant effect and facilitates the release of sputum. The drug has low toxicity. It does not have a significant effect on blood circulation.

Bromhexine method of administration and dosage:
Bromhexine is taken orally (regardless of the intake of food) in the form of tablets. Doses for adults - 0.016 g (16 mg = 2 tablets of 0.008 mg) 3-4 times every day; for babies from 3 to 4 years old - 0.002 g (2 mg), from 5 to 14 years old - 0.004 g (4 mg) 3 times every day; children under 3 years of age are not prescribed the product.
The effect of the product begins to appear usually after 24-48 hours after the start of treatment. The course of treatment is from 4 days to 4 weeks.
For inhalation use, the solution should be diluted 1:1 with distilled water and heated to body temperature to prevent coughing. In patients with bronchial asthma or asmatic bronchitis, a bronchodilator (a drug that expands the lumen of the bronchi) should be taken before inhalation. Inhalation is carried out twice every day for adults 4 ml, children over 10 years old - 2 ml each, children aged 6 to 10 years old - 1 ml each, children aged 2 to years - 10 drops each and children under 2 years old - 1 ml each. 5 drops per inhalation. Parenteral (bypassing the digestive tract) administration of the product is recommended for treatment in severe cases, also in the postoperative period to prevent the accumulation of thick sputum in the bronchi. Enter 1 ampoule subcutaneously, intramuscularly or intravenously 2-3 times every day slowly over 2-3 minutes. Intravenously, the product is administered together with glucose or saline. The drug is incompatible with alkaline solutions.
If necessary, bromtexin is prescribed simultaneously with antibacterial, bronchodilator, heart and other drugs.

Bromhexine contraindications:
There are no absolute contraindications. Relative: high susceptibility to the product, peptic ulcer of the stomach, recent gastric bleeding, first trimester of pregnancy.

Bromhexine side effects:
Rarely, with long-term use - nausea, vomiting, dyspeptic symptoms (digestive disorders), exacerbations of peptic ulcer. Very rarely - angioedema (allergic) Quincke's edema, an increase in the level of transaminases (enzymes) in the blood serum.

Release form:
Tablets of 0.008 g, 0.016 g. Dragees of 0.004 g, 0.008 g, 0.012 g. Syrup (1 ml - 0.0008 g). Potion (1 ml -0.0008 g). Solution for oral (by mouth) use (1 ml - 0.002 g). Elixir (1 ml - 0.0008 g, or 0.00016 g) Solution for inhalation use (1 ml - 0.0002 g). Solution for parenteral use (1 ml - 0.002 g).

Synonyms:
Bromhexine chloride, Bisolvon, Mukovin, Solvin, Brexol, Brodizol, Bromobene, Bromxin, Bizolvon, Bromobenzonium, Brokokin, Lysomucin, Mugocil, Fulpen A.

Storage conditions:
Ordinary.

Attention!
Before using the medication Bromhexine it is necessary to consult a doctor.
The instructions are provided solely for familiarization with " Bromhexine».

Bromhexine is a mucolytic drug with an expectorant effect that reduces the viscosity of sputum, making it thin and easier to cough up.

Release form:

• Tablets 8 mg;
• Tablets Bromhexine for children 4 mg;
• Oral solution 4 mg/5 ml;
• Syrup 4 mg/5 ml

It is a prodrug that is converted into ambroxol in the body. Bromhexine enhances the activity of goblet cell lysosomes, which are part of the epithelium of the respiratory tract. This leads to the release of lysosomal enzymes responsible for the hydrolysis of mucoproteins and mucopolysaccharides.

Bromhexine hydrochloride activates the production of surfactant and neutral polysaccharides, and also normalizes mucociliary clearance.

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.

Indications for use

What helps Bromhexine? According to the instructions, the drug is prescribed in the complex treatment of bronchopulmonary diseases, accompanied by the formation of sputum of increased viscosity:

• bronchial asthma;
• cystic fibrosis;
• pulmonary tuberculosis;
• pneumonia;
• tracheobronchitis;
• obstructive bronchitis;
• bronchiectasis;
• emphysema;
• pneumoconiosis.

Instructions for use Bromhexine, dosage of syrup and tablets

Solution, tablets and syrup are taken orally. The therapeutic effect usually appears on the 4th-6th day of application. The duration of treatment is from 4 to 28 days.

The dosage is determined by age, according to the instructions for use, Bromhexine dosage for children and adults:

• children under 2 years - 2 mg \ 3 times a day;
• from 2 to 6 years - 4 mg \ 3 times a day;
• from 6 to 10 years - 6-8 mg \ 3 times a day;
• older than 10 years and adults - 8 mg \ 3 times a day;

If necessary, the dose can be increased: for adults - up to 16 mg 4 times a day, for children - up to 16 mg 2 times a day.

