Bromhexine syrup 4mg/5ml 100ml

Pharmacodynamics and pharmacokinetics

The drug Bromhexine is characterized by secretolytic (mucolytic) and expectorant properties, for which tablets and syrup of the drug are used for dry cough in adults and children. The secretolytic effectiveness of bromhexine is manifested due to its ability to liquefy and depolymerize mucoprotein and mucopolysaccharide fibers of bronchial secretions . Also important in the productivity of treatment with bromhexine is its stimulation of the formation of surfactant , a surface-active substance that lines the alveoli of the lungs , thereby increasing the protective function of the pulmonary system. In addition to its main effects, the drug has a weak antitussive effect.

Oral (oral) administration of bromhexine leads to its almost complete absorption (99%) from the gastrointestinal tract within 30 minutes. Due to the “ first pass ” effect through the liver, the drug has low bioavailability (about 20%). Plasma protein binding is quite high. Able to penetrate the placental and blood-brain barriers . Hepatic metabolic transformations occur through oxidation and demethylation . T1/2 due to slow reverse tissue diffusion averages 15 hours. Excretion is carried out mostly by the kidneys. Has the ability to accumulate in the body. With kidney pathologies, metabolic products is disrupted.

pharmachologic effect

The drug has a number of therapeutic properties, providing mucolytic, expectorant and antitussive effects.

Effective against dry cough in adults and children. Due to its special composition, its ability to liquefy and remove mucus from the bronchopulmonary system is noted. The drug stimulates the production of a special substance that settles on the surface of the respiratory organs and helps protect them.

Bromhexine is quickly adsorbed in the body. After oral administration, the pharmacological properties develop after 30-60 minutes. The drug products are eliminated through the liver and excretory organs in an average of 12-15 hours.

Indications for use

Indications for the use of Bromhexine are painful conditions of the bronchopulmonary system in the presence of difficult-to-clear viscous sputum ( tracheobronchitis , emphysema , bronchial asthma , pneumoconiosis , cystic fibrosis , bronchiectasis, tuberculosis , obstructive bronchitis , pneumonia ).

The drug is also used in the preoperative period for the sanitation (health improvement) of the bronchial tree ; in the postoperative period for the preventive removal of sputum accumulation in the bronchi; during diagnostic and therapeutic clinical intrabronchial manipulations .

Bromhexine

Dosage form

Oral solution

Composition per 5 ml:

Active substance:

Bromhexine hydrochloride – 4 mg.

Excipients: propylene glycol - 1250 mg, sorbitol - 2000 mg, apricot aromatic concentrate - 2.5 mg, hydrochloric acid 0.1 M solution - 7.8 mg; purified water – up to 5 ml.

Description

Transparent, colorless, slightly viscous liquid with a characteristic apricot odor.

Pharmacotherapeutic group

Expectorant mucolytic agent

ATX Code:

R05CB02.

Pharmacological properties

Pharmacodynamics

Bromhexine has a mucolytic (secretolytic), expectorant and weak antitussive effect. The mucolytic effect is associated with the depolymerization of mucoprotein and mucopolysaccharide fibers and an increase in the serous component of bronchial secretions.

Pharmacokinetics

When taken orally, bromhexine is almost completely (99%) absorbed from the gastrointestinal tract within 30 minutes. Bioavailability depends on the individual characteristics of the body, the activity of renal enzymes during the initial passage of the active substance through the liver and is approximately 20%. 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; some of the resulting metabolites remain active. The maximum half-life is 15 hours due to slow reverse diffusion from tissues. The maximum concentration in the blood is reached approximately 1 hour after administration. Excreted by the kidneys. In chronic renal failure, the release of bromhexine metabolites is impaired. With repeated use, bromhexine may accumulate.

Indications for use

Acute and chronic bronchopulmonary diseases accompanied by the formation of high-viscosity sputum (bronchial asthma, pneumonia, tracheobronchitis, obstructive bronchitis, bronchiectasis, pulmonary emphysema, cystic fibrosis, tuberculosis, pneumoconiosis).

Sanitation of the bronchial tree in the preoperative period and during therapeutic and diagnostic intra-laboratory manipulations, prevention of accumulation of thick viscous sputum in the bronchi after surgery.

Contraindications

Hypersensitivity to bromhexine and other components of the drug. Pregnancy and breastfeeding period.

Peptic ulcer (in the acute stage).

Children under 3 years of age.

Hereditary fructose intolerance (since the drug contains sorbitol).

Carefully

used 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, children aged 3 to 6 years.

Bromhexine solution contains sorbitol. Sorbitol may also have a mild laxative effect.

