Ambroxol tablets instructions for use for children. Release form, composition and packaging. What antibiotics are best to take with Ambroxol?

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Ambroxol cough tablets: application

Ambroxol is a mucolytic agent with an expectorant effect, the active substance of which is ambroxol hydrochloride. The drug has an expectorant effect, stimulates the discharge of sputum during wet cough, reduces the viscosity of the secretion of the bronchial glands. Ambroxol stimulates the bronchi, increases secretion, secretion active substance in the alveoli and bronchi, normalizes the balance between the serous and mucous substance of sputum, reduces the viscosity of sputum, increases movement ciliated epithelium upper respiratory tract. The drug has several forms of release: tablets for oral administration (including prolonged action), effervescent tablets, capsules, syrup for children, solution for oral administration and solution for inhalation. Tablets can be taken by children over 12 years of age and adults 30 mg three times a day for the first two to three days, and then 15 mg three times a day or 30 mg three times a day. Children 6-12 years old are prescribed 15 mg two to three times a day.

Ambroxol syrup for children

Ambroxol syrup is a viscous, colorless liquid with a raspberry odor and sweet taste. The syrup is packaged in dark glass bottles of 100 ml each. This form of the drug is preferable for children under 12 years of age. It is given after meals, then you can drink it with any liquid. Do not give syrup on an empty stomach, as there may be problems with gastrointestinal tract. So, children under 2 years old are prescribed half a measuring spoon twice a day, children 2-6 years old - the same dosage, but three times a day, children 6-12 years old - one measuring spoon two or three times a day. The course of treatment usually lasts no more than 2 weeks. The syrup does not contain sugar, so it can be given to children with diabetes mellitus.

Ambroxol for inhalation

Inhalations with Ambroxol are allowed for children over 5 years of age and adults. For children, it is enough to take one inhalation per day, diluting 2 ml of Ambroxol solution in an isotonic sodium chloride solution. You can use any modern equipment for inhalation, except for a steam inhaler. For adults, the dosage is 3 ml of Ambroxol solution diluted in saline in a 1:1 ratio per inhalation. You need to carry out two such inhalations per day.

Ambroxol: original instructions for use

Name:

Ambroxol (Ambroxolum)

Pharmacological
action:

Mucolytic expectorant. Stimulates the serous cells of the glands of the bronchial mucosa, increasing the content of mucous secretion and, thus, changing the disturbed ratio of serous and mucous components of sputum.
At the same time, hydrolyzing enzymes are activated and the release of lysosomes from Clara cells is enhanced, which leads to a decrease in the viscosity of sputum. Ambroxol increases the content of surfactant in the lungs, which is associated with an increase in its synthesis and secretion in alveolar pneumocytes, as well as a violation of its breakdown.
Increases mucociliary transport of sputum. Slightly suppresses cough.

Pharmacokinetics
After oral administration, ambroxol is almost completely absorbed from the gastrointestinal tract. Cmax in blood plasma is reached after approximately 0.5-3 hours. It does not accumulate.
Plasma protein binding is about 90%.
After ingestion and parenteral administration Ambroxol is quickly distributed in body tissues, most high concentration determined in the lungs.
Penetrates the BBB and placental barrier, is excreted from breast milk.
Metabolized in the liver by conjugation to form pharmacologically inactive metabolites.
T1/2 is 7-12 hours.
It is excreted primarily by the kidneys in the form of metabolites - 90%, unchanged - 5%.
T1/2 increases in severe chronic renal failure.

Indications for
application:

Acute and chronic diseases of the respiratory tract in children and adults, accompanied by difficult elimination of viscous secretions (acute and Chronical bronchitis, bronchiectasis, tracheitis, laryngitis, pharyngitis, sinusitis, rhinitis, pneumonia, asthma);
- respiratory distress syndrome in newborns and adults ( shock lung);
- prevention and treatment pulmonary complications after operation;
- tracheostomy care;
- during preparation for bronchoscopy and after the study;
- pulmonary cystic fibrosis.

Mode of application:

Adult patients and children over 12 years of age Ambroxol is prescribed after meals, 30 mg 2 times, and if necessary - 3 times a day.
During exacerbation chronic diseases the dose can be increased to 60 mg 2 times a day. The therapeutic dose for children is 1.2–1.6 mg/kg/day in 3 divided doses.
Parenterally, adults are usually administered 30–60 mg/day in 3 divided doses.. Maximum single dose- 30 mg. As a rule, the solution is administered intravenously and intramuscularly, although subcutaneous administration is also acceptable.
For shock lung syndrome, the dose of ambroxol is 10 mg/kg/day in 3–4 doses.
If necessary daily dose increase to 30 mg/kg in 3–4 doses.
Solution for inhalation- adults and children over 5 years of age are prescribed 1–2 inhalations per day using about 2–3 ml of solution; Children under 5 years of age are prescribed 1–2 inhalations per day using 2 ml of solution (15 mg of ambroxol).

