These include Ambrohexal, detailed information about which is contained in the instructions for use. The drug is available in several dosage forms and is used for therapy in both adults and children.
Composition and release forms of the drug
The effectiveness of the drug is due to the active substance included in its composition. Physicochemical properties are achieved by adding additional components. The active ingredient of this mucolytic is ambroxol hydrochloride. The composition of additional ingredients of Ambrohexal depends on the form of release.
Pills
Each tablet contains 10 mg ambroxol. The tablets are packaged in aluminum blisters and sold in cardboard boxes.
Table 1. Additional components of tablets
Lactose or milk sugar | Filler and sweetener. Contraindicated in case of individual intolerance |
Corn starch | Filler |
Sodium carboxymethyl starch | Thickener, stabilizer |
Stearic acid | Stabilizer, preservative |
Silicon dioxide colloidal | Enterosorbent |
Syrup
According to the instructions for use, Ambrohexal in syrup form is sold in 100 ml dark glass bottles.
Table 2. Additional substances in the syrup
Benzoic acid | Expectorant, antiseptic |
Glycerol | Alcohol, emulsifier, food additive |
Sorbitol | Alcohol, sweetener |
Flavor "Apricot" | Causes the smell of syrup |
Pripylene glycol | Solvent |
Characteristics of the active substance "ambroxol"
It was already noted above that the active component of the drug is ambroxol. It is a bitter white powder.
Table 3. Effect of the active substance Ambrohexal on the body
EffectMore detailsLeads to liquefaction of viscous tracheobronchial secretions | The action is explained by the rupture of mucopolysaccharide bonds, an increase in the production of glycoproteins |
Stimulates mucus removal | Ambroxol promotes increased movement of epithelial cilia in the bronchi |
Increases surfactant synthesis | The surfactant has a bactericidal effect, stimulates the opening of the alveoli, leads to an increase in local immunity, etc. |
According to the annotation, the active substance of Ambrohexal is almost completely absorbed by the body. In addition, ambroxol rarely causes side effects.
Example of a recipe in Latin
In order to choose among a variety of drugs a medicine based on ambroxol, you can use the name in Latin. In addition to the name of the active substance, the recipe also includes the dosage and release form.
Table 4. Drug prescription depending on dosage form
Release formRecipe for a drug based on ambroxol in LatinPills | Tab. Ambroxoli 0.03 |
Syrup | Sir. Ambroxoli 0.6%-120ml |
What does it help with?
Instructions for use highlight the following properties of ambroxol:
- mucolytic – helps to liquefy tracheobronchial secretions and accelerates excretion from the lungs;
- expectorant – stimulates the removal of mucus from the respiratory tract.
This allows us to draw a conclusion about why it is rational to take Ambrohexal. The product is recommended for respiratory tract pathologies accompanied by cough and the appearance of viscous sputum.
Can I drink it if I have a dry cough?
This drug is not universal. Before answering the question whether ambroxol can be used for a dry cough, you should understand the types of symptoms.
Table 5. Types of cough
Dry (unproductive) | Not accompanied by sputum production |
Wet (productive) | Complicated by the separation of viscous tracheobronchial secretions |
Ambrohexal is very effective against wet cough. The active substance promotes the rapid removal of sputum and accelerates recovery.
Prescribing Ambrohexal for dry cough is not advisable due to the absence of viscous secretions in the respiratory tract. There will be no harm, but no benefit either.
Indications
The drug is used for a wide range of pathologies. Let's look at the most common indications for using Ambrohexal according to the instructions.
Table 6. Diagnoses for which the drug is recommended
NameDetailsBronchitis (including with obstruction) | A collective name for pathologies of various etiologies, expressed in the inflammatory process localized in the bronchi |
Inflammation of the lungs (pneumonia) | The use of the drug Ambrohexal is also recommended for this disease. It is an inflammation of the lung tissue, usually of an infectious nature. |
COPD | Regularly progressive reduction in air flow in the respiratory tract, provoked by an inflammatory process in the lung tissue |
Bronchial asthma | A pathology that affects the respiratory system and leads to obstruction. Mainly occurs due to specific reactions of the immune system |
Bronchiectasis | Suppuration localized in defective bronchi. Can be either acquired or congenital |
Neonatal respiratory distress syndrome | Severe respiratory impairment caused by undeveloped lungs |
What else does Ambrohexal help with? It’s best to check with your doctor. Among the indications there are other pathologies.
Contraindications
There are some restrictions that do not allow the use of tablets or syrup for therapy. It is important not only to find out for which cough Ambrohexal is recommended, but also to familiarize yourself with the list of contraindications.
Table 7. Limitation of use according to these instructions
ContraindicationRead moreIndividual intolerance | The drug is prohibited if you are intolerant to one or more components of the drug. Use may cause an allergic reaction |
Stomach/duodenal ulcer | Represents localized damage to the mucosa. According to the instructions for use, there is a restriction on the consumption of the drug |
Convulsive syndrome | The body's reaction resulting from various types of irritants, expressed in the form of uncontrolled muscle contractions |
Impaired bronchial motility | Taking Ambrohexal will lead to stagnation of mucus in the bronchi |
Excessive mucus production | May cause fluid retention |
Early pregnancy/breastfeeding | According to the instructions for use, Ambrohexal is not safe for the embryo and cannot be used during lactation due to the lack of relevant research |
Instructions and methods of use
How to use?
