Tablets ambrohexal 30 mg instructions for use. Ambrohexal (tablets, capsules, solution): instructions for use. Shelf life and approximate cost

Mucolytic and expectorant drug

pharmachologic effect

Mucolytic drug with expectorant action. It has a secretomotor, secretolytic and expectorant action. Stimulates the serous cells of the bronchial mucosa, increases the content of the mucous secretion and the release of a surfactant (surfactant) in the alveoli and bronchi, normalizes the disturbed ratio of the serous and mucous components of sputum.

By activating hydrolyzing enzymes and increasing the release of lysosomes from Clara cells, ambroxol reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, facilitates the removal of sputum from the respiratory tract.

When taking Ambroxol orally, the effect, on average, occurs after 30 minutes and lasts 6-12 hours, depending on the size of a single dose.

Pharmacokinetics

Suction

After oral administration, Ambroxol is rapidly and almost completely absorbed. T max is 1-3 hours.

Distribution

Plasma protein binding is approximately 85%. Ambroxol crosses the placental barrier and is excreted in breast milk.

Metabolism

It is metabolized in the liver to form metabolites (dibromanthranilic acid, glucuronic conjugates), which are excreted by the kidneys.

breeding

It is excreted mainly by the kidneys - 90% in the form of metabolites, less than 10% unchanged. T 1/2 from plasma is 7-12 hours. T 1/2 of ambroxol and its metabolites is approximately 22 hours.

Pharmacokinetics in special clinical situations

Due to the high protein binding and large V d , as well as the slow reverse penetration from the tissues into the blood, during dialysis or forced diuresis, significant excretion of ambroxol does not occur.

The clearance of ambroxol in patients with severe hepatic insufficiency is reduced by 20-40%.

In severe renal failure T 1/2 ambroxol metabolites increases.

Acute and chronic diseases of the respiratory tract with the release of viscous sputum:

Acute and chronic bronchitis;

Pneumonia;

Bronchial asthma with difficulty in sputum discharge;

bronchiectasis;

Treatment and prevention of respiratory distress syndrome (for 3 mg/ml syrup and oral and inhalation solution).

I trimester of pregnancy;

lactation period (breastfeeding);

Children's age up to 6 years (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.

FROM caution the drug should be used for peptic ulcer of the stomach and duodenum (due to possible exacerbation), renal failure, liver failure, in the II and III trimesters of pregnancy.

Classification of undesirable effects according to the frequency of their development (WHO): very often (≥1/10), often (from ≥1/100 to<1/10), нечасто (от ≥1/1000 до <1/100), редко (от ≥1/10 000 до <1/1000), очень редко (<1/10 000), частота неизвестна - по имеющимся данным установить частоту возникновения не представлялось возможным.

Allergic reactions: rarely - skin rash, urticaria; the frequency is unknown - anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions. For syrup 6 mg / ml additionally: rarely - exanthema, swelling of the face, shortness of breath, itching, fever; very rarely - angioedema; frequency unknown - allergic contact dermatitis.

From the digestive system: often - nausea; infrequently - vomiting, diarrhea, dyspepsia, pain in the abdominal cavity. For syrup 3 mg / ml additionally: infrequently - heartburn. For syrup 6 mg / ml: often - oral and pharyngeal hypesthesia; infrequently - with prolonged use in high doses - gastralgia, nausea, vomiting; rarely - diarrhea.

From the nervous system: often - a change in taste sensations.

From the side of the skin: for syrup 6 mg / ml: very rarely - severe skin reactions (epidermal necrolysis, Stevens-Johnson syndrome).

Others: often - decreased sensitivity in the oral cavity or pharynx; infrequently - dry mouth; frequency unknown - dryness of the mucous membranes of the respiratory tract. For syrup 6 mg / ml: rarely - dry mouth and respiratory tract, rhinorrhea, dysuria, weakness, headache.

Overdose

Symptoms: nausea, vomiting, diarrhea, gastralgia, dyspepsia, increased salivation (syrup 6 mg / ml).

Treatment: cancel the drug, induce artificial vomiting, perform gastric lavage during the first 1-2 hours after taking the drug; intake of fat-containing products; symptomatic therapy.

special instructions

Ambroxol should not be taken concomitantly with antitussive drugs that can inhibit the cough reflex, such as codeine, because. this can make it difficult to remove liquefied sputum from the bronchi.

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Ambroxol should not be taken immediately before bedtime.

In patients with bronchial asthma, ambroxol may increase coughing.

In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - an influenza-like condition may be observed in the early phase: fever, body pain, rhinitis, cough, pharyngitis. With symptomatic therapy, the erroneous prescription of mucolytic agents, such as ambroxol hydrochloride, is possible.