Side effects:

From the outside digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain;
- allergic reactions: skin rash, urticaria, angioedema;
- other: rarely - weakness, headache.

Contraindications:

Gastric ulcer and duodenum;
- convulsive syndrome of various etiologies;
- I trimester of pregnancy;
- hypersensitivity to ambroxol.

Interaction
other medicinal
by other means:

When used simultaneously with antitussives, it becomes difficult to separate sputum while reducing cough; with amoxicillin, doxycycline, cefuroxime, erythromycin - increasing their penetration into the bronchial secretions.
Ambroxol is compatible with drugs that inhibit labor.
In patients suffering from bronchial asthma, in order to avoid nonspecific irritation of the respiratory tract and their spasm, bronchodilators can be used before inhalation of ambroxol.

Pregnancy:

Ambroxol is contraindicated in the first trimester of pregnancy.
If necessary, use in the 2nd and 3rd trimesters should be assessed potential benefits therapy for the mother and possible risk to the fetus.
If it is necessary to use ambroxol during lactation, the issue of stopping it should be decided. breastfeeding.


Ambroxol tablets- mucolytic agent, stimulates prenatal development lungs (increases synthesis, secretion of surfactant and blocks its breakdown). It has secretomotor, secretolytic and expectorant effects; 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 Clark cells, it reduces the viscosity of sputum. Increases motor activity ciliated epithelium, increases mucociliary transport. After oral administration, the effect occurs within 30 minutes and lasts for 6-12 hours.

Pharmacokinetics

Absorption is high, time to reach Cmax is 2 hours, binding to plasma proteins is 80%. Penetrates the blood-brain barrier, placental barrier, and is excreted in breast milk.
Metabolism - in the liver, forms dibromoantranilic acid and glucuronic conjugates. T1/2 - 7-12 hours.
Excreted by the kidneys: 90% in the form of water-soluble metabolites, unchanged - 5%. T1/2 increases with severe chronic renal failure, does not change with impaired liver function.

Indications for use

Pills Ambroxol used for the treatment of respiratory diseases with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchial asthma with difficulty in sputum discharge, bronchiectasis, cystic fibrosis.

Mode of application

Pills Ambroxol take orally, during meals, with a small amount of liquid.
Adults and children over 12 years of age are prescribed 30 mg 3 times a day. in the first 2-3 days, then 30 mg 2 times a day. or 15 mg (half a tablet) 3 times a day.
Children 6-12 years old - 15 mg (half a tablet) 2-3 times a day.
It is not recommended to use without medical prescription for more than 4-5 days.

Side effects

Allergic reactions: skin rash, urticaria, angioedema, in in some cases- allergic contact dermatitis, anaphylactic shock.
Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. At long-term use in high doses - gastralgia, nausea, vomiting.

Contraindications

Contraindications to the use of tablets Ambroxol are: hypersensitivity, childhood up to 6 years, pregnancy (1st trimester).
With caution: the drug should be used with caution in patients with gastric and duodenal ulcers, as well as in patients with renal and liver failure.

Pregnancy

A drug Ambroxol tablets It is not recommended to use during the first trimester of pregnancy. If it is necessary to use Ambroxol in the II-III trimesters of pregnancy and during breastfeeding, the potential benefits for the mother with possible risk for the fetus/child.

Interaction with other drugs

Combined use with antitussive drugs leads to difficulty in sputum discharge while reducing cough. Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretions.

Overdose

Symptoms of an overdose of tablets Ambroxol: nausea, vomiting, diarrhea.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fat-containing foods.

Storage conditions

A drug Ambroxol store in a dry place, protected from light and out of reach of children, at a temperature not exceeding 25°C.
Shelf life - 3 years. Do not use after the date indicated on the package.

Release form

Ambroxol - pills. 10 tablets per blister, 2 blisters per pack.

Compound

1 tablet Ambroxol contains ambroxol hydrochloride in terms of 100% substance - 30 mg; potato starch; lactose monohydrate, calcium stearate.