Use during pregnancy and breastfeeding

Bromhexine penetrates the placental barrier and also into breast milk. The drug is contraindicated for use during pregnancy and breastfeeding. If it is necessary to use the drug during breastfeeding, breastfeeding should be stopped during treatment.

Directions for use and doses

Inside.

Adults and children over 10 years old:

10-20 ml 3 times a day (daily dose – 24-48 mg of bromhexine).

Children from 6 to 10 years old, as well as patients weighing less than 50 kg:

5-10 ml 3 times a day (daily dose – 12-24 mg of bromhexine).

Children from 3 to 6 years old:

2.5-5 ml 3 times a day (daily dose – 12 mg bromhexine).

Dosing is carried out using a measuring cup or measuring spoon.

Side effect

From the gastrointestinal tract:

abdominal pain, dyspepsia, incl. nausea, vomiting, exacerbation of gastric and duodenal ulcers.

Allergic reactions:

hypersensitivity reactions (skin rash, itching, angioedema, rhinitis), urticaria, fever, anaphylactic reactions, including anaphylactic shock.

For the skin and subcutaneous tissues:

Stevens-Johnson syndrome, Lyell's syndrome, acute generalized exanthematous pustulosis.

Other:

dizziness, headache, increased activity of “liver” transaminases in the blood serum.

In patients with sorbitol/fructose intolerance, under the influence of sorbitol contained in the drug, the following may also be observed: nausea, vomiting and diarrhea, decreased blood sugar levels (accompanied by trembling, cold sweat, palpitations, a feeling of fear), increased activity of “liver” transaminases.

Overdose.

Possible symptoms are:

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.

Children:

There are no known life-threatening symptoms of overdose with Bromhexine.

Symptoms:

A study of overdose cases has been published, according to which vomiting was observed in 4 out of 25 overdose cases. In three children, symptoms such as vomiting, as well as stunned consciousness, ataxia, diplopia, mild metabolic acidosis and tachypnea were noted. In children, symptoms did not occur when taking bromhexine at doses up to 40 mg, even in the absence of treatment.

There is no evidence of chronic toxicity of bromhexine in humans.

Treatment:

in case of severe overdose, monitoring of blood circulation and, if necessary, symptomatic treatment are indicated. Due to the low toxicity of bromhexine, as a rule, there is no need for invasive measures aimed at reducing its absorption (forced vomiting, gastric lavage) or accelerating elimination. In addition, due to the pharmacokinetics (high volume of distribution, slow redistribution processes and high degree of protein binding), effective removal of bromhexine from the body by dialysis or forced diuresis should not be expected.

Since in children over 2 years of age, even after taking large doses of bromhexine, only mild symptoms are expected, with a dose of bromhexine hydrochloride up to 80 mg (for example, 100 ml of Bromhexine), detoxification may not be necessary. In younger children, the appropriate dose limit is 60 mg bromhexine hydrochloride (6 mg/kg body weight).

In case of overdose, it is also possible to develop side effects caused by excipients.

Interaction with other drugs

Bromhexine is not prescribed simultaneously with antitussives (including those containing codeine), as they may make it difficult to cough up sputum diluted with bromhexine.

Bromhexine promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin), sulfonamide drugs into the bronchial secretions.

The drug is incompatible with alkaline solutions.

special instructions

During treatment, it is necessary to take a sufficient amount of fluid, which increases the expectorant effect.

In cases of impaired bronchial motility or with a significant volume of sputum secreted (for example, in rare malignant ciliary syndrome), the use of bromhexine requires caution due to the risk of retention of secretions in the respiratory tract.

Instructions for patients with diabetes: 5 ml of solution contains 1.5 g of sorbitol, which corresponds to 0.12 bread units.

Impact on the ability to drive vehicles and machinery

Taking the recommended therapeutic doses (20 ml 3 times a day) does not affect the speed of the patient's psychomotor reactions.

Release form

Oral solution, 4 mg/5 ml.

10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 200, 250 ml of the drug in dark glass bottles or dark plastic bottles made of polyethylene or light-protective bottles made of polyethylene terephthalate, sealed with a plastic screw cap made of polyethylene with/without first opening control, with/without a child protection device.

A label made of writing or label paper or a self-adhesive label is glued to each bottle.

Each bottle, along with instructions for use, is placed in a pack of boxed cardboard for consumer packaging or chrome-ersatz cardboard.

A measuring cup or measuring spoon can be placed in a cardboard package.

Storage conditions

At a temperature not higher than 25 °C.

Keep out of the reach of children.

Best before date

3 years.

Do not use after the expiration date stated on the packaging.

Vacation conditions

Over the counter.