There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding in time with the appointment of the drug. However, there is no causal relationship with drug use.

With the development of the above syndromes, it is recommended to stop taking the drug; the patient should immediately consult a doctor.

The solution for oral administration and inhalation contains sodium metabisulphite (preservative), which can cause the development of hypersensitivity reactions (especially in patients with bronchial asthma), which manifests itself in the form of vomiting, diarrhea, bronchospasm attacks, impaired consciousness or anaphylactic shock. These reactions can be very individual and can also lead to life-threatening consequences.

For syrup 6 mg/ml additionally: in case of violations of bronchial motility and an increase in the amount of secretion (for example, immobile cilia syndrome) due to the risk of accumulation of mucus, the drug can be taken only after consultation with the attending physician and under medical supervision. In case of severe impairment of kidney and liver function, lower concentrations should be used, or the interval between doses of the drug should be increased.

Note for diabetic patients: 1 tablet contains less than 0.01 XE; 1 scoop (5 ml) of 3 mg/ml syrup contains 1.75 g of sorbitol (less than 0.15 XE); 1 scoop (5 ml) of 6 mg/ml syrup contains 2.525 g of sorbitol (0.21 XE).

Influence on the ability to drive vehicles and control mechanisms

Ambrohexal ® does not adversely affect the ability to drive vehicles or work with mechanisms.

With kidney failure

FROM caution the drug should be used in renal failure.

In severe renal impairment, lower concentrations should be used, or the interval between doses of the drug should be increased.

In violation of the functions of the liver

FROM caution the drug should be used in liver failure.

In severe liver dysfunction, lower concentrations should be used, or the interval between doses of the drug should be increased.

Use during pregnancy and lactation

The drug is contraindicated for use in the first trimester of pregnancy.

The use of the drug in the II and III trimesters of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

Ambroxol crosses the placental barrier. AT experimental studies in animals it has been shown that the drug has no effect on embryonic development, childbirth and postnatal development.

Ambroxol is excreted in small amounts in breast milk, therefore, when using the drug Ambrohexal ®, it is necessary to resolve the issue of stopping breastfeeding.

drug interaction

With the simultaneous use of the drug Abrohexal ® with antitussives (including codeine), there is a difficulty in sputum discharge against the background of a decrease in cough.

Abrohexal ® increases the penetration of amoxicillin, cefuroxime, doxycycline, erythromycin into the bronchial secretion.

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, a doctor's consultation is required.

Tablets

The drug should be taken orally after a meal with a sufficient amount of liquid.

Assign 1 tab. (30 mg) 3 times / day for the first 2-3 days. Then the dose of the drug should be reduced to 1 tab. 2 times/day

Assign 1/2 tab. (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 the age of 12 appoint 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 during the entire course of treatment. The maximum dose is 4 scoops (60 mg) 2 times / day (120 mg / day).

Assign 1 scoop 2-3 times / day (30-45 mg / day).

Assign 1/2 measuring spoon 3 times / day (22.5 mg / day).

Children under 2 years of age appoint 1/2 measuring spoon after 2 times / day (15 mg / day). The drug is prescribed only under the supervision of a physician.

Syrup 6 mg/1 ml

The drug should be taken orally.

Adults and children over the age of 12 appoint 1 scoop (5 ml) 3 times / day for the first 2-3 days, then 1 scoop (5 ml) 2 times / day.

Children aged 6 to 12 appoint 1/2 measuring spoon (2.5 ml) 2-3 times / day.

Children aged 2 to 6 years appoint 1/4 measuring spoon (1.25 ml) 3 times / day.

Children under 2 years of age: 1/4 measuring spoon (1.25 ml) 2 times / day. The drug is prescribed only under the supervision of a physician.

Solution for oral and inhalation

Ingestion

The drug should be taken orally after meals in a diluted form with tea, fruit juices, milk or water.

1 ml of solution (20 drops) contains 7.5 mg of ambroxol hydrochloride.

Adults and children over the age of 12 appoint 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 appoint 2 ml (40 drops) 2-3 times / day (30-45 mg / day).

Children aged 2 to 5 years appoint 1 ml (20 drops) 3 times / day (22.5 mg / day).

Children under 2 years old appoint 1 ml (20 drops) 2 times / day (15 mg / day). The drug is prescribed only under the supervision of a physician.

Application in the form of inhalations

Adults and children over 5 years of age it is recommended to carry out inhalations 1-2 times / day for 2-3 ml (40-60 drops, which corresponds to 15-45 mg of ambroxol).