Carrying out therapy requires a systematic approach. How to take Ambrohexal depends on the dosage form of the drug. To improve the effect, it is recommended to consume plenty of liquid.
Table 8. How to take Ambrohexal in tablets and syrup form
Dosage formFeaturesPills | Inside, after eating food, with plenty of water |
Syrup | Regardless of diet, inside |
Dosage
Exceeding the recommended amount can cause dyspeptic disorders and arterial hypotension.
Table 9. Dosage of the drug Ambrohexal depending on the patient’s age
Dosage formAgeQuantityPills | Adults and children over 12 years old | According to the instructions for use, it is recommended: 1 tab * 3 times a day for the first 48-72 hours, then 1 tab * 2 times a day |
6-12 years | ½ tab*2-3 times a day | |
Syrup | For adults and children over 12 years old | 5ml*3 times a day for the first 48-72 hours, then 5ml*2 times a day |
6-12 years | 2.5ml*2-3 times a day | |
2-5 | 1.25ml*3 times a day | |
Up to 2 years | For small children, 1.25 ml of Ambrohexal is recommended 2 times a day |
The method of use and dosage of Ambrohexal can be changed at the discretion of the attending physician.
Important Notes
The drug must not be combined with antitussives. Consumption together may cause complications. The recommended course of treatment with Ambrohexal is no more than 5-7 days. If there is no improvement, it is recommended to contact a specialist again.
Features of children's use
An undoubted advantage is the ability to use the drug to treat the youngest patients. Ambrohexal does not have a negative effect on the child's body when used according to the instructions for use.
The tableted drug can be taken from 6 years of age. Ambrohexal syrup can be given even to children under 2 years of age, but under the supervision of a specialist.
Review Reviews
Most users give a positive assessment to the drug based on ambroxol. Reviews of Ambrohexal note the following advantages:
- high efficiency;
- fast action;
- affordable price;
- variety of dosage forms;
- Possibility to purchase without a prescription.
As for opinions on the use of the drug Ambrohexal for the treatment of children, reviews here also note the possibility of carrying out therapy even in infants. However, there are some disadvantages:
- no effect;
- deterioration of the condition (may be due to non-compliance with the requirement for what cough to take Ambrohexal for);
- the occurrence of an allergic reaction;
- addiction to the drug;
- restrictions on use for pregnant and lactating women, etc.
Analogs
There are other products based on ambroxol that have an identical therapeutic effect.
Table 10. Some analogues of Ambrohexal
Lazolvan | A popular mucolytic, sold in the form of syrup, solution and tablets |
Ambrobene | Available in 4 dosage forms, has similar effect |
Bronchorus | Cheap analogue based on ambroxol |
You should not replace one product with another on your own. Instructions for use of the drug Ambrohexal for children and adults and recommendations for the consumption of the analogue may differ.
What is better – Ambrohexal or Ambrobene?
Both products have almost the same composition, with the exception of some additional components. They are distinguished by manufacturers and instructions for use. It’s difficult to say unequivocally which is better – Ambrohexal or Ambrobene. These are analog drugs.
Source: https://pulmonologiya.com/preparaty/kashel/ambrogeksal.html
Ambrohexal tablets instructions for use
AmbroHEXAL tablets are a representative of the pharmacological group of mucolytics and expectorants. They have a therapeutic effect due to the presence of the main active ingredient ambroxol, namely, they dilute mucus in the respiratory tract and improve its elimination.
Release form and composition
AmbroHEXAL tablets have a round shape, white color and beveled edges. There is a dividing notch on one side for easy breaking of the tablet in half. The package contains 20 tablets - 2 blisters of 10 tablets each. The concentration of the main active ingredient, ambroxol hydrochloride, in each tablet is 30 mg. It also contains the following excipients:
- Lactose monohydrate – 102 mg.
- Calcium hydrogen phosphate dihydrate – 50 mg.
- Corn starch – 10 mg.
- Sodium carboxymethyl starch – 4 mg.
- Magnesium stearate – 2 mg.
- Colloidal silicon dioxide – 2 mg.
The presence of a dividing notch makes it possible to conveniently break the tablet in half when prescribing it at half the dose. The presence of blisters of 10 tablets provides ease of purchase for a specific course of using AmbroHEXAL.
Pharmacological action of the drug
The main active ingredient of AmbroHEXAL tablets is ambroxol. It belongs to the pharmacological group of mucolytics and expectorants due to several main effects:
- Increased production of liquid sputum by serous cells of the bronchial mucosa.
- Initiation of cell synthesis of enzymes that break down the intramolecular bonds of mucopolysaccharide molecules, which are the basis of sputum, thereby reducing its viscosity.
- An increase in mucociliary clearance is the movement of the cilia of the respiratory tract mucosa, which are aimed at removing sputum, due to this, various foreign agents that cause inflammation and cough are removed (bacteria, viruses, dust particles, aggressive chemical compounds, allergens).