Contraindications

Before taking Bromhexine in tablets or syrup, you should familiarize yourself with the contraindications to its use.

Absolute contraindications include:

• lactation;
• peptic ulcer of the gastrointestinal tract in the period of exacerbation;
• pregnancy in the first trimester;
• children under 2 years of age for syrup and up to 6 years for tablets;
• personal hypersensitivity ;
• sugar intolerance.

Carefully:

• / kidney pathologies ;
• diabetes;
• tendency to gastrointestinal bleeding ;
• bronchopulmonary painful conditions with the accumulation of excessive amounts of secretion ;
• pregnancy in the second and third trimester.

special instructions

The drug is used with extreme caution for bronchial asthma, especially during exacerbation.

Patients with ulcerative processes of the digestive tract and bleeding from the gastrointestinal tract should take the medication under the supervision of a physician.

It is not recommended to combine the medicine with codeine. Because it interferes with the liquefaction and coughing up of sputum.

Brombexine is best taken together with natural combined action products that contain essential oils (eucalyptus, anise, peppermint or menthol).

Side effects

• dyspeptic manifestations;
• nausea, vomiting;
• feeling dizzy ;
• exacerbation of peptic ulcer disease;
• headache;
• allergic phenomena (skin rash / itching , rhinitis , Quincke's edema , etc.);
• increased activity enzymes .

Side effects

Taking an antitussive drug may cause side effects. They develop when the course or therapeutic dose is not followed. The most commonly observed conditions are:

1. Nausea followed by vomiting.
2. Headache.
3. Dizziness.
4. Increased activity of liver enzymes.
5. Exacerbation of ulcerative pathologies of the gastrointestinal tract.
6. Allergic reactions - hyperemia, swelling, itching, skin rashes.
7. Pain in the epigastric region, stool disturbance.

Instructions for use of Bromhexine

Bromhexine tablets, instructions for use

Bromhexine tablets are intended for oral (inside) administration. Tablets can be taken regardless of meals, with 100-200 ml of water. Adults are advised to take a single dose of 8-16 mg of the drug 3-4 times every 24 hours. From 6 to 14 years of age they take 8 mg 3 times a day. The effect of therapy can only develop on days 4-6.

Bromhexine syrup, instructions for use

The syrup of the drug is mainly intended for use in pediatrics, although it does not exclude the use of the drug by adult patients in the same dosages and frequency of administration as prescribed for tablets (8-16 mg 3-4 times a day).

Children's syrup is produced with a mass content of the active ingredient of 4 mg/5 ml and is often equipped with a measuring beaker for ease of dosing, such as Bromhexine Nycomed , a measuring cup or spoon.

Instructions for use of Bromhexine for children recommend that patients aged 2-6 years take 2.5-5 ml (2-4 mg); 6-10 years – 5-10 ml (4-8 mg); after 10 years - 10 ml (8 mg) of syrup for children three times a day.

When using Bromhexine for children, it is recommended to simultaneously use a vibration massage of the child’s chest or a postural drainage in order to further facilitate the discharge of secretions .

The course of treatment for any of the pharmacological forms of the drug can last from 4 to 28 days. During therapy, the patient should be provided with sufficient fluid intake to maintain productive secretological action.

How to take Bromhexine for adults

The product must be used as directed by a specialist. The dosage and duration of the course depend on the diagnosis, general health and age of the patient.

Adult patients are prescribed the drug in different forms. Tablets should be taken regardless of food, 1-2 tablets up to 4 times a day, with a sufficient volume of water.

The medicine in the form of syrup is drunk according to a similar scheme as tablets. The recommended dosage is 8-16 mg 3-4 times a day.

The duration of treatment with Bromhexine is at least 4 days, maximum 4 weeks. It is important to maintain water balance while using the drug.

Interaction

Do not prescribe in parallel with antitussive drugs (for example, codeine-containing ones ) due to difficulty in the discharge of bronchial secretions.

Combined use with NSAIDs can irritate the gastrointestinal mucosa and even lead to the formation of erosions and ulcers .

The use of Bromhexine favors the penetration of sulfonamide drugs and antibiotics ( Oxytetracycline , Erythromycin , Amoxicillin , Cephalexin ) into the bronchial secretions in the first 4-5 days of antibiotic therapy.