Ambroxol INN (caps. prolong., oral solution, oral solution alcohol., oral solution and d/ing., syrup, tab., tablet prolong)

Ambroxol INN (caps. prolong., solution inside, solution inside alcohol., solution inside and d/ing., syrup, tab., tab. prolon, tablet spike.

Dosage form: extended-release capsules, oral solution, oral solution [alcoholic], oral and inhalation solution, syrup, tablets, extended-release tablets, effervescent tablets

Pharmachologic effect:

A mucolytic agent that stimulates the prenatal development of the lungs (increases the synthesis and secretion of surfactant and blocks its breakdown). It has secretomotor, secretolytic and expectorant effects; 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 Clark cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport. After oral administration, the effect occurs within 30 minutes, with rectal administration- after 10-30 minutes and continues for 6-12 hours.

Pharmacokinetics:

Absorption is high (for any route of administration), TCmax is 2 hours, binding to plasma proteins is 80%. Penetrates through the BBB, placental barrier, and is excreted in breast milk. Metabolism - in the liver, forms dibromoantranilic acid and glucuronic conjugates. T1/2 - 7-12 hours. Excreted by the kidneys: 90% in the form of water-soluble metabolites, unchanged - 5%. T1/2 increases with severe chronic renal failure, does not change with impaired liver function.

Indications:

Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, COPD, bronchial asthma with difficulty in sputum discharge, bronchiectasis. Stimulation of prenatal lung maturation, treatment and prevention (if there is a threat of premature birth and with indicated artificial premature birth between 28 and 34 weeks of pregnancy, if clinical picture allows us to assume an extension of the gestational age by 3 days) respiratory distress syndrome in premature babies and newborns.

Contraindications:

Hypersensitivity, pregnancy (first trimester), phenylketonuria (for dosage forms containing aspartame). Caution. Liver failure, kidney failure, peptic ulcer stomach and duodenum, pregnancy (II-III trimester), lactation period.

Dosage regimen:

Inside, during meals, with a small amount of liquid. Adults and children over 12 years of age are prescribed tablets: 30 mg 3 times a day in the first 2-3 days, then 30 mg 2 times or 15 mg 3 times a day, or 1 retard capsule (75 mg) in the morning; children 6-12 years old - 15 mg 2-3 times a day. Oral solution (7.5 mg/ml) for adults during the first 2-3 days - 4 ml, and then 2 ml 3 times a day or 4 ml 2 times a day; children under 2 years old - 1 ml 2 times a day, 2-5 years old - 1 ml 3 times a day, 5-12 years old - 2 ml 2-3 times a day. Syrup (3 mg/ml) for adults - 10 ml in the first 2-3 days, and then 5 ml 3 times a day or 10 ml 2 times a day. IN severe cases disease, the dose is not reduced during the entire course of treatment. Children 5-12 years old are prescribed 15 mg 2-3 times a day, 2-5 years old - 7.5 mg 3 times a day, up to 2 years old - 7.5 mg 2 times a day. In the form of inhalations, adults and children over 5 years old are prescribed 15-22.5 mg, children under 2 years old - 7.5 mg, children from 2-5 years old - 15 mg 1-2 times a day. In cases where it is not possible to carry out more than one inhalation per day, tablets, solution or syrup are additionally administered orally.

Side effects:

Allergic reactions: skin rash, urticaria, angioedema, in some cases - allergic contact dermatitis, anaphylactic shock. Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With long-term use in high doses - gastralgia, nausea, vomiting. With rapid intravenous administration - a feeling of numbness, adynamia, intense headaches, decreased blood pressure, shortness of breath, hyperthermia, chills. Overdose. Symptoms: nausea, vomiting, diarrhea, dyspepsia. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; intake of fat-containing foods.

Special instructions:

It should not be combined with antitussive drugs that impede the removal of sputum. Inhalation solution can be used using any modern equipment for inhalation (except steam inhalers). Before inhalation, the drug is mixed with 0.9% NaCl solution(for optimal air humidification can be diluted in a 1:1 ratio) and heated to body temperature. Inhalations should be carried out in normal breathing mode (so as not to provoke coughing shocks). Patients suffering from bronchial asthma, in order to avoid nonspecific irritation of the respiratory tract and their spasm, should use bronchodilators before inhaling ambroxol. For patients suffering from diabetes, it can be administered in the form of syrup (5 ml of syrup contains sorbitol and saccharin in an amount corresponding to 0.18 XE). It is not recommended to use 15 mg suppositories for children under 5 years of age; 30 mg for children under 12 years of age (15 mg suppositories are used for them).