All these effects of ambroxol, which is the main active ingredient of AmbroHEXAL tablets, help accelerate the transition of a dry cough into a productive cough with a gradual decrease in its intensity.
Therapeutic concentration in the organs of the respiratory system (the amount of the drug that has a therapeutic effect) is achieved 20-30 minutes after taking the AmbroHEXAL tablet.
It persists for 8-10 hours, then ambroxol begins to inactivate in the liver with splitting into metabolic products that are excreted by the kidneys in the urine. The half-life (the time during which 50% of the active substance of the drug is eliminated from the body) reaches 12 hours.
Indications for use
The main indication for the use of AmbroHEXAL tablets are diseases of the respiratory tract and lungs, which are accompanied by an inflammatory process in them with the secretion of thick sputum, difficulty in removing it and a dry cough. Such diseases include:
- Infectious bronchitis with an acute or chronic course is an inflammation of the bronchial mucosa caused by viruses or bacteria.
- Pneumonia is an inflammation of the lungs caused by various microorganisms.
- Bronchiectasis is a chronic pathological process with dilation of part of the bronchi and bronchioles, in which viscous sputum accumulates.
- Bronchial asthma or atopic bronchitis is a pathology of an allergic nature, accompanied by a narrowing of the bronchi (bronchospasm) and the accumulation of thick sputum in their lumen.
- Tracheitis is an inflammatory process in the mucous membrane of the trachea, caused by various reasons, most often by infection.
- Chronic obstructive bronchitis is a disease most often caused by prolonged irritation of the bronchial mucosa by various aggressive chemical compounds, in particular smoking.
- Cystic fibrosis is a severe hereditary disease in which viscous sputum is produced without an inflammatory reaction in the respiratory tract.
The effect of ambroxol primarily affects the pathogenesis of most inflammatory processes in the bronchial tree, namely improving the protective function of the respiratory tract.
Contraindications for use
AmbroHEXAL tablets have several contraindications for use, which include:
- First trimester of pregnancy - ambroxol penetrates the placenta into the fetus. Since the absence of its negative effects has not been proven, it is recommended to exclude use in the early stages of pregnancy.
- Erosive or ulcerative pathology of the gastric or duodenal mucosa - ambroxol in AmbroHEXAL tablets can lead to additional damage to cells in the area of ulcer or erosion.
- Individual intolerance to any component of the drug - may manifest itself as general symptoms (weakness, headache) and skin rash. This condition requires discontinuation of the drug and is a contraindication to its subsequent use.
Pregnancy in the second and third trimester, lactation (breastfeeding) are relative contraindications. A doctor may prescribe AmbroHEXAL tablets for medical reasons if the expected benefit to the mother significantly exceeds the potential negative effect of the drug on the fetus.
Directions for use and dosage
AmbroHEXAL tablets are taken whole. They are not chewed and washed down with a significant amount of water. 1 tablet contains 30 mg of ambroxol hydrochloride. The dosage of the drug depends on the severity of the pathological process in the respiratory system and age:
- Children from 2 to 6 years old - the recommended dose is ½ tablet once a day (the daily dose is 15 mg).
- Children from 6 to 12 years old – ½ tablet 2-3 times a day (daily concentration of ambroxol – 30-45 mg).
- For children over 12 years of age and adults - for the first 2-3 days from the start of therapeutic measures, 1 tablet is prescribed 2-3 times a day (60-90 mg per day). Then switch to a maintenance dose of 1 tablet 2 times a day (daily dose 60 mg). In the absence of the expected effect or in case of individual rapid metabolism of ambroxol in the liver, the total dose of the drug can be increased to 2 tablets 2 times a day (120 mg ambroxol per day).
AmbroHEXAL tablets have a fairly high therapeutic dosage range, therefore, for a sufficient effect of their use, the doctor can adjust the dose depending on the individual characteristics of the patient or the severity of the pathological process in the respiratory organs.
Side effects
Ambroxol in AmbroHEXAL tablets is well tolerated. Sometimes it is possible to develop its side effects, which are characterized by the following manifestations:
- Allergic reactions to any of the components of the drug, including ambroxol, manifest themselves in the form of a rash on the skin, which may be accompanied by itching. With a more pronounced reaction of the body, urticaria develops (a rash on the skin appears against the background of slight swelling, which looks like a nettle burn), Quincke's edema (angioedema of the skin and subcutaneous tissue in the face or external genitalia). It is extremely rare to develop anaphylactic shock - a severe allergic reaction in which a progressive decrease in systemic blood pressure and loss of consciousness occurs.
- Symptoms of digestive system dysfunction are nausea, vomiting, periodic bloating, which are accompanied by dry mucous membranes. Somewhat less often, abdominal pain may appear, which is spastic in nature.
- From the nervous system – a slight disturbance of taste sensations.
- A change in a person’s general well-being after taking the drug, which is accompanied by headache, fever, and general weakness.
Cases of the development of severe skin lesions (Steven-Jones syndrome), the appearance of which was associated with taking drugs based on ambroxol, have been described.