Analogs

Level 4 ATX code matches:
Mukolik

Abrol

Ambrosan

Bronchorus

ACC 100

ACC 200

ACC Long

ACC

Mukolwan

Lazolvan

Bromhexine 8

Bromhexine 8 Berlin-Chemie

Bronchobos

Carbocisteine

Erdomed

Pulmozyme

Pectolvan C

Halixol

Ambrobene

Acetylcysteine

If for some reason the use of Bromhexine is impossible, the doctor may recommend the following analogues:

• Ambrobene;
• Libexin;
• Acestine;
• Lazolvan;
• AmbroHexal;
• Ascoril;
• Bronchoxol;
• Ambroxol;
• ACC;
• Bronchosan;
• Acetylcysteine;
• Flavamed;
• Fluditek;
• Fluimucil , etc.

For children

The instructions for the drug prohibit taking tablets up to 6 years and taking syrup up to 2 years.

The main prescribed dosage form of Bromhexine for children from 2 to 6 years old, due to the possibility of more accurate dosing (measuring spoon or beaker) and ease of swallowing, is oral syrup for children, used in the above dosages. The mass fraction of bromhexine in tablets for children is 4 mg and is prescribed to children over 6 years of age in doses appropriate to their age category.

Bromhexine syrup 4mg/5ml 100ml

Compound

Active substance: bromhexine hydrochloride 4 mg. Excipients: methyl parahydroxybenzoate - 5 mg, ethanol 96% - 0.625 ml, sorbitol solution (stabilized) - 2860 mg (in terms of 100% sorbitol - 2000 mg), levomenthol - 0.55 mg, anise oil - 0.00025 ml, peppermint oil - 0.00025 ml, fennel oil - 0.00025 ml, purified water - 2.20 ml.

Pharmacokinetics

Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes intensive metabolism 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. Ambroxol is a metabolite of bromhexine.

The binding of bromhexine to plasma proteins is high. T1/2 in the terminal phase is about 12 hours.

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

Only small amounts are excreted in urine with a T1/2 of 6.5 hours.

The clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.

Indications for use

Acute and chronic lung diseases, accompanied by the formation of high-viscosity sputum (bronchial asthma, cystic fibrosis, tuberculosis, pneumonia, tracheobronchitis, obstructive bronchitis, bronchiectasis, emphysema, pneumoconiosis). Chest injuries.

Contraindications

• hypersensitivity to the components of the drug, including sorbitol (syrup), lactose and sucrose (tablets for children);
• pregnancy;
• lactation period;
• stomach ulcer;
• children under 1 year of age for syrup.

Directions for use and doses

Bromhexine is taken orally regardless of food intake. During treatment, it is recommended to consume a sufficient amount of fluid, which supports the secretolytic effect of bromhexine. The course of treatment is from 4 to 28 days.

Tablets for children. Children from 6 to 14 years old - 4-8 mg 3 times a day.

Children aged 1 to 6 years are recommended to take bromhexine syrup.

Syrup. Take 3 times a day.

The patient should consult a doctor if his condition does not improve during 6 days of treatment with bromhexine.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25 °C.

Best before date

5 years. Do not use after the expiration date stated on the package.

special instructions

• For gastric ulcers, as well as when there is a history of gastric bleeding, bromhexine should be used under the supervision of a physician.
• Use with caution in patients suffering from bronchial asthma.
• Bromhexine is not used simultaneously with medications containing codeine, because this makes it difficult to cough up thin mucus.
• Used as part of combination preparations of plant origin with essential oils (including eucalyptus oil, anise oil, peppermint oil, menthol).
• 5 ml of syrup contains 2 g of sorbitol.
• The syrup contains 12.5 vol. % alcohol. This should be taken into account when using syrup for pregnant women, children and high-risk groups: patients with liver disease, brain diseases, alcoholism, epilepsy and a tendency to develop drug addiction.
• During treatment, it is necessary to take a sufficient amount of fluid, which increases the expectorant effect of bromhexine.
• In children, treatment should be combined with postural drainage or vibration massage of the chest, which facilitates the evacuation of secretions from the bronchi.

Description

Mucolytic and expectorant drug.

Dosage form

Colorless or slightly colored transparent liquid with a characteristic odor.

Use in children

Use with caution in children - according to indications, in doses and dosage forms recommended according to age.

Action

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

Side effects

Rarely, long-term use of the drug may cause dizziness, headache, nausea, vomiting, dyspepsia, exacerbation of gastric and duodenal ulcers, allergic reactions (skin rash, facial swelling, rhinitis, etc.), increased levels of transaminases in the blood serum. In these cases, the drug should be discontinued.