Interaction:

Combined use with antitussive drugs leads to difficulty in sputum discharge while reducing cough. Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretions. The injection solution cannot be used with solutions having a pH higher than 6.3.

Farm group:

Release form: Liquid dosage forms. Syrup.



General characteristics. Compound:

Active ingredient: ambroxol hydrochloride - 0.3 g.

Excipients: sodium benzoate - 0.5 g; Sorbitol - 40.0 g; Citric acid monohydrate - 0.067 g; Sodium citrate pentasesquihydrate - 0.17 g; 1,2-Propylene glycol - 20.0 g; Riboflavin - 0.0025 g; Fruit flavoring - 0.1 g (aromatic food essence); Purified water - up to 100 ml

Clear liquid yellow color with a fruity smell.


Pharmacological properties:

Pharmacodynamics.

It has secretomotor, secretolytic and expectorant effects; stimulates the serous cells of the glands 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 Clark cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.
After oral administration, the effect occurs within 30 minutes and lasts for 6-12 hours.

Pharmacokinetics.

Absorbed quite completely through any route of administration. Penetrates the blood-brain barrier, placental barrier, and is excreted in breast milk. It undergoes biotransformation in the liver, forms dibromanthranilic acid and glucuronic conjugates. In the form of water-soluble metabolites, 90% is excreted in the urine; Only 5% is excreted unchanged. The half-life increases in severe cases, but does not change in cases of liver dysfunction.

Indications for use:

Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic, and bronchial asthma with difficulty in sputum discharge.


Important! Get to know the treatment

Directions for use and dosage:

The syrup is taken orally after meals with a sufficient amount of warm liquid. Adults: 3 times a day, 10 ml of syrup in the first 2-3 days of treatment, in next days 10 ml of syrup 2 times a day or 5 ml of syrup 3 times a day.

Children under 2 years of age: 2.5 ml of syrup 2 times a day (15 mg/day).

Children from 2 to 5 years: 2.5 ml 3 times a day (22.5 mg/day).

Children from 5 to 12 years: 5 ml 2-3 times a day (30-45 mg/day).

Features of application:

Carefully:
Liver failure, renal failure, and duodenum.

Pregnancy and lactation:
The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in the II-III trimesters of pregnancy, the potential benefit for the mother should be assessed with the possible risk to the fetus.

During breastfeeding, use the drug with caution, as it is excreted into breast milk.

It should not be combined with antitussive drugs that impede the removal of sputum.

5 ml of syrup contains sorbitol in the amount of 2 g, which must be taken into account by patients suffering from diabetes mellitus.

Impact on the ability to drive vehicles. Wed and fur.:
The drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.

Side effects:

Allergic reactions: , angioedema, in some cases - allergic, .

Rarely - weakness, dry mouth and respiratory tract, rhinorrhea, constipation. With long-term use in high doses -,.

Interaction with other drugs:

Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretions.

Combined use with antitussive drugs leads to difficulty in sputum discharge while reducing cough.

Contraindications:

Increased sensitivity to ambroxol or other components of the syrup, pregnancy (first trimester).

Overdose:

Symptoms: nausea, vomiting, diarrhea,.

Treatment: artificial vomiting, in the first 1-2 hours after taking the drug; intake of fat-containing foods.

Storage conditions:

In a place protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life: 2 years. Do not use after the expiration date indicated on the package.

Vacation conditions:

Over the counter

Package:

50 or 100 ml in orange glass bottles. Each bottle, along with a measuring spoon for medicines and instructions for use, is placed in a cardboard box.


The autumn-winter period is invariably characterized by the presence of colds and viral diseases. Most often, these ailments are accompanied by a runny nose and cough, which requires separate therapeutic measures. There are many various means for the treatment of dry cough, but how to choose the most effective and safe?
One of the most popular drugs is Ambroxol tablets, reviews of which are very numerous. They inform about the effectiveness of the drug, and also that its great advantage is permission to treat children.

Release form

"Ambroxol" is a herbal mucolytic drug with a pronounced expectorant property. It effectively liquefies and removes even hard-to-clear mucus from the lungs. Available in two main forms - syrup and Ambroxol tablets. For dry cough in children under 6 years of age, it is prescribed liquid form of the drug, in adults and children over 6 years old - tablet form.
Ambroxol tablets are flat, cylindrical in shape and White color. They are placed in blisters with separate contour cells, which are packaged in packs. A cardboard pack contains from 1 to 5 blisters.