However, such skin lesions are associated more with the underlying disease rather than with ambroxol.
If any manifestations, symptoms or reactions to taking AmbroHEXAL tablets appear, you must stop taking them and consult a doctor.
special instructions
Before you start using AmbroHEXAL tablets, you must read the instructions for the drug. It is important to take into account a number of features during subsequent use:
- The use of the drug in children under 2 years of age, pregnant or lactating women is possible only after a doctor’s prescription.
- Tablets can be taken only after meals - this will reduce their negative effect on the mucous membrane of the stomach and duodenum.
- During the course of treatment with AmbroHEXAL tablets, it is imperative to consume a significant amount of fluid, which will facilitate the process of liquefying sputum.
- The course of treatment with this drug is usually 4-5 days; if a dry cough continues and sputum stagnation in the bronchi occurs, the attending physician may extend the therapeutic course.
- AmbroHEXAL tablets can be combined well with other medications. In particular, this drug increases the concentration of antibiotics in sputum, which helps to quickly destroy the bacterial infection.
- AmbroHEXAL should not be combined with antitussives that suppress cough, as this can lead to accumulation of sputum in the bronchial tree and lungs.
- The drug can be used with caution in case of concomitant pathology of the liver or kidneys, and periodic monitoring of their functional activity must be carried out.
- AmbroHEXAL tablets do not affect a person’s attention and the speed of his reactions, so they can be used by people whose activities involve increased attention and the need for a quick reaction.
In pharmacies, AmbroHEXAL tablets are sold without a prescription (OTC group or group of over-the-counter drugs). If you have any additional questions regarding its use, dosage or duration of treatment, it is advisable to consult your doctor.
Overdose
Due to the wide range of therapeutic doses and low toxicity of the drug, there are practically no cases of overdose.
A significant increase in its concentration in the blood can be accompanied by nervous excitement, dryness of the mucous organs of the digestive and respiratory systems, and the development of diarrhea.
When such symptoms appear, gastric and intestinal lavage and detoxification therapy are performed.
Terms and conditions of storage
The shelf life of AmbroHEXAL tablets is 2 years. Storage must be ensured in a place protected from light, at an air temperature no higher than 25° C. It is also necessary to ensure that the storage area of the drug is inaccessible to children.
Analogs of AmbroHEXAL tablets
Preparations that contain ambroxol as the main active ingredient are Ambrobene, Lazolvan, Bronkhoxol, Medox, Flavamed, Ambrosan.
Price for AmbroHEXAL
AmbroHEXAL tablets 30 mg, 20 pcs. — from 82 rub.
Source: https://bezboleznej.ru/ambrogeksal-tab
AMBROHEXAL
Clinical and pharmacological group
Mucolytic and expectorant drug
Active substance
- ambroxol hydrochloride (ambroxol)
Release form, composition and packaging
◊ Tablets are white, round, flat, with beveled edges, scored on one side.
1 tab. | |
ambroxol hydrochloride | 30 mg |
Excipients: lactose monohydrate - 102 mg, calcium hydrogen phosphate dihydrate - 50 mg, corn starch - 10 mg, sodium carboxymethyl starch - 4 mg, magnesium stearate - 2 mg, colloidal silicon dioxide - 2 mg.
10 pieces. — contour cell packaging (2) — cardboard packs.
◊ The syrup is colorless or slightly yellowish, transparent or almost transparent.
1 ml | |
ambroxol hydrochloride | 3 mg |
Excipients: benzoic acid - 2 mg, sodium metabisulfite - 0.2 mg, citric acid monohydrate - 1 mg, sodium hydroxide - 0.92 mg, povidone - 25 mg, sorbitol 70% solution - 500 mg, glycerol 85% - 130 mg, sodium cyclamate - 4 mg, raspberry flavor - 2 mg, purified water to 1 ml - 473.58 mg.
100 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.
◊ The syrup is colorless to light yellow, transparent or almost transparent.
1 ml | |
ambroxol hydrochloride | 6 mg |
Excipients: benzoic acid - 2 mg, glycerol 85% - 127.5 mg, hyaetellose - 1 mg, sorbitol (70% solution) - 250 mg, apricot flavor - 2.5 mg, propylene glycol - 30 mg, levomenthol - 0.08 mg, purified water - up to 1 ml.
100 ml - dark glass bottles with a dosing device (1) complete with a measuring spoon - cardboard packs.
◊ Solution for oral administration and inhalation, colorless, transparent.
1 ml (20 drops) | |
ambroxol hydrochloride | 7.5 mg |
Excipients: methyl parahydroxybenzoate - 1.3 mg, propyl parahydroxybenzoate - 0.2 mg, sodium metabisulfite - 0.2 mg, citric acid - 2.5 mg, sodium hydroxide - 1 mg, water - 993.3 mg.
50 ml - dark glass dropper bottle (1) complete with a measuring cup - cardboard packs.
pharmachologic effect
Mucolytic drug with expectorant action. It has secretomotor, secretolytic and expectorant effects. Stimulates serous cells of the bronchial mucosa, increases the content of mucous secretions and the release of surfactant (surfactant) in the alveoli and bronchi, normalizes the disturbed ratio of serous and mucous components of sputum.