The solution for inhalation can be used using any modern inhalation equipment (except for steam inhalers). The drug is mixed with saline, to achieve the optimal level of air humidification in the respirator, the drug can be diluted in a ratio of 1:1. Since during inhalation therapy a deep breath can provoke coughing shocks, inhalations should be carried out in normal breathing mode. Before inhalation, it is usually recommended to warm the inhalation solution to body temperature. Patients with asthma may be advised to inhalation after taking bronchodilator drugs.

Storage conditions and shelf life

The drug in the form of tablets should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C. Shelf life - 5 years. The drug in the form of a syrup should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C. Shelf life - 2 years. The drug in the form of a solution for oral administration and inhalation should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C. Shelf life - 4 years.

Vacation from pharmacies

The drug is approved for use as a non-prescription drug.RU1509383330

INSTRUCTIONS
on the use of a medicinal product for medical use

Registration number:

P N012596/01-261107

Trade name of the drug:

Ambrohexal ® .

International non-proprietary name:

ambroxol.

Dosage form:

tablets.

Compound:

One tablet contains:
active substance: ambroxol hydrochloride - 30.0 mg;
Excipients: lactose monohydrate - 102.0 mg; calcium hydrophosphate 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, notched on one side.

Pharmacotherapeutic group:

ATX code: R05CB06.

Pharmacological properties

Indications for use

Contraindications

Carefully: liver failure, renal failure, peptic ulcer of the stomach and duodenum, pregnancy (II-III trimester).

Use during pregnancy and during breastfeeding

Dosage and administration

Ambrohexal ® is used orally after a meal with a sufficient amount of liquid.
Adults and children over 12 years of age: 1 tablet (30 mg of Ambroxol) 3 times a day for the first 2-3 days, then the dose of the drug should be reduced to 1 tablet 2 times a day.
Children from 6 to 12 years old: 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 plenty of fluids (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 of development as follows: very often (≥1/10), often (from ≥1/100 to<1/10), нечасто (от ≥1/1,000 до <1/100), редко (от ≥1/10,000 до <1/1,000), очень редко (<1/10,000); частота неизвестна – по имеющимся данным установить частоту возникновения не представлялось возможным.
allergic reactions
rarely: skin rash, urticaria;
frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions.
From the gastrointestinal tract
often: nausea;
infrequently: vomiting, diarrhea, dyspepsia and pain in the abdominal cavity.
From the side of the nervous system
often: change in taste sensations.
Other
often: decreased sensitivity in the oral cavity or pharynx;
infrequently: dry mouth;
frequency unknown: dryness of the mucous membranes of the respiratory tract.

Overdose

Interaction with other drugs

Simultaneous use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough. Increases penetration into bronchial secretions amoxicillin, cefuroxime, erythromycin and doxycycline.

special instructions

Influence on the ability to drive vehicles, mechanisms

Ambrohexal ® does not adversely affect the ability to drive a car or work with mechanisms.

Release form

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

5 years.
Do not use the drug after the expiration date.

Holiday conditions

Manufacturer

Ambrohexal is a drug that has a mucolytic, secretolytic and expectorant effect, and the active ingredient of the drug is ambroxol.

The mechanism of action of this drug is associated with a decrease in sputum viscosity as a result of depolymerization of sputum mucopolysaccharides, which consists in breaking disulfide bonds in molecules, enhancing the release of active hydrolyzing enzymes from Clark cells.

On this page you will find all the information about Ambrohexal: full instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Ambrohexal. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

A drug with secretolytic, mucolytic and expectorant effects.

Terms of dispensing from pharmacies

No prescription needed.

Prices

How much does Ambrohexal cost? The average price in pharmacies depends on the form of release:

1. The cost of Ambrohexal tablets is about 84 rubles for 20 pieces.
2. Long-acting capsules will cost 120 rubles for 10 pieces.
3. A bottle of liquid for inhalation costs about 92 rubles per 50 ml.
4. The syrup costs about 103 rubles per 100 ml.

Release form and composition

To date, the drug is sold in the following dosage forms:

• Tablets of 10 pieces in a blister, in one box 2, 5 or 10 blister packs;
• Capsules - 10 pieces in a blister, in cardboard packs of 1, 2 or 5 blister packs;
• Solution for inhalation and oral administration - 50 or 100 ml in vials with a measuring cup included;
• Syrup - in bottles of 100 or 250 ml with a measuring spoon included.

The active ingredient of the drug is ambroxol. Auxiliary components are different and depend on the form of release.

Pharmacological effect

The mechanism of action is based on increased stimulation of the movement of the ciliated epithelium of the bronchi. Ambrohexal improves bronchial motility and stimulates sputum secretion. The drug copes with a number of therapeutic tasks: reduction of cough, improvement of bronchial secretion, normalization of sputum separation, promotion of sputum along the bronchopulmonary pathways.