Composition of the drug

One cough tablet "Ambroxol" contains 30 mg of the main active substance- ambroxol hydrochloride. In addition, the composition includes additional components:


Medicinal properties

The drug is effective medicine plant origin. Reviews of Ambroxol tablets indicate that they have the ability to cure dry coughs with difficult to separate sputum.
The effect of the drug is due to the restoration of mucociliary transport, which reduces the viscosity of the secretion by changing chemical composition its mucopolysaccharides. In addition to being an expectorant, the drug has the following properties:

  • antioxidant;
  • anti-inflammatory.

The product prevents penetration into Airways pathogenic microorganisms, which accelerates the appearance positive dynamics. The element vasicine was isolated from the plant Adhatoda vasica, which was then synthesized into the substance bromhexine. Ambroxol is its active metabolite, but is characterized by a lack of toxicity and greater effectiveness.

How does it work?

The effect of Ambroxol tablets, patient reviews confirm this, begins literally 30 minutes after use. Therapeutic effect it lasts for 10 hours, absorption of the drug into the blood and tissues is observed almost immediately, it is completely absorbed.

It reaches its highest concentration in the blood plasma from 30 minutes to 3 hours. The percentage of its binding to blood proteins is very high, reaching 90%. Active ingredient quickly settles in the tissues of the body, the largest amount of it ends up in the lungs. The liver is involved in the metabolization process, and the drug is excreted by the kidneys, 5% is released in its original form.

In what cases is it used?

The complete instructions for "Ambroxol" inform you that the drug is successfully used for all types of diseases accompanied by the presence of difficult to separate sputum. Prescribed for such ailments as:

  • bronchitis in acute and chronic form;
  • obstructive bronchitis;
  • COPD (chronic obstructive pulmonary disease);
  • bronchial asthma;
  • pneumonia;
  • bronchiectasis;
  • cystic fibrosis;
  • trancheobronchitis.

Contraindications and side effects

Despite its relatively safe composition, the drug has some restrictions on its use. It is contraindicated for:


In addition, as reviews confirm, the expectorant "Ambroxol" can provoke whole line negative phenomena:

  • from the gastrointestinal tract - nausea, vomiting, diarrhea, thirst, heartburn, dyspepsia;
  • from the central nervous system - headache, weakness, drowsiness;
  • allergic manifestations - urticaria, skin rash and itching, angioedema.

Stevens-Johnson syndrome and Lyell's syndrome can be observed extremely rarely. Considering these factors, consultation with a specialist is required before taking the drug.

How to take it correctly?

Depending on the form of the drug, treatment with Ambroxol has a different scheme.
1. The syrup has different concentration active substance, this directly affects the dosage. It is calculated as follows: a single dose should not exceed more than 30 mg of the drug for adults and children over 12 years of age. For children under 12 years of age, 15 mg of the drug is sufficient for a single dose. This amount of the drug is taken three times a day.
2. Ambroxol tablets are intended for oral administration. They should be consumed simultaneously with food, washed down with water. A unit of the tablet form of the drug contains 30 mg of the main component, therefore therapeutic dose It is calculated as follows: adults and children over 12 years of age need to take 1 tablet three times a day for the first three days. After this, change the regimen - take 0.5 tablets three times a day, or the whole tablet, but twice a day.
Children under 12 years of age are treated as follows: 0.5 tablets twice or thrice a day, the dosage is prescribed by the doctor individually.

The duration of therapy ranges from 3 to 5 days; if necessary, the course can be extended, but only with the permission of the attending physician.

Taking Ambroxol during pregnancy and children

Taking tablets is strictly contraindicated in children under 6 years of age. It is also not prescribed during the first trimester of pregnancy, since this period is the most dangerous. Starting from the second trimester, Ambroxol can be prescribed only for strict indications.
During lactation, a specialist can prescribe a remedy only if potential threat for the baby will be much less than the benefit for the mother.

Overdose

Excessive intake of the drug can cause intoxication of the body. This manifests itself in symptoms such as:

  • nausea;
  • vomit;
  • diarrhea.

IN similar cases first aid should be provided - induce vomiting, take a product containing fat, and induce ambulance. The victim's stomach will be rinsed and supportive therapy prescribed.

Concomitant use of drugs

It is unacceptable to take Ambroxol simultaneously with drugs that have antitussive properties - this will reduce the effectiveness of treatment. The passage of amoxicillin, erythromycin and dioxycillin into the bronchial secretion increases.