By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clara cells, ambroxol reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, and facilitates the removal of mucus from the respiratory tract.
When ambroxol is taken orally, the effect, on average, occurs after 30 minutes and lasts 6-12 hours, depending on the size of the single dose.
Pharmacokinetics
Suction
After oral administration, ambroxol is quickly and almost completely absorbed. Tmax is 1-3 hours.
Distribution
Plasma protein binding is approximately 85%. Ambroxol penetrates the placental barrier and is excreted in breast milk.
- Metabolism
- Metabolized in the liver to form metabolites (dibromanthranilic acid, glucuronic conjugates), which are excreted by the kidneys.
- Removal
It is excreted primarily by the kidneys - 90% in the form of metabolites, less than 10% unchanged. T1/2 from plasma is 7-12 hours. T1/2 of ambroxol and its metabolites is approximately 22 hours.
- Pharmacokinetics in special clinical situations
- Due to high protein binding and large Vd, as well as slow re-penetration from tissues into the blood, significant elimination of ambroxol does not occur during dialysis or forced diuresis.
- The clearance of ambroxol in patients with severe liver failure is reduced by 20-40%.
- In severe renal failure, T1/2 of ambroxol metabolites increases.
Indications
- Acute and chronic diseases of the respiratory tract with the release of viscous sputum:
- - acute and chronic bronchitis;
- - pneumonia;
- - COPD;
- - bronchial asthma with difficulty in sputum discharge;
- - bronchiectasis;
- - treatment and prevention of respiratory distress syndrome (for syrup 3 mg/ml and solution for oral administration and inhalation).
Contraindications
- — I trimester of pregnancy;
- - lactation period (breastfeeding);
- - children under 6 years of age (for tablets);
- - lactase deficiency, lactose intolerance, glucose-galactose malabsorption (for tablets);
- — hereditary fructose intolerance (for syrup);
- - hypersensitivity to ambroxol and other components of the dosage forms of the drug.
- with caution in case of gastric and duodenal ulcers (due to possible exacerbation), renal failure, liver failure, and in the second and third trimesters of pregnancy.
Dosage
During treatment with Ambrohexal, it is necessary to drink plenty of fluids (juices, tea, water) to enhance the mucolytic effect of the drug.
The duration of treatment with Ambrohexal is determined by the doctor individually and depends on the severity of the disease. If it is necessary to use the drug for more than 4-5 days, consult a doctor.
Pills
The drug should be taken orally after meals with sufficient liquid.
Adults and children over 12 years of age are prescribed 1 tablet. (30 mg) 3 times/day for the first 2-3 days. Then the dose of the drug should be reduced to 1 tablet. 2 times/day.
Children aged 6 to 12 years are prescribed 1/2 tablet. (15 mg) 2-3 times/day.
Syrup 3 mg/1 ml
The drug should be taken orally after meals. 1 scoop of Ambrohexal syrup (5 ml) contains 15 mg of ambroxol hydrochloride.
Adults and children over 12 years of age are prescribed 2 scoops 2-3 times/day (60-90 mg/day) in the first 2-3 days, then 2 scoops 2 times/day (60 mg/day). In severe cases of the disease, the dose is not reduced throughout the entire course of treatment. The maximum dose is 4 scoops (60 mg) 2 times a day (120 mg/day).
Children aged 5 to 12 years are prescribed 1 scoop 2-3 times a day (30-45 mg/day).
Children aged 2 to 5 years are prescribed 1/2 measuring spoon 3 times a day (22.5 mg/day).
Children under 2 years of age are prescribed 1/2 scoop 2 times a day (15 mg/day). The drug is prescribed only under the supervision of a doctor.
- Syrup 6 mg/1 ml
- The drug should be taken orally.
- Adults and children over 12 years of age are prescribed 1 measuring spoon (5 ml) 3 times a day for the first 2-3 days, then 1 measuring spoon (5 ml) 2 times a day.
Children aged 6 to 12 years are prescribed 1/2 measuring spoon (2.5 ml) 2-3 times a day.
Children aged 2 to 6 years are prescribed 1/4 measuring spoon (1.25 ml) 3 times a day.
Children under 2 years old: 1/4 measuring spoon (1.25 ml) 2 times a day. The drug is prescribed only under the supervision of a doctor.
- Solution for oral administration and inhalation
- Ingestion
- The drug should be taken orally after meals, diluted with tea, fruit juices, milk or water.
1 ml of solution (20 drops) contains 7.5 mg of ambroxol hydrochloride.
Adults and children over 12 years of age are prescribed 4 ml (80 drops) 3 times/day (90 mg/day) in the first 2-3 days, then 4 ml (80 drops) 2 times/day (60 mg/day ).
Children aged 5 to 12 years are prescribed 2 ml (40 drops) 2-3 times a day (30-45 mg/day).
Children aged 2 to 5 years are prescribed 1 ml (20 drops) 3 times a day (22.5 mg/day).
Children under 2 years of age are prescribed 1 ml (20 drops) 2 times a day (15 mg/day). The drug is prescribed only under the supervision of a doctor.