Use during pregnancy and breastfeeding

Use is contraindicated in the first trimester of pregnancy. Use in the II-III trimesters of pregnancy and during breastfeeding is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Interaction

• Bromhexine can be prescribed simultaneously with other drugs used in the treatment of bronchopulmonary diseases.
• Bromhexine is not prescribed simultaneously with medications containing codeine, since suppression of the cough reflex makes it difficult to cough up liquefied sputum.
• Bromhexine promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline) into the lung tissue.
• The ethanol (alcohol) contained in the syrup may change the effect of other medications.
• Concomitant use of bromhexine with certain non-steroidal anti-inflammatory drugs (for example, salicylates, phenylbutazone or butadione) may cause irritation of the gastric mucosa.
• Bromhexine is not compatible with alkaline solutions.

Overdose

Bromhexine intoxication in humans has not yet been established.

Acute drug poisoning in experimental animals causes increased salivation, nausea, diarrhea, vomiting and decreased blood pressure.

In case of an overdose of bromhexine administered orally, it is necessary first of all to rinse the stomach, monitor circulatory parameters, and carry out symptomatic therapy.

Impact on the ability to drive vehicles and operate machinery

There is no information about the adverse effects of bromhexine on the ability to drive vehicles and operate mechanisms that require increased concentration and speed of psychomotor reactions.

Reviews of Bromhexine

As a rule, reviews of Bromhexine from adult patients who understand exactly what the drug tablets are needed for, namely, to liquefy viscous sputum in order to remove it as quickly as possible, are positive. In most cases, the drug copes with its task perfectly and practically, with rare exceptions, does not lead to side effects. The situation is a little more complicated when the question concerns young patients and their mothers, who want to cure their child’s cough as soon as possible and, if this does not happen quickly, are ready to speak negatively about any medicine. Let us remind you once again that Bromhexine syrup for children is intended to solve the problem of softening bronchial secretions , and various bronchopulmonary diseases may require treatment with different drugs from many drug groups and often in combination. Therefore, before giving your baby any medicine, you simply need to seek qualified advice from a pediatrician and strictly follow his instructions.

Bromhexine price, where to buy

The price of the drug, depending on the manufacturer and the number of tablets or bottle volume, differs slightly, but remains within the limits available to almost every consumer.

So the price of Bromhexine in tablets 8 mg No. 50 varies from 25 to 50 rubles; the price of Bromhexine syrup 8 mg/5ml 150 ml is within 150 rubles, and syrup for children 4 mg/5 ml 100 ml can be bought for 60-80 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Bromhexine tablets 8 mg 20 pcs. JSC Pharmstandard (ICN) Leksredstva Kursk
  41 rub. order
• Bromhexine tablets 8 mg 20 pcs. JSC Akrikhin

  88 rub. order

• Bromhexine tablets 8 mg 28 pcs. AO Update PFK

  103 rub. order

• Bromhexine-Akrikhin syrup 4mg/5ml 100mlMedana Pharma A.O.

  RUB 218 order

• Bromhexine apricot syrup 4mg/5ml 100ml Pharmstandard-Leksredstva OJSC

  140 rub. order

Pharmacy Dialogue

• Bromhexine tablets 8 mg No. 25Berlin-Chemie AG/Menarini

  RUB 225 order

• Bromhexine Nycomed bottle 0.8mg/ml 150mlTakeda

  146 RUR order

• Bromhexine (syrup 4 mg/5 ml 100 ml) Rozlex Pharm LLC

  66 RUR order

• Bromhexine tablets 8 mg No. 28Update PFK ZAO

  91 rub. order

• Bromhexine (8 mg tablet No. 50) BZMP

  67 RUR order

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Pharmacy24

• Bromhexine 8 No. 25 tablets Berlin Chemi AG, Nimechchina
  20 UAH. order
• Bromhexine 0.008 N20 tablets PAT Monpharm, Ukraine

  5 UAH order

• Bromhexine-8 20 ml drops Crevel Meuselbach GmbH, Niemecchina

  60 UAH.order

• Bromhexine-Darnitsa No. 20 tablets PrAT” Pharmaceutical company “Darnitsa”, Ukraine

  7 UAH order

• Bromhexine 4 60 ml oral solution Berlin Chemi AG, Nimechchina

  53 UAH order

PaniPharmacy

• Bromhexine tablets Bromhexine 8 BERLIN-CHEMIE tablets 8 mg No. 25 Germany, Berlin-Chemie

  27 UAH order

• Bromhexine liquid Bromhexine drops 8 mg/ml 20 ml Germany, Krewel Meuselbach

  82 UAH order

• Bromhexine tablets Bromhexine tablets. 8mg No. 50 Ukraine, Darnitsa ChAO

  17 UAH order

• Bromhexine liquid Bromhexine solution 4mg/5ml 60ml Germany, Berlin-Chemie

  62 UAH.order

• Bromhexine tablets Bromhexine tablets. 8mg No. 20 Ukraine, Darnitsa ChAO

  7 UAH order

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