Bromhexine tablets

According to the instructions, children over 10 years old and adults are prescribed 1 tablet 3 to 4 times a day.

Children from 6 to 10 years old are prescribed half a tablet or 1 tablet 3 times a day.

If necessary, the doctor may increase the dosage to 2 tablets / 3 times a day for adults and 2 tablets / 2 times a day for children.

Side effects

The instruction warns of the possibility of developing the following side effects when prescribing Bromhexine:

• On the part of the digestive system: dyspeptic phenomena, a 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.

Contraindications

Bromhexine is contraindicated in the following cases:

• hypersensitivity to bromhexine and other components of the drug;
• peptic ulcer (in the acute stage).

With caution: in case of renal and / or liver failure, bronchial disease, accompanied by excessive accumulation of secretions, history of gastric bleeding.

Syrup and tablets are contraindicated in children under 2 years of age. Children under 6 years of age, in view of the peculiarities of the dosage, it is advisable to take syrup, over 6 years old - syrup and tablets for children.

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.

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.

Overdose

Overdose symptoms - nausea, vomiting, diarrhea and other dyspeptic disorders.

If an overdose is detected in the first 60-120 minutes, induce vomiting and gastric lavage. Subsequently, symptomatic treatment is indicated.

Bromhexine analogues, price in pharmacies

If necessary, you can replace Bromhexine with an analogue of the active substance - these are drugs:

1. Bromhexine Berlin-Chemie;
2. Bronchothil;
3. Solvin;
4. Bromhexine Nycomed;
5. Flekoksin;
6. Vero-Bromhexine;
7. Phlegamine.

ATX code:

• Bronchosan,
• Bronchostop,
• Solvin,
• Phlegamine,
• Flekoksin.

When choosing analogues, it is important to understand that the instructions for use of Bromhexine, price and reviews, do not apply to drugs of similar action. It is important to consult a doctor and not to make an independent replacement of the drug.

Price in Russian pharmacies: Bromhexine 8 mg 50 tablets - from 17 to 29 rubles, the price of Bromhexine Grindeks syrup 4 mg / 5 ml 100 ml - from 149 to 198 rubles, according to 502 pharmacies.

Store in a dry, dark place at a temperature not exceeding 25 °C. Shelf life - 5 years.

Terms of dispensing from pharmacies - without a prescription.

Bromhexine is the not so rare case when the trade name of the drug corresponds to the international non-proprietary name and is consonant with the pharmacologically active substance that is part of it. The first duty of bromhexine, which he successfully copes with, is to make the mucus accumulated in the bronchial tree transportable and ready for evacuation from the body. In other words, the drug is endowed with expectorant and mucolytic (thinning mucus) action. The mucolytic (also called secretolytic) effect of bromhexine is associated with its ability to depolymerize and destroy mucopolysaccharide and mucoprotein fibers of mucus. It improves the rheological properties and facilitates sliding along the epithelium of the bronchopulmonary secret.

The drug also has a mild antitussive effect. The functional state of the cells of the bronchial alveoli is one of the important components of a well-functioning and stable breathing process. Bromhexine stimulates the secretion of endogenous surfactant, which has a stabilizing and protective effect on the alveoli. However, one should not expect an instant effect from the drug: its effect begins to fully manifest itself 2-5 days after the start of administration.

There is one “golden” rule that is fully applicable to bromhexine: taking mucolytics cannot be combined with drugs that suppress the cough center (for example, codeine derivatives): otherwise, all thinned mucus will remain in the airways and the effect of the expectorant will be reduced to zero. Treatment with bromhexine obliges the patient to provide his body with plenty of liquid so that nothing hinders the manifestation of the secretolytic properties of the drug. In order to facilitate the discharge of sputum from the bronchi, taking Bromhexine in pediatric patients is recommended to be combined with postural drainage (the attending pediatrician can tell you in detail about the technique of this procedure) and / or chest massage.

Bromhexine tablets are taken without regard to the patient's diet at a dose of 8-16 mg 3-4 times a day. In children aged 6 to 14 years, a single dose should not exceed 8 mg. The duration of admission is from 4 days to 1 month. Similarly (with the same frequency of administration and dose), Bromhexine is taken in the form of a syrup and solution. To facilitate the dosing of the drug, the syrup package is equipped with a measuring spoon.

Pharmacology

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.

Release form

100 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.

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.

Interaction

Bromhexine is incompatible with alkaline solutions.

Side effects

On the part of the digestive system: dyspeptic phenomena, a 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.

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, bronchial asthma, cystic fibrosis, chronic pneumonia.