- Use in the form of inhalations
- Adults and children over 5 years of age are recommended to inhale 1-2 times a day, 2-3 ml (40-60 drops, which corresponds to 15-45 mg of ambroxol).
- Children under 5 years of age are recommended to inhale 2 ml (40 drops, which corresponds to 15-30 mg of ambroxol) 1-2 times a day.
The inhalation solution can be used using any modern inhalation equipment (except steam inhalers). The drug is mixed with saline; to achieve an optimal level of air humidification in the respirator, the drug can be diluted in a 1:1 ratio.
Since during inhalation therapy, a deep breath can provoke coughing impulses, inhalations should be carried out in normal breathing mode. Before inhalation, it is usually recommended to warm the inhalation solution to body temperature.
For patients with bronchial asthma, inhalation may be recommended after taking bronchodilators.
Classification of undesirable effects according to the frequency of their development (WHO): very often (≥1/10), often (from ≥1/100 to
Source: https://health.mail.ru/drug/ambrohexal/
Ambrohexal tablets - official instructions for use, analogues, price, availability in pharmacies
catad_pgroup Mucolytics and expectorants Analogs, articles Comments
INSTRUCTIONS for the use of the medicinal product for medical use
Registration number:
P N012596/01-261107
Trade name of the drug:
Ambrohexal®.
International nonproprietary name:
One tablet contains: active ingredient: ambroxol hydrochloride – 30.0 mg; excipients: lactose monohydrate – 102.0 mg; calcium hydrogen phosphate dihydrate – 50.0 mg; corn starch – 10.0 mg; sodium carboxymethyl starch – 4.0 mg; magnesium stearate – 2.0 mg; colloidal silicon dioxide – 2.0 mg.
Description : white, round, flat tablets with beveled edges, scored on one side.
Pharmacotherapeutic group:
expectorant, mucolytic agent.
ATX code : R05CB06.
Pharmacological properties
Pharmacodynamics
It has a secretomotor, secretolytic and expectorant effect, stimulates the serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and the release of surfactant in the alveoli and bronchi, normalizes the disturbed ratio of serous and mucous components of sputum.
By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, and facilitates the removal of mucus from the respiratory tract.
On average, the effect of taking ambroxol orally occurs within 30 minutes and lasts 6-12 hours, depending on the size of the single dose.
Pharmacokinetics
Ambroxol after oral administration is quickly and almost completely absorbed. The time to reach maximum concentration (TCmax) after oral administration is 1-3 hours. Metabolized in the liver to form metabolites excreted through the kidneys (dibromanthranilic acid, glucuronides). Plasma protein binding is approximately 85%.
The half-life (T1/2) from blood plasma is 7-12 hours. T1/2 of ambroxol and its metabolites is approximately 22 hours. 90% of ambroxol in the form of metabolites is excreted through the kidneys. Less than 10% of ambroxol is excreted unchanged through the kidneys.
Due to high protein binding and a large volume of distribution, as well as slow re-penetration from tissues into the blood, significant elimination of ambroxol does not occur during dialysis or forced diuresis. The clearance of ambroxol in patients with severe liver failure is reduced by 20-40%.
In severe renal failure, T1/2 of ambroxol metabolites increases. Ambroxol penetrates the placental barrier and into breast milk.
Indications for use
Acute and chronic diseases of the respiratory tract with the release of viscous sputum: • acute and chronic bronchitis; • chronic obstructive pulmonary disease (COPD); • pneumonia; • bronchial asthma with difficulty in sputum discharge;
• bronchiectasis.
• hypersensitivity to any component of the drug; • pregnancy (first trimester); • breastfeeding period; • lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• children under 6 years of age.
With caution : liver failure, renal failure, peptic ulcer of the stomach and duodenum, pregnancy (II-III trimester).
Use during pregnancy and breastfeeding
The drug is contraindicated for use during the first trimester of pregnancy.
The use of Ambrohexal® during pregnancy (II-III trimester) is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Ambroxol penetrates the placental barrier. Animal studies have shown that the drug has no effect on embryofetal development, childbirth and postnatal development.
Ambroxol is excreted in small quantities into breast milk, therefore, when taking Ambrohexal®, it is necessary to decide whether to stop breastfeeding.
Ambrohexal® is taken orally after meals with sufficient liquid.
Adults and children over 12 years of age: 1 tablet (30 mg ambroxol) 3 times a day for the first 2-3 days, then the dose of the drug must be reduced to 1 tablet 2 times a day.
Children from 6 to 12 years: 1/2 (15 mg ambroxol) tablets 2-3 times a day. It is not recommended to use without medical prescription for more than 4-5 days.
During treatment, it is necessary to drink a lot of liquid (juices, tea, water), as it enhances the mucolytic effect of the drug.
Side effect
According to the World Health Organization (WHO), adverse effects are classified according to their frequency as follows: very common (≥1/10), common (≥1/100 to
Source: https://medi.ru/instrukciya/ambrogeksal-tabletki_3127/
Ambrohexal
Ambrohexal is an expectorant and mucolytic medication used in the treatment of respiratory diseases.