Indications for use

The doctor prescribes Ambrohexal cough tablets in case of a disease of the lungs or respiratory tract, accompanied by thick sputum, the removal of which is problematic (often the patient also suffers from a dry cough).

The list of such ailments is as follows:

• - inflammation in the tracheal mucosa due to infection and other causes;
• - such a pathology is of an allergic origin, with it the bronchi narrow, and thick sputum accumulates in their lumen;
• cystic fibrosis - such a disease is hereditary, distinguished by its severity (characterized by the production of viscous sputum);
• (inflammation of the lungs), occurs due to the presence of various bacteria;
• infectious (chronic or acute course) - with it, the mucous membrane of the bronchi becomes inflamed, which is provoked by bacteria or viruses;
• bronchiectasis, which is a pathological chronic process characterized by partial expansion of the bronchi and bronchioles (places of accumulation of viscous sputum);
• - most often provoked by long-term irritation of the bronchial mucosa by smoking and the influence of various chemical compounds.

First of all, after taking the medicine, the protective function of the respiratory tract improves.

Contraindications

You can not use Ambrohexal in the treatment of hypersensitivity to the active components of the drug, as well as with a stomach or duodenal ulcer. In severe liver and kidney damage, the mucolytic is used with great care. If the cough reflex is disturbed, congestion may occur due to the accumulation of sputum.

Use during pregnancy and lactation

Taking Ambrohexal during pregnancy is contraindicated, because there is always a risk of negative effects on the developing fetus.

However, due to the fact that ambroxol is a stimulant of lung development in the perinatal period, by increasing the synthesis of surfactant and blocking its decay, it is prescribed to pregnant women with suspected development of fetal malnutrition to stimulate lung maturation, as well as with the threat of premature birth.

Instructions for use Ambrohexal

The instructions for use indicate that the drug in the form of tablets and capsules is taken orally with water after meals.

1. Tablets adults and children over 12 years of age are prescribed at a dosage of 30 mg (1 tablet) three times a day for the first 2-3 days. Further, the dosage is reduced to 1 tablet twice a day. Children aged 6 to 12 years are prescribed half a tablet (15 mg) two to three times a day. Do not take the drug for more than 4-5 days without a doctor's prescription. During the entire treatment, the patient is advised to drink more fluids to enhance the mucolytic effect.
2. A drug in the form of capsules prescribed for adults and children over 12 years of age at a dosage of 1 capsule (75 mg) per day after meals in the morning or evening. Capsules are also not recommended to be taken for more than 5 days without a doctor's prescription.
3. Solution for oral administration and preparation of inhalations adults and children over 12 years of age are prescribed 4 ml (30 mg) 3 times a day for the first 2-3 days, then 4 ml once a day. Children from 5 to 12 years old are prescribed 2 ml two to three times a day. Children from 2 to 5 years - 1 ml three times a day. Children under two years old - 1 ml 2 times a day only under medical supervision. The solution should be dissolved in tea, water, juice or milk.

Inhalations with Ambrohexal solution for adults and children over 5 years old are carried out 1-2 times a day at a dosage of 2-3 ml, for children under 5 years old - 2 ml each. Inhalations should be carried out using a special device.

The course of treatment can be prescribed only by the attending physician.

Side effects

Ambroxol as part of AmbroGEKSAL tablets is well tolerated. Sometimes it is possible to develop its side effects, which are characterized by such manifestations:

• Symptoms of disruption of the digestive system - nausea, vomiting, periodic bloating, which are accompanied by dryness of the mucous membranes. Somewhat less often, pain in the abdomen, which is spastic in nature, may appear.
• On the part of the nervous system - a slight violation of taste sensations.
• A change in the general well-being of a person after taking the drug, which is accompanied by headache, fever, general weakness.
• 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 a slight edema, 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 there is a progressive decrease in systemic blood pressure and loss of consciousness.

Cases of the development of severe skin lesions (Stephen-Jones syndrome) have been described, the appearance of which was associated with the use of drugs based on ambroxol. However, such skin lesions are associated more with the underlying disease than with ambroxol. In the event of any manifestations, symptoms or reactions to taking AmbroGEXAL tablets, you must stop taking them and consult a doctor.

drug interaction

Simultaneous use with antibiotics (erythromycin, amoxicillin) leads to an increase in their concentration in sputum and bronchopulmonary secretions.

When combined with antitussives containing codeine, sputum stagnation is possible due to inhibition of the cough center.

Ambrohexal can be used with drugs used in bronchial syndrome (bronchospasmolytics, glucocorticosteroids, cardiac glycosides, diuretics).