Release form and composition
The drug is released in the form:
- Round white tablets containing 30 mg of ambroxol hydrochloride and excipients: lactose monohydrate, calcium hydrogen phosphate dihydrate, corn starch, sodium carboxymethyl starch, magnesium stearate, colloidal silicon dioxide. In blisters of 10 pieces;
- Long-acting hard gelatin capsules containing 75 mg of ambroxol hydrochloride and excipients: microcrystalline cellulose, eudragit RL30D and RS30D, triethyl citrate, magnesium stearate, titanium dioxide, red iron oxide dye. In blisters of 10 pieces;
- A colorless solution for inhalation and oral administration containing 1 ml (1 ml = 20 drops) 7.5 mg of ambroxol hydrochloride and excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium disulfite, citric acid, sodium hydroxide, water. In dropper bottles of 50 ml;
- Yellowish syrup containing in 1 ml 3 or 6 mg of ambroxol hydrochloride and excipients: benzoic acid, sodium disulfite, citric acid monohydrate, sodium hydroxide, povidone, sorbitol 70% solution, glycerol 85%, sodium cyclamate, raspberry flavor, purified water. In dark bottles of 100 ml with a measuring spoon.
Pharmacological properties
Pharmacodynamics
Ambroxol, the active component of Ambrohexal, is characterized by expectorant, secretolytic and secretomotor effects. It stimulates the work of serous cells of the glands located in the bronchial mucosa, increases the production of mucous secretion and enhances the release of surfactant in the bronchi and alveoli.
Ambroxol also normalizes the disturbed balance of the mucous and serous components of sputum and reduces the viscosity of sputum by activating enzymes responsible for hydrolysis and promoting the release of lysosomes from Clara cells.
This compound intensifies the motor activity of the ciliated epithelium, activates mucociliary transport and facilitates the process of removing mucus from the respiratory tract.
Typically, the therapeutic effect of ambroxol taken orally is observed after 30 minutes and lasts 6–12 hours, depending on the dose taken.
Pharmacokinetics
When taken orally, ambroxol is absorbed quickly and almost completely. The maximum concentration of the substance in this case is achieved 1–3 hours after administration.
Ambroxol is metabolized in the liver, forming metabolites excreted in the urine (glucuronides, dibromanthranilic acid). It binds to plasma proteins by approximately 85%.
The half-life from blood plasma is 7–12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours. 90% of the compound is excreted through the kidneys in the form of metabolites.
Less than 10% of ambroxol is excreted unchanged in the urine.
Since ambroxol binds to proteins to a significant extent and has a large volume of distribution, and is also characterized by slow re-penetration from tissues into the blood, forced diuresis or dialysis does not significantly affect its elimination.
In patients with severe hepatic dysfunction, the clearance of ambroxol is reduced by 20–40%. In severe renal failure, the half-life of ambroxol metabolites increases. The substance also easily penetrates the placental barrier and into breast milk.
Indications for use
Ambrohexal is prescribed for the treatment of:
- Acute and chronic diseases of the respiratory tract, characterized by the formation of viscous secretions;
- Bronchial asthma with difficulty in sputum discharge;
- Chronic obstructive pulmonary disease;
- Pneumonia;
- Acute and chronic bronchitis;
- Bronchiectasis.
Ambrohexal syrup and solution for oral administration and inhalation is also used for the treatment and prevention of respiratory distress syndrome.
Contraindications
- First trimester of pregnancy;
- Hypersensitivity to the active substance (ambroxol) and auxiliary components of the drug.
According to the instructions, Ambrohexal in the form of tablets is allowed from 6 years of age, capsules - from 12 years of age.
The medication is prescribed with caution to nursing women, as well as against the background of:
- Peptic ulcer of the stomach and duodenum (due to the risk of possible exacerbation of the disease);
- Kidney and liver failure.
Instructions for use of Ambrohexal: method and dosage
Ambrohexal syrup is prescribed for children over 12 years of age and adults 3 times a day, 2 scoops (30 mg). Maximum – 120 mg per day. After the condition improves, it is recommended to reduce the frequency of administration to 2 times a day.
For children, syrup is used according to the following scheme:
- Children 6-12 years old – one measuring spoon 2-3 times a day;
- Children 2-5 years old – 0.5 scoops 3 times a day;
- Children under two years old – 0.5 scoops 2 times a day.
For children over 12 years of age and adults, the first few days of treatment are prescribed 1 tablet of Ambrohexal 3 times a day, after which the frequency of use must be reduced to 2 times a day. A single dosage for children 6-12 years old is 1/2 tablet.
Capsules are taken after meals in the morning or evening. The daily dosage for adults and children over 12 years of age is 1 capsule.
Solution for oral administration and inhalation Ambrohexal is usually prescribed 3 times a day, 4 ml (30 mg). After the condition improves, the frequency is reduced to 2 times a day.
For children 5-12 years old, the maximum daily dose of the drug in this dosage form is 45 mg, divided into several doses, for children 2-5 years old - 15 mg.
The solution is taken after meals by adding it to tea, fruit juice, milk or water.
Inhalations with Ambrohexal solution are indicated up to 2 times a day. Single dosage for all age groups – 2-3 ml.
The duration of treatment is determined by the doctor individually depending on the indications and severity of the disease. A doctor's supervision is necessary when taking the product for longer than 4-5 days.
Side effects
The drug may cause:
- Urticaria;
- Contact allergic dermatitis;
- Skin rash;
- Angioedema;
- Anaphylactic shock;
- Dry mouth;
- Diarrhea;
- Headache;
- Weakness;
- Nausea;
- Vomiting;
- Rhinorrhea;
- Constipation;
- Gastralgia.
When using ambroxol in high doses, you may also experience nausea, diarrhea, vomiting, and dyspepsia. For treatment, induce vomiting, wash the stomach, and eat fat-containing foods.
Overdose
Symptoms of overdose include increased salivation (when taking 6 mg/ml syrup), dyspepsia, nausea, vomiting, gastralgia, diarrhea.
It is recommended to immediately stop taking the drug, induce artificial vomiting and rinse the stomach during the first 1-2 hours after the drug enters the body.
Eating fat-containing foods and symptomatic therapy will also help improve the patient's condition.
special instructions
- Caution requires the use of Ambrohexal against the background of a weakened cough reflex or impaired mucociliary transport, since there is a risk of sputum accumulation.
- Against the background of severe impairment of liver or kidney function, the use of lower concentrations of Ambrohexal or an increase in the interval between doses of the medication is indicated.
- Use of the medicine before bedtime is not recommended.
- Against the background of bronchial asthma, Ambrohexal may increase cough.
During drug therapy, breathing exercises are not recommended. In cases of severe disease, it is necessary to perform aspiration of liquefied sputum.
Impact on the ability to drive vehicles and complex mechanisms
According to the instructions, Ambrohexal does not have a negative effect on the ability to drive a car or operate highly complex mechanisms.
Use during pregnancy and lactation
Ambrohexal is prohibited for use in the first trimester of pregnancy. Its administration in the second and third trimesters is allowed if the possible benefits of treatment for the mother significantly outweigh the potential risks for the fetus.
Ambroxol easily penetrates the placental barrier.
The results of animal experiments confirmed that the drug does not have a significant effect on embryofetal and postnatal development, as well as childbirth.
The active component of the drug is excreted in small quantities into breast milk, so during treatment it is necessary to consider the advisability of stopping breastfeeding.
For impaired renal function
Ambrohexal is prescribed with caution in case of renal failure. In case of severe renal dysfunction, it is recommended to switch to lower concentrations of the drug or increase the interval between doses.
For liver dysfunction
Ambrohexal should be used with caution in case of liver failure. In case of severe liver function disorders, the dose of the drug should be reduced or the interval between doses should be increased.
Drug interactions
When Ambrohexal is combined with other antitussive drugs (including codeine) against the background of cough suppression, difficulty in sputum discharge may occur.
The drug increases the degree of penetration of erythromycin, amoxicillin, doxycycline, and cefuroxime into the bronchial secretions.
Analogs
The following drugs are analogues of Ambrohexal:
- By active substance - Ambrobene, Flavamed, Ambroxol, Halixol, Bronchoxol, Bronchorus, Ambrolor, Neo-Bronchol, Lazolvan, Medox, Lazongin, Remebrox;
- According to the mechanism of action - Cashnol, Joset, Fluifort, Bromhexine, Ascoril, Acestine, ACC, Acetylcysteine, Bronchobos, Fluditek, Erdomed, Bronchotil, Mukonex, Sinupret, Solvin, Pulmozim, Fluimucil, Bronchostop.
Terms and conditions of storage
The shelf life of tablets is 5 years, capsules and syrup – 3 years, solution for inhalation and oral administration – 4 years.
Store in a dry, dark place at a temperature not exceeding 25 °C.
Conditions for dispensing from pharmacies
Available without a prescription.
Reviews about Ambrohexal
According to reviews, Ambrohexal in tablet form is very well tolerated and demonstrates high effectiveness in the treatment of severe dry cough. There are practically no side effects when treating with the drug.
Many patients like it because of its low cost and availability. The syrup has the same pharmacological properties and attracts patients with a pleasant sweetish taste.
Usually, within a week after the start of therapy, the cough in most patients disappears without a trace.
Inhalations with Ambrohexal solution also have positive reviews.
The main advantages of the drug are the variety and convenience of release forms, acceptable treatment results and rapid recovery with its use.
Parents note that inhalations with Ambrohexal and saline help to relieve children from painful coughing attacks in the shortest possible time. However, there are references to the unpleasant taste of this dosage form.
Price for Ambrohexal in pharmacies
The price of Ambrohexal tablets in most pharmacies averages 109–117 rubles (the package includes 20 pieces).
Ambrohexal syrup with a dosage of 3 mg/ml can be purchased for 93–112 rubles, and with a dosage of 6 mg/ml – for 205–229 rubles (per 100 ml bottle).
The solution for inhalation and oral administration costs approximately 89–102 rubles (per 50 ml bottle). Extended-release capsules are currently not commercially available.
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